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Cover of Evidence review for hip replacement approach

Evidence review for hip replacement approach

Joint replacement (primary): hip, knee and shoulder

Evidence review M

NICE Guideline, No. 157

.

London: National Institute for Health and Care Excellence (NICE); .
ISBN-13: 978-1-4731-3722-6

1. Hip replacement approach

1.1. Review question: In adults having primary elective hip replacement, what is the most clinical and cost-effective approach: posterior, direct anterior, anterolateral, direct superior or SuperPATH?

1.2. Introduction

There are a number of different surgical ways (approaches) to access the hip joint. Over the last decade total hip replacements have been performed using 2 main approaches: The posterior approach in which the hip joint is approached from the back by releasing and reflecting the short external rotators and dividing the capsule at the back of the hip; and the anterolateral (Hardinge) approach in which the hip joint is approached from the side by releasing a portion of the hip abductors and dividing the underlying hip capsule. Neither of these approaches follow a true internervous plane and both are thought to have advantages and disadvantages with respect to complications such as dislocation, nerve injury and post-operative limp.

There is increasing interest in alternatives to these two approaches such as the direct anterior, direct superior and super path (supercapsular percutaneously assisted). These approaches are attractive as they either use a true internervous plane or are reported to minimise soft tissue damage around the hip, both of which should theoretically improve recovery times and reduce length of hospital stay. This review aims to assess the clinical and cost effectiveness of all the approaches including the main approaches and newer approaches.

1.3. PICO table

For full details see the review protocol in Appendix A:

Table 1. PICO characteristics of review question.

Table 1

PICO characteristics of review question.

1.4. Clinical evidence

1.4.1. Included studies

A search was conducted for randomised controlled trials comparing the effectiveness of different surgical hip replacement approaches utilised for knee joint replacement surgery. Twenty six RCTs were included in the review;2,3,9,10,12,13,15,16,41,52,56,59,64,74,81,87,88,90,95,97,108–110,115,118,124,128,130 these are summarised in Table 2 below.

Studies covering four comparisons were found. These were:

Direct anterior approach compared to anterolateral approach – 10 RCTs

Direct anterior approach versus posterior approach – 8 RCTs

Posterior approach versus anterolateral approach – 7 RCTs

SuperPATH approach versus posterior approach – 1 RCT

Evidence from these studies is summarised in the clinical evidence summary below (Table 3).

See also the study selection flow chart in Appendix C: study evidence tables in Appendix D: forest plots in Appendix E: and GRADE tables in Appendix H:

1.4.2. Excluded studies

See the excluded studies list in Appendix I:

1.4.3. Summary of clinical studies included in the evidence review

Table 2. Summary of studies included in the evidence review.

Table 2

Summary of studies included in the evidence review.

See Appendix D: for full evidence tables.

1.4.4. Quality assessment of clinical studies included in the evidence review

Table 3. Clinical evidence summary: Direct anterior approach versus anterolateral approach.

Table 3

Clinical evidence summary: Direct anterior approach versus anterolateral approach.

Table 4. Clinical evidence summary: Direct anterior approach versus posterior approach.

Table 4

Clinical evidence summary: Direct anterior approach versus posterior approach.

Table 5. Clinical evidence summary: Posterior approach versus anterolateral approach.

Table 5

Clinical evidence summary: Posterior approach versus anterolateral approach.

Table 6. Clinical evidence summary: SuperPATH approach versus posterior approach.

Table 6

Clinical evidence summary: SuperPATH approach versus posterior approach.

See Appendix F: for full GRADE tables.

1.5. Economic evidence

1.5.1. Included studies

Two health economic studies were identified with the relevant comparison and have been included in this review.82,102 The studies are summarised in the health economic evidence profile below (Table 7) and the health economic evidence table in Appendix H:

1.5.2. Excluded studies

Two studies relating to this review question were identified but were excluded due to limited applicability.14,18 Two studies relating to this review question were identified but were excluded due to very serious limitations.28,54 The studies are listed in Appendix I: with reasons for exclusion.

See also the health economic study selection flow chart in Appendix G:

1.5.3. Summary of studies included in the economic evidence review

Table 7. Health economic evidence profile: Anterior THR versus posterior THR versus lateral THR.

Table 7

Health economic evidence profile: Anterior THR versus posterior THR versus lateral THR.

1.5.4. Unit costs

Relevant unit costs are provided below to aid consideration of cost effectiveness.

Table 8. Weighted average unit costs for HRG HN12 (Elective Very Major Hip Procedures for Non-Trauma) including excess bed days.

Table 8

Weighted average unit costs for HRG HN12 (Elective Very Major Hip Procedures for Non-Trauma) including excess bed days.

