Clinical trial NCT04243447: Identification of Predictors for Clinical Outcomes in Femoroacetabular Impingement Surgery
Official title: Identification of Predictors for Clinical Outcomes in Femoroacetabular Impingement Surgery
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Femoracetabular Impingement
Keywords: Femoracetabular Impingement (FAI)
Low-dose computed tomography (CT)
Patient Reported Outcomes (PROs)
Academic Network for Conservational Hip Outcomes Research (ANCHOR)
Hip Arthroscopy
Osteoarthritis (OA)
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: San Antonio Military Medical Center
name: William Beaumont Hospitals
name: Boca Raton Regional Hospital
name: Boston Children's Hospital
name: CHU de Quebec-Universite Laval
name: Mayo Clinic
name: Twin Cities Orthopedics
name: Regents of the University of Michigan
name: Ottawa Hospital Research Institute
name: University of Texas Southwestern Medical Center
name: University of Iowa
name: University of Colorado, Denver
name: Children's Hospital of Eastern Ontario
name: University of Wisconsin, Madison
First posted: 2020-01-28
Enrollment: 800
Sex: ALL
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Skeletally mature patients being treated surgically for FAI after failing conservative treatment.

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.

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.

Eligibility 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

Primary outcomes:
measure: Hip disability and Osteoarthritis Outcome Score (HOOS)
timeFrame: 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.
measure: Short Form Health Survey (SF-12)
timeFrame: 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
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference (PI)
timeFrame: 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
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function (PF)
timeFrame: 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
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) - Mobility (M)
timeFrame: 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
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression (D)
timeFrame: 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
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety (A)
timeFrame: 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
Secondary outcomes:
measure: University of California Los Angeles Activity Score (UCLA Score)
timeFrame: 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
measure: International Hip Outcome Tool (iHot-12)
timeFrame: 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
measure: Modified Harris Hip Score (mHHS)
timeFrame: 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
measure: Brief Resilience Scale (BRS)
timeFrame: Pre operative (Baseline)
measure: Mobility, Stability, and Pain (MSP Question)
timeFrame: Pre operative (Baseline), 3 months, 6 month
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Edina
country: United States
facility: Twin Cities Orthopedics
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Dallas
country: United States
facility: Scottish Rite Hospital for Children
state: Texas
city: San Antonio
country: United States
facility: San Antonio Military Medical Center
state: Texas
city: Madison
country: United States
facility: University of Wisconsin, Madison
state: Wisconsin
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Quebec City
country: Canada
facility: CHU de Quebec - Universite Laval
state: Quebec
Study officials:
affiliation: Washington University School of Medicine
name: John C Clohisy, MD
role: PRINCIPAL_INVESTIGATOR
References: