Head diameter THA
Question
What is the preferred diameter of the head in total hip arthroplasty?
Recommendation
Preferably use a 32mm head size in standard hip arthroplasty.
Considerations
In the past, most total hip implants had a femoral head diameter of 22, 28 or 32mm. To overcome one of the major complications after a total hip arthroplasty - dislocation - there has been a trend to larger heads of 36mm and more. However, this trend is not without disadvantages. Larger heads lead to more friction and more wear. In addition, especially in these larger head sizes the choice of the bearings seems to be more critical.
There is a strong trend in many registries to use 32mm heads. This trend is relatively safe, the dislocation tendency of a 32mm head is lower than a 22 or 28mm head and there is no evidence that it will result in higher overall revision rates. However, in some studies using heads larger than 32mm to prevent dislocation, less favourable results have been reported.
It is rather complicated to draw clear scientific conclusions as other factors also play a role, like patient selection, type of bearing and surgical approach. In addition, as already stated the rate of dislocations who have been treated conservatively are greatly underestimated in many studies due to the study design.
It is advisable to use 32mm heads in most patients. Smaller heads still may be indicated in cases with abnormal anatomy. If a larger head diameter than 32mm is indicated, it seems best to use a ceramic-on-ceramic prosthesis, although there is little scientific evidence to support that.
Dual mobility cups
In the last decade there is a new trend to use dual mobility cups in primary THA to prevent dislocation, especially in patients with a higher risk of dislocation. These implants do not fit within the definitions used in this chapter to study the effect of head size on dislocation. However, since this type of implant is being used in the same patients, it is important to pay attention to these devices in this considerations paragraph.
In a literature analysis performed on 6 january 2018 four studies of interest were found. The largest study by Darrith (2018) was based on a literature review of 54 papers and the authors included 10,783 THAs who had a dual mobility cup, with a mean follow-up of 8.5 years (range 2 to 16.5). The mean rate of extra-articular dislocation was 0.46% (41 hips), which is lower than after routine single bearing THA. The overall rate of revision (any revision of the acetabular component or the dual mobility bearing) was 2.0% (178 hips). However, in the 2016 Report of the Australian Registry, dual mobility prostheses have a higher rate of revision compared to other acetabular prostheses at 5 years or more.
Dual mobility articulations are a viable alternative to traditional bearing surfaces in cases with a high risk for dislocation, however high-quality studies are needed to evaluate further the use of dual mobility components in THA.
Evidence
Background
Since the last version of the Dutch guidance on primary total hip arthroplasty (THA), more data have become available, especially from the registries, on the trends in head sizes used worldwide and there is more evidence about the most effective head size. However, head size cannot be seen independently from the coupling bearing used.
The most frequently used head sizes of hip prostheses are 28 and 32 mm. Larger and smaller head sizes are also used and especially in the last decade there is a trend towards the use of bigger heads. The hypothesis is that larger head sizes are associated with lower dislocation rates. We are especially interested in the effect of head size on the frequency of dislocation, on complications, on the risk of revision for instability and on the overall risk of revision.
To include the relatively new trend of using dual mobility cups in primary THA to prevent dislocation, we have added a short comment on the growing use of these newer designs in the considerations section.
Conclusions
Risk of revision
|
Very low GRADE |
It is unclear whether head size has an effect on revision rate for hip prostheses consisting of a metal head on a highly-cross-linked-polyethylene liner.
Based on registry data in most cases a 32mm head on a highly-cross-linked-polyethylene liner tends to be the safest option.
Sources (Allepuz, 2014; AOANJRR, 2016; NJR, 2016) |
|
Very low GRADE |
There seems to be a lower risk of revision when a larger head was used using ceramic-on-ceramic implant.
Sources (Sedrakyan, 2014; AOANJRR, 2016; NJR, 2016) |
Literature summary
Description of studies
Two large studies based on registries were included in the literature analysis (Allepuz, 2014; Sedrakyan, 2014). They both described data from the same six national and regional registries: Kaiser Permanente, HealthEast, the Emilia-Romagna region in Italy, the Catalan region in Spain, Norway, and Australia. However, the reviews focus on outcome of head size with different bearing types.
Allepuz (2014) studied the effect of femoral head size on the risk of revision when an HXLPE liner was used on a metal head. In this study, 14,372 THAs were included. Main outcome was risk of revision (for any reason). A possible bias of this study was that the included group of patients was limited in age (only patients between the age of 45 to 65 were included) Allepuz, (2014).
