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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04243447
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : May 21, 2020
Sponsor:
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
Case Western Reserve University
University of Iowa
University of Colorado, Denver
Children's Hospital of Eastern Ontario
Information provided by (Responsible Party):
Washington University School of Medicine

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.

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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 : July 30, 2023
Estimated Study Completion Date : September 30, 2023



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) - 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.

  4. 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.

  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. Univeristy 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243447


Contacts
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Contact: Caroline E Drain, MHS 314-747-2579 drain.caroline.e@wustl.edu
Contact: Zachary D Robben, MS 314-454-5345 zachary.robben@wustl.edu

Locations
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United States, Colorado
University of Colorado Active, not recruiting
Aurora, Colorado, United States, 80045
United States, Florida
BocaCare Orthopedics Not yet recruiting
Boca Raton, Florida, United States, 33486
Contact: Pilar Zuniga       Pzuniga@brrh.com   
Principal Investigator: James R Ross, MD         
United States, Iowa
University of Iowa Not yet recruiting
Iowa City, Iowa, United States, 52242
Contact: John Gentile    319-467-8328    armand-gentile@uiowa.edu   
Principal Investigator: Robert Westermann, MD         
United States, Massachusetts
Boston Children's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Lauren Hutchinson, MPH    617-355-4011    Lauren.Hutchinson@childrens.harvard.edu   
Sub-Investigator: Michael Millis, MD         
Sub-Investigator: Young-Jo Kim, MD         
Principal Investigator: Eduardo Novais, MD         
Sub-Investigator: Yi-Meng Yen, MD         
United States, Michigan
University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Bethany Ruffino    734-615-0768    bruffino@med.umich.edu   
Contact: Jaimee Gauthier       jaimeeg@med.umich.edu   
Principal Investigator: Asheesh Bedi, MD         
William Beaumont Hospital Not yet recruiting
Royal Oak, Michigan, United States, 48073
Contact: Shalinee Mylvaganam, MS    248-551-0194    Shalinee.Mylvaganam@beaumont.org   
Contact: Lisa Motowski    248-551-6679    lisa.motowski@beaumont.org   
Principal Investigator: Ira Zaltz, MD         
United States, Minnesota
Twin Cities Orthopedics Active, not recruiting
Edina, Minnesota, United States, 55435
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55902
Contact: Jonathan Furuseth       furuseth.jonathan@mayo.edu   
Contact: Makinzee Kazeck       kazeck.makinzee@mayo.edu   
Principal Investigator: Rafael Sierra, MD         
Sub-Investigator: Robert Trousdale, MD         
Sub-Investigator: Bruce Levy, MD         
Sub-Investigator: Aaron Krych, MD         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Caroline E Drain, MHS    314-747-2579    drain.caroline.e@wustl.edu   
Contact: Zachary D Robben, MS    314-454-5345    zachary.robben@wustl.edu   
Principal Investigator: John C Clohisy, MD         
Sub-Investigator: Jeffrey J Nepple, MD         
Sub-Investigator: Cecilia Pascual-Garrido, MD         
Sub-Investigator: Perry Schoenecker, MD         
United States, Ohio
UH Cleveland (Case Western) Not yet recruiting
Cleveland, Ohio, United States, 44106
Principal Investigator: Michael J Salata, MD         
United States, Texas
Texas Scottish Rite Hospital for Children Active, not recruiting
Dallas, Texas, United States, 75219
San Antonio Military Medical Center Not yet recruiting
San Antonio, Texas, United States, 78219
Contact: Dennis Mann    210-916-6685    dennis.w.mann.civ@mail.mil   
Contact: Liza Summerfield    210-916-8592    lizabeth.m.summerfield.ctr@mail.mil   
Principal Investigator: Matthew Schmitz, MD         
Canada, Ontario
Children's Hospital of Eastern Ontario Not yet recruiting
Ottawa, Ontario, Canada, (+4) K1H 8L1
Contact: Holly Livock    613-737-7600 ext 1360    hlivock@cheo.on.ca   
Principal Investigator: Sasha Carsen, MD         
The Ottawa Hospital Not yet recruiting
Ottawa, Ontario, Canada
Contact: Cheryl Kreviazuk    613-737-8899 ext 74710    ckreviazuk@ohri.ca   
Contact: Holly Livock    613-737-7600 ext 4120    hlivock@cheo.on.ca   
Principal Investigator: Paule Beaule, MD         
Sub-Investigator: Geoffrey Wilkin, MD         
Sub-Investigator: Sasha Carsen, MD         
Canada, Quebec
CHU de Quebec - Universite Laval Not yet recruiting
Quebec City, Quebec, Canada
Contact: Sylvie Turmel    418-525-4444 ext 66175    turmel.sylvie@chudequebec.ca   
Principal Investigator: Etienne Belzile, MD         
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
Case Western Reserve University
University of Iowa
University of Colorado, Denver
Children's Hospital of Eastern Ontario
Investigators
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Principal Investigator: John C Clohisy, MD Washington University School of Medicine
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04243447    
Other Study ID Numbers: 201909174
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020

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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:
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Femoracetabular Impingement
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes