Identification of Predictors for Clinical Outcomes in Femoroacetabular Impingement Surgery (DoD FAI-2)

• ClinicalTrials.gov Identifier: NCT04243447
• Recruitment Status: Active, not recruiting
• First Posted: January 28, 2020
• Last Update Posted: February 8, 2023
• Sponsor: Washington University School of Medicine
• Collaborators: San Antonio Military Medical Center; William Beaumont Hospitals; Boca Raton Regional Hospital; Boston Children's Hospital; CHU de Quebec-Universite Laval; Mayo Clinic; Twin Cities Orthopedics; Regents of the University of Michigan; Ottawa Hospital Research Institute; University of Texas Southwestern Medical Center; University of Iowa; University of Colorado, Denver; Children's Hospital of Eastern Ontario; University of Wisconsin, Madison
• Information provided by (Responsible Party): Washington University School of Medicine

Study Description

Brief Summary:

The overarching goal of the study is to improve the surgical treatment outcomes of FAI, which is affecting an increasing number of military personnel and young active individuals in the general population. The proposed study will investigate critical patient, disease, and surgical treatment predictors of FAI surgery outcomes.

Condition or disease
Femoracetabular Impingement

Detailed Description:

PROCEDURES:

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.

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 800 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 2 Years
• Official Title: Identification of Predictors for Clinical Outcomes in Femoroacetabular Impingement Surgery
• Actual Study Start Date: February 2, 2020
• Estimated Primary Completion Date: August 31, 2024
• Estimated Study Completion Date: September 30, 2024

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Hip disability and Osteoarthritis Outcome Score (HOOS) [ Time Frame: Pre operative (Baseline), change from baseline HOOS at 3 months, change from baseline HOOS at 6 months, change from baseline HOOS at 1 year, and change from baseline HOOS at 2 year. ]
   HOOS is a questionnaire constructed to assess patient-relevant outcomes in five separate sub-scales (pain, symptoms, activity of daily living, sport and recreation function and hip-related quality of life). HOOS is scored 0-100 with higher scores being the best outcome.
2. Short Form Health Survey (SF-12) [ Time Frame: Pre operative (Baseline), change from baseline SF-12 at 3 months, change from baseline SF-12 at 6 months, change from baseline SF-12 at 1 year, and change from baseline SF-12 at 2 year ]
   The SF-12 is a shortened, validated, patient-reported survey of patient health with questions pulled directly from the longer form SF-36. SF-12 is scored 0-100 with higher scores being the best outcome.
3. Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference (PI) [ Time Frame: Pre operative (Baseline), change from baseline PROMIS - PI at 3 months, change from baseline PROMIS - PI at 6 months, change from baseline PROMIS -PI at 1 year, and change from baseline PROMIS - PI at 2 year ]
   PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. This specific PROMIS survey assesses a patient's pain interference. PROMIS - PI is scored from 38.7-83.8 with the lower scores being the best outcome.
4. Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function (PF) [ Time Frame: Pre operative (Baseline), change from baseline PROMIS - PF at 3 months, change from baseline PROMIS - PF at 6 months, change from baseline PROMIS -PF at 1 year, and change from baseline PROMIS - PF at 2 year ]
   PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. This specific PROMIS survey assesses a patient's physical function. PROMIS - PF is scored from 14.7-75.6 with the higher scores being the best outcome.
5. Patient-Reported Outcomes Measurement Information System (PROMIS) - Mobility (M) [ Time Frame: Pre operative (Baseline), change from baseline PROMIS - M at 3 months, change from baseline PROMIS - M at 6 months, change from baseline PROMIS -M at 1 year, and change from baseline PROMIS - M at 2 year ]
   PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. This specific PROMIS survey assesses a patient's mobility. PROMIS - M is scored from 18.2-60.2 with the higher scores being the best outcome.
6. Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression (D) [ Time Frame: Pre operative (Baseline), change from baseline PROMIS - D at 3 months, change from baseline PROMIS - D at 6 months, change from baseline PROMIS - D at 1 year, and change from baseline PROMIS - D at 2 year ]
   PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. This specific PROMIS survey assesses a patient's depression. PROMIS - D is scored from 34.2-84.4 with the lower scores being the best outcome.
7. Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety (A) [ Time Frame: Pre operative (Baseline), change from baseline PROMIS - A at 3 months, change from baseline PROMIS - A at 6 months, change from baseline PROMIS - A at 1 year, and change from baseline PROMIS - A at 2 year ]
   PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. This specific PROMIS survey assesses a patient's anxiety. PROMIS - A is scored from 32.9-84.9 with the lower scores being the best outcome.

