Longitudinal Evaluation of Hip Cartilage Degeneration: FAI

NCT02408276 | Completed

• 2 other identifiers: 2016-168R01AR066069-01
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Femoroacetabular impingement (FAI) is one of the most common mechanisms leading to the development of early cartilage and labral damage in the non-dysplastic hip. Anatomic abnormalities of the proximal femur and/or acetabulum result in repetitive injury during dynamic hip motion, leading to abnormal regional loading of the femoral head-neck junction against the acetabular rim. The resulting damage to the cartilage, labrum, and surrounding capsular structures predispose the patient to developing hip pain and early osteoarthritic changes. Clinically, patients with FAI are a heterogeneous group, with a wide array of presentation from pain to instability that may or may not be related to activity. To date no studies have identified specific prognostic indicators associated with successful surgical treatment of FAI, leaving surgeons without adequate criteria to determine which patients are best suited for arthroscopy. The investigators propose to address this critical knowledge gap by identifying the patient characteristics and morphological features of the hip that are associated with the optimal clinical outcomes in patients undergoing hip arthroscopy or non-operative management for treatment of suspected FAI in order to establish a treatment algorithm for FAI patients.

Conditions

Femoroacetabular Impingement

Outcome Measures

Primary Outcomes (1)

• degree of cartilage degeneration

  degree of cartilage degeneration at 5 years post-presentation based on changes in cartilage morphology assessed using MRI (a two-dimensional fast spin echo sequence in the coronal and sagittal planes).

  5 years post operation

Secondary Outcomes (1)

• dGEMERIC MRI measurements

  2 year post operation

Study Arms (1)

dGEMERIC MRI technique

All tests and imaging are part of standard of care except follow up MRI, which will be performed in a random group from within the cohort and paid for through this grant.

Other: dGEMERIC MRI technique

Interventions

dGEMERIC MRI technique OTHER

Patients will be treated surgically (hip arthroscopy) or nonoperatively (physical therapy) and pain medications as needed. For surgical patients, cartilage samples and surgeon operative reports will be a source of research. For both cohorts, MRIs, radiographs and patient reported outcome surveys will be additional research sources. All tests and imaging are part of standard of care except follow up MRI, which will be performed in a random group from within the cohort and paid for through this grant.

dGEMERIC MRI technique

Eligibility Criteria

• Age: 10 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

35 years of age or younger enrolled in the HSS Hip Preservation Registry prior to September 30, 2016 with an MRI confirmed diagnosis of FAI

You may qualify if:

• Patients who agree to participate must complete a baseline questionnaire consisting of: 1) Modified Harris Hip Score (MHHS), an overall measure of hip condition; 2) the Hip Outcome Score (HOS), a measure developed specifically for younger active patients that measures quality of life and levels of sports and recreation; and 3) International Hip Outcome Tool (iHOT33), a newly developed hip specific outcome score, which measures a number of subscores relating to physical and social functioning with hip problems.

You may not qualify if:

• Patients over age 35 will be excluded as the focus of this study is early changes that may predispose to later degenerative changes.
• Patients undergoing revision hip arthroscopy as their first treatment in the Registry will not be eligible, as these are patients who have failed initial therapy.
• Patients with no complete questionnaires at any time point will be excluded.

Sponsors & Collaborators

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen Lyman, PhD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2015
• First Posted: April 3, 2015
• Study Start: December 1, 2014
• Primary Completion: December 18, 2025
• Study Completion: December 18, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-02

Locations

US (1)