Sedrakyan (2014) compared femoral head sizes of >28mm and ≤28 mm for ceramic-on-ceramic articulations and compared ceramic-on-ceramic with metal-on-HXLPE articulations. A total of 34,985 patients were included. Main reported outcome was risk of revision (for any reason) Sedrakyan, (2014).
In addition, annual registry reports from Australia and the UK of 2016 were analysed and included, as both reports focussed on the influence of head size on the outcomes, with endpoints revision for dislocation or revision for any reason (AOANJRR, 2016; NJR, 2016).
Results
Revision
In the study by Allepuz (2014), for highly-cross-linked-polyethylene liner on metal head implants, the risk of revision (for any reason) did not differ significantly between <32mm and 32-mm head sizes (hazard ratio (HR) = 0.91, 95% confidence interval (CI) = 0.69 to 1.19) or between >32-mm and 32-mm sizes (HR = 1.05, 95% CI = 0.70 to 1.55) Allepuz,(2014).
Sedrakyan (2014) found a lower risk of revision associated with use of ceramic-on-ceramic implants when a larger head size (>28mm) was used, compared to ≤28mm (HR (hazard ratio) = 0.73, 95% CI (confidence interval) = 0.60 to 0.88, p = 0.001). Use of ≤28mm head in ceramic-on-ceramic bearings was associated with a higher risk of failure compared with any head size metal-on- highly-cross-linked-polyethylene bearings (HR = 1.36, 95% CI = 1.09 to 1.68, p = 0.006). Use of >28mm head ceramic-on-ceramic bearings was associated with a small protective effect relative to any head size metal-on- highly-cross-linked-polyethylene bearings (not subdivided by head size) in years zero to two, but this difference dissipated over the longer term Sedrakyan, (2014).
The Australian registry report 2016 (AOANJRR, 2016) showed that risk of revision for any reason varied depending on head size. This was most evident for non-cross-linked-polyethylene (table HT29), where the rate of revision after five years was 8.7% (95% CI 5.6 to 13.2) for >32mm, compared to 3.7% (95% CI 3.2 to 3.6) for 32 mm, and 3.4% (95% CI 3.2 to 3.6) for <32mm. However, the number of patients in the >32mm group was small. After ten years, the rate of revision was 5.9% (95% CI 5.0 to 6.9) for 32 mm and 6.5% (95% CI 6.2 to 6.8) for <32mm heads (no data for >32mm) (AOANJRR, 2016).
For highly cross-linked-polyethylene, 32mm head size had the lowest rate of revision relative to both smaller and larger heads. There was no difference between head sizes smaller than 32mm and bigger than 32mm. The rate of revision after five years was 3.1% (95% CI 2.9 to 3.2) for >32mm, compared to 2.6% (95% CI 2.5 to 2.7) for 32 mm, and 2.9% (95% CI 2.8 to 3.1) for <32mm. After ten years, the rate of revision was 4.4% (95% CI 4.0 to 4.8) for >32mm head, 3.8% (95% CI 3.6 to 4.1) for 32 mm and 4.4% (95% CI 4.1 to 4.6%) for <32mm heads (AOANJRR, 2016).
For ceramic-on-ceramic articulations (AOANJRR, 2016; table HT31), head size ≥32mm had a lower rate of revision compared to head sizes 28mm or less. There was no difference when head size 32 mm was compared to the 36-38mm head size group. Head sizes 40 mm or larger had a lower rate of revision compared to the other sizes, although marginally significant and depending on fixation type. After five years, the rate of revision for ≤28mm was 4.3% (95% CI 3.8 to 4.8), for 32mm 3.1% (95% CI 2.9 to 3.3), for 36 to 38mm 3.1% (95% CI 2.9 to 3.3), and for ≥40mm 2.4% (95% CI 2.0 to 3.0). After ten years, the rate of revision for ≤28mm was 6.6% (95% CI 6.0 to 7.3), for 32mm 4.8% (95% CI 4.4 to 5.1) and for 36-38mm 5.0% (95% CI 4.5 to 5.5). There were no data for ≥40mm after ten years (AOANJRR, 2016).
The UK report 2016 of the National Joint Registry (NJR, 2016) showed that for metal-on- polyethylene (unspecified) cemented monobloc cups, there was a statistically significant effect of head size (overall difference P<0.001 by logrank test) on revision rates (NJR, 2016). Up to five years, implants with a head diameter of 36mm had the worst failure rates compared to all smaller heads. At ten years, implants with a head diameter of 32mm were worse than those with head sizes of 22-25mm, 26mm and 28mm (NJR, 2016).
