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

September 3, 2026 updated by: Joseph Patterson, University of Southern California

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

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.

Study Overview

Status

Recruiting

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.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 1Z4
        • Recruiting
        • University of British Columbia
        • Contact:
          • Aresh Sepehri, MD
        • Contact:
        • Principal Investigator:
          • Aresh Sephri, MD
      • Vancouver, British Columbia, Canada
        • Recruiting
        • Fraser Health Authority
        • Contact:
        • Contact:
          • Phone Number: 604-777-5577
        • Principal Investigator:
          • Darius Viskontas, MD
    • Ontario
      • London, Ontario, Canada, N6A 5W9,
        • Recruiting
        • London Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Emil Schemitsch, MD
      • Grålum, Norway, 1714
        • Recruiting
        • Sykehuset Østfold HF / Østfold Hospital Trust
        • Contact:
          • Frede Frihagen, MD
        • Contact:
        • Principal Investigator:
          • Frede Frihagen, MD
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
        • Principal Investigator:
          • Carlos Alberto Piedra-Calle, MD
      • Barcelona, Spain
        • Not yet recruiting
        • Consorci Sanitari de l'Alt Penedès i Garraf (CSAPG)
        • Principal Investigator:
          • Alfred Dealbert, MD
        • Contact:
    • California
      • Irvine, California, United States, 92660
        • Recruiting
        • University of California, Irvine
        • Principal Investigator:
          • Gerard Slobogean, MD
        • Contact:
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Principal Investigator:
          • Carol Lin, MD
        • Contact:
      • Los Angeles, California, United States, 90033
        • Recruiting
        • University of Southern California
        • Principal Investigator:
          • Joshua L Gary, MD
        • Contact:
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Los Angeles General Medical Center
        • Principal Investigator:
          • Joshua L Gary, MD
        • Contact:
    • Florida
      • Miami, Florida, United States, 33146
        • Not yet recruiting
        • University of Miami
        • Contact:
        • Principal Investigator:
          • Giselle Hernandez, MD
    • Indiana
      • Bloomington, Indiana, United States, 47405
        • Recruiting
        • Indiana University
        • Principal Investigator:
          • Dillon O'Neill, MD
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland, Baltimore - R Adams Cowley Shock Trauma Center
        • Principal Investigator:
          • Mark Gage, MD
        • Contact:
      • Largo, Maryland, United States, 20774
        • Recruiting
        • University of Maryland Capital Region Health
        • Principal Investigator:
          • Todd Jaeblon, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Not yet recruiting
        • Beth Israel Deaconess Medical Center
        • Contact:
        • Principal Investigator:
          • Ishaq Ibrahim, MD
    • Mississippi
      • University, Mississippi, United States, 38677
        • Recruiting
        • University of Mississippi
        • Principal Investigator:
          • Patrick Bergin, MD
        • Contact:
    • New York
      • New York, New York, United States, 10016
        • Not yet recruiting
        • NYU Langone Health System
        • Contact:
        • Principal Investigator:
          • Ran Schwarzkopf, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45221
        • Recruiting
        • University of Cincinnati
        • Contact:
        • Principal Investigator:
          • Michael Beltran, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Principal Investigator:
          • Brandon Hull, MD
        • Contact:
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18102
        • Recruiting
        • St. Luke's University Health System
        • Principal Investigator:
          • Dustin Greenhill, MD
        • Contact:
    • South Carolina
      • Greenville, South Carolina, United States, 29601
    • Tennessee
      • Nashville, Tennessee, United States, 37235
        • Recruiting
        • Vanderbilt University
        • Contact:
        • Principal Investigator:
          • Lauren Tatman, MD
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Recruiting
        • University of Utah
        • Principal Investigator:
          • Lucas Marchand, MD
        • Contact:
    • Vermont
      • Burlington, Vermont, United States, 05405
        • Not yet recruiting
        • University of Vermont
        • Contact:
        • Principal Investigator:
          • Michael Blankstein, MD
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Inova Health Care Services
        • Principal Investigator:
          • Greg Gaski, MD
        • Contact:
    • Wisconsin
      • Madison, Wisconsin, United States, 53706
        • Recruiting
        • University of Wisconsin - Madison
        • Principal Investigator:
          • Chris Domes, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Active Comparator: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite outcome of death, ambulation status, and days alive and out of hospital.
Time Frame: 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.
120 days after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite outcome of death, ambulation status, and days alive and out of hospital.
Time Frame: 365 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.
365 days after randomization
Death
Time Frame: 120 days post-randomization
Death consists of time to all-cause mortality.
120 days post-randomization
Death
Time Frame: 12 months post-randomization
Death consists of time to all-cause mortality.
12 months post-randomization
Ambulation status
Time Frame: 120 days post-randomization
Ambulation will be evaluated using an ordinal ranking of independence
120 days post-randomization
Ambulation status
Time Frame: 12 months post-randomization
Ambulation will be evaluated using an ordinal ranking of independence
12 months post-randomization
Days alive and out of hospital
Time Frame: 120 days post-randomization

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 post-randomization
Days alive and out of hospital
Time Frame: 12 months post-randomization

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.
12 months post-randomization
Health-related quality of life
Time Frame: 120 days days post-randomization
EQ-5D-5L - Range: 0 to 1, Higher scores indicates better self-perceived health
120 days days post-randomization
Health-related quality of life
Time Frame: 12 months post-randomization
EQ-5D-5L - Range: 0 to 1, Higher scores indicates better self-perceived health
12 months post-randomization
Numeric Pain Rating Scale
Time Frame: During hospitalization in the first seven postoperative days
The highest level of pain recorded daily in the participant's medical record - Range: 0-10, higher score indicates higher level of pain
During hospitalization in the first seven postoperative days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Joseph T Patterson, MD, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2026

Primary Completion (Estimated)

February 28, 2029

Study Completion (Estimated)

January 31, 2030

Study Registration Dates

First Submitted

October 31, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Actual)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

September 9, 2026

Last Update Submitted That Met QC Criteria

September 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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