1.6. Evidence statements

1.6.1. Clinical evidence statements

Direct anterior approach versus anterolateral approach

Evidence from 10 RCTs was found for this comparison.

A benefit was found for direct anterior approach in length of stay (n=247, very low quality), deep infection at 6 weeks or earlier (n=70, very low quality), and hyperesthesia at later than 2 years (n=87, very low quality).

A benefit was found for anterolateral approach in surgery time (n=432, very low quality), lateral femoral cutaneous nerve injury at 6 weeks or earlier (n=70, very low quality) and 3 outcomes at later than 2 years: dislocation (n=235, very low quality), revision (n=87, very low quality), and deep infection (n=87, very low quality).

No difference between approaches was found for blood loss during surgery (n=169, low quality), 4 quality of life or PROMs outcomes at 6 weeks or earlier (n=138 to226, low to very low quality) and 4 quality of life or PROMs outcomes at later than 6 weeks up to 1 year (n=78 or 325, low or very low quality).

Direct anterior approach versus posterior approach

Evidence from 8 RCTs was found for this comparison.

A benefit was found for direct anterior approach in Harris Hip Score at 6 weeks or earlier (n=87, very low quality), revision later than 6 weeks up to 1 year (n=160, very low quality), and dislocation later than 6 weeks up to 1 year (n=261, very low quality).

A benefit was found for posterior approach in surgery time (n=354, very low quality), lateral cutaneous nerve of the thigh neuropraxia (n=73, moderate quality), blood loss (n=166, low quality), and deep infection at 6 weeks or earlier (n=46, low quality).

No difference between approaches was found for length of stay (n=405, low quality) and 5 quality of life or PROMs outcomes at 6 weeks or earlier were (n=73 to160, low to very low quality), quality of life or 9 PROMs outcomes at later than 6 weeks to 1 year (n=73 to308, low to very low quality), and 3 PROMs outcomes at later than 2 years (n=75 to79, low to very low quality).

Direct anterior approach versus posterior approach

Evidence from 7 RCTs was found for this comparison.

A benefit was found for direct anterior approach for surgical blood loss (n=110, moderate quality), reoperation later than 6 weeks up to 1 year (n=68, very low quality), and revision later than 2 years (n=243, very low quality).

A benefit was found for posterior approach in superficial surgical site infection later than 6 weeks up to 1 year (n= 60, moderate quality).

No difference between approaches was found for surgery time (n=374, very low quality), Harris Hip Score (n=68, very low quality) or pain (n=22, low quality) later than 6 weeks up to 1 year, and Harris Hip Score (n=196, low quality) or dislocation (n=371, low quality) later than 2 years.

SuperPATH approach versus posterior approach

Evidence from 1 RCT was found for this comparison (n=92).

A clinically important benefit for the SuperPATH approach was found for length of stay (moderate quality) PROMS measured with the Barthel Index and Harris Hip Score at 6 weeks or earlier, dislocation later than 6 weeks up to 1 year and (low to very low quality).

No outcomes favoured posterior approach over SuperPATH approach.

No difference between approaches was found for surgery time (low quality) and PROMs measured with the Barthel Index and HHS score at later than 6 weeks up to 1 year and (low to very low quality).

1.6.2. Health economic evidence statements

Two cost comparisons found that the anterior THR approach was cost saving compared to both the lateral and posterior approaches. Both studies were assessed as partially applicable with potentially serious limitations.

1.7. The committee’s discussion of the evidence

1.7.1. Interpreting the evidence

1.7.1.1. The outcomes that matter most

The critical outcomes were mortality, quality of life, revision rate of joint replacement and Patient Reported Outcome Measures (PROMs) at 6 weeks or earlier (short term) later than 6 weeks up to 1 year (moderate term) or after at least 2 years (long term). The benefits of knee joint replacement operations may not present themselves immediately after surgery; they may take months or years to become apparent. Therefore, multiple time points were necessary to capture this variation in outcomes as rehabilitation occurs.

The important outcomes were deep and superficial surgical site infection, length of stay, reoperation or dislocation rate, intraoperative complications such as nerve damage and surgery time.

1.7.1.2. The quality of the evidence

Twenty six RCTs were included in the review, showing outcomes ranging from very low to moderate quality due to risk of bias, imprecision or inconsistency. The majority of the evidence was very low quality mainly due to lack of allocation concealment and blinding, contributing to a higher risk of bias. There was often imprecision due to confidence intervals crossing default minimal important difference. Inconsistency was present several times due to heterogeneity unexplained by subgroup analysis or the number of zero events varying across arms.

1.7.1.3. Benefits and harms

There were four approach comparisons included in this review; direct anterior compared to anterolateral in 10 RCTs, direct anterior compared to posterior in 8 RCTs, posterior compared to anterolateral in 7 RCTs, and SuperPATH compared to posterior in 1 RCT.

