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

NCT07244211 · tracked via the Priya Life Science Spain tracker

Sponsor

University of Southern California

Phase

Not applicable

Started

2026-01-23

Last updated

2026-09-30

Condition(s) studied

Femoral Neck Fractures

Investigational drug(s) / intervention(s)

Hip arthroplastyInternal fixation

Hip arthroplasty: 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: 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.

Study summary

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

Sex

ALL

Min age

60 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Composite outcome of death, ambulation status, and days alive and out of hospital. — 120 days after randomization
Death consists of time to all-cause mortality. Ambulation will be evaluated using an ordinal ranking of independence. Days alive and out of hospital will be calculated by subtracting the sum of days meeting one of two criteria below: * Days not alive. * Any day on which the participant had an overnight stay in a hospital, inpatient rehabilitation, skilled nursing facility, nursing home, inpatient mental health care facility, or long-term care facility.

Trial sites (31)

Facility	City	Region	Status
University of California, Irvine	Irvine	California	Recruiting
Los Angeles General Medical Center	Los Angeles	California	Recruiting
University of Southern California	Los Angeles	California	Recruiting
Cedars-Sinai Medical Center	Los Angeles	California	Recruiting
University of California San Francisco	San Francisco	California	Recruiting
University of Miami	Miami	Florida	Not Yet Recruiting
Indiana University	Bloomington	Indiana	Recruiting
University of Maryland, Baltimore - R Adams Cowley Shock Trauma Center	Baltimore	Maryland	Recruiting
University of Maryland Capital Region Health	Largo	Maryland	Recruiting
Beth Israel Deaconess Medical Center	Boston	Massachusetts	Not Yet Recruiting
University of Mississippi	University	Mississippi	Recruiting
NYU Langone Health System	New York	New York	Recruiting
University of Cincinnati	Cincinnati	Ohio	Recruiting
University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	Recruiting
St. Luke's University Health System	Allentown	Pennsylvania	Recruiting
Prisma Health-Upstate	Greenville	South Carolina	Recruiting
Vanderbilt University	Nashville	Tennessee	Recruiting
University of Utah	Salt Lake City	Utah	Recruiting
University of Vermont	Burlington	Vermont	Not Yet Recruiting
Inova Health Care Services	Fairfax	Virginia	Recruiting
University of Wisconsin - Madison	Madison	Wisconsin	Recruiting
University of British Columbia	Vancouver	British Columbia	Recruiting
Fraser Health Authority	Vancouver	British Columbia	Recruiting
London Health Sciences Centre	London	Ontario	Recruiting
The Ottawa Hospital	Ottawa	Canada	Not Yet Recruiting
Sykehuset Østfold HF / Østfold Hospital Trust	Grålum	Norway	Recruiting
Hospital Universitario Mutua de Terrassa	Barcelona	Spain	Not Yet Recruiting
Consorci Sanitari de l'Alt Penedès i Garraf (CSAPG)	Barcelona	Spain	Not Yet Recruiting
FRCB-IDIBAPS (Hospital Clinic Barcelona)	Barcelona	Spain	Not Yet Recruiting
Hospital Universitari Vall d'Hebron	Barcelona	Spain	Not Yet Recruiting
University of Edinburgh	Edinburgh	United Kingdom	Not Yet Recruiting

More University of Southern California trials in Spain

Trial-Ready Cohort-Down Syndrome (TRC-DS) Recruiting

Other trials for the same condition

Minimally Displaced Femoral Neck Fracture Pilot Study Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07244211 on ClinicalTrials.gov ↗ ← All trials in Spain