Indicaties en contra-indicaties voor THP
Uitgangsvraag
Wat zijn de indicaties en contra-indicaties voor een totale heupprotese bij patiënten met artrose?
Aanbeveling
Bied patiënten met artrose van de heup een totale heupvervanging aan als er sprake is van pijn en/of functieverlies, als er radiologische afwijkingen zijn die wijzen op een eindstadium van heupartrose, en als conservatieve behandeling heeft gefaald.
Een maligniteit (in de anamnese), diabetes en overgewicht zijn geen contra-indicaties.
Neem het besluit om al dan niet te opereren samen met de patiënt, nadat deze geïnformeerd is dat:
- Patiënten met diabetes of met overgewicht (BMI >30 kg/m²) een grotere kans hebben op complicaties en mogelijk minder baat hebben van de heupvervanging.
- De levensduur van het implantaat minder is bij patiënten met een maligniteit in de anamnese en bij patiënten met diabetes of overgewicht.
Overwegingen
THA is an effective and successful surgical procedure for end stage osteoarthritis of the hip when conservative treatment has failed. Recommendations about conservative treatment are described in the guideline 'Conservatieve behandeling van artrose in heup of knie'. In the early development of THA, only healthy patients with single end stage osteoarthritis underwent surgery. Nowadays patients with comorbidities are also eligible for surgery. It is questionable whether outcomes in these patients are comparable to patients without comorbidities.
In general, comorbidities are associated with higher anaesthetic risks and operative complications after THA. For comorbidities, a distinction should be made between diseases causing osteoarthritis and disorders coexisting with (primary or secondary) osteoarthritis.
In this literature analysis, comorbidities affecting the outcome of THAs were studied. The term “comorbidity” is used as a container concept to describe possible risk factors for impaired outcome (for example smoking is not a real comorbidity). In addition, one patient with a history of malignancy might have an impaired physical condition and life expectancy, while another patient might have been cured years ago and have a (nearly) normal life expectancy. The study by Jämsen (2013) concluded that in general a history of malignancy was associated with impaired survival of the hip prosthesis in patients with osteoarthritis.
Studies reporting adverse reactions, complications, survival, functional gain and pain relief after THA in patients with osteoarthritis and a history of malignancy, diabetes, obesity, who are smokers or are using immunosuppressants were selected. These factors were selected because the prevalence of these comorbidities is increasing. Furthermore, these comorbidities influence anaesthesia and functional gain after THA.
Obese patients have higher surgical risks. A higher BMI is associated with an increased incidence of peri-operative complications and decreased functional gain after the THA (Chee, 2010; Fu, 2016; Li, 2017, Davis, 2011). Ideally, diabetes mellitus should be divided in type 1 and 2, because the duration of the disease is different in these patients. These differences have different effects on surgery. Proper control of the diabetes will diminish the peri-operative complication rate. Having diabetes was not associated with more joint infections. Moreover, the survival of the prosthesis was also not impaired Jämsen, (2013). We found no studies investigating the influence of smoking habits and the use of immunosuppressants on the defined outcomes. Only five observational studies were found (Chee, 2010; Fu, 2016; Li, 2017; Jämsen, 2013, Davis, 2011). Because of the observational design of the included studies the evidence was graded low.
Generally, studies from Joint Replacement Registries showed worse outcomes after a THA in patients suffering from avascular osteonecrosis or rheumatoid arthritis compared to patients with idiopatic osteoarthritis.
Surgeons must weigh the risks against the benefits for each patient with comorbidities individually. In the pre-operative phase, they must evaluate if there are any comorbidities that can increase the surgical risk. The life expectancy of the individual patient with a history of malignancy should be evaluated, diabetes patients must have proper control and obese patients should be advised to lose weight. To decide upon surgery the surgeon should consult other medical professionals like an anaesthesiologist or oncologist. Finally, the surgeon will discuss the possibilities with the patient and make decisions together. Option grids are useful to facilitate shared decision making.
