Overview

This trial is active, not recruiting.

Condition femoroacetabular impingement
Treatments arthroscopic surgery, physical therapy
Sponsor Madigan Army Medical Center
Start date March 2013
End date July 2016
Trial size 60 participants
Trial identifier NCT01993615, 213011

Summary

The purpose of this study is to compare the outcomes for patients that receive two different treatments used for FAI (Femoroacetabular Impingement). The programs are 1) a 6-week supervised physical therapy program and 2) arthroscopic surgery. Enrollment is limited to patients that have already been determined surgical candidates. The study is following patients for a 2-year period.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Arthroscopic surgery at the femoroacetbular joint, followed by a standardized post-operative rehabilitation protocol in physical therapy.
arthroscopic surgery
The hip arthroscopy will consist of acetabular rim trimming, labral repair or debridement and femoroplasty, all as indicated based on the surgeon's clinical judgment with input from pre-operative imaging, exam findings and intra-operative findings.
(Active Comparator)
An impairment-based supervised in-clinic physical therapy program.
physical therapy
Subjects will participate in two 45-minute sessions for six weeks (total of 12 sessions). The physical therapy treatment plan will be based on individual impairments identified during the initial evaluation, and include manual therapy to the hip, lumbar spine, and pelvis, as well as therapeutic exercise all tailored to individual patient impairments.

Primary Outcomes

Measure
Change from Baseline in Hip Outcome Score at 24 months
time frame: 24 months
Change from Baseline in International Hip Outcome Score (IHOT33) to 24 months
time frame: 24 months

Secondary Outcomes

Measure
Global Rating of Change
time frame: 24 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Tricare beneficiaries between the ages of 18 and 65 - Diagnosis of FAI and/or labral pathology confirmed by a combination of the following: - Pain at the anterior hip or groin - Pain with hip flexion - Positive FADIR test - Patient report relief of pain after intra-articular injection - Surgical candidate for hip arthroscopy defined by (must have both): - No less than 2 mm of joint space based on imaging (CT scan, radiographs and MR arthrogram) - Positive crossover sign and/or alpha angle >50 deg based on imaging (CT scan, radiographs and MR arthrogram) - Failed 6 weeks of conservative management Exclusion Criteria: - Pregnancy - Has other concurrent systemic disease that may affect the condition (cancer, rheumatoid arthritis, or other systemic arthralgia/arthritis) - Has had surgery on the same hip that will be analyzed in the study - Diagnosis of hip osteoarthritis is more likely - Clearing the lumbar spine reproduces the patient's hip symptoms - Plans to move/relocate out of the local area within 6 months - Pending litigation for their hip condition - Unable to give informed consent to participate in the study - Unable to speak or read or write in English (due to inability to fill out outcome measures)

Additional Information

Official title A Supervised Physical Therapy Program vs. Arthroscopic Surgery for Femoroacetabular Impingement: A Randomized Clinical Trial
Principal investigator Nancy Mansell, PT, DPT
Description This study plans to enroll a total of 60 Tricare beneficiaries primarily from the Madigan Healthcare System with a diagnosis of FAI that are surgical candidates and have already failed at least six weeks of conservative treatment. This is a randomized controlled study comparing outcomes for the standard treatment for FAI and/or acetabular labral pathology (arthroscopy with or without labral repair) versus physical therapy. For subjects in the arthroscopy group, the surgery will be performed by the Orthopedic Surgical Service at Madigan Army Medical Center. Subjects randomized to the physical therapy group will follow a treatment plan implemented by a physical therapist within the Madigan Army Healthcare System. After consent, subjects will be randomized into one of two arms (Group I = hip arthroscopy, Group II = physical therapy). Group I will undergo hip arthroscopy with or without labral repair. Group II will follow a FAI-based physical therapy program x 12 sessions (6 weeks). The arthroscopy group will complete outcome measures at time of consent and following surgery at 6 months, 1 year and 2 year time periods. Subjects in this group will follow a standardized post-operative rehabilitation protocol. The physical therapy group will complete outcomes measures at time of consent and at 6 month, 1 year and 2 year time periods following the initial physical therapy evaluation. Subjects in this group will complete 6 weeks of an impairment-based physical therapy program. In addition to the outcome measures taken, healthcare utilization and associated costs for hip-related care during this 2-year period will also calculated for comparison between the 2 groups.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Madigan Army Medical Center.