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MAPT Protocol: Fixation Versus Arthroplasty Surgical Treatments for Early Recovery After HIP Fracture (FASTER-HIP)

RecruitingNA

Sponsor: University of Southern California

Conditions: Femoral Neck Fractures

Interventions: Hip arthroplasty, Internal fixation

Countries: United States, Canada, Spain, United Kingdom

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 overview

Sex: ALL

Age: 60 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.
* Low energy injury mechanism.
* Surgeons with expertise in internal fixation and total hip arthroplasty or hemiarthroplasty are available to perform surgery.

Exclusion Criteria:

* 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.
* Unable to obtain informed consent due to language barriers.
* Unable to obtain informed consent because the legally authorized representative was unavailable.
* Problems, in the judgment of the study personnel, with maintaining follow-up with the patient.
* Currently enrolled in a study or intervention domain that does not permit co-enrollment.
* Prior enrollment in the specific platform trial intervention domain.
* Patient or legally authorized representative did not provide informed consent (declined participation).
* Eligible patient or legally authorized representative was not approached within the screening window (missed participant).
* Other reasons to exclude the patient, as approved by the data coordinating center.
* Associated lower extremity injury that prevents post-operative weight-bearing.
* Retained hardware around the hip that precludes either study treatment.
* Infection around the hip (soft tissue or bone).
* Pathologic fracture with a lytic lesion in the femoral neck that precludes internal fixation.
* Injury did not occur within 21 days of screening.
* Patient is too ill, in the judgment of the attending surgeon, for internal fixation.
* Patient is too ill, in the judgment of the attending surgeon, for arthroplasty.

Locations (21)

Irvine, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Miami, Florida, United States
Bloomington, Indiana, United States
Baltimore, Maryland, United States
Largo, Maryland, United States
University, Mississippi, United States
Cincinnati, Ohio, United States
Oklahoma City, Oklahoma, United States
Allentown, Pennsylvania, United States
Greenville, South Carolina, United States
Nashville, Tennessee, United States
Salt Lake City, Utah, United States
Fairfax, Virginia, United States
Madison, Wisconsin, United States
Vancouver, British Columbia, Canada
Vancouver, British Columbia, Canada
Barcelona, Spain
London, ON, United Kingdom