Onderbouwing
Achtergrond
Pain and loss of function, in combination with radiographic changes due to end stage osteoarthritis of the hip, are the mean reasons for total hip arthroplasty (THA).
The indication for hip replacement, which is increasing in many parts of the world, does not depend only on the incidence and prevalence of osteoarthritis, but is also influenced by other factors like the more and more active style of living in the elderly, higher life expectancy, improved outcomes of arthroplasties, changing reimbursement systems, etc. Therefore, indications for total hip arthroplasty differ around the world, and can only be given in general terms: the indication should be based on pain, loss of function, and radiographic changes after failure of conservative treatment, considering the individual contra-indications, in a shared – decision making process with the patient.
Since the population is getting older and more patients suffer from comorbidities, the question is which patients will benefit most from THA and should comorbid conditions be considered contra-indications?
Conclusies
PICO 2
|
Very Low GRADE |
Survival of the prosthesis after total hip arthroplasty for osteoarthritis seems to be impaired in patients with a history of malignancy, compared to patients without a history of malignancy.
Sources Jämsen, (2013) |
PICO 3
|
Very low GRADE |
There seems to be no difference in survival of the prosthesis after total hip arthroplasty for osteoarthritis in patients with diabetes compared to patients without diabetes.
Sources Jämsen, (2013) |
PICO 4
|
Very low GRADE |
Complication rates after total hip arthroplasty for osteoarthritis seem to be higher in obese patients compared to non-obese patients.
Sources (Chee, 2010; Fu, 2016; Davis, 2011) |
|
Very low GRADE |
Survival of the prosthesis after total hip arthroplasty for osteoarthritis seems to be lower in obese patients compared to non-obese patients.
Sources Chee, (2010) |
|
Very low GRADE |
Functional gain after total hip arthroplastyfor osteoarthritis seems to be lower in obese patients compared to non-obese patients.
Sources (Li, 2017; Davis, 2011) |
|
Very low GRADE |
There seems to be no difference in pain relief after total hip arthroplasty for osteoarthritis in obese patients compared to non-obese patients.
Sources (Li, 2017; Davis, 2011) |
Samenvatting literatuur
Description of studies
Five studies were included in the literature summary (Chee, 2010; Li, 2017; Fu, 2016; Jämsen, 2013, Davis, 2011).
The prospectively matched study by Chee (2010) compared THAs performed in morbidly obese patients with osteoarthritis (n=55) with a matched group of non-obese patients (n=53). Morbid obesity was defined as a BMI >40 kg/m2 or as >35 kg/m2 with at least one comorbidity. Participants were categorised as non-obese when their BMI was <30 kg/m2. The participants were matched for age, gender, type of prosthesis, laterality and pre-operative Harris Hip Score (HHS). Reported outcome measures were post-operative HHS, SF-36 scores, complication rate (superficial wound infection, deep joint infection, deep-vein thrombosis, pulmonary embolism, peri-operative mortality and dislocations) and survival (with revision surgery as endpoint) Chee, (2010).
The prospective national cohort study by Li (2017) evaluated to which extent osteoarthritis patients (n=2040) with various levels of obesity benefited from THA. The study was based on a large, prospective national cohort of patients treated with THA Li, (2017). Patients were grouped according to their pre-operative BMI as underweight or normal weight (≤24.99 kg/m2), overweight (25.00 to 29.99 kg/m2), obese (30.00 to 34.99 kg/m2), severely obese (35.00 to 39.99 kg/m2) or morbidly obese (≥40.00 kg/m2). Adjustments were performed for baseline function and pain score, gender, age, ethnicity, household income, education, living alone, type of insurance, medical comorbidities, low back pain, number of other painful joints and surgical volume of the hospital. Reported outcome measures were physical function (Physical Component Summary (PCS) score) and pain (Hip disability and Osteoarthritis Outcome Score (HOOS score)) Li, (2017).