The direct anterior versus anterolateral comparison indicated no clinically important difference in 8 for quality of life or PROMs outcomes across short and moderate time points, and blood loss. A clinically important benefit for anterolateral approach was found for revision at 5 years after surgery, dislocation, deep infection (later than 2 years from surgery), lateral femoral cutaneous nerve injury and surgery time. A clinically important benefit for direct anterior approach was found for deep infection at 6 weeks, hyperesthesia and length of stay. The direct anterior versus posterior comparison indicated no clinically important difference for and length of stay, 5 quality of life or PROMs outcomes at short time points, 9 quality of life or PROMs outcomes moderate time points, and 3 PROMs outcomes at the long time point. However there was a clinically important benefit for direct anterior with 1 PROMs outcome (Harris hip score at 6 weeks) along with revision, and dislocation. There was a clinically important benefit for posterior for deep infection, lateral cutaneous nerve of the thigh neuropraxia, blood loss, and surgery time.

The posterior versus anterolateral comparison showed no clinically important difference for 2 PROMs (Harris hip score) outcomes at moderate and long term time points, dislocation, surgery time and pain. There was a clinically important benefit of the anterolateral approach for revision at around 3 years, reoperation and blood loss. There was a clinically important benefit for the posterior approach for superficial surgical site infection.

SuperPATH versus posterior approach found no clinically important difference for 2 PROMs outcomes in the moderate term and also surgery time. The review found a clinically important benefit of the SuperPATH approach for 2 PROMs outcomes in the short term, and also dislocation and length of stay. No clinically important benefits were found for the posterior approach.

The committee related the evidence from the review to their own knowledge and experiences of the various approaches. The direct anterior appears better in the short term, with the committee noting the these are seen in the first 6 weeks after surgery, but these benefits tend to equalise after for the moderate to long term outcomes. Going home the day after surgery, feeling comfortable and getting back to work quickly are often important factors for patients.

Lateral cutaneous nerve of the thigh is a very painful adverse event and was found to be associated with the direct anterior approach in 2 comparisons. 1 outcome was nerve injury in the direct anterior versus anterolateral comparison and the other was neuropraxia in the direct anterior versus posterior comparison. The former showed a small increase in the direct anterior group while the latter affected over 80% in the direct anterior group and no people in the posterior group at 12 weeks. This was discussed by the committee and it was considered that such a high number of events may have been caused by the study’s definition of the outcome which was the absence of normal sensation rather than pain or discomfort. The committee were cognisant that this outcome was not associated with lower PROMs in the study as it is conceivable that absence of normal sensation for a limited period of time does not have a significant negative affect on a person’s experience of the post-surgery period.

There was some evidence at the long time point for 3 of the 4 comparisons. However the committee felt that much longer time horizons of at least 10 years would have given a better view of revision, quality of life, and PROMs outcomes.

The committee agreed the evidence did not indicate the superiority of any single approach.

In the NHS the great majority of people undergo hip replacement via the posterior or anterolateral approaches. In 2017 the National Joint Registry showed the breakdown of surgical approach for hip replacement as 72% for the posterior approach, 25% for the anterolateral approach, and 4% for other approaches. The committee agreed that most surgeons can use an anterolateral approach or posterior approach as initial training provides this. However the other approaches are less commonly used and would require training and experience to carry out effectively. tThe committee also agreed that the surgeon undertaking the approach should have experience and competence in that particular approach to get consistently good results.

The committee were aware that there was very limited RCT data investigating newer approaches. Therefore they agreed to make a consider recommendation for posterior or anterolateral surgical approaches, as they are established approaches and evidence did not show a benefit of one over the other. The also agreed to make a research recommendation to compare SuperPATH approach, direct superior approach, and direct anterior approach to either of the ‘traditional’ posterior or anterolateral approaches.

1.7.2. Cost effectiveness and resource use

The economic evidence showed that the anterior approach was cost saving compared to both the lateral and posterior approaches to total hip replacement, despite having the most expensive operating room costs. The net cost savings for the anterior approach were a result of reduced inpatient length of stay after the initial procedure. The quality of the evidence was very low; it was particularly notable that there was no multivariate adjustment, although there was no significant difference in key characteristics, such as BMI. The presented study also had a short follow-up (3 months) which is problematic as it may not have captured the benefits of the posterior and lateral approaches after this time.

The implant and closure costs between the different approaches will be roughly similar. The similarity in many of the costs and resource use between the approaches is shown through them all mapping to the same HRG code (HN12). However, additional resource use may be associated training surgeons to use the newer anterior approach. Most surgeons will be able to conduct lateral or posterior approaches as these make up the large majority of current practice. The anterior approach is likely to require a longer learning curve and there may be resource implications to this. The clinical review also suggested that the anterior approach may be associated with more neuropraxia at 12 weeks compared to the other approaches, there may be costs associated with treating this adverse event. Given this, the committee made a ‘consider’ recommendation for the lateral and posterior approaches.

