Fixation versus arthroplasty for faster recovery after minimally displaced femoral neck fractures (FASTER-HIP)

Musculoskeletal Adaptive Platform Trial (MAPT): Fixation Versus Arthroplasty Surgical Treatments for Early Recovery After HIP Fracture (FASTER-HIP)

This trial will test whether replacing the hip (arthroplasty) instead of fixing the bone (internal fixation) helps people aged 60 and older with minimally displaced femoral neck fractures recover faster, stay alive and walking, and spend more days at home over the first year.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 600 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: University of Southern California (Academic / other)
• Locations: 9 sites (Irvine, California and 8 other locations)
• Trial ID: NCT07244211 on ClinicalTrials.gov

What this trial studies

FASTER-HIP is a pragmatic, randomized, open-label comparative effectiveness domain within the Musculoskeletal Adaptive Platform Trial that randomizes older adults with minimally displaced femoral neck fractures to arthroplasty or in situ internal fixation. Eligible patients are age 60 or older with low-energy, minimally displaced complete femoral neck fractures judged by the surgeon to be treatable with either option, and procedures are performed by experienced surgeons. Primary outcomes include death, preservation of ambulation, days alive and out of hospital, and patient-reported health status measured at 4 and 12 months. The platform design allows this domain to run alongside other interventions under shared infrastructure and prespecified stopping rules.

Who should consider this trial

Good fit: Adults aged 60 or older with a low-energy, minimally displaced complete femoral neck fracture that the attending surgeon believes could be treated either with arthroplasty or in situ internal fixation and who are medically fit for surgery are ideal candidates.

Not a fit: Patients whose fractures are not minimally displaced, who are not clinically suitable for either surgical option, who have expected survival under 12 months, or who cannot consent are unlikely to benefit from this comparison.

Why it matters

Potential benefit: If arthroplasty is superior, patients could experience fewer deaths and reoperations, better walking ability, and more days alive and at home in the months after injury.

How similar studies have performed: Observational studies and limited randomized data have suggested arthroplasty may reduce reoperation and mortality and improve ambulation for some displaced or minimally displaced femoral neck fractures, but high-quality randomized evidence for this specific comparison remains limited.

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.

Where this trial is running

Irvine, California and 8 other locations

• University of California, Irvine — Irvine, California, United States (Recruiting)
• Los Angeles General Medical Center — Los Angeles, California, United States (Recruiting)
• University of Southern California — Los Angeles, California, United States (Recruiting)
• Indiana University — Bloomington, Indiana, United States (Recruiting)
• University of Maryland, Baltimore - R Adams Cowley Shock Trauma Center — Baltimore, Maryland, United States (Recruiting)
• University of Maryland Capital Region Health — Largo, Maryland, United States (Recruiting)
• University of Mississippi — University, Mississippi, United States (Recruiting)
• University of British Columbia — Vancouver, British Columbia, Canada (Recruiting)
• Fraser Health Authority — Vancouver, British Columbia, Canada (Recruiting)

Study contacts

• Principal investigator: Joseph T Patterson, MD — University of Southern California
• Study coordinator: Joseph Patterson, MD

Conditions Femoral Neck Fractures; Minimally displaced femoral neck fractures; arthroplasty; hip fractures; femoral fractures; orthopaedic procedures; older adults; patient-centered outcomes