Femoral Neck Fractures
Conditions
Keywords
Minimally displaced femoral neck fractures, arthroplasty, hip fractures, femoral fractures, orthopaedic procedures, older adults, patient-centered outcomes, adaptive trial, internal fixation, pragmatic trial
Brief summary
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.
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.
Interventions
PROCEDUREHip 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.
PROCEDUREInternal 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.
Sponsors
University of Southern California
Patient-Centered Outcomes Research Institute
McMaster University
University of Maryland, Baltimore
Evellere Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
The participant, treating clinicians, the research team, and the outcome assessors will not be blinded to the treatment allocation and outcome assessments. The data analysts and those interpreting the results of the trial will be blinded.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite outcome of death, ambulation status, and days alive and out of hospital. | 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
| Measure | Time frame | Description |
|---|---|---|
| Composite outcome of death, ambulation status, and days alive and out of hospital. | 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 | 120 days post-randomization | Death consists of time to all-cause mortality. |
| Ambulation status | 120 days post-randomization | Ambulation will be evaluated using an ordinal ranking of independence |
| Days alive and out of hospital | 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. |
| Health-related quality of life | 120 days days post-randomization | EQ-5D-5L - Range: 0 to 1, Higher scores indicates better self-perceived health |
| Numeric Pain Rating Scale | 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 |
Countries
Canada, United States
Contacts
CONTACTJoseph Patterson, MD
PRINCIPAL_INVESTIGATORJoseph T Patterson, MD
University of Southern California
Outcome results
None listed