The observational study by Fu (2016) investigated the independent morbidity risk of malnutrition relative to obesity in patients with osteoarthritis (n=20,210) who underwent a THA. Data from the National Surgical Quality Improvement Program (NSQIP) database were used in this study. Despite the quality and prospective nature of data collection for the NSQIP, pre-operative serum albumin data were not available for a significant percentage of cases. Demographic variables, modified CCI, and obesity classifications were compared between patients with and without pre-operative albumin measurements. Propensity scores were used as a control for potential selection bias in this analysis. Patients were classified as non-obese (BMI: 18.5 to 29.9), obese I (BMI: 30 to 34.9), obese II (BMI: 35 to 39.9), or obese III (BMI >40). Reported outcome measures were 30-day complications (any complications, any major complications, wound complications, respiratory complications, blood transfusions, return to operation room within 30 days, extended length of stay (LOSS)) Fu, (2016).
The register-based study by Jämsen (2013) examined how comorbid diseases affect survival in patients with osteoarthritis (n=43,737) who underwent THA. The reported outcome measure was survival. Adjustments were performed for age, gender, year of operation, laterality of operation (unilateral, simultaneous bilateral), method of prosthesis fixation and type of operating hospital (university, central, regional or other type of hospital) Jämsen, (2013).
The observational study by Davis (2011) examined the effect of body mass index (BMI) on the medium-term outcome after THA in patients with osteoarthritis (n=1617). The reported outcome measures were dislocation, revision, duration of surgery, deep and superficial infection, HHS and SF-36. In the multivariate analysis adjustments were performed for age, gender, operating consultant, pre-operative HHS and SF-36 scores and a diagnosis of malignancy, atherosclerotic disease, cardiac disease, diabetes mellitus, osteoporosis or phlebitis Davis, (2011).
Results
PICO 1: What are the favourable and unfavourable effects of total hip arthroplasty in patients with osteoarthritis using immunosuppressants, versus patients with osteoarthritis not using immunosuppressants?
No studies were found describing the outcomes in patients using immunosuppressants compared to patients not using immunosuppressants.
PICO 2: What are the favourable and unfavourable effects of total hip arthroplasty in patients with osteoarthritis and (a history of) malignancy, versus patients with osteoarthritis and without (a history of) malignancy?
No studies were found describing complications, functional gain and pain relief in patients with (a history of) malignancy compared to patients without (a history of) malignancy.
Survival
In the study by Jämsen (2013) a history of malignancy was associated with impaired survival of the hip prostheses (revision surgery) during ten years of follow-up in the univariate (HR: 1.28 (95%CI 1.06 to 1.55)) and multivariate (HR: 1.27 (95% CI 1.05 to 1.54)) adjusted model Jämsen, (2017).
Grading of evidence
Grading the evidence started at a level of low evidence, because the data used was derived from an observational study. Downgrading by one level was necessary, because of width of confidence interval (imprecision).
PICO 3: What are the favourable and unfavourable effects of total hip arthroplasty in patients with osteoarthritis and diabetes, versus patients with osteoarthritis and no diabetes?
No studies were found describing complications, functional gain and pain relief in patients with diabetes compared to patients without diabetes.
Survival
In the study by Jämsen (2013) diabetes did not affect survival of hip arthroplasties up to 5 years of follow-up in the univariate (HR: 1.08 (95%CI 0.88 to 1.34)) and multivariate (HR: 1.03 (95%CI 0.83 to 1.27)) adjusted model. Diabetes also did not affect survival of hip arthroplasties after five years of follow up in the univariate (HR: 0.77 (95%CI 0.29 to 2.06)) and multivariate (HR: 0.60 (95%CI 0.22 to 1.63)) adjusted model Jämsen, (2013).
Grading of evidence
Grading the evidence started at a level of low evidence, because the data used was derived from an observational study. Downgrading by one level was necessary because there was imprecision (width of confidence interval).
PICO 4: What are the favourable and unfavourable effects of total hip arthroplasty in obese patients with osteoarthritis, versus non-obese patients with osteoarthritis?
Complications
The study by Chee (2010) reported a significantly higher overall peri-operative complication rate in morbidly obese patients (12) compared to non-obese patients (3) (22% versus 5%, p = 0.012) Chee, (2010).
