Type lagering bij THP
Uitgangsvraag
Welk type lagering geniet de voorkeur bij totale heupprothese?
Aanbeveling
Gebruik bij voorkeur een metalen of keramische kop en een cross-linked polyethyleen kom.
Overwegingen
Considering the ever younger patient group being treated with THA, there is a growing need for more wear-resistant bearing materials that allows the use of larger femoral head components preventing dislocation, without increasing friction and allowing motion without component to component impingement.
During the last decade the tribological characteristics of bearing couples in hip arthroplasty have been improved resulting in less particle wear, diminished osteolysis and improved survivorship. On the one side the innovation in hard on hard bearings has led to better ceramics, using hot isostatic pressing with different and smaller grain sizes as well as higher grain density resulting in lower fracture risk. Modern ceramics show better wettability and lubrication and almost no wear, while furthermore these products are inert and locally not bioactive and therefore do not cause osteolysis. Additionally, improvements of designs have almost excluded rim impingement and chipping.
Polyethylene quality has been dramatically improved by cross-linking of the polyethylene chains. This can be performed by gamma irradiation creating free radicals that in turn are used for cross-linking. Free radicals however are also responsible for oxidative degradation of polyethylene. This can either be prevented through vitamin E stabilisation, or through heating of the polyethylene, in that way capturing remaining free radicals. Heating is performed by remelting or annealing (below melting temperature of the polyethylene), which have both advantages and disadvantages in terms of changing polyethylene crystallinity and wear properties.
Most information concerning the tribological properties of these materials has come from in-vitro preclinical testing using hip simulators. Furthermore, the clinical assessment of linear and volumetric wear has been improved by using radiostereometry. However long-term data on survivorship using different combinations of bearing materials have been lacking and only gradually become available.
Summarising the available evidence, it can be said that metal-on-conventional-polyethylene carries a higher risk of revision than all other couplings (metal–on-cross linked-polyethylene, ceramic-on-conventional-polyethylene, ceramic-on-cross-linked-polyethylene, ceramic-on-ceramic). Because ceramic-on-ceramic shows lowest volumetric wear, it allows the use of large femoral heads diminishing the risk of dislocation in the young and active age group. In some studies however, survivorship of this coupling seems to be compromised through ceramic fractures and chipping of the older designs. Because of the more wear-resistant properties of cross-linked polyethylene (compared to conventional polyethylene), thinner cross-linked polyethylene is possible, also allowing larger femoral head components. Consequently, the use of these improved polyethylenes has a similar advantage as ceramic liners in terms of reducing dislocation risk. In some cases of ceramic-on-ceramic couplings, patients may complain of squeaking. Although there is no evidence of any relation with wear or higher fracture risk, this may be a cause for revision because of the annoying sound. The combination of ceramic or metal on cross-linked polyethylene seems to be the most safe, durable and cost-effective, although there is no clear evidence of its superiority over ceramic-on-conventional polyethylene in long-term follow-up studies of good quality. In certain circumstances (younger non-obese patients, head size ≥32mm) ceramic-on-ceramic might also be a good choice.
Onderbouwing
Achtergrond
Only a few materials are suitable as joint bearings for a total hip prosthesis. Traditionally the bearing materials consist of a metal femoral head and a polyethylene cup. Some disadvantages of these materials include wear, with osteolysis and implant loosening, and - dependent on head size - dislocation. To diminish these risks, alternative materials have been developed, creating less wear and at the same time providing the opportunity of using larger heads to decrease the risk of dislocation. Although the more wear-resistant properties of these materials have been illustrated in hip simulators and short-term to mid-term clinical follow-up, it is still unknown whether improved tribological properties will result in reduced wear and osteolysis and consequently in improved implant survival, in the mid to long term. Currently, a number of total hip bearing materials are available, which are used in the following combinations (see Table 1).
Table 1
|
Head |
Cup |
|
Metal |
Conventional polyethylene |
|
Metal |
Cross-linked polyethylene |
|
Metal |
Metal |
|
Ceramic |
Conventional polyethylene |
|
Ceramic |
Cross-linked polyethylene |
|
Ceramic |
Ceramic |
The working group chose to focus this chapter on three relatively new bearing materials (compared to traditional materials):
- Cross-linked polyethylene cup (compared to conventional polyethylene cup).
- Ceramic head (compared to metal head).
- Ceramic insert (compared to conventional or cross-linked polyethylene insert) in uncemented cup.
There is strong advice against the use of large-head metal on metal articulations in the Netherlands (NOV, 2015) and the disappointing outcomes of these large-head metal on metal articulations reported in the European and Australian registries confirm the problems associated with these articulations. There are many unexpected findings in the metal on metal articulations leading to toxic metal ion loads in patients causing general medical problems and local hip joint problems, such as pseudotumours and loosening. Therefore, studies using metal on metal articulations are not included in this analysis.
Conclusies
PICO 1
Revision
|
Very low GRADE |
Highly-cross-linked-polyethylene cups might be associated with a lower revision risk than conventional polyethylene cups.
Sources (Yin, 2015; Paxton, 2014; Paxton, 2015; Epinette, 2016; AOANJRR, 2016) |
Wear
|
High GRADE |
Wear is reduced for highly-cross-linked polyethylene cups as compared to conventional polyethylene cups.
Sources (Shen, 2014; Langlois, 2015; Glyn-Jones, 2015) |
Osteolysis
|
High GRADE |
No differences in osteolysis were found after 5 to 10 years follow-up for highly cross-linked cups compared to conventional polyethylene cups.
Sources Shen, (2014) |
PICO 2
Revision
|
Low GRADE |
There seems to be no difference in risk of revision between ceramic heads and metal heads (both on (highly-cross-linked) polyethylene cups).
Sources Yin, (2015) |
PICO 3
Revision
|
Low GRADE |
Ceramic-on-ceramic versus ceramic-on-highly-cross-linked-polyethylene showed similar revision risks.
Sources (Yin, 2015; Dong, 2015; Hu, 2015; Si, 2015, Beaupré, 2016) |
Ceramic fractures
|
Moderate GRADE |
Ceramic-on-ceramic showed a 4 to 6 times higher rate of ceramic fractures than ceramic-on-polyethylene.
Sources (Dong, 2015; Hu, 2015; Si, 2015) |
Dislocation
|
Low GRADE |
The incidence of dislocation seems to be comparable for ceramic-on-ceramic and ceramic-on-highly-cross-linked-polyethylene.
Sources (Dong, 2015; Hu, 2015; Si, 2015; Beaupré, 2016) |
Wear
|
Moderate GRADE |
Wear is reduced for ceramic-on-ceramic as compared to ceramic-on-(highly-cross-linked)-polyethylene.
Sources Dong, (2015) |
Osteolysis
|
Moderate GRADE |
No differences in osteolysis were found for ceramic-on-ceramic as compared to ceramic-on-highly-cross-linked-polyethylene.
Sources (Dong, 2015; Hu 2015) |
Samenvatting literatuur
Description of studies
Systematic reviews
A network meta-analysis was included that analysed the difference in the risk of revision or prosthesis survival using 40 RCTs involving 5321 total hip arthroplasties (THAs), with a postoperative follow-up of at least two years, for different bearing material combinations Yin, (2015). This study systematically reviewed and meta-analysed RCTs among commonly used THA bearing surfaces, including ceramic-on-ceramic, ceramic-on-conventional polyethylene, ceramic-on-highly-cross-linked polyethylene, metal-on-conventional polyethylene, metal-on-highly-cross-linked polyethylene and metal-on-metal articulations Yin, (2015).
Furthermore, four systematic reviews were found that compared two combinations of bearing materials each time, partly these included the same RCTs as Yin (2015).
Dong (2015) compared ceramic-on-ceramic and ceramic-on-polyethylene (highly cross-linked polyethylene, polyethylene, uncrosslinked ultrahigh molecular weight polyethylene and ultrahigh molecular weight polyethylene liner) total hip prostheses including eight RCTs enrolling a total of 1,508 patients and 1,702 THA surgeries. Follow-up of the included studies varied from 2 to 12 years. Outcomes reported were clinical outcomes, complications such as fractures, dislocation, osteolysis and revision rates, and radiographic outcomes Dong, (2015).
Hu (2015) compared ceramic-on-ceramic versus ceramic-on-polyethylene (highly cross-linked polyethylene, uncrosslinked ultrahigh molecular weight polyethylene) bearing surfaces for THA in 9 RCTs involving 1575 patients (1747 hips). Follow-up varied from 12 to 96 months postoperatively. Outcomes reported were ceramic fractures, dislocation, revision and osteolysis Hu, (2015).
Shen (2014) compared highly cross-linked polyethylene with conventional polyethylene bearing surfaces for THA in 8 RCTs involving 735 patients. Follow-up ranged from 5 to 10 years. Outcomes reported were wear-related revision and osteolysis Shen, (2014).
Si (2015) compared ceramic-on-ceramic with ceramic-on-polyethylene (highly cross-linked polyethylene, moderately cross-linked polyethylene, uncross-linked ultra-high-molecular-weight polyethylene) bearing surfaces for THA in 13 RCTs involving 2488 THAs. Follow-up ranged from one to twelve years. Outcomes reported were revision and overall ceramic fractures Si, (2015).
RCTs
In addition, three RCTs were found that were not included in the network meta-analysis of Yin (2015).
Beaupré (2016) compared ceramic-on-ceramic with ceramic-on-highly-cross-linked-polyethylene in an RCT in 92 subjects. Ten-year follow-up was completed in 35 of the 48 patients in the ceramic-on-ceramic group and in 33 of the 44 patients in the ceramic-on-highly-crosslinked-polyethylene group. Outcomes reported were PROMs, wear and revision Beaupré, (2016).
Glyn-Jones (2015) performed an RCT that compared long-term steady wear of highly-cross-linked-polyethylene with ultra-high-molecular-weight-polyethylene. Outcomes reported were revision and wear Glyn-Jones, (2015).
Langlois (2015) conducted a prospective randomised study to assess the rates of penetration in 100 patients of two distinct types of polyethylene in otherwise identical cemented all-polyethylene acetabular components. After 8 years of follow-up 68 hips had complete follow-up data Langlois, (2015).
Registry studies
Several registry studies were found. Paxton (2014) compared risk of revision between metal-on-conventional-polyethylene and metal-on-highly-cross-linked-polyethylene in six national and regional registries: USA (Kaiser Permanente, HealthEast), Italy (Emilia-Romagna region), Spain (Catalan region), Norway and Australia. Inclusion criteria were osteoarthritis as the primary diagnosis, cementless implant fixation and a patient age of 45 to 64 years. These criteria resulted in a sample of 16,571 primary THAs Paxton, (2014).
