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The World Hip Trauma Evaluation Study 3: Hemiarthroplasty Evaluation by Multicentre Investigation - WHITE 3: HEMI -
A L Sims1, N Parsons2, J Achten3
1Northumbria NHS, Foundation Trust, Northumbria Healthcare, NE63 9JJ, UK asims@nhs.net.
Insights
This study compares two hip hemiarthroplasty prostheses to determine optimal patient outcomes for displaced intracapsular hip fractures. It aims to provide evidence for improved hip fracture management and prosthesis selection.
Area of Science:
- Orthopaedic surgery
- Trauma surgery
- Biomedical engineering
Background:
- Displaced intracapsular hip fractures are common, with hemiarthroplasty or total hip arthroplasty as standard treatments.
- National Institute for Health and Care Excellence (NICE) guidance recommends cemented stem arthroplasty with an Orthopaedic Device Evaluation Panel (ODEP) rating of 3B or higher.
- The Thompsons prosthesis lacks an ODEP rating, leading to varied adherence to guidelines and debate on optimal prosthesis choice.
Purpose of the Study:
- To provide high-quality evidence on the optimum choice of prosthesis for hip hemiarthroplasty.
- To address the lack of empirical evidence guiding national hip fracture management recommendations.
- To inform clinical decision-making for hip fracture treatment.
Main Methods:
- A multi-centre, multi-surgeon, parallel, two-arm, standard-of-care pragmatic randomised controlled trial (RCT).
- The study is embedded within the WHiTE Comprehensive Cohort Study (ISRCTN63982700).
- Main analysis involves a two-way equivalence comparison between Hemi-Thompson and Hemi-Exeter polished taper with Unitrax head, supplemented by the National Hip Fracture Database (NHFD).
Main Results:
- Equivalence comparison between Hemi-Thompson and Hemi-Exeter prostheses.
- Secondary outcomes include radiological leg length discrepancy, mortality, re-operation rates, and hospital stay.
- Data will be supplemented by the National Hip Fracture Database (NHFD).
Conclusions:
- There is a lack of evidence regarding the optimal prosthesis for hip hemiarthroplasty.
- Current national guidance relies on expert opinion rather than empirical data.
- The study aims to provide crucial evidence as hip fracture incidence is projected to increase.
Background:
Approximately half of all hip fractures are displaced intracapsular fractures. The standard treatment for these fractures is either hemiarthroplasty or total hip arthroplasty. The recent National Institute for Health and Care Excellence (NICE) guidance on hip fracture management recommends the use of 'proven' cemented stem arthroplasty with an Orthopaedic Device Evaluation Panel (ODEP) rating of at least 3B (97% survival at three years). The Thompsons prosthesis is currently lacking an ODEP rating despite over 50 years of clinical use, likely due to the paucity of implant survival data. Nationally, adherence to these guidelines is varied as there is debate as to which prosthesis optimises patient outcomes.
Design:
This study design is a multi-centre, multi-surgeon, parallel, two arm, standard-of-care pragmatic randomised controlled trial. It will be embedded within the WHiTE Comprehensive Cohort Study (ISRCTN63982700). The main analysis is a two-way equivalence comparison between Hemi-Thompson and Hemi-Exeter polished taper with Unitrax head. Secondary outcomes will include radiological leg length discrepancy measured as per Bidwai and Willett, mortality, re-operation rate and indication for re-operation, length of index hospital stay and revision at four months. This study will be supplemented by the NHFD (National Hip Fracture Database) dataset.
Discussion:
Evidence on the optimum choice of prosthesis for hemiarthroplasty of the hip is lacking. National guidance is currently based on expert opinion rather than empirical evidence. The incidence of hip fracture is likely to continue to increase and providing high quality evidence on the optimumCite this article: A. L. Sims. The World Hip Trauma Evaluation Study 3: Hemiarthroplasty Evaluation by Multicentre Investigation - WHITE 3: HEMI - An Abridged Protocol. Bone Joint Res 2016;5:18-25. doi: 10.1302/2046-3758.51.2000473.
