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

NCT ID: NCT07244211

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2030-01-31

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.

Detailed Description

The Musculoskeletal Adaptive Platform Trial (MAPT) is an adaptive platform trial protocol that enables the simultaneous evaluation of multiple interventions (i.e., intervention domains) within a consistent infrastructure. Each intervention being evaluated in the MAPT will have an intervention domain protocol that describes additional eligibility criteria, interventions, secondary outcomes, and statistical stopping rules. The overarching objective of the MAPT trial platform is to incrementally decrease decisional uncertainty and identify treatments that will optimize patient outcomes. The platform focuses on the comparative effectiveness of available treatment options.

Adult patients aged 60 years or older with a low-energy minimally displaced femoral neck fracture treated with surgery are eligible for the FASTER-HIP intervention domain. Nearly half of all elderly hip fractures are femoral neck fractures, and approximately 20% are minimally displaced. Internal fixation has remained the treatment of choice for these injuries because these fractures can be fixed in situ, and the surgical implants can be inserted with little surgical dissection. Patients treated with internal fixation experience high complication rates, with the pooled risk of reoperation and mortality each above 14%. Preliminary data have suggested arthroplasty for minimally displaced fractures may lead to better patient outcomes, including improved ambulation, fewer reoperations, and a lower risk of death compared to internal fixation. While the preliminary data supporting the use of arthroplasty for minimally displaced fractures is promising, the necessary evidence to make this practice change remains lacking.

FASTER-HIP is a pragmatic, randomized, open-label, comparative effectiveness trial comparing hip arthroplasty versus internal fixation for minimally displaced femoral neck fractures. Randomization in this domain occurs in a 1:1 ratio (hip arthroplasty:internal fixation). The primary outcome is a composite of death within 120 days, ambulation status at 120 days, and days alive and out of hospital within 120 days of randomization. The primary outcome will be hierarchically assessed using the Win ratio. Secondary outcomes include the same composite at 365 days, individual components of the composite, health-related quality of life (EQ-5D-5L), and pain scores during hospitalization.

Conditions

Femoral Neck Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hip arthroplasty

Group Type: ACTIVE_COMPARATOR

Hip arthroplasty

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

Internal fixation

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: collaborator

Evellere Group

UNKNOWN

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Joseph Patterson

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph T Patterson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

Los Angeles General Medical Center

Los Angeles, California, United States

University of Southern California

Los Angeles, California, United States

Countries

United States

Central Contacts

Pui Yan, MS

Role: CONTACT

puiyan@med.usc.edu

+13234426984

Facility Contacts

Pui Yan, MS

Role: primary

puiyan@med.usc.edu

+13234426984

Pui Yan, MS

Role: primary

puiyan@med.usc.edu

+13234426984

Other Identifiers

BPS-2024C1-37436

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

BPS-2024C1-37436

Identifier Type: -

Identifier Source: org_study_id