RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: University of Southern California • ClinicalTrials.gov ID: NCT07244211

Registry updated: 2026-10-05

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Description

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.

Interventions

Hip arthroplasty (Procedure)
Participants will undergo surgical treatment using standard hip arthroplasty techniques for femoral minimally displaced femoral neck fracture. A modern porous-coated press-fit or cemented hip arthroplasty prosthesis will be used at the treating surgeon's discretion. Press-fit implants that have no ingrowth or ongrowth surface will not be permitted. The type of hip prosthesis (hemiarthroplasty or total hip arthroplasty), bearing (single or dual mobility), or the method of arthroplasty fixation (cemented or uncemented) will be at the discretion of the treating surgeon.
Internal fixation (Procedure)
Participants will undergo surgical treatment using standard fixation techniques for minimally displaced femoral neck fractures. The treating surgeon may perform fracture reduction maneuvers if desired. Fixed-angle devices and multiple screws will be permitted. The internal fixation device(s) will be inserted through a small lateral incision. Internal fixation constructs combining cancellous screws and fixed-angle devices will be permitted.

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.

Conditions

Femoral Neck Fractures

Locations

University of California, Irvine — Irvine, California, United States
Los Angeles General Medical Center — Los Angeles, California, United States
University of Southern California — Los Angeles, California, United States
Cedars-Sinai Medical Center — Los Angeles, California, United States
University of California San Francisco — San Francisco, California, United States
University of Miami — Miami, Florida, United States
Indiana University — Bloomington, Indiana, United States
University of Maryland, Baltimore - R Adams Cowley Shock Trauma Center — Baltimore, Maryland, United States
University of Maryland Capital Region Health — Largo, Maryland, United States
Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
University of Mississippi — University, Mississippi, United States
NYU Langone Health — New York, New York, United States
University of Cincinnati — Cincinnati, Ohio, United States
University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
St. Luke's University Health System — Allentown, Pennsylvania, United States
Prisma Health-Upstate — Greenville, South Carolina, United States
Vanderbilt University — Nashville, Tennessee, United States
University of Utah — Salt Lake City, Utah, United States
University of Vermont — Burlington, Vermont, United States
Inova Health Care Services — Fairfax, Virginia, United States
University of Wisconsin - Madison — Madison, Wisconsin, United States
University of British Columbia — Vancouver, British Columbia, Canada
Fraser Health Authority — Vancouver, British Columbia, Canada
London Health Sciences Centre — London, Ontario, Canada
The Ottawa Hospital — Ottawa, Canada
Sykehuset Østfold HF / Østfold Hospital Trust — Grålum, Norway
Hospital Universitario Mutua de Terrassa — Barcelona, Spain
Consorci Sanitari de l'Alt Penedès i Garraf (CSAPG) — Barcelona, Spain
FRCB-IDIBAPS (Hospital Clinic Barcelona) — Barcelona, Spain
Hospital Universitari Vall d'Hebron — Barcelona, Spain
University of Edinburgh — Edinburgh, United Kingdom

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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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