Paxton (2015) describes 26,823 THAsfrom the Kaiser Permanente’s Total Joint Replacement Registry performed between April 2001 and December 2011. Endpoints of interest were all-cause and aseptic revisions. Of the 26,823 THAs included in the study, 1815 (7%) were metal-on-conventional polyethylene and 25,008 (93%) were metal-on-highly-cross-linked-polyethylene Paxton, (2015).
Epinette (2016) analysed data from the National Joint Registry (England and Wales) of 45,877 hips. It compared cross-linked annealed polyethylene (n=21,470) with conventional polyethylene (n=8,225) and ceramic-on-ceramic (n=16,182) at six years follow-up and focused on revision risk Epinette, (2016).
Furhermore, the 2016 Annual Report of the Australian Orthopedic Association National Joint Replacement Registry (AOANJRR) was used (AOANJRR, 2016).
Results
PICO 1: What are the effects of a cross-linked polyethylene cup, compared to a conventional polyethylene cup, on ceramic fractures, dislocation, wear, revision, survival and osteolysis in primary total hip arthroplasty for osteoarthritis or avascular necrosis?
Revision
The network meta-analysis of 40 RCTs showed no significant difference in relative risk (RR) of revision for metal-on-highly-cross-linked-polyethylene versus metal-on-conventional-polyethylene (11 studies, RR for conventional polyethylene vs highly-cross-linked-polyethylene = 2.04 (0.89 to 5.09) Yin, (2015).
The study by Paxton (2014) showed a five-year rate of revision surgery ranging from 1.9% to 3.2% among the different registries. There was no significant difference in revision rates between bearing surfaces, with a hazard ratio of 1.20 (95% CI 0.80 to 1.79) for metal-on conventional-polyethylene compared to metal-on-highly-crosslinked-polyethylene Paxton, (2014).
The large registry study by Paxton (2015) included 26,823 patients with a follow-up up to 10 years (median follow-up 5.1 years). The adjusted risks of all-cause revision (HR 1.75; 95%CI, 1.37 to 2.24; p<0.001) and aseptic revision (HR 1.91; 95% CI, 1.46 to 2.50; p<0.001) were higher in patients with metal-on-conventional-polyethylene bearing surfaces compared with metal-on-highly-cross-linked-polyethylene. At 7 years follow-up, the cumulative incidence of revision was 5.4% (95% CI, 4.4% to 6.7%) for metal-on-conventional-polyethylene and 2.8% (95% CI, 2.6% to 3.2%) for metal-on-highly-cross-linked-polyethylene. When accounting for differences in femoral head size distribution, the results were not substantively different Paxton, (2015).
The National Joint Registry of England and Wales hip data set, including 45,877 hips, showed better survival (revision for any cause) for cross-linked annealed polyethylene (6 years survival rate 98.0%; 95%CI 0.976-0.983) versus conventional polyethylene (6 years survival rate 97.3%; 95%CI 0.969-0.977; p=0.072) Epinette, (2016). When considering revision for bearing related failures, 6-year survival was significantly better for cross-linked annealed polyethylene (99.6%) than for conventional polyethylene (98.8%; P<0.001). Separate analyses were carried out for small metallic heads, small alumina heads and large heads. For metallic and alumina small heads (≤32mm), survival of cross-linked annealed polyethylene was significantly better than of conventional polyethylene. For large heads this comparison could not be made because there were no large heads used in combination with conventional polyethylene liners Epinette, (2016).
According to the 2016 Annual Report of the Australian Orthopedic Association National Joint Replacement Registry (AOANJRR), which contains 363,561 primary THAs, of which 44,710 hips were added in 2015, cross-linked-polyethylene has a lower rate of revision than conventional polyethylene regardless of the femoral head used (both independent of size and bearing material); the 15-year cumulative percent revision for cross-linked-polyethylene is 5.6% versus 10.5% for non-cross-linked-polyethylene (AOANJRR, 2016). The cumulative incidence of loosening/lysis and prosthesis dislocation at 15 years is 1.1% and 1.2% for cross-linked-polyethylene, compared to 3.6% and 1.6% for non-cross-linked-polyethylene bearings respectively (AOANJRR, 2016).
Revision varies depending on head size. In the Australian registry, this is most evident for non-cross-linked-polyethylene where the rate of revision increases with larger head size, mainly due to osteolysis and loosening (AOANJRR, 2016). For cross-linked-polyethylene there is no difference between head sizes <32 mm and >32 mm, but revision risk is lowest for 32 mm heads (AOANJRR, 2016).
Comparing all bearing combinations, the cumulative percent revision at 10 years for ceramic-on-cross-linked-polyethylene and metal-on-cross-linked-polyethylene is lower (respectievelijk 4.4; 4.0 to 4.8 and 4.3; 4.1 to 4.5), compared to ceramic-on-non-cross-linked-polyethylene and metal-on-non-cross-linked-polyethylene (7.0; 6.3 to 7.8 and 6.3; 6.1 to 6.6). The percent revision of ceramic-on-ceramic lies in between the cross-linked-polyethylene and non-cross-linked-polyethylene values (5.0; 4.8 to 5.3) (AOANJRR, 2016).
Fractures
Highly-cross-linked-polyethylene versus conventional polyethylene
None of the studies reported fractures.
Dislocation
Highly-cross-linked-polyethylene versus conventional polyethylene
None of the studies reported dislocation.
Wear
Highly-cross-linked-polyethylene versus conventional polyethylene
A meta-analysis of 8 RCTs that compared highly-cross-linked with conventional polyethylene showed significantly reduced radiological wear (weighted mean difference = -0.09; 95% CI - -0.15 to -0.03; p=0.006) of cross-linked polyethylene, but no difference in wear-related revision (RD = -0,02, 95% CI =-0.05 to 0.01, P=0.20) after five to ten years follow-up Shen, (2014). However, the study did not provide information on the bearing material at the femoral side Shen,(2014).
Two small RCTs were published after this review.
Langlois (2015) showed that at nine year follow-up the yearly linear wear can be significantly reduced by using a highly cross-linked PE (-0.0002 mm/year versus 0.132 mm/year for contemporary annealed polyethylene, p<0.001) Langlois, (2015).
Glyn-Jones (2015) reported linear wear (using radiostereometric analysis) for the highly cross-linked polyethylene being significantly less (0.003 mm/year) than for the conventional ultrahigh-molecular weight polyethylene (0.030 mm/year; p<0.001) at 10 years. The volumetric wear between 1 and 10 years was lower in the highly-cross-linked-polyethylene group (14 mm3) compared to the conventional ultrahigh-molecular weight polyethylene group (98 mm3, p = 0.01) Glyn-Jones, (2015).
Osteolysis
Highly-cross-linked-polyethylene versus conventional polyethylene
A meta-analysis of 8 RCTs that compared highly cross-linked with conventional polyethylene showed no difference in osteolysis (RD = -0.12, 95% CI =-0.26 to 0.03, P=0.12) after five to ten years follow-up Shen, (2014).
Grading of evidence
Revision
Level of evidence started as low as the conclusion was based on the network meta-analysis of Yin (2015) together with observational registry data, and was downgraded to very low because of heterogeneity in the results.
Wear
The level of evidence was graded as high since the conclusion for wear was based on the systematic review of Shen (2014), which was of good quality, together with two RCTs.
Osteolysis
The level of evidence was graded as high as the systematic review of Shen (2014) was of good quality.
PICO 2: What are the effects of a ceramic head, compared to a metal head, on fractures, dislocation, wear, revision, survival and osteolysis in primary total hip arthroplasty for osteoarthritis or avascular necrosis (with use of the same type of polyethylene on the cup side)?
Revision
The network meta-analysis of 40 RCTs showed no significant difference in risk of revision for ceramic-on-conventional-polyethylene prosthesis versus metal-on-conventional-polyethylene (3 studies; RR 1.74 (0.58 to 5.24) Yin, (2015). There was also no significant difference in risk of revision for ceramic-on-highly-cross-linked-polyethylene versus metal-on-highly-cross-linked polyethylene (2 studies; RR 0.74; 95% CI 0.17; 3.01) Yin, (2015).
Ceramic fractures
None of the studies reported ceramic fractures.
Dislocation
None of the studies reported dislocation.
Wear
None of the studies reported wear.
Osteolysis
None of the studies reported osteolysis.
Grading of evidence
Revision
The conclusion is based on the meta-analysis of RCT’s by Yin (2015), therefore the level of evidence started as high. The level of evidence was downgraded one level for risk of bias (in most included studies details regarding randomisation and blinding were not clear) and one level for heterogeneity of the results. Level of evidence was graded as low.
PICO 3: What are the effects of a ceramic insert (in uncemented cup), compared to a (conventional or cross-linked) polyethylene insert (in uncemented cup), on fractures, dislocation, wear revision, survival and osteolysis in primary total hip arthroplasty for osteoarthritis or avascular necrosis?
Revision
A network meta-analysis of 40 RCTs showed that the relative risk of revision for ceramic-on-highly-cross-linked polyethylene versus ceramic-on-ceramic was 1.95 (4 studies; 95% CI 0.68-6.60) Yin, (2015).
A meta-analysis of 8 RCTs that compared ceramic-on-ceramic versus ceramic-on-(highly cross-linked)-polyethylene showed no difference in revision rate (RR=0.99; 95% CI (0.54 to 1.83)) Dong, (2015).
Another meta-analysis of 9 RCTs that made the same comparison, did not show differences in revision rates for ceramic-on ceramic compared to ceramic-on-polyethylene (2.7% versus 2.8%) Hu, (2015).
A third meta-analysis of 13 RCTs showed no differences with respect to revisions (RR 1.28 (0.60 to 2.75)) Si, (2015).
The RCT by Beaupré (2016) reported three revisions in the ceramic-on-highly-crosslinked-polyethylene group and no revisions in the ceramic-on-ceramic group. The results might be caused by the differences in head sizes (mainly 28 mm ceramic-on-highly-crosslinked-polyethylene vs 32 mm in ceramic-on-ceramic) Beaupré, (2016).
Ceramic fractures
A meta-analysis of 8 RCTs that compared ceramic-on-ceramic versus ceramic-on-(highly cross-linked)-polyethylene showed a higher rate of fractures (5 studies) for ceramic-on-ceramic fracture than ceramic-on-(highly-cross-linked) polyethylene (RR = 4.46, 95% CI: 1.16 to 17.25; P = 0.03) Dong, (2015).