The study by Fu (2016) reported significant differences in any complication(s) overall, any major complication(s), wound complications, blood transfusions, return to the operating room and extended LOS between the different obesity classes (all P <0.004). All obesity classes were associated with having any complication (obese I OR 1.19, CI: 1.01 to 1.40 ; obese II OR 1.29, CI: 1.05 to 1.59; and obese III OR 1.54, CI: 1.21 to 1.98) and wound complications (obese I OR 1.80, CI: 1.30 to 2.50; obese II OR 2.18, CI: 1.47 to 3.25; and obese III OR 3.23, CI: 2.09 to 4.99). Obese II and obese III were also associated with return to operating room (obese II OR 1.59, CI: 1.16 to 2.18 and obese III OR 1.80, CI: 1.22 to 2.63). Obese III was the only obesity class that reached statistical significance as a predictor of extended LOS (OR 1.22, CI: 1.05 to 1.43) Fu, (2016).
The study by Davis (2011) reported a 6.8% risk of dislocation in patients with a BMI ≥35 kg/m2 compared with a 3.2% risk of dislocation in patients with a BMI between 30 and 34.9, a 2.0% risk in patients with a BMI between 25 and 29.9 and a 1.5% risk in patients with a BMI lower than 25 kg/m2. Multivariate adjustments showed a 113.9% increase in odds per 10 point BMI increase (CI: 11.5 to 308.1, p-value = 0.023). The risk of superficial infection was 14.2% in patients with a BMI of 35 kg/m2 compared to 4.6% in patients with a BMI of 30 to 34.9, 3.7% in patients with a BMI between 25 and 29.9 and 4.4% in patients with a BMI lower than 25 kg/m2. Multivariate analysis showed that there were no statistically significant differences between adjacent BMI groups, until the comparison between BMI ≥35 and 30 to 34.9, where patients in the heavier group had a 3.37 times (CI: 1.494 to 7.583) greater chance of superficial wound infection than those with a BMI between 30 and 34.9. Revision and deep infection were also not significantly different with a 10 point BMI increase Davis, (2011).
Grading of evidence
Grading the evidence started at a level of low evidence, because the data used was derived from observational studies. Downgrading by one level was, however, necessary as there were risk of bias (small sample size) and imprecision (width confidence interval).
Survival
The study by Chee (2010) reported a five-year survival, using revision surgery as an endpoint, of 90.9% (CI: 82.9 to 98.9) for morbidly obese patients and 100% for non-obese patients Chee, (2010).
Grading of evidence
Grading the evidence started at a level of low evidence, because the data used was derived from an observational study. Downgrading by one level was, however, necessary as there was imprecision (small sample size).
Functional gain
The study by Li (2017) reported that greater levels of obesity were associated with lower (worse) Physical Component Summary (PCS) scores 6 months after THR (trend test, p <0.001). However, the mean preoperative-to-postoperative changes in PCS scores did not significantly differ by BMI status (P=0.07). Differences in pre-operative-to-postoperative changes in the PCS score became greater after covariate adjustment, with severely and morbidly obese patients having substantially less gain than other patients (p <0.001) Li, (2017).
The study by Davis (2011) reported a 8.19% significant decrease in SF-36 score on physical function by 10 points BMI increase (CI: 4.74 to 11.63, p-value <0.001). This study also reported a 10.41 significant decrease in score for the category physical role limitation (CI: 4.64 to 16.18, p-value <0.001) Davis, (2011).
Grading of evidence
Grading the evidence started at a level of low evidence, because the data used was derived from an observational study. Downgrading by one level was necessary as there was a short follow-up time (risk of bias).
Pain relief
The study by Li (2017) reported that patients with greater levels of obesity had a greater improvement in the mean pre-operative-to-postoperative changes in Hip disability and Osteoarthritis Outcome Score (HOOS) (trend test, p <0.001). However, after covariate adjustment, pre-operative-to-postoperative pain relief did not significantly differ by BMI level Li, (2017).
