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Compares treatment options for Femoral Neck Fractures
Official title MAPT Protocol: Fixation Versus Arthroplasty Surgical Treatments for Early Recovery After HIP Fracture (FASTER-HIP)
ClinicalTrials.gov ID: NCT07244211
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- 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...
- Minimally displaced fracture that could be, in the judgment of the attending surgeon, managed with either arthroplasty or in situ internal fixation...
- Low energy injury mechanism.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Irvine, California, United States
- Los Angeles, California, United States
- Bloomington, Indiana, United States
- Baltimore, Maryland, United States
- Largo, Maryland, United States
- University, Mississippi, United States
- Cincinnati, Ohio, United States
- Greenville, South Carolina, United States
- Nashville, Tennessee, United States
- Salt Lake City, Utah, United States
- Fairfax, Virginia, United States
- Vancouver, British Columbia, Canada
- London, ON, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Irvine, California, United States; Los Angeles, California, United States; Bloomington, Indiana, United States; Baltimore, Maryland, United States; Largo, Maryland, United States; University, Mississippi, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.