Another meta-analysis of 9 RCTs also showed a higher incidence of intra- and postoperative fractures (6 studies) for ceramic-on-ceramic than ceramic-on-polyethylene (Risk ratio 5.10 (1.32 to 19.71); P=0.02) Hu, (2015).
A third meta-analysis of 13 RCTs also showed a higher rate of overall fractures (6 studies) for ceramic-on-ceramic than ceramic-on-polyethylene (RR 6.02 (95%CI (1.77 to 20.1)) Si, (2015).
Dislocation
A meta-analysis of 8 RCTs that compared ceramic-on-ceramic versus ceramic-on-(highly-cross-linked) polyethylene showed no significant difference in dislocation rate (RR=0.73 (95%CI 0.44 to 1.19). There was no information on head sizes used in the studies Dong, (2015).
Another meta-analysis of 9 RCTs Hu, (2015) made the same comparison and found no significant difference in dislocation rates between ceramic-on-ceramic versus ceramic-on-polyethylene (3.1% versus 4%, RR = 0.77 (0.47 to 1.25); P=0.29).
A third meta-analysis of 13 RCTs showed no differences with respect to dislocations (RR 0.72 (95%CI (0.43 to 1.19)) Si, (2015).
The RCT by Beaupré (2016) reports four patients with recurrent dislocations in the ceramic-on-highly-crosslinked-polyethylene group (of which three underwent a surgical revision), and two in the ceramic-on-ceramic group.
Wear
Three studies in the meta-analysis by Dong (2015) that compared ceramic-on-ceramic versus ceramic-on-(highly-cross-linked) polyethylene reported wear rate. In the ceramic-on-ceramic group, the mean linear wear rate was 30.5 ± 7.0 μm/year and the mean volumetric wear rate was 21.5 ± 4.5 mm3/year. In the ceramic-on-polyethylene group, the mean linear wear rate was 218.2 ± 13.7 μm/year and the mean volumetric wear rate was 136.2 ± 8.5 mm3/year. The increase in mean linear and volumetric wear rates in the ceramic-on-polyethylene group was statistically significant (P <0.001) Dong, (2015).
Osteolysis
Dong (2015) showed no significant difference in osteolysis rate in a meta-analysis (four studies reported osteolysis) between the ceramic-on-polyethylene and the ceramic-on-ceramic group (RR = 0.39 (in favour of COC), 95% CI: 0.10 to 1.56, P = 0.18).
A pooled analysis of 7 studies (1155 hips) revealed no significant difference in the incidence of osteolysis and radiolucent lines in the ceramic-on-ceramic and ceramic-on-polyethylene groups (0.3% versus 1.2%, respectively; RR=0.43; 95% CI, 0.11-1.68; P=.22; homogeneity, P=.80) Hu, (2015).
Grading of evidence
Revision
Level of evidence was graded as low as the systematic literature search by Dong (2015) and Hu (2015) was not completely clear and results were heterogeneous.
Fractures
The level of evidence was graded as moderate as the systematic literature search by Dong (2015) and Hu (2015) was not completely clear and adjustment for potential confounders was unclear in Dong (2015) and Si (2015). Due to these methodological limitations it was graded as moderate.
Dislocation
The level of evidence was downgraded by two levels to low. One level because the systematic literature search by Dong (2015) and Hu (2015) was not completely clear and adjustment for potential confounders was unclear in Dong (2015) and Si (2015). In addition, the level was downgraded by one level because results were heterogeneous.
Wear
The level of evidence was graded as moderate as the systematic literature search by Dong (2015) was not completely clear.
Osteolysis
The level of evidence was graded as moderate as the systematic literature search by Dong (2015) was not completely clear.
Zoeken en selecteren
To answer the question, a systematic literature analysis was performed for the following research questions:
PICO 1: What are the effects of a cross-linked polyetheylene cup, compared to a conventional polyethylene cup, in primary total hip arthroplasty for osteoarthritis or avascular necrosis?
P: primary total hip arthroplasty for osteoarthritis or avascular necrosis;
I: cross-linked polyethylene cup;
C: conventional polyethylene cup;
O: periprosthetic fractures, dislocation, wear, revision, survival, osteolysis.
PICO 2: What are the effects of a ceramic head, compared to a metal head, in primary total hip arthroplasty for osteoarthritis or avascular necrosis (with use of the same type of polyethylene on the cup side)?
P: primary total hip arthroplasty for osteoarthritis or avascular necrosis;
I: ceramic head;
C: metal head;
O: periprosthetic fractures, ceramic fractures, dislocation, wear, revision, survival, osteolysis.
PICO 3: What are the effects of a ceramic insert (in uncemented cup), compared to a cross-linked polyethylene insert (in uncemented cup), in primary total hip arthroplasty for osteoarthritis or avascular necrosis?
P: primary total hip arthroplasty for osteoarthritis or avascular necrosis;
I: ceramic insert (in uncemented cup);
C: conventional or cross-linked polyethylene insert (in uncemented cup);
O: periprosthetic fractures, ceramic fractures, dislocation, wear, revision, survival, osteolysis.
Relevant outcome measures
De working group decided that revision (for any reason) and survival were critical outcome measures for decision-making; and osteolysis and wear were important for decision-making.
The working group defined these outcomes in the following way:
- Revision was defined as the exchange of any component of the femoral implant (stem and/or head) or the acetabular implant (cemented cup or uncemented cup and/or insert), for aseptic loosening and/or any other reason.
- Survival was defined as the revision-free presence of the implant component(s) in the human body during clinical follow-up.
- Wear is the tribological phenomenon of volumetric loss of material due to friction of contacting surfaces in relative motion. Amongst others, this can be assessed with conventional radiography or radiostereometry. Dependent on the type of wear (abrasive, adhesive, fatigue, delamination or third body), the type of material (metal, ceramic, polyethylene, other materials) and the size and dose of the wear-particles, this can result in osteolysis and eventually loosening of the implant.
Search and select (Method)
A literature search was performed with relevant search terms on 17 november 2016 in the databases Medline (OVID) and Embase (via Embase.com). The search strategy is provided in the tab “Methods”. The literature search resulted in 1558 hits. Studies were selected using the following selection criteria: systematic reviews of RCTs or RCTs, comparing the material combinations in the research questions identified, follow-up of preferably five to ten years or more. After obtaining full text, relevant and high quality studies were included in the literature analysis. Based on title and abstract 43 studies were pre-selected. After reading full text, 36 studies were excluded (see exclusion table below) and 7 studies were selected. In addition, four national hip registry studies were included.
The most important study characteristics are described in evidence tables. The assessment of risk of bias is provided in risk of bias tables.
Referenties
- Beaupre LA, Al-Houkail A, Johnston DW. A Randomized Trial Comparing Ceramic-on-Ceramic Bearing vs Ceramic-on-Crossfire-Polyethylene Bearing Surfaces in Total Hip Arthroplasty. J Arthroplasty. 2016;31(6):1240-5. PubMed PMID: 26730451.
- Dong YL, Li T, Xiao K, et al. Ceramic on Ceramic or Ceramic-on-polyethylene for Total Hip Arthroplasty: A Systemic Review and Meta-analysis of Prospective Randomized Studies. Chin Med J (Engl). 2015;128(9):1223-31. PubMed PMID: 25947407.
- Epinette JA, Jolles-Haeberli BM. Comparative results from a national joint registry hip data set of a new cross-linked annealed polyethylene versus both conventional polyethylene and ceramic bearings. J. Arthroplasty. 2016;31(7):1483-91.
- Glyn-Jones S, Thomas GE, Garfjeld-Roberts P, et al. The John Charnley Award: Highly crosslinked polyethylene in total hip arthroplasty decreases long-term wear: a double-blind randomized trial. Clin Orthop Relat Res. 2015;473(2):432-8. PubMed PMID: 25123239.
- Hu D, Yang X, Tan Y, et al. Ceramic-on-ceramic versus ceramic-on-polyethylene bearing surfaces in total hip arthroplasty. Orthopedics. 2015;38(4):e331-8. doi: 10.3928/01477447-20150402-63. Erratum in: Orthopedics. 2015 Jun;38(6):346. PubMed PMID: 25901628.
- Jonsson BA, Kadar T, Havelin LI, et al. Oxinium modular femoral heads do not reduce polyethylene wear in cemented total hip arthroplasty at five years: a randomised trial of 120 hips using radiostereometric analysis. Bone Joint J. 2015;97-B(11):1463-9. PubMed PMID: 26530646.
- Langlois J, Atlan F, Scemama C, et al. A randomised controlled trial comparing highly cross-linked and contemporary annealed polyethylene after a minimal eight-year follow-up in total hip arthroplasty using cemented acetabular components. Bone Joint J. 2015;97-B(11):1458-62.
- Nederlandse Orthopaedische Vereniging. Advies Metaal-op-Metaal Heupprothesen per 1 augustus 2015.
- Paxton E, Cafri G, Havelin L, et al. Risk of Revision Following Total Hip Arthroplasty: Metal-on-Conventional Polyethylene Compared with Metal-on-Highly Cross-Linked Polyethylene Bearing Surfaces. International Results from Six Registries. J Bone Joint Surg Am. 2014;96 Suppl 1(E):19-24.
- Paxton EW, Inacio MC, Namba RS, et al. Metal-on-conventional polyethylene total hip arthroplasty bearing surfaces have a higher risk of revision than metal-on-highly crosslinked polyethylene: results from a US registry. Clin Orthop. 2015:473(3):1011-21.
- Shen C, Tang ZH, Hu JZ, et al. Does cross-linked polyethylene decrease the revision rate of total hip arthroplasty compared with conventional polyethylene? A meta-analysis. Orthop Traumatol Surg Res. 2014;100(7):745-50. doi: 10.1016/j.otsr.2014.07.015. PubMed PMID: 25281549.
- Si H, Zeng Y, Cao F, et al. Is a ceramic-on-ceramic bearing really superior to ceramic-on-polyethylene for primary total hip arthroplasty? A systematic review and meta-analysis of randomised controlled trials. Hip Int 2015; 25 (3): 191-198.
- Yin S, Zhang D, Du H, et al. Is there any difference in survivorship of total hip arthroplasty with different bearing surfaces? A systematic review and network meta-analysis. Int J Clin Exp Med. 2015;8(11):21871-85. PubMed PMID: 26885157.
- Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). Annual Report. Adelaide: AOA; 2016.
Evidence tabellen
Research question: Which type of hip prosthesis bearing is preferable?
