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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Recruiting
• Indiana University
  Bloomington, Indiana, United States Recruiting

Study contacts

• Principal investigator: Joseph T Patterson, MD — University of Southern California
• Study coordinator: Joseph Patterson, MD
• Email: OrthoTraumaResearch@med.usc.edu
• Phone: +13234426984

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.