RecruitingNCT07244211ClinicalTrials.gov record

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

Femoral Neck Fractures

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THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Not applicable
Age range: 60 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 600 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: No masking

Hip arthroplasty

Not reported in this registry record.

Procedure: Hip arthroplasty

Internal fixation

Not reported in this registry record.

Procedure: Internal fixation

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.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

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.

Secondary measures

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.

Death

Time frame: 120 days post-randomization

Death consists of time to all-cause mortality.

Death

Time frame: 12 months post-randomization

Death consists of time to all-cause mortality.

Ambulation status

Time frame: 120 days post-randomization

Ambulation will be evaluated using an ordinal ranking of independence

Ambulation status

Time frame: 12 months post-randomization

Ambulation will be evaluated using an ordinal ranking of independence

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.

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.

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

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

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

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

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Research locations (32)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

Find a location in this study

32 locations

University of California, IrvineIrvine, California, United StatesRecruiting

Gerard Slobogean, MDCONTACTgsloboge@hs.uci.edu 714-456-1699

Gerard Slobogean, MDPRINCIPAL_INVESTIGATOR

What this study involves

About the research

Who may be able to participate?

Treatment, groups and participation

What researchers are measuring

Primary measures

Secondary measures

Research locations (32)

Study team and timeline

Official study contacts

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