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

The Washington University

Status: Active, not recruiting

Conditions: Femoracetabular Impingement

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04243447

201909174

Details and patient eligibility

About

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.

Full 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.

Enrollment: 747 patients

Sex: All

Ages: 14 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design