Is there a significant benefit of (highly) cross-linked polyethyleen (PE) or Vitamine E-stabilised PE over a conventional PE after (moderate)long-term with outcome parameter PE-wear (linear or volumetric), osteolysis, prothesis survival, with use of same head material and size?
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Study reference |
Study characteristics |
Patient characteristics |
Intervention (I) |
Comparison / control (C) |
Follow-up |
Outcome measures and effect size |
Comments |
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Dong et al., 2015
Study characteristics and results are extracted from the SR (unless stated otherwise) |
SR and meta-analysis of 8 RCTs
Literature search up to 2013
A: Kim, 2013 B: Lauren, 2013 C: Bal, 2005 D: Derek, 2011 E: Lombardi, 2010 F: Cai, 2012 G: Lewis, 2010 H: Hamilton, 2010
Country: China
Source of funding: unknown
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Inclusion criteria SR: RCT of Ceramic On Ceramic THA and Ceramic On Polyethylene‑THA that provided sufficient numerical information on at least one of the following prespecified endpoints: Revision for any cause, local and general complications, radiographic outcomes. >=2 yrs follow-up
Exclusion criteria SR: quasi RCTs and non-RCTs
N=1508 patients and 1702 THA
N pts (hips), mean age A: 105 (210), 45.3 yrs B: 92 (92), 51.3 vs 53.6 yrs C: 479 (500), 58.0 yrs D: 312 (357), 50.4 vs 54.7 yrs E: 109 (110), 57.0 vs 60.0 yrs F: 93 (113), 42.1 vs 42 yrs G: 55 (56), 41.5 vs 42.8 yrs H: 263 (264), 56.4 vs 57.3 yrs
Sex (% male): A: 66.0 B: 54.0 C: 51.0 D: 63.9 vs 57.5 E: 55.0 vs 53.0 F: 58.0 vs 54.0 G: 51.0 H: 51.0 vs 54.0
Groups comparable at baseline? Not reported |
Describe intervention:
A: alumina on alumina B: alumina on alumina C: alumina on alumina D: alumina on alumina E: alumina matrix composite F: Alumina G: Alumina H: Ceramic on ceramic
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Describe control:
A: alumina on highly cross-linked polyethylene B: alumina on highly cross-linked polyethylene C: alumina on polyethylene D: alumina on uncross-linked ultrahigh molecular weight polyethylene E: highly cross-linked polyethylene F: ultrahigh molecular weight polyethylene liner G: ultrahigh molecular weight polyethylene liner H: Delta ceramic on highly cross‑linked polyethylene
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End-point of follow-up: 2 to 12.4 y
A: 12.4 y B: 5 y C: 2 y D: 5 y E: 6 y F: 3.2 y G: 8 y H: 2.6 y
For how many participants were no complete outcome data available? (intervention/control) unclear
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Outcome measure-1 fracture meta‑analysis shows that the COC has a significant higher rate of fracture than the COP (RR = 4.46, 95% CI: 1.16 to 17.25; P = 0.03).
Outcome measure-2 dislocation dislocation rates in COC group seemed a little lower but it didn’t reach a statistical significant difference (RR = 0.73, 95% CI: 0.44 to 1.19; P = 0.21)
Outcome measure-3 Revision Overall revision rate between the groups was similar (RR = 0.99, 95% CI: 0.54 to 1.83; P = 0.98).
Outcome measure-4 Osteolysis Four studies reported osteolysis. The meta‑analysis results demonstrated a little higher osteolysis rate in the COP group (RR = 0.39, 95% CI: 0.10 to 1.56), but didn’t reach a significant statistical difference (P = 0.18).
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Lauren 2013 should be Beaupré 2013 (author is named Lauren Beaupré) |
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Hu, 2015
Study characteristics and results are extracted from the SR (unless stated otherwise) |
SR and meta-analysis of 9 RCTs
Literature search up to October, 2013
A: Ammanatulah, 2011 B: Beaupre, 2013 C: Cai, 2012 D: Hamilton, 2010 E: Kim, 2013 F: Lewis, 2010 G: Lombardi, 2010 H: Ochs, 2007 I: Sonny, 2005
Setting and Country: A: USA B: Canada C: China D: Canada E: South Korea F: Canada G: USA H: Germany I: USA
Source of funding: SR: The authors have no relevant financial relationships to disclose. Included RCTs: 4 were sponsored by companies |
Inclusion criteria SR: patients underwent primary THA; (2) study compared COC and COP bearing surfaces; (3) studies reported clinical or radiographic outcomes of THA (at least 1 desirable outcome); (4 studies were prospective RCTs; and (5) fulltext was published in English.
Exclusion criteria SR: not enough details
Important patient characteristics at baseline: N, mean age A: I: 50.4 C:54.7 B: I:51.3 C:53.6 C: I:42.1 C:42.0 D: I: 56.4 C:57.3 E: 45.3 F: I: 41.5 C:42.8 G: I: 57 C:60 H: I: 56.0 C: 61.5 I: I: 55.0 C:61
Groups comparable at baseline? SR: not reported |
Describe intervention: Liner material: A: Alumina B: Alumina C: Alumina matrix D: Alumina matrix E: Alumina F: Alumina G: Alumina matrix H: Unkown I: Alumina
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Describe control: Liner material: A: HXLPE B: HXLPE C: UHMWPE D: HXLPE E: HXLPE F: UHMWPE G: HXLPE H: Unkown I: HXLPE
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Mean follow-up (months):
A: >60 B: >60 C: 40 (36 to 45) D: 31 (21 to 49) E: 12.4 (11 to 13) F: 96 (60 to 120) G: 73 (26 to 108) H: 96 (85.2 to 110.4)>24 I: >24
For how many participants were no complete outcome data available? (intervention/control) unclear
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Outcome measure-1 ceramic fracture The total incidence of intra- and postoperative implant fractures in the COC group was statistically significantly higher (P=.02) than that of the COP group (Figure 8), indicating that COC increased the total implant fracture rate.
Outcome measure-2 dislocation A forest plot of all 9 studies (1747 hips) indicated no significant difference in THA dislocation rates between the COC and COP groups (3.1% vs 4.0%, respectively; RR=0.77; 95% CI, 0.47-1.25; P=.29; homogeneity, P=.98)
Pooled fixed effects Outcome measure-3 revision
Effect measure: RR, RD, mean difference (95% CI): No significant difference was found in the THA revision rates of the COC and COP groups (2.7% vs 2.8%, respectively; RR=0.95; 95% CI, 0.54-1.68; P=.85; homogeneity, P=.56)
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Shen, 2014
PS., study characteristics and results are extracted from the SR (unless stated otherwise) |
SR and meta-analysis of 8 RCTs
Literature search up to July 2013
A: Engh, 2012 B: Johanson, 2012 C: Garcia-Rey, 2012 D: Thomas, 2011 E: Mutimer, 2010 F: McCalden, 2009 G: Geerdink, 2009 H: Nikolao, 2012
Setting and Country: Not reported
Source of funding: No conflicts of interes
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Inclusion criteria SR: patients underwent THA, 28mm femoral head, reported wear-related revision, follow-up >= 5 years
Exclusion criteria SR:-
Important patient characteristics at baseline: Number of hips A: I: 116 hips, 62.5 (26 to 87) yrs C: 114 hips, 62.0 (34 to 84) yrs B: I: 25 hips, 55 (42 to 68) yrs C: 27 hips, 56 (41 to 70) yrs C: I: 42 hips, 67.4 (47 to 78) yrs C: 41 hips, 61.1 (25 to 78) yrs D: I: 22 hips, 68 (52 to 76) yrs C: 22 hips, 67 (51 to 76) yrs E: I: 55 hips, 62 (46 to 75) yrs C: 55 hips, 61 (48 to 75) yrs F: I: 50 hips, 72.3 (56 to 79) yrs C: 50 hips, 72.6 (56 to 79) yrs G: I: 22 hips, 64 (48 to 74) yrs C: 26 hips, 64 (54 to 72) yrs H: I: 32 hips, 55.1 (41 to 64) yrs C: 36 hips, 52.6 (20 to 64) yrs
Sex (% male) A: I: 44 C: 50 B: I: 48 C: 44 C: I: 43 C: 46 D: I: 45 C: 50 E: I: 64 C: 47 F: I: 34 C: 28 G: I: 65 C: 57 H: I: 44 C: 50
Groups comparable at baseline? Yes |
Describe intervention:
A: Highly cross-linked polyethylene (Marathon, DePuy) N=116 B: Highly cross-linked polyethylene (Durasul, Zimmer) N=25 C: Highly cross-linked polyethylene (Durasul, Zimmer) N=42 D: Highly cross-linked polyethylene (Longevity, Zimmer) N=22 E: Highly cross-linked polyethylene (Marathon, DePuy) N=55 F: Highly cross-linked polyethylene (Longevity, Zimmer) N=50 G: Highly cross-linked polyethylene (Duration Stryker) N=22 H: Highly cross-linked polyethylene (Smith &Nephew) N=32
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Describe control:
A: Conventional polyethylene (Enduron, Depuy) N=114 B: Conventional polyethylene (Sulene, Zimmer) N=27 C: Conventional polyethylene (Sulene, Zimmer) N=41 D: Conventional polyethylene (Zimmer) N=22 E: Conventional polyethylene (Enduron, De Puy) N=55 F: Conventional polyethylene (Trilogy, Zimmer) N=50 G: Conventional polyethylene N=26 H: Conventional polyethylene (Smith &Nephew) N=36
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End-point of follow-up:
A: 10 y ± 1.8 B: 10 C: 10 to 12 D: 7 E: 5 F: 6.8 G: 8 H: 5
Risk assessment for incomplete outcome data? (intervention/control) A: low risk B: low risk C: low risk D: low risk E: high risk F: low risk G: low risk H: low risk
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Wear-related revision Meta-analysis of the wear-related revision incidence showed that there was no difference between the wear-related revision rate between cross-linked and conventional polyethylene group (RD -0,02 95% CI (-0.05 to-0.01); P=0.20; fig 2 provides details)
Osteolysis Meta-analysis of the incidence of osteolysis showed that there was no difference between the cross-linked and conventional polyethylene group (RD -0.12 95% CI (-0.26 to 0.03) P=0.12)
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The current limited evidence suggests that cross-linked polyethylene significantly reduced the radiological wear compared with conventional polyethylene at midterm follow-up periods. However, there is no evidence that cross-linked polyethylene had an advantage over conventional polyethylene in terms of reducing osteolysis or wear-related revision. Nevertheless, future long-term RCTs on this topic are needed.
