- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07244211
MAPT Protocol: Fixation Versus Arthroplasty Surgical Treatments for Early Recovery After HIP Fracture (FASTER-HIP) (FASTER-HIP)
Musculoskeletal Adaptive Platform Trial (MAPT): Fixation Versus Arthroplasty Surgical Treatments for Early Recovery After HIP Fracture (FASTER-HIP)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Joseph Patterson, MD
- Phone Number: +13234426984
- Email: OrthoTraumaResearch@med.usc.edu
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V6T 1Z4
- Recruiting
- University of British Columbia
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Contact:
- Aresh Sepehri, MD
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Contact:
- Email: aresh.sepehri@vch.ca
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Principal Investigator:
- Aresh Sephri, MD
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Vancouver, British Columbia, Canada
- Recruiting
- Fraser Health Authority
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Contact:
- Darius Viskontas, MD
- Phone Number: 604-777-5577
- Email: dariusviskontas@yahoo.ca
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Contact:
- Phone Number: 604-777-5577
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Principal Investigator:
- Darius Viskontas, MD
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Ontario
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London, Ontario, Canada, N6A 5W9,
- Recruiting
- London Health Sciences Centre
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Contact:
- Emil Schemitsch, MD
- Email: emil.schemitsch@lhsc.on.ca
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Principal Investigator:
- Emil Schemitsch, MD
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Grålum, Norway, 1714
- Recruiting
- Sykehuset Østfold HF / Østfold Hospital Trust
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Contact:
- Frede Frihagen, MD
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Contact:
- Email: Frede.Frihagen@so-hf.no
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Principal Investigator:
- Frede Frihagen, MD
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Barcelona, Spain
- Not yet recruiting
- Hospital Universitari Vall d'Hebron
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Contact:
- Carlos Alberto Piedra-Calle, MD
- Email: carlosalberto.piedra@vallhebron.cat
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Principal Investigator:
- Carlos Alberto Piedra-Calle, MD
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Barcelona, Spain
- Not yet recruiting
- Consorci Sanitari de l'Alt Penedès i Garraf (CSAPG)
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Principal Investigator:
- Alfred Dealbert, MD
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Contact:
- Alfred Dealbert Dealbert, MD
- Email: adealbert@csapg.cat
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California
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Irvine, California, United States, 92660
- Recruiting
- University of California, Irvine
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Principal Investigator:
- Gerard Slobogean, MD
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Contact:
- Gerard Slobogean, MD
- Phone Number: 714-456-1699
- Email: gsloboge@hs.uci.edu
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Los Angeles, California, United States, 90048
- Recruiting
- Cedars-Sinai Medical Center
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Principal Investigator:
- Carol Lin, MD
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Contact:
- Carol Lin, MD
- Email: carol.lin@cshs.org
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Los Angeles, California, United States, 90033
- Recruiting
- University of Southern California
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Principal Investigator:
- Joshua L Gary, MD
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Contact:
- Joshua Gary, MD
- Phone Number: +13234426984
- Email: OrthoTraumaResearch@med.usc.edu
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Los Angeles, California, United States, 90033
- Recruiting
- Los Angeles General Medical Center
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Principal Investigator:
- Joshua L Gary, MD
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Contact:
- Joshua Gary, MD
- Phone Number: +13234426984
- Email: OrthoTraumaResearch@med.usc.edu
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Florida
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Miami, Florida, United States, 33146
- Not yet recruiting
- University of Miami
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Contact:
- Giselle Hernandez, MD
- Email: g.hernandez@med.miami.edu
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Principal Investigator:
- Giselle Hernandez, MD
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Indiana
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Bloomington, Indiana, United States, 47405
- Recruiting
- Indiana University
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Principal Investigator:
- Dillon O'Neill, MD
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Contact:
- Dillon O'Neill, MD
- Email: doneill5@iuhealth.org
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Maryland
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Baltimore, Maryland, United States, 21201
- Recruiting
- University of Maryland, Baltimore - R Adams Cowley Shock Trauma Center
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Principal Investigator:
- Mark Gage, MD
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Contact:
- Mark Gage, MD
- Email: mgage@som.umaryland.edu
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Largo, Maryland, United States, 20774
- Recruiting
- University of Maryland Capital Region Health
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Principal Investigator:
- Todd Jaeblon, MD
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Contact:
- Todd Jaeblon, MD
- Email: tjaeblon@som.umaryland.edu
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Not yet recruiting
- Beth Israel Deaconess Medical Center
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Contact:
- Ishaq Ibrahim, MD
- Email: ioibrahi@bidmc.harvard.edu
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Principal Investigator:
- Ishaq Ibrahim, MD
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Mississippi
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University, Mississippi, United States, 38677
- Recruiting
- University of Mississippi
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Principal Investigator:
- Patrick Bergin, MD
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Contact:
- Patrick Bergin, MD
- Email: pbergin@umc.edu
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New York
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New York, New York, United States, 10016
- Not yet recruiting
- NYU Langone Health System
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Contact:
- Ran Schwarzkopf, MD
- Email: Ran.schwarzkopf@nyulangone.org
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Principal Investigator:
- Ran Schwarzkopf, MD
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Ohio
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Cincinnati, Ohio, United States, 45221
- Recruiting
- University of Cincinnati
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Contact:
- Michael Beltran, MD
- Email: beltrame@ucmail.uc.edu
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Principal Investigator:
- Michael Beltran, MD
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Recruiting
- University of Oklahoma Health Sciences Center
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Principal Investigator:
- Brandon Hull, MD
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Contact:
- Brandon Hull, MD
- Email: Brandon-Hull@ou.edu
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Pennsylvania
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Allentown, Pennsylvania, United States, 18102
- Recruiting
- St. Luke's University Health System
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Principal Investigator:
- Dustin Greenhill, MD
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Contact:
- Dustin Greenhill, MD
- Email: dustin.greenhill@sluhn.org
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South Carolina
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Greenville, South Carolina, United States, 29601
- Recruiting
- Prisma Health-Upstate
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Principal Investigator:
- Kyle Jeray, MD
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Contact:
- Kyle Jeray, MD
- Email: kyle.jeray@prismahealth.org
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Tennessee
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Nashville, Tennessee, United States, 37235
- Recruiting
- Vanderbilt University
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Contact:
- Lauren Tatman, MD
- Email: lauren.m.tatman@vumc.org
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Principal Investigator:
- Lauren Tatman, MD
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Utah
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Salt Lake City, Utah, United States, 84108
- Recruiting
- University of Utah
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Principal Investigator:
- Lucas Marchand, MD
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Contact:
- Lucas Marchand, MD
- Email: lucas.marchand@hsc.utah.edu
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Vermont
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Burlington, Vermont, United States, 05405
- Not yet recruiting
- University of Vermont
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Contact:
- Michael Blankstein, MD
- Email: michael.blankstein@uvmhealth.org
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Principal Investigator:
- Michael Blankstein, MD
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Virginia
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Fairfax, Virginia, United States, 22031
- Recruiting
- Inova Health Care Services
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Principal Investigator:
- Greg Gaski, MD
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Contact:
- Grag Gaski, MD
- Email: greg.gaski@inova.org
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Wisconsin
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Madison, Wisconsin, United States, 53706
- Recruiting
- University of Wisconsin - Madison
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Principal Investigator:
- Chris Domes, MD
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Contact:
- Chris Domes, MD
- Email: domes@ortho.wisc.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Hip 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.
|
|
Active Comparator: Internal 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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:
|
120 days after randomization
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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:
|
365 days after randomization
|
|
Death
Time Frame: 120 days post-randomization
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Death consists of time to all-cause mortality.
|
120 days post-randomization
|
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Death
Time Frame: 12 months post-randomization
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Death consists of time to all-cause mortality.
|
12 months post-randomization
|
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Ambulation status
Time Frame: 120 days post-randomization
|
Ambulation will be evaluated using an ordinal ranking of independence
|
120 days post-randomization
|
|
Ambulation status
Time Frame: 12 months post-randomization
|
Ambulation will be evaluated using an ordinal ranking of independence
|
12 months post-randomization
|
|
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:
|
120 days post-randomization
|
|
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:
|
12 months post-randomization
|
|
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
|
120 days days post-randomization
|
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Health-related quality of life
Time Frame: 12 months post-randomization
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EQ-5D-5L - Range: 0 to 1, Higher scores indicates better self-perceived health
|
12 months post-randomization
|
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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
|
During hospitalization in the first seven postoperative days
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Joseph T Patterson, MD, University of Southern California
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Wounds and Injuries
- Leg Injuries
- Fractures, Bone
- Hip Injuries
- Femoral Fractures
- Hip Fractures
- Femoral Neck Fractures
- Therapeutics
- Surgical Procedures, Operative
- Arthroplasty, Replacement
- Arthroplasty
- Orthopedic Procedures
- Plastic Surgery Procedures
- Prosthesis Implantation
- Fracture Fixation
- Arthroplasty, Replacement, Hip
- Fracture Fixation, Internal
Other Study ID Numbers
- BPS-2024C1-37436 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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