About this trial
This study is an intervention domain of the Musculoskeletal Adaptive Platform Trial. The primary goal of this pragmatic, randomized, open-label, comparative effectiveness trial is to evaluate if arthroplasty is superior to internal fixation when used to treat minimally displaced femoral neck fractures in older adults ≥60 years old. We hypothesize that arthroplasty will reduce death, preserve ambulation, increase days alive and out of hospital, and improve health status compared to internal fixation within 4 months and 12 months from randomization.
Eligibility criteria
Qualifiers
60 years of age or older undergoing surgery due to a minimally displaced femoral neck fracture
The patient has a health condition affecting physical mobility.
Complete fracture of the femoral neck (AO/OTA 31B) confirmed with anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging.
Minimally displaced fracture that could be, in the judgment of the attending surgeon, managed with either arthroplasty or in situ internal fixation without reduction.
Disqualifiers
The patient is not clinically suitable for either compared treatment.
Expected injury survival of less than 12 months.
Terminal illness with expected survival of less than 12 months.
Incarceration.
Trial design
Treatments tested in this trial
- Hip arthroplasty
- Internal fixation
Treatment groups
Sponsors and collaborators
University of Southern California
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
McMaster University
Collaborator
University of Maryland, Baltimore
Collaborator
Evellere Group
Collaborator