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About
The purpose of this study is to determine whether significant functional benefits are seen in patients who have a bipolar hemiarthroplasty as treatment for hip fracture compared to those who have a unipolar hemiarthroplasty.
Full description
Proposed study design
Randomized controlled trial of unipolar vs bipolar hip hemiarthroplasty for intracapsular fracture of the femoral neck
The trial will be conducted in accordance with the GCP (Good Clinical Practice) guidelines and will be reported in line with the CONSORT statement
Study Centre
The Royal Infirmary of Edinburgh admits 1000 patients a year with a hip fracture; the largest number in any one centre in Scotland. Of these, 500 have intracapsular fractures, which is the type addressed in this study. Some patients will be better suited to a total hip replacement (5-10% of this group), and others may refuse to consent to the trial (previous experience has suggested a rate of 15-20%). Investigators therefore expect just over 300 patients to be recruitable each year, and so plan to allow up to two years for recruitment, and two years to complete follow up of the last patient
Brief Study Method
Power analysis and number of patients
200 patients in each arm of study (total 400) allowing for expected 27% mortality at one year.
DMC (Data Monitoring Committee)
A data monitoring committee will review the results during the study period to allow the project to be terminated if statistical significance is reached or if there are any untoward events.
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria
Exclusion Criteria
Primary purpose
Allocation
Interventional model
Masking
400 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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