The study by Davis (2011) reported a 3.98 significant decrease in SF-36 score on pain with every 10 points BMI increase (CI: 0.29 to 7.66, p-value <0.034) Davis, (2011).
Grading of evidence
Grading the evidence started at a level of low evidence, because the data used was derived from an observational study. Downgrading by one level was necessary as there were limitations in study design (short follow-up time) and imprecision (overlap confidence intervals).
PICO 5: What are the favourable and unfavourable effects of total hip arthroplasty in smokers with osteoarthritis, versus non-smokers with osteoarthritis?
No studies were found describing the outcomes in patients undergoing total hip arthroplasty who smoked compared to patients who did not smoke.
Zoeken en selecteren
To answer the question a systematic literature analysis was performed for the following research questions:
PICO 1: What are the favourable and unfavourable effects of total hip arthroplasty in patients with osteoarthritis using immunosuppressants, versus patients with osteoarthritis not using immunosuppressants?
P: patients with osteoarthritis of the hip who underwent total hip arthroplasty;
I: taking immunosuppressive medication;
C: not taking immunosuppressive medication;
O: complications, survival, functional gain, pain relief.
PICO 2: What are the favourable and unfavourable effects of total hip arthroplasty in patients with osteoarthritis and malignancy, versus patients with osteoarthritis and no malignancy?
P: patients with osteoarthritis of the hip who underwent total hip arthroplasty;
I: patients with malignancy;
C: patients without malignancy;
O: complications, survival, functional gain, pain relief.
PICO 3: What are the favourable and unfavourable effects of total hip arthroplasty in patients with osteoarthritis and diabetes, versus patients with osteoarthritis and no diabetes?
P: patients with osteoarthritis of the hip who underwent total hip arthroplasty;
I: patients with diabetes;
C: patients without diabetes;
O: complications, survival, functional gain, pain relief.
PICO 4: What are the favourable and unfavourable effects of total hip arthroplasty in obese patients with osteoarthritis, versus non-obese patients with osteoarthritis?
P: patients with osteoarthritis of the hip who underwent total hip arthroplasty;
I: patients with obesity;
C: patients without obesity;
O: complications, survival, functional gain, pain relief.
PICO 5: What are the favourable and unfavourable effects of total hip arthroplasty in smokers with osteoarthritis, versus non-smokers with osteoarthritis?
P: patients with osteoarthritis of the hip who underwent total hip arthroplasty;
I: patients who smoke;
C: patients who do not smoke;
O: complications, survival, functional gain, pain relief.
Relevant outcome measures
The working group did not define outcomes a priori, but used definitions as provided in the studies.
Search and select (Method)
A literature search was performed in the Medline database (via OVID) with relevant search terms on 18 September 2017. The search strategy is provided in the tab “Methods”. The literature search resulted in 476 hits. Studies reporting complications, survival, functional gain and pain relief after THA in patients with osteoarthritis and obesity, malignancy, diabetes, patients using immunosuppressants or who smoke were selected. Initially, 16 studies were selected. After obtaining full text, 5 studies were included in the literature analysis.
The most important study characteristics are described in evidence-tables. The assessment of risk of bias is provided in risk of bias tables.
Referenties
- Chee YH, Teoh KH, Sabnis BM, et al. Total hip replacement in morbidly obese patients with osteoarthritis: results of a prospectively matched study. J Bone Joint Surg Br. 2010;92(8):1066-71. doi: 10.1302/0301-620X.92B8.22764. PubMed PMID: 20675748.
- Davis AM, Wood AM, Keenan ACM, et al. BallantyneDoes body mass index affect clinical outcome post-operatively and at five years after primary unilateral total hip replacement performed for osteoarthritis? J Bone Joint Surg Br. 2011;93(9):1178-82. doi: 10.1302/0301-620X.93B9.26873.
- Fu MC, D'Ambrosia C, McLawhorn AS, et al. Malnutrition Increases With Obesity and Is a Stronger Independent Risk Factor for Postoperative Complications: A Propensity-Adjusted Analysis of Total Hip Arthroplasty Patients. J Arthroplasty. 2016;31(11):2415-2421. doi:10.1016/j.arth.2016.04.032. Epub 2016 May 6. PubMed PMID: 27237966.
