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

NCT07244211 | Recruiting DMC

• 1 other identifier: BPS-2024C1-37436
• Study Type: interventional
• Target: 600
• Locations: 2 countries
• Sites: 8

Brief 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.

Conditions

Femoral Neck Fractures

Keywords

Minimally displaced femoral neck fractures; arthroplasty; hip fractures; femoral fractures; orthopaedic procedures; older adults; patient-centered outcomes; adaptive trial; internal fixation; pragmatic trial

Outcome Measures

Primary Outcomes (1)

• Composite outcome of death, ambulation status, and days alive and out of hospital.

  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.

  120 days after randomization

Secondary Outcomes (10)

• Composite outcome of death, ambulation status, and days alive and out of hospital.

  365 days after randomization

• Death

  120 days post-randomization

• Death

  12 months post-randomization

• Ambulation status

  120 days post-randomization

• Ambulation status

  12 months post-randomization

Study Arms (2)

Hip arthroplasty

ACTIVE COMPARATOR

Procedure: Hip arthroplasty

Internal fixation

ACTIVE COMPARATOR

Procedure: Internal fixation

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.

Hip arthroplasty

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.

Internal fixation

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute: collaborator
• Evellere Group: collaborator
• University of Southern California: lead
• McMaster University: collaborator
• University of Maryland, Baltimore: collaborator

Study Sites (8)

University of California, Irvine

Irvine, California, 92660, United States

RECRUITING

Los Angeles General Medical Center

Los Angeles, California, 90033, United States

RECRUITING

University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

Indiana University

Bloomington, Indiana, 47405, United States

RECRUITING

University of Maryland, Baltimore - R Adams Cowley Shock Trauma Center

Baltimore, Maryland, 21201, United States

RECRUITING

University of Maryland Capital Region Health

Largo, Maryland, 20774, United States

RECRUITING

University of Mississippi

University, Mississippi, 38677, United States

RECRUITING

Fraser Health Authority

Vancouver, British Columbia, Canada

RECRUITING

MeSH Terms

Conditions

Femoral Neck Fractures; Hip Fractures; Femoral Fractures

Interventions

Arthroplasty, Replacement, Hip; Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation; Fracture Fixation; Therapeutics

Study Officials

• Joseph T Patterson, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Patterson, MD

CONTACT

+13234426984; OrthoTraumaResearch@med.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The participant, treating clinicians, the research team, and the outcome assessors will not be blinded to the treatment allocation and outcome assessments. The data analysts and those interpreting the results of the trial will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 31, 2025
• First Posted: November 24, 2025
• Study Start: January 23, 2026
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): January 31, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

US (7); CA (1)