Note: 7 of these 8 RCTs were included in network meta-analysis Yin,
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Si, 2015
Study characteristics and results are extracted from the SR (unless stated otherwise) |
SR and meta-analysis of (RCTs / cohort / case-control studies)
Literature search up to August 2014
A: Kim, 2013 B: Beaupre, 2013 C: Cai, 2012 D: Amanatullah, 2011 E: Lombardi, 2010 F: Lewis, 2010 G: Hamilton, 2010 H: Poggie, 2007 I: Kim, 2007 J: Bal, 2005 K: Nygaard, 2004 L: Pitto, 2003 M: Pitto, 2000
Setting: hospital
Source of funding: China Health Ministry Program (201302007). |
Inclusion criteria SR: 1) published RCTs (Level I evidence); 2) compared CoC with CoP THAs with regard to functional outcomes, radiographic outcomes and/or complications; 3) all patients received a primary THA; 4) written in English
Exclusion criteria SR: review articles, case reports, meeting abstracts, technique articles or expert opinions
13 studies included
Important patient characteristics at baseline: Mean age varied from 42 to 68
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Describe intervention: Ceramic on ceramic
A: Alumina-Alumina Ceramic B: Alumina-Alumina ceramic C: Delta-Delta ceramic D: Alumina-Alumina ceramic E: Delta-Alumina ceramic F: Alumina-alumina ceramic G: Delta-delta ceramic H: Alumina-alumina ceramic I: Alumina-alumina ceramic J: Alumina-alumina ceramic K: Alumina-alumina ceramic L Alumina-alumina ceramic M: Alumina-alumina ceramic |
Describe control: Ceramic on polyethylene
A: Alumina Ceramic-HCL PE B: Alumina Ceramic-HCL PE C: Alumina Ceramic-UCL PE D: Alumina Ceramic-UCL PE E: Zirconia Ceramic-HCL PE F: Alumina Ceramic-UCL PE G: Delta Ceramic-MCL PE H: Alumina Ceramic-UCL PE I: Alumina Ceramic-UCL PE J: Alumina Ceramic- PE (UC) K: Zirconia Ceramic-UCL PE L Alumina Ceramic-UCL PE M: Alumina Ceramic- PE (UC) |
End-point of follow-up:
A: 12.4 year B: 5 year C: 3.3 year D: 5 year E: 6 year F: 8 year G: 2.6 year H: 2 year I: 4.8 year J: 2 year K: 1 year L 1.1 year M: 5 year
Risk assessment for incomplete outcome data? (intervention/control) A: low risk B: high risk C: low risk D: low risk E: low risk F: low risk G: low risk H: low risk I: low risk J: unclear risk K: low risk L: low risk M: low risk
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Outcome measure-1 revision Defined as revisions with follow-up >= 5 years (5 studies) 26 events in 813 THA Effect measure: RR (95% CI): 1.28 (0.60 to 2.75)
Outcome measure-2 Overall ceramic fracture I: 24/1053 C: 0/761 Pooled effect (fixed effects model) RR: 6.02 (95% CI 1.77 to 20.51) favoring Ceramic on polyethylene. Heterogeneity (I2): 0%
Outcome measure-3 Dislocation 58 events in 1490 THA Effect measure: RR (95% CI): 0.72 (0.43 to 1.19)
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Yin, 2015
PS., study characteristics and results are extracted from the SR (unless stated otherwise) |
SR and network meta-analysis of 40 RCTs, see PDF for all details of these studies
Literature search up to May 2015
Source of funding: unknown
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Inclusion criteria SR: all RCTs comparing survivorship or revision rates between THA bearing surfaces for the treatment of degenerative hip diseases in English were identified through an electronic search and manual research by two clinical librarians (S Yin and D Zhang) independently, patients younger than 75 years of age at the time of surgery, (inclusion of arms treated with THA procedures with different bearing surfaces, such as CoC, CoPc, CoPxl, MoPc, MoPxl or MoM bearings, (5) included studies had to report valid data of survivorship or revision rates of bearing prostheses
Exclusion criteria SR: lack of relevance
Important patient characteristics at baseline: N=5321 hips |
In network meta-analysis the following comparisons were used that were made in the studies: MoPc versus MoPxl versus CoPc versus CoPxl (8), one MoPc versus MoPxl versus CoC (9), one MoPc versus MoM versus CoPc (10), eleven MoPc versus MoPxl (11-21), five MoPc versus MoM (22-26), four CoC versus CoPc (27-30), four CoC versus CoPxl (31-34), three CoC versus MoPc (35-37), three MoPc versus CoPc (38-40), two MoPxl versus CoPxl (41, 42), two MoPxl versus MoM (43, 44), one CoC versus MoPxl (45), one CoC versus MoM (46), and one CoPc versus MoM (47). MoPc = metal-on-conventional polyethylene, MoPxl = metal-on-highly crosslinked polyethylene, CoPc = ceramic-on-conventional polyethylene, CoPxl = ceramic-on-highly crosslinked polyethylene, CoC = ceramic-on-ceramic, MoM = metal-on-metal |
End-point of follow-up: at least two years
Average 6.6 (2 to 12) years; Subgroup analysis presented for at least 10 year follow-up
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Outcome measure-1 revision The pooled data of network meta-analysis showed no difference in terms of risk of revision among CoC, CoPc, CoPxl and MoPxl implants. However, MoM implants were associated with significant higher risks of revision when compared with CoC (RR 5.10; 95% CI=1.62 to 16.81), CoPc (RR 4.80; 95% CI=1.29 to 17.09), MoPxl (RR 3.85; 95% CI=1.16 to 14.29), and a non-significant trend towards a increased risk of revision when compared with CoPxl implants (RR 2.56; 95% CI=0.51 to 12.16). MoPc implants were demonstrated with a significant increased risk of revision compared with CoC RR 2.83; 95% CI=1.20 to 6.63), and non-significant trends of higher risk of revision when compared with CoPc (RR 2.64; 95% CI=0.89 to 7.04), CoPxl (RR 1.42; 95% CI=0.35 to 5.46) and MoPxl (RR 2.10; 95% CI=0.82 to 5.48) implants.
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Summary of author’s conclusion: present evidence indicated the similar performance in survivorship among CoC, CoPc, CoPxl and MoPxl bearing implants, and that all likely have superiority compared with the MoM and MoPc bearing implants in THA procedures. Long-term RCT data are required to confirm these conclusions and better inform clinical decisions.
Sensitivity analyses When the network meta-analysis was restricted to trials with at least 10 years follow-up time, the MoM implants were non-significantly associated with a 11-fold, 11-fold, 4-fold and 4-fold increased risks of revision when compared with CoPxl, CoC, MoPxl, and CoPc implants, respectively (Table 1). MoPc implants were non-significantly associated with a 5-fold, 5-fold, 2-fold and 2-fold increased risks of revision when compared with CoPxl, CoC, MoPxl, and CoPc implants, respectively. |
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Research question: Which type of hip prosthesis bearing is preferable?
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Study reference |
Study characteristics |
Patient characteristics 2 |
Intervention (I) |
Comparison / control (C) 3
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Follow-up |
Outcome measures and effect size 4 |
Comments |
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Beaupré, 2016 |
Type of study: RCT
Setting: hospital
Country: Canada
Source of funding: Trial was supported by grant from Stryker Canada Inc for the first five years of follow-up, no funding was received for the last five years |
Inclusion criteria: subjects undergoing THA and <61 years recruited from 1998 to 2003 in a Canadian health region. Standard surgical technique a Hardinge or posterolateral approach, all subjects had noncemented femoral and acetabular fixation
Exclusion criteria: Not reported
Prognostic factors (completed 10 y follow-up): Age ± SD: 53.2 ± 6.4 Sex: 53%M
Groups comparable at baseline? Demographics: yes. Ceramic group more 32mm heads, polyethylene group more 28mm heads (p<0.001) |
Describe intervention
Ceramic-on-ceramic bearing
CERAMIC group received an arc-deposited hydroxylapatite (HA)-coated shell (Secure fit arc-deposited HA surface ceramic) and an aluminia-bearing couple ceramic insert and ceramic C-taper head Femoral stem Omnifit HA More likely to receive 32 mm femoral head N=48
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Describe control
Ceramic-on-highly-crosslinked-polyethylene
POLYETHYLENE group received secure fit shell, a crossfire insert, and a ceramic C-taper head Femoral stem Omnifit HA More likely to receive 28mm femoral head N=44 |
Length of follow-up: 10 years
Loss-to-follow-up: Intervention: 5 Control: 1 Reasons (describe): 7% deceased
Incomplete outcome data: 68 (79%) completed the HRQL and/or radiographic follow-up at 10 years; 44 (51%) completed both clinical and radiographic follow-ups, 11 (13%) completed only the clinical follow-up, and 13 (15%) completed only the radiographic follow-up
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Outcome measures and effect size (include 95%CI and p-value if available):
Complications: I: 3 injurious falls C: 4 dislocations, with 2 head/cup/liner revisions, another revision in year 5 to 10 due to recurrent instability
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Epinette, 2016 |
Type of study: registry study
Setting: hospital
Country: England and Wales
Source of funding: unknown |
Inclusion criteria: trident acetabular system variations between april 2003 and March 2013; primary hip arthroplasty; complete data about material and diameterof head and material and diameter of implanted liner; metal or alumina head featuring a 22.2 diameter or over; fixed nonconstrained liner, excluding both mobile bearings and constrained liners; either X3, N2vac, or AL liners, other types of HXLPE liners which were not sequentially irradiated and annealed were excluded (namely Crossfire liners), osteoarthritis as the only indication, HA-coated Trident as metallic shell
N total at baseline: 45,877
Important prognostic factors2: Age ± SD: Alumina: 60.13 ± 11.3 N2Vac UHMPE: 68.8 ± 9.2 X3 HXLPE: 69.9 ± 9.7 Sex: Not significantly different between groups
Groups comparable at baseline? yes |
Describe intervention (treatment/procedure/test):
HA coated trident shell, in osteoarthritis, with fixed-nonconstrained liners, and inserts belonging to either X3HXLPE, N2 Vac UHMPE or Alumina types |
Describe control (treatment/procedure/test):
See intervention group |
Length of follow-up:6 years
Loss-to-follow-up: -