- Jämsen E, Peltola M, Eskelinen A, et al. Comorbid diseases as predictors of survival of primary total hip and knee replacements: a nationwide register-based study of 96 754 operations on patients with primary osteoarthritis. Ann Rheum Dis. 2013;72(12):1975-82. doi: 10.1136/annrheumdis-2012-202064. Epub 2012 Dec 19. PubMed PMID: 23253916; PubMed Central PMCID: PMC3841739.
- Li W, Ayers DC, Lewis CG, et al. Functional Gain and Pain Relief After Total Joint Replacement According to Obesity Status. J Bone Joint Surg Am. 2017;99(14):1183-1189. doi: 10.2106/JBJS.16.00960. PubMed. PMID: 28719557; PubMed Central PMCID: PMC5508191.
Evidence tabellen
Research question: What are the indications and contra-indications for total hip arthroplasty in patients with osteoarthritis?
|
Study reference |
Study characteristics |
Patient characteristics |
Intervention (I) |
Comparison / control (C) |
Follow-up |
Outcome measures and effect size |
Comments |
|
Chee et al., 2010 |
Type of study: Prospectively matched study (The groups were matched for age, gender, type of prosthesis, laterality (right or left, unilateral or bilateral) and pre-operative HHS. It was not always possible to identify a non-obese patient with exactly the same pre-operative HHS as a morbidly obese patient. In this instance, the control with the next ‘worst’ score was identified. If no other control with a ‘worse’ score could be identified, the control with the next ‘better’ score was used.)
Setting: Patients from 1 hospitals, THA operations between 1998 and 2003
Country: United Kingdom
Source of funding: No |
Inclusion criteria: Morbidly obese patients (BMI >40 or BMI >35 with at least on serious comorbidity) with osteoarthritis who underwent THAs between 1998 and 2013. Comorbidities included hypertension, cardiovascular disease, diabetes, cancer, previous deep-vein thrombosis or pulmonary embolus.
Exclusion criteria: Unclear
N total at baseline: N = 108 (53 morbidly obese patients and 53 non-obese patients)
Important characteristics: Age and sex = not relevant (matched study)
Groups comparable at baseline? = not relevant (matched study)
|
THA in morbidly obese patients. Two types of cemented femoral component were used: the Charnley primary THR (De Puy International, Leeds, United Kingdom) and the Lubinus SPII (Waldemar-Link GmbH, Hamburg, Germany). Each harnley component had a 22.225 mm femoral head and each Lubinus one of 32 mm. All acetabular components were cemented Charnley allpolyethylene components. A standard anterolateral approach was used by all eight surgeons. Thromboprophylaxis with low molecular weight heparin was used in all patients. A routine post-operative rehabilitation programme, based on an integrated care pathway, was used. Independent prospective follow-up was undertaken by a dedicated audit team consisting of two specialist nurses. All patients were followed up at six, 18, 36 and 60 months.
|
The same intervention as described in the column ‘Intervention only performed in patients without morbidly obesity.
|
Length of follow-up: Five years of follow-up
Loss-to-follow-up: Nine patients (10 hips) were excluded because of incomplete follow-up, a further three were lost to follow-up and ten (11 hips) had died. |
Complications Morbidly obese: 1
|
Only patients with complete follow-up were include in the data-analysis. |
|
Li et al. (2017) |
Type of study: multiple research questions including: What is the relative role of body mass index (BMI) on postoperative functional status? |
Inclusion criteria: and March 2013; diagnosis of osteoarthritis.