No economic evidence was available for the SuperPath or direct superior approaches. Similarly to the anterior approach, SuperPath and direct superior are newer approaches which have not yet been fully explored in the literature. According the NJR, roughly 1/25 total hip replacements are done by anterior or SuperPath. The committee thought that there was some evidence for the short term benefits of these newer approaches, but evidence was lacking for the long term benefits and costs. Therefore a research recommendation was made addressing this.

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Appendices

Appendix B. Literature search strategies

The literature searches for this review are detailed below and complied with the methodology outlined in Developing NICE guidelines: the manual 2014.72

For more detailed information, please see the Methodology Review.

B.1. Clinical search literature search strategy

Searches were constructed using a PICO framework where population (P) terms were combined with Intervention (I) and in some cases Comparison (C) terms. Outcomes (O) are rarely used in search strategies for interventions as these concepts may not be well described in title, abstract or indexes and therefore difficult to retrieve. Search filters were applied to the searches where appropriate.

Table 11. Database date parameters and filters used

Medline (Ovid) search terms

Embase (Ovid) search terms

Cochrane Library (Wiley) search terms

B.2. Health Economics literature search strategy

Health economic evidence was identified by conducting a broad search relating to joint replacement population in NHS Economic Evaluation Database (NHS EED – this ceased to be updated after March 2015) and the Health Technology Assessment database (HTA) with no date restrictions. NHS EED and HTA databases are hosted by the Centre for Research and Dissemination (CRD). Additional health economics searches were run on Medline and Embase.

Table 12. Database date parameters and filters used

Medline (Ovid) search terms

Embase (Ovid) search terms

NHS EED and HTA (CRD) search terms

Appendix D. Clinical evidence tables

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Appendix E. Forest plots

Appendix H. Health economic evidence tables

Download PDF (187K)

Appendix I. Excluded studies

I.2. Excluded health economic studies

Studies that meet the review protocol population and interventions, and the economic study inclusion criteria but have not been included in the review based on applicability and/or methodological quality are summarised below with reasons for exclusion.

Table 18. Studies excluded from the health economic review

Appendix J. Research recommendations

J.1. Surgical approaches in primary elective hip replacement

Research question: Do the direct anterior, direct superior and supercapsular percutaneously assisted(SuperPATH) approaches to hip replacement improve patient-recorded outcome measures and reduce length of hospital stays, revision rates, neurological complications and surgical site infections compared with the posterior and anterolateral approaches?

Why this is important:

The posterior and anterolateral approaches to the hip and the most commonly used approaches for hip replacement surgery. In 2017 NJR data reported that 93,161 of 96,717 (96.3%) of primary hip replacements were performed through one of these two approaches.73 Hip replacements undertaken through these two approaches have excellent results with low 10 year failure rates, significant improvement in functional outcome scores and low rates of complications. In recent years there has been increased uptake and interest in alternative hip approaches (direct anterior, direct superior, superPATH). These approaches have theoretical advantages but often require additional specialist equipment and surgery can take longer to perform, both of which may have cost implications. Furthermore the NICE evidence review raised concerns about the rates of specific complications with some of these newer approaches. There is currently no evidence to support the wider adoption of these approaches and this research recommendation had therefore been developed to support specific research in this area.

PICO question

Population: Patients receiving an elective primary total hip replacement

Intervention(s): Direct anterior, direct superior or superPATH surgical approaches to the hip

Comparison: Posterior or anterolateral approaches to the hip

Outcome(s): Patient reported outcome measures including health related quality of life, Surgical time, Length of stay, rates of complications including the risk of nerve injury and/or neuropraxia, infection, dislocation and problems relating to wound healing

Study designMulticentre Randomised controlled trial comparing one or more interventions to one of the current standard practices (comparators)
Other detailsNICE evidence review raised concerns over the high rates of nerve injury and/or neuropraxia reported in previous studies examining outcomes after the direct anterior approach. The committee also had concerns about infected and wound healing problems related to some of the newer approaches. The committee felt it essential that these outcomes be measured as secondary endpoints in any trial but that a PROM / Health related quality of life measure should be the primary outcome.

Final

Intervention evidence review underpinning recommendation 1.8.1 and the research recommendation in the NICE guideline

This evidence review was developed by the National Guideline Centre, hosted by the Royal College of Physicians

Disclaimer: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and, where appropriate, their carer or guardian.

Local commissioners and providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.

NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn.

Copyright © NICE 2020.
Bookshelf ID: NBK561418PMID: 32881466

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