Secondary Outcome Measures :

1. University of California Los Angeles Activity Score (UCLA Score) [ Time Frame: Pre operative (Baseline), change from baseline UCLA Score at 3 months, change from baseline UCLA Score at 6 months, change from baseline UCLA Score at 1 year, and change from baseline UCLA Score at 2 year ]
   UCLA Score represents a reliable tool for assessing the level of physical activity and the return to sport high functional demand after hip surgery. The UCLA Score is scored from 0-10 with higher scores being the best outcome.
2. International Hip Outcome Tool (iHot-12) [ Time Frame: Pre operative (Baseline), change from baseline iHOT-12 at 3 months, change from baseline iHOT-12 at 6 months, change from baseline iHOT-12 at 1 year, and change from baseline iHOT-12 at 2 year ]
   iHOT-12 is a validated 12-item short form of iHot-33. It was designed to measure the impact of hip disease in young, active patients and to measure the effect of treatment of this disease.
3. Modified Harris Hip Score (mHHS) [ Time Frame: Pre operative (Baseline), change from baseline mHHS at 3 months, change from baseline mHHS at 6 months, change from baseline mHHS at 1 year, and change from baseline mHHS at 2 year ]
   The mHHS is a reliable and valid tool for assessment of functional outcome, post total hip replacement in Indian patients, with a positive correlation with the standard Harris Hip Score. mHHS is scored 0-100 with higher scores being the best outcome.
4. Brief Resilience Scale (BRS) [ Time Frame: Pre operative (Baseline) ]
   The BRS was created to assess the ability to bounce back or recover from stress.
5. Mobility, Stability, and Pain (MSP Question) [ Time Frame: Pre operative (Baseline), 3 months, 6 month ]
   Outcome measure to assess a patient's greatest issue with their hip. Asks a patient to rank mobility, stability, and pain from biggest problem to least problem.

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 40 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Skeletally mature patients being treated surgically for FAI after failing conservative treatment.

Criteria

Inclusion Criteria:

1. Age 14 - 40 years
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:

1. Not a surgical candidate
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

Contacts and Locations

Locations

United States, Colorado

University of Colorado

Aurora, Colorado, United States, 80045

United States, Florida

BocaCare Orthopedics

Boca Raton, Florida, United States, 33486

United States, Iowa

University of Iowa

Iowa City, Iowa, United States, 52242

United States, Massachusetts

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48106

William Beaumont Hospital

Royal Oak, Michigan, United States, 48073

United States, Minnesota

Twin Cities Orthopedics

Edina, Minnesota, United States, 55435

Mayo Clinic

Rochester, Minnesota, United States, 55902

United States, Missouri

Washington University School of Medicine

Saint Louis, Missouri, United States, 63110

United States, Texas

Scottish Rite Hospital for Children

Dallas, Texas, United States, 75219

San Antonio Military Medical Center

San Antonio, Texas, United States, 78219

United States, Wisconsin

University of Wisconsin - Madison

Madison, Wisconsin, United States, 53706

Canada, Ontario

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada, (+4) K1H 8L1

The Ottawa Hospital

Ottawa, Ontario, Canada

Canada, Quebec

CHU de Quebec - Universite Laval

Quebec City, Quebec, Canada

Sponsors and Collaborators

Washington University School of Medicine

San Antonio Military Medical Center

William Beaumont Hospitals

Boca Raton Regional Hospital

Boston Children's Hospital

CHU de Quebec-Universite Laval

Mayo Clinic

Twin Cities Orthopedics

Regents of the University of Michigan

Ottawa Hospital Research Institute

University of Texas Southwestern Medical Center

University of Iowa

University of Colorado, Denver

Children's Hospital of Eastern Ontario

University of Wisconsin, Madison

Investigators

• Principal Investigator: John C Clohisy, MD; Washington University School of Medicine

More Information

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT04243447
• Other Study ID Numbers: 201909174
• First Posted: January 28, 2020
• Last Update Posted: February 8, 2023
• Last Verified: February 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Washington University School of Medicine:

Femoracetabular Impingement (FAI); Low-dose computed tomography (CT); Patient Reported Outcomes (PROs); Academic Network for Conservational Hip Outcomes Research (ANCHOR); Hip Arthroscopy; Osteoarthritis (OA)

Additional relevant MeSH terms:

Femoracetabular Impingement; Joint Diseases; Musculoskeletal Diseases; Pathologic Processes