Age (Mean±SD) Sex (Male%) Groups comparable at baseline? = No p-values were calculated. However, some percentages of prognostic risk factors were different at baseline (e.g. ≥1 medical comorbidities (%), moderate or severe low-back pain (%), ≥1 painful joint).
|
Type of THA is not described in the study. |
Type of THAis not described in the study. |
Length of follow-up: |
Of the patients who underwent THR:
|
Type of intervention not described. |
|
Fu et al. (2016) |
Type of study: Source of funding: conflicts of interest, which may include receipt of payment, either direct or indirect, institutional support, or association with an entity in the biomedical field which may be perceived to have potential conflict of interest with this work.) |
Inclusion criteria: codes 715.15, 715.35, and 715.95. emergent basis, and cases with missing preoperative information such as age, gender, height, and weight were excluded. Obese III |
Type of THA is not described in the study. |
Type of THA is not described in the study. |
Length of follow-up: |
Complications (%) Obese I = 5.4 Obese I = 3.9 Obese I = 1.5 Obese I = 0.5 Obese I = 0.4 Obese I = 0.6 Obese I = 13.5 8. Urinary complications Obese I = 1.3 Obese I = 2.1 Obese I = 0.7 Obese I = 18.9
Obese I = 0.2 Return to OR within 30 d |
Odds ratios were calculated. Odds ratio may only be used in prospective cohort studies when the risk on the outcome <10% (this was not the case for the outcomes: blood transfusions and extended los. |
|
Jämsen (2017) |
Type of study: Source of funding: |
Inclusion criteria: |
Type of THA is not described in this study. |
Type of THA is not described in this study. |
Length of follow-up: |
Survival (HR (95% C.I.): |
|
|
Davis (2011) |
Type of study: Source of funding: |
Inclusion criteria: Patients with osteoarthritis which underwent THA.
|
Most operations (96.8%) involved cemented stems using either a Charnley prosthesis (De Puy International, Leeds, United Kingdom), a Charnley Elite prosthesis (De Puy International), or a Lubinus SPII prosthesis (Waldemar-Link GmbH, Germany). Each Charnley component had a 22 mm femoral head and each Lubinus a 32 mm head. All acetabular components were cemented Charnley all-polyethylene Ogee cups. A standard anterolateral surgical approach was used by all surgeons. Low molecular weight heparin was used for thromboprophylaxis in all patients. The post-operative rehabilitation programme was the same in every case, mobilising with a physiotherapist on the first post-operative day, with daily physiotherapy thereafter until discharge. Independent prospective follow-up was undertaken at five years by an audit team consisting of two specialist nurses who were not directly involved in this, or any other, study during data collection. |
The same intervention as described in the column ‘Intervention only performed in patients without morbidly obesity.
|
Length of follow-up: 5 years. A follow-up of around 70%. |
Complications: Overall odds of event: 0.0541
|
|
Risk of bias table for intervention studies (observational: non-randomized clinical trials, cohort and case-control studies)
Research question: What are the indications and contra-indications for total hip arthroplasty in patients with osteoarthritis?
|
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) |
|
Chee, 2010 |
Likely |
Unclear |
Unlikely |
Unlikely |
|
Li, 2017 |
Unlikely |
Likely |
Unlikely |
Unlikely |
|
Fu,2016 |
Unlikely |
Likely |
Unlikely |
Unlikely |
|
Jämsen, 2013 |
Unlikely |
Unlikely |
Unlikely |
Unlikely |
|
Davis, 2011 |
Unlikelly |
Unclear |
Unlikely |
Unlikely |
- 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.
Verantwoording
Autorisatiedatum en geldigheid
Laatst beoordeeld : 12-02-2019
Laatst geautoriseerd : 12-02-2019
Geplande herbeoordeling : 01-01-2024
|
Module |
Party in control |
Year of authorization |
Next assessment of actuality |
Frequency of assessment of actuality |
Which party/parties monitors actuality? |
Important factors that might lead to change in recommendations |
|
Indications and contra-indications |
NOV |
2018 |
2023 |
5 years |
NOV |
Worse outcome for several comorbities |
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.
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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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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
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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 for implementation1 |
Actions for implementation2 |
Reponsibility for these actions3 |
Other remarks |
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All |
<1 year |
No |
No |
No |
No |
NOV |
No |
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.
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
- Onderzoek