Identification of Predictors for Clinical Outcomes in Femoroacetabular Impingement Surgery

Femoracetabular Impingement Clinical Trial

— DoD FAI-2  

Official title:

Identification of Predictors for Clinical Outcomes in Femoroacetabular Impingement Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04243447
• Other study ID #: 201909174
• Status: Active, not recruiting
• Start date: February 2, 2020
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: September 30, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Femoracetabular Impingement

Locations

Country	Name	City	State
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	CHU de Quebec - Universite Laval	Quebec City	Quebec
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Colorado	Aurora	Colorado
United States	BocaCare Orthopedics	Boca Raton	Florida
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Scottish Rite Hospital for Children	Dallas	Texas
United States	Twin Cities Orthopedics	Edina	Minnesota
United States	University of Iowa	Iowa City	Iowa
United States	University of Wisconsin - Madison	Madison	Wisconsin
United States	Mayo Clinic	Rochester	Minnesota
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	San Antonio Military Medical Center	San Antonio	Texas

Sponsors (15)

Lead Sponsor

Collaborator

Washington University School of Medicine

Boca Raton Regional Hospital, Boston Children's Hospital, Children's Hospital of Eastern Ontario, CHU de Quebec-Universite Laval, Mayo Clinic, Ottawa Hospital Research Institute, Regents of the University of Michigan, San Antonio Military Medical Center, Twin Cities Orthopedics, University of Colorado, Denver, University of Iowa, University of Texas Southwestern Medical Center, University of Wisconsin, Madison, William Beaumont Hospitals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hip disability and Osteoarthritis Outcome Score (HOOS)	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.	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.
Primary	Short Form Health Survey (SF-12)	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.	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
Primary	Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference (PI)	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.	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
Primary	Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function (PF)	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.	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
Primary	Patient-Reported Outcomes Measurement Information System (PROMIS) - Mobility (M)	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.	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
Primary	Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression (D)	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.	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
Primary	Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety (A)	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.	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	University of California Los Angeles Activity Score (UCLA Score)	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.	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
Secondary	International Hip Outcome Tool (iHot-12)	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.	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
Secondary	Modified Harris Hip Score (mHHS)	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.	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
Secondary	Brief Resilience Scale (BRS)	The BRS was created to assess the ability to bounce back or recover from stress.	Pre operative (Baseline)
Secondary	Mobility, Stability, and Pain (MSP Question)	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.	Pre operative (Baseline), 3 months, 6 month