Incomplete outcome data: -
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Outcome measures and effect size (include 95%CI and p-value if available):
Survival: Global X3: 98.6% Global CoC: 97.6% AL-S and X3: 99.0% AL-S and CoC: 97.8% AL-L and X3: 98.3% AL-L and CoC: 97.4%
Bearing-related failures: Global X3: 99.8% Global CoC: 99.4% AL-S and X3: 99.9% AL-S and CoC: 99.4% AL-L and X3: 99.7% AL-L and CoC: 99.3%
A first study demonstrated better survivorship with X3-HXLPE liners vs conventional ultrahigh molecular weight polyethylene. On the second parallel study, the cumulative survival rates were better for X3 liners as compared to CoC bearings. Moreover, when ranking the yearly cumulative percent revision rates, again the best results were obtained with X3 liners with small alumina heads (cumulative revision rate at 0.298). |
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Glyn-Jones, et al., 2015 |
Type of study: RCT
Setting: University Hospital Orthopaedic Centre
Country: United Kingdom
Source of funding: not reported. Conflicts of interest: see remarks |
Inclusion criteria: patients with hip osteoarthritis from routine inpatient waiting list between 2001 and 2002
Exclusion criteria:
N total at baseline: N=54, 39 with complete follow-up
Important prognostic factors2: Age ± SD: I: 68 (52 to 76) C: 67 (51 to 76)
Sex: I: 55% M C: 47% M
Groups comparable at baseline? yes
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Describe intervention (treatment/procedure/test):
Highly cross-linked polyethylene
cemented, collarless, polished, tapered femoral component (CPT; Zimmer, Warsaw, IN, USA) with a 28-mm bearing surface and an uncemented acetabular component (Trilogy; Zimmer) were used. At the time of surgery with HXLPE liner (Longevity; Zimmer) N=27
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Describe control (treatment/procedure/test):
Conventional polyethylene
cemented, collarless, polished, tapered femoral component (CPT; Zimmer, Warsaw, IN, USA) with a 28-mm bearing surface and an uncemented acetabular component (Trilogy; Zimmer) were used. At the time of surgery with a conventional UHMWPE acetabular liner (Zimmer) (N = 27)
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Length of follow-up: 10 years
Loss-to-follow-up: Intervention: N (%) 3 Reasons (describe) 1 deceased and 2 ill health
Control: N (%) 4 Reasons (describe) 2 deceased and 2 ill health
Incomplete outcome data: 8 patients had radiographs that were inadequate
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Outcome measures and effect size (include 95%CI and p-value if available):
Revision: There were no revision operations during the period of study
At 10 years there was significantly less wear of HXLPE (0.003 mm/year; 95% confidence interval (CI), ± 0.010; SD 0.023; range, -0.057 to 0.074) compared with UHMWPE (0.030 mm/year; 95% CI, ± 0.012; p\0.001; SD 0.0.27; range, -0.001 to 0.164). The volumetric penetration from 1 to 10 years for the UHMWPE group was 98 mm3 (95% CI, ± 46 mm3; SD 102 mm3; range, -4 to 430 mm3) compared with 14 mm3 (95% CI, ± 40 mm3; SD 91 mm3; range, -189 to 242 mm3) for the HXLPE group (p = 0.01). |
One of the authors (GERT) has received funding from Orthopaedic Research UK and the Jean Shanks Foundation. The institution of the authors has received research funding from Zimmer, Inc (Warsaw, IN, USA). Internal funding was received from the Oxford NIHR Biomedical Research Unit in Musculoskeletal Disease. One or more authors (SG-J, AT) certify that he or she or a member of his or her immediate family, has or may receive payments or benefits, during the study period, an amount of USD 10,000 to USD 100,000 from a commercial entity (Zimmer, Inc). |
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Langlois, 2015 |
Type of study: RCT
Setting: hospital
Country: France
Source of funding: unknown No conflicts of of interest reported |
Inclusion criteria: between July 2000 and July 2002 100 patients (100 hips) with primary or secondary osteoarthritis who needed THA were enrolled
Exclusion criteria: -
Important prognostic factors2:
age ± SD: 66.4 ± 12.9 (21-86 years) Sex: 45% M
Groups comparable at baseline? Not reported |
Describe intervention (treatment/procedure/test):
Highly XL all-PE acetabular component (Durasul, Centrepulse OrthopaedicsLtD) N=50
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Describe control (treatment/procedure/test):
Annealed contemporary component (Duration, Stryker-Howmedica, Herouville, Saint-Clare, France) N=50 |
Length of follow-up: minimum eight years
Loss-to-follow-up: Intervention: 4 (died), Control: 7 (died), 2 (complications requiring early revision), N (%) Reasons (describe)
Incomplete outcome data: unclear
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Outcome measures and effect size (include 95%CI and p-value if available):
Revision: C: 2 patients required revision, 1 due to early deep surgical site infection and 1 due to recurrent dislocation within 3 years.
Osteolysis: No loosening or osteolysis was seen in relation to either component in any patient
Wear: I: femoral head penetration 0.012 mm/year (SD 0.684) C: 1.090 mm/year (SD 0.904) Steady state wear rate I: -0.0002 mm/year (SD 0.108) C: 0.1382 mm/year (SD 0.129 |
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Paxton, 2015 |
Type of study: registry study
Country: USA
Setting: hospital
Source of funding: Kaiser Permanente orthopaedic surgeons who contribute to the TJRR and the Surgical Outcomes and Analysis Department, which coordinates Registry operations |
Inclusion criteria: elective nonbilateral primary THAs, in which patients were at least 18 years old at the time of their procedure and had metal-on-conventional polyethylene or metal-on-HXLPE bearing surfaces registered between April 1, 2001, and December 31, 2011, were included in the sample
Exclusion criteria: Revision procedures, bilateral (same-day) primary procedures, and conversion procedures
N total at baseline: N= 26823 THAs
Mean age: 70 ± 10
Sex: 40 % M |
Describe intervention (treatment/procedure/test):
metal-on-highly cross-linked polyethylene (all head sizes)
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Describe control (treatment/procedure/test):
metal-on-conventional polyethylene (head size of <32 mm) |
Length of follow-up: metal-on-HXLPE: 2.9 years Duraloc cohort: 8.2 years Reflection cohort: 5.1 years
Loss-to-follow-up: unclear
Incomplete outcome data: unclear
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Outcome measures and effect size (include 95%CI and p-value if available):
Revision: Metal on conventional: 5.4% (95%CI 4.4%-6.7%) Metal on XLPE: 2.8% (95% CI 2.6%- 3.2%)
Reasons (metal-on conventional): instability (49%), aseptic loosening (20%), infection (15%), other (22%)
Reasons (metal-on-HXLPE): instability (40%), infection (25%), periprosthetic fracture (13%) and other (14%)
Duraloc cohort: Metal on conventional polyethylene: 8.3% (95% CI 5.8%-11%) Metal on HXLPE polyethylene: 2.6% (95% CI 1.7% to 4.2%)
Reasons (metal-onconventional polyethylene): instability (43%), aseptic loosening (27%), infection (20%), and other (33% each).
Reasons (metal-on-HXLPE): instability (68%), aseptic loosening (14%), pain (14%), infection (9%), and periprosthetic fracture (9%).
Reflection cohort: Metal on conventional polyethylene: 4.6% (3.2% to 6.6%) Metal on HXLPE: 2.2% (95% CI 1.7% to 2.7%)
Reasons (metal on conventional polyethylene): instability (65%), other (26%), infection (13%), periprosthetic fracture (10%), and aseptic loosening (10%). Reasons (metal-on-HXLPE group): instability (40%), infection (26%), other (17%), and periprosthetic fracture (12%). |
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Type of study: Annual report registry
Country: Australia |
Inclusion criteria: Primary total hip replacement procedures
N total at baseline: Total population in the registry: 346,782
Mean age: 67.7 years (total population in the registry)
Sex: 55.1% female (total population in the registry)
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Non XLPE N=40,391 |
XLPE N=174,409 |
Length of follow-up: 1-15 years
Revisions Non XLPE: 2,548 XLPE: 4,725 |
HR - adjusted for age and gender
Non XLPE vs XLPE 0-3 m: HR=0.83 (0.74 to 0.94), p=0.002 3-6m: HR=1.05 (0.83 to 1.32), p=0.704 6m-1.5y: HR=1.49 (1.30 to 1.70), p<0.001 1.5-2.5y: HR=1.30 (1.09-1.54), p=0.002 2.5-6.5y: HR=1.73 (1.56-1.91), p<0.001 6.5-9y: HR=2.29 (1.96-2.68), p<0.001 >9y: HR=3.14 (2.61- 3.78), p<0.001 |
|
|
|
Paxton (2014) |
Type of study: registry study
Country: USA, Italy, Spain, Norway, Australia
Funding/ financial disclosure: authors have financial relationships with third parties that
|
Inclusion criteria: THA between 2001 and 2010, osteoarthritis as the primary diagnosis, cementless implant fixation, age 45-64 y
Exclusion criteria: Not reported
N total at baseline: N= 16,571 THAs
Mean age: not reported
Sex: M 8070 (49%) F 8501 |
metal-on-conventional polyethylene implants with a head size of <32 mm
M 1127 (51%) F 1072
|
metal-on-highly cross-linked polyethylene implants (head sizes of <32, 32, and >32 mm).
M 6943 (48%) F 7429 |
Length of follow-up: not clearly reported, up to 9 years
Loss to follow-up: Not reported
Incomplete outcome data: unclear |
Outcome measures and effect size (include 95%CI and p-value if available):
There was insufficient evidence of a difference in risk of revision between bearing surfaces (hazard ratio for conventional PE: 1.20 (95% CI 0.80 to 1.79); p = 0.384). |
|
Notes:
- Prognostic balance between treatment groups is usually guaranteed in randomized studies, but non-randomized (observational) studies require matching of patients between treatment groups (case-control studies) or multivariate adjustment for prognostic factors (confounders) (cohort studies); the evidence table should contain sufficient details on these procedures.
- Provide data per treatment group on the most important prognostic factors ((potential) confounders).
- For case-control studies, provide sufficient detail on the procedure used to match cases and controls.
- For cohort studies, provide sufficient detail on the (multivariate) analyses used to adjust for (potential) confounders.