Revision rates for different head sizes for metal-on-polyethylene uncemented metal shell with polyethylene liners were also analysed. There was a statistically significant effect of head size (overall P<0.001), with head size 44mm showing worse failure rates, but there were small numbers after five years (NJR, 2016)
For ceramic-on-polyethylene cemented monobloc cups there was a statistically significant difference between the head sizes overall (P=0.002) and the largest head size 36mm showing worse failure rates (NJR, 2016).
For ceramic-on-polyethylene uncemented metal shells used with polyethylene liners, there was a statistically significant difference between the three head sizes (P=0.005), the best survival rate was in the intermediate size group (32mm) with 28mm and 36mm both showing similar worse outcomes (NJR, 2016).
For ceramic-on-ceramic uncemented metal shells used with ceramic liners head sizes 28mm, 32mm, and 36mm showed similar worse failure rates (P=0.01). Head size 40mm showed the best survival rate, though there were small numbers available (NJR, 2016).
Grading of evidence
Risk of revision
Risk of revision was reported in several registries, which are observational studies that are graded as low level of evidence. Results for highly cross-linked polyethylene were inconsistent. Moreover, the number of included patients with a ceramic-on-ceramic implant was limited. Therefore, the level of evidence was downgraded to very low.
Search and select
To answer the question a systematic literature analysis was performed for the following research question:
PICO 1: What are the favourable and unfavourable effects of a total hip arthroplasty with a head diameter of 22mm, 36mm or >36 mm, compared to a toal hip arthroplasty with a head diameter of 28 or 32 mm?
P: patients planned for total hip arthroplasty;
I: total hip arthroplasty with head diameter of 22mm, 36mm or >36 mm;
C: total hip arthroplasty with head diameter of 28 or 32 mm;
O: number of revisions (both specifically for dislocation as well as for any reason)
Relevant outcome measures
The working group decided that number of revisions (both specifically for dislocation as well as for any reason) was the most important outcome measure for decision-making.
The working group did not define outcomes a priori, but used definitions as provided in the studies.
Only studies with a minimum follow-up of five years after surgery - and preferably ten years or more - were included.
The working group tried to balance the data based on the number of patients available in the original papers and the statistical analysis provided in these documents.
The working group has taken into account that one of the most important outcome measurements, the rate of dislocation, is underreported. Most dislocations are treated conservatively and are not reported in registries, unless they lead to revision of one or more prosthetic components. This is a severe methodological flaw and hence this limits the conclusions on this topic. Therefore, only revisions are included as outcome measure in this module.
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 575 hits. Studies were selected using the following selection criteria: (1) total hip arthroplasty with head diameter of 22m, 36m or >36m compared to total hip arthroplasty with head diameter of 28 or 32 mm; (2) follow-up of at least 5 years; (3) outcome reported as number of revisions (both specifically for dislocation as well as for any reason). Based on title and abstract seventheen studies were pre-selected. After obtaining full text, fifteen studies were excluded, and two studies were included in the literature analysis. In addition, data from two registries (Australian and United Kingdom) were used.
The most important study characteristics are described in evidence tables. The assessment of risk of bias is provided in risk of bias tables.
References
- Allepuz A, Havelin L, Barber T, et al. Effect of Femoral Head Size on Metal-on-HXLPE Hip Arthroplasty Outcome in a Combined Analysis of Six National and Regional Registries. J Bone Joint Surg Am. 2014;96 Suppl 1(E):12-18. http://dx.doi.org/10.2106/JBJS.N.00461.
- Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). Annual Report. Adelaide: AOA; 2016.
- Darrith B, Courtney PM, Della Valle CJ. Outcomes of dual mobility components in total hip arthroplasty: a systematic review of the literature. Bone Joint J. 2018;100-B(1):11-19. doi: 10.1302/0301-620X.100B1.BJJ-2017-0462.
- National Joint Registry for England, Wales, Northern Ireland and the Isle of Man (NJR). 13th Annual Report. www.njrreports.org.uk. 2016.
- Nederlandse Orthopaedische Vereniging. Advies Metaal-op-Metaal Heupprothesen per 1 augustus 2015.
