Identification of Predictors for Clinical Outcomes in Femoroacetabular Impingement Surgery
NCT ID: NCT04243447
Last Updated: 2025-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
747 participants
OBSERVATIONAL
2020-02-02
2025-11-29
Brief Summary
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Detailed Description
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Potential participants will be identified at their initial PI's outpatient clinic at which the PI will meet with the patient and determine if the patient should be treated surgically due to a diagnosis of FAI. Once the PI identifies the patient as a surgical candidate, the research study team in the clinic will approach the patient with study information to discuss. If the patient would like to participate, the patient will sign an informed consent document (assent document for minors) and begin completing study-specific information. If the patient would like to take the study documents home to consider participation, the research team member will provide his/her contact information to the patient.
SPECIFIC AIMS:
1. Determine the predictors of mid-term patient-reported outcomes (PROs) and treatment failures in an established prospective longitudinal cohort of Femoroacetabular Impingement (FAI) surgeries.
2. Determine the impact of three-dimensional femoral and acetabular morphology on PROs at short-term follow-up in a novel prospective longitudinal cohort of arthroscopic FAI surgery.
3. Determine if the new Patient-Reported Outcome Measurement Information System (PROMIS) correlates with legacy PROs in patients undergoing FAI surgery.
DATA COLLECTION:
1. Retrospective Follow-up (FAI-1): The original cohort includes previously consented participants in a closed-to-enrollment study who underwent FAI surgical treatment in the past. This cohort will be followed to investigate the most important predictors of FAI surgery outcomes. In Specific Aim 1, we propose to analyze mid-term follow-up (minimum 8 years) of the FAI-1 cohort to identify important predictors of treatment outcomes and failures in FAI surgery.
2. Prospective Enrollment (FAI-2): Consented participants, in the actively enrolling study, will be enrolled in a new multicenter longitudinal prospective arthroscopic FAI surgery cohort and followed to a minimum 2 years post-surgery (T2). The primary outcome measures will be the collection of the patient report outcomes (PROs) that will be analyzed in order to improve surgical care and outcomes. These clinical outcome metrics will be assessed at baseline, 3 months, 6 month, 1 year, and 2 year postoperatively.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Skeletally Mature
3. Failure of 6 weeks of conservative treatment
4. Primary surgery (Hip Arthroscopic Treatment)
a. Surgical treatment of FAI with hip arthroscopy
5. Tonnis 0 -1 OA, with greater than 2 mm of joint space
6. Clinical diagnosis of FAI (cam or combined; alpha \>50 degrees)
Exclusion Criteria
2. Skeletally Immature
3. Acetabular Dysplasia (LCEA \< 20)
4. Tonnis 2+ OA
5. Previous ipsilateral hip surgery
6. Previous major hip trauma (hip fractures, hip dislocations)
7. Additional disease processes (e.g., Avascular Necrosis (AVN), synovial disease, Ehlers-Danlos Syndrome (EDS), neuromuscular disorders)
8. Unable to consent due to mental faculty
9. Pregnant women
10. Non-English speaking patients
11. Prisoners or other vulnerable populations
14 Years
40 Years
ALL
No
Sponsors
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San Antonio Military Medical Center
FED
William Beaumont Hospitals
OTHER
Boston Children's Hospital
OTHER
CHU de Quebec-Universite Laval
OTHER
Mayo Clinic
OTHER
Twin Cities Orthopedics
OTHER
Regents of the University of Michigan
UNKNOWN
Ottawa Hospital Research Institute
OTHER
University of Texas Southwestern Medical Center
OTHER
University of Iowa
OTHER
University of Colorado, Denver
OTHER
Children's Hospital of Eastern Ontario
OTHER
University of Wisconsin, Madison
OTHER
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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John C Clohisy, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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University of Colorado
Aurora, Colorado, United States
University of Iowa
Iowa City, Iowa, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Twin Cities Orthopedics
Edina, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Scottish Rite Hospital for Children
Dallas, Texas, United States
San Antonio Military Medical Center
San Antonio, Texas, United States
University of Wisconsin, Madison
Madison, Wisconsin, United States
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
CHU de Quebec - Universite Laval
Québec, Quebec, Canada
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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201909174
Identifier Type: -
Identifier Source: org_study_id
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