Table of quality assessment for systematic reviews of RCTs and observational studies
Based on AMSTAR checklist (Shea, 2007; BMC Methodol 7: 10; doi:10.1186/1471-2288-7-10) and PRISMA checklist (Moher, 2009; PLoS Med 6: e1000097; doi:10.1371/journal.pmed1000097)
|
Study
First author, year |
Appropriate and clearly focused question?1
Yes/no/unclear |
Comprehensive and systematic literature search?2
Yes/no/unclear |
Description of included and excluded studies?3
Yes/no/unclear |
Description of relevant characteristics of included studies?4
Yes/no/unclear |
Appropriate adjustment for potential confounders in observational studies?5
Yes/no/unclear/notapplicable |
Assessment of scientific quality of included studies?6
Yes/no/unclear |
Enough similarities between studies to make combining them reasonable?7
Yes/no/unclear |
Potential risk of publication bias taken into account?8
Yes/no/unclear |
Potential conflicts of interest reported?9
Yes/no/unclear |
|
Dong, 2015 |
Yes |
Yes, not completely clear |
Yes |
Yes |
Unclear |
Yes |
Yes |
Yes, but not assessed with funnel plots |
Yes |
|
Hu, 2015 |
Yes |
Yes, not completely clear |
Yes |
Yes |
No |
|
|
Yes, assessed with funnel plots |
Yes |
|
Shen, 2014 |
Yes |
Yes |
Yes |
Yes |
Unclear |
No |
Yes |
No |
Yes |
|
Si, 2015 |
Yes |
Yes |
Yes |
Yes |
Unclear |
Yes |
Yes |
No |
Yes |
|
Yin, 2015 |
Yes |
Yes |
Yes |
Yes |
n.a. |
Yes |
Yes |
No |
Yes |
- Research question (PICO) and inclusion criteria should be appropriate and predefined.
- Search period and strategy should be described; at least Medline searched; for pharmacological questions at least Medline + EMBASE searched.
- Potentially relevant studies that are excluded at final selection (after reading the full text) should be referenced with reasons.
- Characteristics of individual studies relevant to research question (PICO), including potential confounders, should be reported.
- Results should be adequately controlled for potential confounders by multivariate analysis (not applicable for RCTs).
- Quality of individual studies should be assessed using a quality scoring tool or checklist (Jadad score, Newcastle-Ottawa scale, risk of bias table et cetera).
- Clinical and statistical heterogeneity should be assessed; clinical: enough similarities in patient characteristics, intervention and definition of outcome measure to allow pooling? For pooled data: assessment of statistical heterogeneity using appropriate statistical tests (for example. Chi-square, I2)?
- An assessment of publication bias should include a combination of graphical aids (for example funnel plot, other available tests) and/or statistical tests (for example Egger regression test, Hedges-Olken). Note: If no test values or funnel plot included, score “no”. Score “yes” if mentions that publication bias could not be assessed because there were fewer than 10 included studies.
- Sources of support (including commercial co-authorship) should be reported in both the systematic review and the included studies. Note: To get a “yes,” source of funding or support must be indicated for the systematic review AND for each of the included studies.
Risk of bias table for intervention studies (randomized controlled trials)
Research question: Which type of hip prosthesis bearing is preferable?
|
Study reference
(first author, publication year) |
Describe method of randomisation1 |
Bias due to inadequate concealment of allocation?2
(unlikely/likely/unclear) |
Bias due to inadequate blinding of participants to treatment allocation?3
(unlikely/likely/unclear) |
Bias due to inadequate blinding of care providers to treatment allocation?3
(unlikely/likely/unclear) |
Bias due to inadequate blinding of outcome assessors to treatment allocation?3
(unlikely/likely/unclear) |
Bias due to selective outcome reporting on basis of the results?4
(unlikely/likely/unclear) |
Bias due to loss to follow-up?5
(unlikely/likely/unclear) |
Bias due to violation of intention to treat analysis?6
(unlikely/likely/unclear) |
|
Beaupré (2016) |
Not described |
Unclear |
Unclear |
Likely |
Unclear |
Unlikely |
Unlikely |
Unlikely |
|
Glyn-Jones (2016) |
Not described |
Unclear |
Unlikely
|
Unlikely |
Unlikely |
Unclear |
Unlikely |
Unlikely |
|
Langlois (2015) |
Computer-generated random number table |
Unclear |
Unlikely (radiographic endpoint) |
Unlikely |
Unlikely (blinding of outcome assessors)
|
Unclear |
Unlikely |
Unlikely |
- Randomisation: generation of allocation sequences have to be unpredictable, for example computer generated random-numbers or drawing lots or envelopes. Examples of inadequate procedures are generation of allocation sequences by alternation, according to case record number, date of birth or date of admission.
- Allocation concealment: refers to the protection (blinding) of the randomisation process. Concealment of allocation sequences is adequate if patients and enrolling investigators cannot foresee assignment, for example central randomisation (performed at a site remote from trial location) or sequentially numbered, sealed, opaque envelopes. Inadequate procedures are all procedures based on inadequate randomisation procedures or open allocation schedules..
- Blinding: neither the patient nor the care provider (attending physician) knows which patient is getting the special treatment. Blinding is sometimes impossible, for example when comparing surgical with non-surgical treatments. The outcome assessor records the study results. Blinding of those assessing outcomes prevents that the knowledge of patient assignement influences the proces of outcome assessment (detection or information bias). If a study has hard (objective) outcome measures, like death, blinding of outcome assessment is not necessary. If a study has “soft” (subjective) outcome measures, like the assessment of an X-ray, blinding of outcome assessment is necessary.
- Results of all predefined outcome measures should be reported; if the protocol is available, then outcomes in the protocol and published report can be compared; if not, then outcomes listed in the methods section of an article can be compared with those whose results are reported.
- If the percentage of patients lost to follow-up is large, or differs between treatment groups, or the reasons for loss to follow-up differ between treatment groups, bias is likely. If the number of patients lost to follow-up, or the reasons why, are not reported, the risk of bias is unclear
- Participants included in the analysis are exactly those who were randomized into the trial. If the numbers randomized into each intervention group are not clearly reported, the risk of bias is unclear; an ITT analysis implies that (a) participants are kept in the intervention groups to which they were randomized, regardless of the intervention they actually received, (b) outcome data are measured on all participants, and (c) all randomized participants are included in the analysis.
Verantwoording
Autorisatiedatum en geldigheid
Laatst beoordeeld : 12-02-2019
Laatst geautoriseerd : 12-02-2019
Geplande herbeoordeling : 01-01-2024
In theory, assessment will take place after five years to determine whether this module is still up-to-date. Are there reasons to suspect a need for earlier revision? For example, large studies that still need to be published?
|
Module |
Party in control |
Year of authorization |
Next assessment of actuality |
Frequency of assessment actuality |
Which party/parties monitors actuality |
Important factors that might lead to change in recommendations |
|
Bearing surface total hip arthroplasty |
NOV |
2018 |
2023 |
Every 5 years |
NOV |
- |
Algemene gegevens
The development of this guideline was funded by the Stichting Kwaliteitsgelden Medisch Specialisten (SKMS; Foundation for Quality Funding for Medical Specialists).
Doel en doelgroep
Aim of the guideline
The main purpose of the guideline is to provide the best possible care to patients with osteoarthritis of the hip, by informing optimal treatment decisions and reducing unwarranted variation in the delivery of care and long-term failure of the implants.
Envisaged users of the guideline
This guideline was developed for all Dutch healthcare providers of patients with osteoarthritis of the hip.
Samenstelling werkgroep
This guideline was developed and sponsored by the Netherlands Orthopaedic Association (NOV), using government funding from the Quality Funding for Medical Specialists (Stichting Kwaliteitsgelden Medisch Specialisten in the Netherlands, SKMS). Patient participation was cofinanced by the Quality Funding Patient Consumers (Stichting Kwaliteitsgelden Patiënten Consumenten, SKPC) within the program ‘Quality, insight and efficiency in medical specialist care’ (Kwaliteit, Inzicht en Doelmatigheid in de medisch specialistische Zorg, KIDZ). The early preparative phase started in October 2016. The guideline was officially authorised by the Netherlands Orthopaedic Association on February 12, 2019. Decisions were made by consensus. At the start of guideline development, all working group members completed conflict of interest forms.
Members of the guideline development working group
- Dr. B.A. Swierstra, orthopaedic surgeon, Sint Maartenskliniek, Nijmegen, NOV, Chair
- Dr. R.H.M. ten Broeke, orthopaedic surgeon, Maastricht University Medical Centre, NOV
- Drs. P.D. Croughs, medical microbiologist, Erasmus University Medical Center, NVMM
- Dr. R.A. Faaij, geriatrician, Diakonessen Hospital, Utrecht, NVKG
- Dr. P.C. Jutte, orthopaedic surgeon, University Medical Center Groningen, NOV
- D.E. Lopuhaä, policy worker patient advocacy, Dutch Arthritis Society
- Dr. W.F.H. Peter, physiotherapist, Leiden University Medical Center, KNGF
- Dr. B.W. Schreurs, orthopaedic surgeon, Radboud University Medical Centre, Nijmegen, NOV
- Dr. S.B.W. Vehmeijer, orthopaedic surgeon, Reinier de Graaf Hospital, Delft, NOV
- Dr. A.M.J.S. Vervest, orthopaedic surgeon, Tergooi Hospital, Hilversum, NOV
- J. Vooijs†, patient with osteoarthritis, National Association ReumaZorg Nederland
- Drs. G. Willemsen-de Mey, chairperson, National Association ReumaZorg Nederland
Readers:
- S. Nijssen, medical microbiologist, VieCuri Medical Center, Venlo, NVMM
- R.J. Rentenaar, medical microbiologist, University Medical Center, Utrecht, NVMM
- Dr. A.T. Bernards, medical microbiologist, Leiden University Medical Center, NVMM
With the help of:
- Dr. M.A. Pols, senior advisor, Knowledge Institute of the Dutch Association of Medical Specialists
- Dr. M.L. Molag, advisor, Knowledge Institute of the Dutch Association of Medical Specialists
- A.L.J. Kortlever- van der Spek, junior advisor, Knowledge Institute of the Dutch Association of Medical Specialists
- M.E. Wessels MSc, clinical librarian, Knowledge Institute of the Dutch Association of Medical Specialists
Belangenverklaringen
At the start of the project, the members of the working group have declared in writing if, in the last five years, they have held a financially supported position with commercial businesses, organisations or institutions that may have a connection with the subject of the guidelines. Enquiries have also been made into personal financial interests, interests pertaining to personal relationships, interests pertaining to reputation management, interests pertaining to externally financed research, and interests pertaining to valorisation of knowledge. These declarations of interest can be requested from the secretariat of the Knowledge Institute of the Dutch Association of Medical Specialists. See below for an overview.