- Sedrakyan A, Graves S, Bordini B, et al. Comparative Effectiveness of Ceramic-on-Ceramic Implants in Stemmed Hip Replacement. A Multinational Study of Six National and Regional Registries. J Bone Joint Surg Am. 2014;96 Suppl1(E):34-41.http://dx.doi.org/10.2106/JBJS.N.00465
Evidence tables
Evidence-table for intervention studies (randomized controlled trials and non-randomized observational studies (cohort studies, case-control studies, case series))1
Research question: What is the preferred diameter of the head in total hip arthroplasty?
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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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Allepuz, 2014 |
Type of study: meta-analysis of six registries (cohort studies)
Setting: distributed health data network ICOR (International consortium of Orthopaedic Registries), international collaborative of orthopaedic registries and US FDA
Country: Italy, Spain, Norway and Australia
Source of funding: unknown |
Inclusion criteria: patients with osteoarthritis who underwent THA without cement from 2001 to 2010
Exclusion criteria: age <45 or >64
N total at baseline: 14,372 |
Describe intervention (treatment/procedure/test):
Metal on HXLPE articulations involving various head sizes: <32, 32 and >32 mm
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Describe control (treatment/procedure/test):
Metal on HXLPE articulations with head size 32 mm
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Length of follow-up: Maximum 8 years, results presented in one year intervals, main results presented after five years
Loss-to-follow-up: Not described
Incomplete outcome data: Not described
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Outcome measures and effect size (include 95%CI and p-value if available):
Five year rate of revision surgery varied from 1.9 to 3.2%
A head size of <32 mm was not associated with an increased risk of revision compared with a size of 32 mm HR=0.91 95%CI (0.69 to 1.19) A head size of >32 mm was not associated with an increased risk of revision compared with 32 mm HR 1.05 95%CI (0.71 to 1.53) |
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Sedrakyan, 2014 |
Type of study: registry Six national and regional registries (Kaiser Permanente and HealthEast in the U.S., Emilia-Romagna region in Italy, Catalan region in Spain, Norway, and Australia)
Setting: hospital
Source of funding: unknown
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Inclusion criteria: THA performed without cement from 2001 to 2010 in patients forty-five to sixty-four years of age with osteoarthritis.
N total at baseline: 34,985
Important prognostic factors2: Mean age: not reported
Sex 48% male
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Describe intervention (treatment/procedure/test):
>28 mm |
Describe control (treatment/procedure/test):
<=28 |
Length of follow-up: maximum ten years
Loss-to-follow-up: average follow-up rate >90%
Incomplete outcome data: Not reported
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Outcome measures and effect size (include 95%CI and p-value if available):
CC implants >28mm and <=28mm lower risk of C-C implant revision associated with use of larger compared with smaller head size (HR (hazard ratio) = 0.73, 95% CI (confidence interval) = 0.60 to 0.88, p = 0.001)
<=28mm C-C implants and M-HXLPE any head size: Smaller C-C bearings were associated with a higher risk of failure compared with M-HXLPE bearings (HR = 1.36, 95% CI = 1.09 to 1.68, p = 0.006)
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Loss to follow-up might occur if patients move to another region. |
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AOANJRR (2016) |
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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Revision rates for different head sizes |
Length of follow-up: 1-15 years |
Outcome measures and effect size (include 95%CI and p-value if available):
% Revision (5 years) Non-XLPE (n=40,391) <32mm: 3.4 (3.2 to 3.6) 32mm: 3.7 (3.1to 4.4) >32mm: 8.7 (5.6 to 13.2) XLPE (n=174,409) <32mm: 2.9 (2.8 to 3.1) 32mm: 2.6 (2.5 to 2.7) >32mm: 2.9 to 3.2) Ceramic-on-ceramic (n=72,139) ≤28mm: 4.3 (3.8 to 4.8) 32mm: 3.1 (2.9 to 3.9) 36-38mm: 3.1 (2.9 to 3.9) ≥40mm: 2.4 (2.0 to 3.0) |
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NJR (2016) |
Type of study: Annual report registry
Country: United Kingdom |
Inclusion criteria: Primary total hip replacement procedures
N total at baseline: Total population in the registry: 796,636
Median age: 69 years (total population in the registry)
Sex: 60% female (total population in the registry)
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Effect of head size for selected bearing surfaces/fixation sub-groups (a) Metal-on-polyethylene cemented monobloc cups n=257,577 (b) Metal-on-polyethylene uncemented metal shells with polyethylene liners n=206,758 (c) Metal-on-metal uncemented metal cups or metal shells with metal liners n=30,777 (d) Ceramic-on-polyethylene cemented monobloc cups n=34,444 (e) Ceramic-on-polyethylene uncemented metal shells with polyethylene liners n=79,377 (f) Ceramic-on-ceramic uncemented metal shells with ceramic liners n=122,723 |
Length of follow-up: 1-12 years |
Outcome measures: (a): 5y: 36mm worst failure rates. 10y: 32mm worse than 22.25mm, 26mm and 28mm. (b): 44mm showing worse failure rates (small numbers after 5y). (c): not relevant (d): largest head size 36mm showing worse failure rates. (e): best survival rate for 32mm, with 28mm and 36mm both showing similar worse outcomes (f): 28mm, 32mm, and 36mm showed similar worse failure rates. 40mm best survival rate (but small numbers). |
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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.
