Longitudinal Evaluation of Hip Cartilage Degeneration: FAI

Femoroacetabular Impingement Clinical Trial

Official title:

Longitudinal Evaluation of Hip Cartilage Degeneration: the Effect of Femoroacetabular Impingement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02408276
• Other study ID #: 2016-168
• Secondary ID: R01AR066069-01
• Status: Recruiting
• Start date: December 2014
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Hospital for Special Surgery, New York
• Contact: Stephen Lyman, PhD
• Phone: 646-714-6460
• Email: lymans[@]hss.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 35 Years

Eligibility

Inclusion Criteria:

• All patients 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 will be eligible for inclusion in this study regardless of surgery status.
• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Femoracetabular Impingement
• Femoroacetabular Impingement

Intervention

Other:
• dGEMERIC MRI technique
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.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	dGEMERIC MRI measurements	We will use MRI to localize and measure chondral and labral abnormalities to determine whether extent, location, or type of defect affect the outcome of hip arthroscopy in FAI.	2 year post operation