|
Werkgroeplid |
Mogelijke conflicterende belangen met betrekking tot deelname werkgroep |
Toelichting |
|
Dr. B.W. Schreurs |
Presentaties voor Stryker over de Exeter totale heupprothese (educational fee naar afdeling) Doet reviews voor DEKRA KEMA (betaald) Voorzitter European Hip Society (onbetaald) Voorzitter wetenschappelijke adviesraad LROI (onbetaald) Voorzitter adviesraad botbank Sanquin (onbetaald) Lid Commissie Orthopedisch Implantaten Classificatie NOV (onbetaald) |
|
|
Dr. P.C. Jutte |
Hoofdonderzoeker LEAK-studie (ZonMW) Voorzitter werkgroep weke delen en bottumoren Lid werkgroep orthopedische infecties NOV Lid werkgroep bottumoren NOV Lid commissie beentumoren Nederland Lid onderwijscommissie NOV Lid medische adviesraad patientvereniging Sarcoma NL |
|
|
D.E. Lopuhaä |
Geen belangen |
|
|
Dr. R.H.M. ten Broeke |
Voorzitter werkgroep "Heup" (Dutch Hip Society) NOV sinds 2015 (onbetaald) Daarvoor gedurende 3 jaar reeds bestuurslid van deze werkgroep (onbetaald) Klinisch onderzoek gefinancierd door firma Stryker (RSA en PET-CT-onderzoek bij vergelijking van 2 ongecementeerde cupdesigns) (onbetaald) |
|
|
Dr. W.F.H. Peter |
Geen belangen |
|
|
Dr. P.D. Croughs |
Geen belangen |
|
|
Dr. S.B.W. Vehmeijer |
Directeur Orthoparc (onbetaald) Bestuurslid Dutch Hip Society (onbetaald) National Representative European Hip Society (onbetaald) Consulent Zimmer Biomet (betaald) |
|
|
Dr. B.A. Swierstra |
Voorzitter Stichting OrthoResearch (onbetaald) Advisory Board Arthroplasty Watch (onbetaald) Lid Wetenschappelijke Advies Raad Landelijke Registratie Orthopaedische Implantaten (onbetaald) Board of Directors International Society of Orthopaedic Centers (onbetaald) Coeditor Acta Orthopaedica (onkostenvergoeding) |
|
|
Dr. R.A. Faaij |
Geen belangen |
|
|
Dr. A.M.J.S. Vervest |
Lid-beroepsgenoot Regionaal Tuchtcollege voor de Gezondheidszorg Den Haag (betaald) Voorzitter Centrale Opleidings Commissie Tergooi (onbetaald) |
|
|
J. Vooijs |
Geen belangen |
|
|
Drs. G. Willemsen – de Mey |
Geen belangen |
|
|
Meelezers |
||
|
Drs. S. Nijssen |
ISO 15189 auditor, betaald door RvA |
|
|
Dr. R.J. Rentenaar |
Commissie bacteriologie Stichting Kwaliteitsbewaking Medische Laboratoria (SKML) (tegen onkostenvergoeding). Verschillende producenten stellen soms kleine hoeveelheden van producten ter beschikking kosteloos of tegen gereduceerd tarief t.b.v. verificatie doeleinden |
|
|
Dr. A.T. Bernards |
Geen belangen |
|
Inbreng patiëntenperspectief
Attention was paid to the patients’ perspective by participation in the working group of the Dutch Arthritis Society and National Association ReumaZorg Nederland. In addition, the Patients Federation Netherlands assessed the draft guideline during the consultation phase and made suggestions for improvement of the guideline.
Methode ontwikkeling
Evidence based
Implementatie
|
Recommendation |
Time needed for implementation: 1 to 3 years or >3 years |
Expected effects on costs |
Conditions for implementation |
Possible barriers to implementation1 |
Actions for implementation2 |
Reponsibility for these actions3 |
Other remarks |
|
All |
1 to 3 years |
Reduction |
No |
Surgeons might not be used to work with this type of bearing |
Annual quality audit. Adjustment of NOV classification
|
NOV |
|
Werkwijze
The guideline was developed in agreement with the criteria set by the advisory committee on guideline development of the Dutch Association of Medical Specialists (Medisch Specialistische Richtlijnen 2.0; OMS 2011), which are based on the AGREE II instrument (Brouwers (2010); www.agreetrust.org). The guideline was developed using an evidence-based approach endorsing GRADE methodology, and meeting all criteria of AGREE-II. Grading of Recommendations Assessment, Development and Evaluation (GRADE) is a systematic approach for synthesising evidence and grading of recommendations offering transparency at each stage of the guideline development (Guyatt, 2011; Schünemann, 2013).
The guideline development process involves a number of phases: a preparatory phase, development phase, commentary phase, and authorisation phase. After authorisation, the guideline has to be disseminated and implemented and its uptake and use have to be evaluated. Finally, the guideline has to be kept up-to-date. Each phase involves a number of practical steps Schünemann, (2014).
As a first step in the early preparatory phase, a broad forum discussion was held and all relevant stakeholders were consulted to define and prioritise the key issues the recommendations should address. Subsequently, the methodologist together with the chairman of the working group created a draft list of key issues, which was extensively discussed in the working group.
Despite aiming for an update of the guideline from 2010, due to financial constraints not all clinical questions from the former edition could be updated, so it was decided to perform a so-called modular update. Selecting modules with a higher priority for update formed part of this discussion and selection process. This resulted in the following approach.
Modules that were updated:
- Indications for primary total hip arthroplasty.
- Type of bearing (part of the module surgical techniques).
- Diameter of the head (part of the module surgical techniques).
- Surgical approach (part of the module surgical techniques).
- Systemic antibiotics (part of the module perioperative care in primary total hip arthroplasty).
- Antibiotic-impregnated bone cement (part of the module perioperative care in primary total hip arthroplasty).
- Preoperative decolonisation (part of the module perioperative care in primary total hip arthroplasty).
- Routine follow-up (part of the module postoperative care).
Modules considered still valid:
- cemented versus uncemented hip prosthesis (part of the module surgical techniques in primary total hip arthroplasty).
Modules removed from the guideline:
- Resurfacing hip prosthesis (part of the module surgical techniques in primary total hip arthroplasty).
- Minimally invasive surgery (part of the module surgical techniques in primary total hip arthroplasty).
- Guidelines for MRSA carriers (part of the module perioperative care in primary total hip arthroplasty).
Modules that were replaced by a reference to related guidelines:
- Hematogenous infection (part of the module postoperative care).
- Prevention of thrombo-embolic complications (part of the module perioperative care in primary total hip arthroplasty).
- Physcial therapy (part of the module perioperative care in primary total hip arthroplasty).
Modules not updated because guidelines are expected soon:
- Anaesthesiological technique (part of the module perioperative care in primary total hip arthroplasty).
Modules that were added:
- Patient Reported Outcome Measures.
- Place and organisation of fasttrack.
- Organization of care for frail elderly.
The selected (high priority) issues were translated into carefully formulated clinical questions, defining patient/problem, intervention, and prioritising the outcomes relevant for decision-making.
The literature was systematically searched using the databases MEDLINE (Ovid), Embase and the Cochrane Database of Systematic Reviews. Selection of the relevant literature was based on predefined inclusion and exclusion criteria and was carried out by a member of the working group in collaboration with the methodologist. For each of the clinical questions, the evidence was summarised by the guideline methodologist using the GRADE approach: a systematic review was performed for each of the relevant outcomes and the quality of evidence was assessed in one of four grades (high, moderate, low, very low) by analysing limitations in study design or execution (risk of bias), inconsistency of results, indirectness of evidence, imprecision, and publication bias. The evidence synthesis was complemented by a working group member considering any additional arguments relevant to the clinical question. Evidence synthesis, complementary arguments, and draft recommendations were extensively discussed in the working group and final recommendations were formulated. Final recommendations are based on the balance of desirable and undesirable outcomes, the quality of the body of evidence across all relevant outcomes, values and preferences, and (if relevant) resource use. The strength of a recommendation reflects the extent to which the guideline panel was confident that desirable effects of the intervention outweigh undesirable effects, or vice versa, across the range of patients for whom the recommendation is intended. The strength of a recommendation is determined by weighting all relevant arguments together, the weight of the body of evidence from the systematic literature analysis, as well as the weight of all complementary arguments. Guideline panels must use judgment in integrating these factors to make a strong or weak recommendation. Thus, a low quality of the body of evidence from the systematic literature analysis does not exclude a strong recommendation, and weak recommendations may follow from high quality evidence Schünemann, (2013).
After reaching consensus in the working group, the draft guideline was subjected to peer review by all relevant stakeholders. Amendments were made and agreed upon by the working group, and the final text was presented to the Netherlands Orthopaedic Association (NOV), the Royal Dutch Society for Physical Therapy (KNGF), the Dutch Society of Medical Microbiology (NVMM) and the Dutch Geriatrics Society (NVKG) for formal authorisation and to the National Association ReumaZorg Nederland and the Dutch Arthritis Society for approval. The final guideline was approved by the National Association ReumaZorg Nederland and the Dutch Arthritis Society, and was officially authorised by the Netherlands Orthopaedic Association, the Royal Dutch Society for Physical Therapy, the Dutch Society of Medical Microbiology and the Dutch Geriatrics Society. The guideline was published and is freely accessible in the Dutch guideline database (Richtlijnendatabase, www.richtlijnendatabase.nl). The Dutch guideline database has a modular structure, with each clinical question as a separate entry, thus allowing for modular updates.
References
Brouwers M, Kho ME, Browman GP, et al. AGREE II: Advancing guideline development, reporting and evaluation in healthcare. Can Med Assoc J. Dec;182:E839-842; doi: 10.1503/cmaj.090449.
Guyatt G, Oxman AD, Akl EA, et al. GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. Journal of Clinical Epidemiology. 2011;64 383–394. (doi:10.1016/j.jclinepi.2010. 04.026).
Schünemann H, Brożek J, Guyatt G, et al. GRADE handbook for grading quality of evidence and strength of recommendations. Updated October 2013. The GRADE Working Group, 2013. Available from https://www.gradepro.org/
Schünemann HJ, Wiercioch W, Etxeandia I, et al. Guidelines 2.0: systematic development of a comprehensive checklist for a successful guideline enterprise. CMAJ. 2014;186(3):E123-42. doi: 10.1503/cmaj.131237. Epub 2013 Dec 16. PubMed PMID: 24344144.
OMS, Orde van Medisch Specialisten. Eindrapport Medisch Specialistische Richtlijnen 2.0. Available from: https://www.demedischspecialist.nl/onderwerp/raad-kwaliteit. 2011.
Zoekverantwoording
Zoekacties zijn opvraagbaar. Neem hiervoor contact op met de Richtlijnendatabase.
Bijlagen
- Relevant voor patiënten
- Achtergrond en definities