Identification of Predictors for Clinical Outcomes in Femoroacetabular Impingement Surgery

  • STATUS
    Recruiting
  • participants needed
    800
  • sponsor
    Washington University School of Medicine
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Updated on 19 February 2024
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conservative management
arthroscopy
hip arthroscopy
femoroacetabular impingement

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.

Details
Condition Femoroacetabular Impingement
Age 14years - 40years
Clinical Study IdentifierNCT04243447
SponsorWashington University School of Medicine
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age 14 - 40 years
Skeletally Mature
Failure of 6 weeks of conservative treatment
Primary surgery (Hip Arthroscopic Treatment)
Surgical treatment of FAI with hip arthroscopy
Tonnis 0 -1 OA, with greater than 2 mm of joint space
Clinical diagnosis of FAI (cam or combined; alpha >50 degrees)

Exclusion Criteria

Not a surgical candidate
Skeletally Immature
Acetabular Dysplasia (LCEA < 20)
Tonnis 2+ OA
Previous ipsilateral hip surgery
Previous major hip trauma (hip fractures, hip dislocations)
Additional disease processes (e.g., Avascular Necrosis (AVN), synovial disease, Ehlers-Danlos Syndrome (EDS), neuromuscular disorders)
Unable to consent due to mental faculty
Pregnant women
Non-English speaking patients
Prisoners or other vulnerable populations
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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