An interventional study of Hip arthroplasty and Internal fixation in Femoral Neck Fractures, sponsored by University of Southern California. Recruiting at 32 sites in 5 countries. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by University of Southern California · Not applicable, Interventional, and Treatment
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.
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.
207 studies on the registry are indexed under Femoral Neck Fractures; 40 are open to participants now.
This study's planned enrollment of 600 is above the median of 100 across 142 interventional studies indexed under Femoral Neck Fractures.
Browse Femoral Neck Fractures studies →University of Southern California is the lead sponsor of 791 studies on the registry; 136 are open to participants now.
Of its 70 completed or terminated interventional studies of FDA-regulated products, 32 (46%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Hip arthroplasty
Procedure: Internal fixation
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.
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.
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.
Time frame: 120 days after randomization
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.
Time frame: 365 days after randomization
Death
Death consists of time to all-cause mortality.
Time frame: 120 days post-randomization
Death
Death consists of time to all-cause mortality.
Time frame: 12 months post-randomization
Ambulation status
Ambulation will be evaluated using an ordinal ranking of independence
Time frame: 120 days post-randomization
Ambulation status
Ambulation will be evaluated using an ordinal ranking of independence
Time frame: 12 months post-randomization
Days alive and out of hospital
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.
Time frame: 120 days post-randomization
Days alive and out of hospital
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.
Time frame: 12 months post-randomization
Health-related quality of life
EQ-5D-5L - Range: 0 to 1, Higher scores indicates better self-perceived health
Time frame: 120 days days post-randomization
Health-related quality of life
EQ-5D-5L - Range: 0 to 1, Higher scores indicates better self-perceived health
Time frame: 12 months post-randomization
Numeric Pain Rating Scale
The highest level of pain recorded daily in the participant's medical record - Range: 0-10, higher score indicates higher level of pain
Time frame: During hospitalization in the first seven postoperative days
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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