Risk of bias table for intervention studies (observational: non-randomized clinical trials, cohort and case-control studies)
Research question: What is the preferred diameter of the head in total hip arthroplasty?
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Study reference
(first author, year of publication) |
Bias due to a non-representative or ill-defined sample of patients?1
(unlikely/likely/unclear) |
Bias due to insufficiently long, or incomplete follow-up, or differences in follow-up between treatment groups?2
(unlikely/likely/unclear) |
Bias due to ill-defined or inadequately measured outcome ?3
(unlikely/likely/unclear) |
Bias due to inadequate adjustment for all important prognostic factors?4
(unlikely/likely/unclear) |
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Allepuz, 2014 |
Unlikely |
Unlikely |
Unlikely |
Unlikely |
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Sedrakyan, 2014 |
Unlikely |
Unlikely |
Unlikely |
Unlikely |
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AOANJRR, 2016 |
Unlikely |
Unlikely |
Unlikely |
Unlikely |
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NJR, 2016 |
Unlikely |
Unlikely |
Unlikely |
Unclear |
- Failure to develop and apply appropriate eligibility criteria: a) case-control study: under- or over-matching in case-control studies; b) cohort study: selection of exposed and unexposed from different populations.
- 2 Bias is likely 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; or length of follow-up differs between treatment groups or is too short. The risk of bias is unclear if: the number of patients lost to follow-up; or the reasons why, are not reported.
- Flawed measurement, or differences in measurement of outcome in treatment and control group; bias may also result from a lack of blinding of those assessing outcomes (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.
- Failure to adequately measure all known prognostic factors and/or failure to adequately adjust for these factors in multivariate statistical analysis.
Methods
Authorization date and validity
Last review : 12-02-2019
Last authorization : 12-02-2019
Planned reassessment : 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?
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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 |
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Head diameter |
NOV |
2018 |
2023 |
5 years |
NOV |
- |
General details
The development of this guideline was funded by the Stichting Kwaliteitsgelden Medisch Specialisten (SKMS; Foundation for Quality Funding for Medical Specialists).
Scope and target group
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
Declaration of interest
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.
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Werkgroeplid |
Mogelijke conflicterende belangen met betrekking tot deelname werkgroep |
Toelichting |
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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) |
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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 |
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D.E. Lopuhaä |
Geen belangen |
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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) |
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Dr. W.F.H. Peter |
Geen belangen |
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Dr. P.D. Croughs |
Geen belangen |
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Dr. S.B.W. Vehmeijer |
Directeur Orthoparc (onbetaald) Bestuurslid Dutch Hip Society (onbetaald) National Representative European Hip Society (onbetaald) Consulent Zimmer Biomet (betaald) |
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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) |
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Dr. R.A. Faaij |
Geen belangen |
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Dr. A.M.J.S. Vervest |
Lid-beroepsgenoot Regionaal Tuchtcollege voor de Gezondheidszorg Den Haag (betaald) Voorzitter Centrale Opleidings Commissie Tergooi (onbetaald) |
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J. Vooijs |
Geen belangen |
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Drs. G. Willemsen – de Mey |
Geen belangen |
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Meelezers |
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Drs. S. Nijssen |
ISO 15189 auditor, betaald door RvA |
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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 |
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Dr. A.T. Bernards |
Geen belangen |
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Patient involvement
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.
Method of development
Implementation
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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 |
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All |
1 to 3 years |
Reduction |
No |
Not used to work with this type of head |
Annual quality audit |
NOV |
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Methods and proces
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.
Search strategy
Searches are available upon request. Please contact the Richtlijnendatabase.