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 — PROCEDUREParticipants 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 — PROCEDUREParticipants 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
- Joseph Patterson, MD+13234426984
Locations (11)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California, Irvine | Irvine | California | 92660 | Gerard Slobogean, MD (PRINCIPAL_INVESTIGATOR) |
| Los Angeles General Medical Center | Los Angeles | California | 90033 | Joshua L Gary, MD (PRINCIPAL_INVESTIGATOR) |
| University of Southern California | Los Angeles | California | 90033 | Joshua L Gary, MD (PRINCIPAL_INVESTIGATOR) |
| Indiana University | Bloomington | Indiana | 47405 | Dillon O'Neill, MD Dillon O'Neill, MD (PRINCIPAL_INVESTIGATOR) |
| University of Maryland, Baltimore - R Adams Cowley Shock Trauma Center | Baltimore | Maryland | 21201 | Mark Gage, MD Mark Gage, MD (PRINCIPAL_INVESTIGATOR) |
| University of Maryland Capital Region Health | Largo | Maryland | 20774 | Todd Jaeblon, MD Todd Jaeblon, MD (PRINCIPAL_INVESTIGATOR) |
| University of Mississippi | University | Mississippi | 38677 | Patrick Bergin, MD Patrick Bergin, MD (PRINCIPAL_INVESTIGATOR) |
| University of Cincinnati | Cincinnati | Ohio | 45221 | Michael Beltran, MD Michael Beltran, MD (PRINCIPAL_INVESTIGATOR) |
| Vanderbilt University | Nashville | Tennessee | 37235 | Lauren Tatman, MD Lauren Tatman, MD (PRINCIPAL_INVESTIGATOR) |
| University of Utah | Salt Lake City | Utah | 84108 | Lucas Marchand, MD Lucas Marchand, MD (PRINCIPAL_INVESTIGATOR) |
| Inova Health Care Services | Fairfax | Virginia | 22031 | Grag Gaski, MD Greg Gaski, MD (PRINCIPAL_INVESTIGATOR) |
Find similar trials in Irvine, CA
By research site
University of California, Irvine· Irvine, CALos Angeles General Medical Center· Los Angeles, CAUniversity of Southern California· Los Angeles, CAIndiana University· Bloomington, INUniversity of Maryland, Baltimore - R Adams Cowley Shock Trauma Center· Baltimore, MDUniversity of Maryland Capital Region Health· Largo, MD
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