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

Part of paid clinical trials in Irvine, California.

Sponsor
University of Southern California
Study ID
NCT07244211
Status
Recruiting

Conditions

  • Femoral Neck Fractures

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jan 23, 2026
Status verified
Jun 2026
Primary completion
Feb 28, 2029
Completion
Jan 31, 2030

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Hip arthroplasty
  • Active Comparator: Internal fixation

Primary Outcome Measure

Composite outcome of death, ambulation status, and days alive and out of hospital. [ Time Frame: 120 days after randomization ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
University of California, IrvineIrvineCalifornia92660
Gerard Slobogean, MD
714-456-1699
Gerard Slobogean, MD (PRINCIPAL_INVESTIGATOR)
Los Angeles General Medical CenterLos AngelesCalifornia90033
Joshua Gary, MD
+13234426984
Joshua L Gary, MD (PRINCIPAL_INVESTIGATOR)
University of Southern CaliforniaLos AngelesCalifornia90033
Joshua Gary, MD
+13234426984
Joshua L Gary, MD (PRINCIPAL_INVESTIGATOR)
Indiana UniversityBloomingtonIndiana47405
Dillon O'Neill, MD
Dillon O'Neill, MD (PRINCIPAL_INVESTIGATOR)
University of Maryland, Baltimore - R Adams Cowley Shock Trauma CenterBaltimoreMaryland21201
Mark Gage, MD
Mark Gage, MD (PRINCIPAL_INVESTIGATOR)
University of Maryland Capital Region HealthLargoMaryland20774
Todd Jaeblon, MD
Todd Jaeblon, MD (PRINCIPAL_INVESTIGATOR)
University of MississippiUniversityMississippi38677
Patrick Bergin, MD
Patrick Bergin, MD (PRINCIPAL_INVESTIGATOR)
University of CincinnatiCincinnatiOhio45221
Michael Beltran, MD
Michael Beltran, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt UniversityNashvilleTennessee37235
Lauren Tatman, MD
Lauren Tatman, MD (PRINCIPAL_INVESTIGATOR)
University of UtahSalt Lake CityUtah84108
Lucas Marchand, MD
Lucas Marchand, MD (PRINCIPAL_INVESTIGATOR)
Inova Health Care ServicesFairfaxVirginia22031
Grag Gaski, MD
Greg Gaski, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Irvine, CA

Related Studies