Arthroscopic Labral Repair Versus Physical Therapy for Tears of the Acetabular Labrum

Osteoarthritis, Hip Clinical Trial

Official title: Arthroscopic Labral Repair Versus Physical Therapy for Tears of the Acetabular Labrum in Patients Age 40 and Older

Status Active, not recruiting

Clinical Trial Summary

Tears of the acetabular labrum appear to be common with the prevalence of asymptomatic tears in the general population approaching 66% and 70% based on cadaveric dissection and magnetic resonance imaging, respectively. Despite this prevalence, there is no currently accepted justification for performing labral repair in an asymptomatic patient despite the many postulated biomechanical benefits that an intact labrum imparts to the hip joint.

Representing a smaller proportion of all tears, symptomatic tears of the acetabular labrum present a therapeutic challenge. Current treatment modalities range from conservative measures to open surgical intervention. Conservative measures have typically included: activity modification, the use of non-steroidal anti-inflammatory drugs (NSAIDs), physical therapy (PT), core strengthening and improvement of sensory motor control. In the past two decades, technological advances in the form of surgical instrumentation and traction devices have facilitated less invasive arthroscopic techniques to diagnose and treat hip problems and as such is now the preferred treatment modality for many orthopedic surgeons treating patients with hip pathology.

Determining which patients, using age and arthritic burden as predictors, can benefit from labral repair is paramount for several reasons. Showing arthroscopic repair is of little or no benefit to a specific cohort can reduce the number of unnecessary surgeries performed, increase the use of conservative therapy (if validated) and reduce the interval between diagnosis and total hip replacement.

Clinical Trial Description

There has been only one prospective study documenting the outcomes of patients treated with physical therapy for intra-articular conditions of the hip. These conditions included mild FAI and mild developmental dysplasia of the hip. Here, physical therapy was given as a first line treatment. Those who did not make satisfactory improvements in pain or wished to have surgery were then scheduled for surgery to repair the defects. Patients saw improvement in validated outcome measures at one year.

Although there have been studies looking at age secondarily in patients with labral tears, there is no prospective evidence to endorse or refute a recommendation of hip arthroscopy for patients of any age being treated for a tear of the acetabular labrum.

Most recently, the authors involved in this study performed a retrospective investigation (unpublished data) to capture patients with clinically and radiographically confirmed acetabular labral pathology electing to undergo conservative management defined as the refusal of surgical intervention. Based on a retrospective review of 894 patients presenting to clinic over a 10-year period, the investigators identified 22 patients with labral pathology that were treated non-operatively. Retrospective case control analysis was performed using outcome questionnaires administered to both surgical and non-surgical cohorts. The investigators found that patients with labral tears managed non-operatively appear to score highly on hip function outcome scores, preliminarily indicating there may be some benefit in using conservative management alone in the treatment of labral pathology.

This is a 12-month prospective randomized control trial (RCT), which will enroll 121 subjects with evidence consistent with a tear of the acetabular labrum. Labral tear will be diagnosed by clinical exam and positive MRI findings. Subjects will receive conservative physical therapy treatment alone or arthroscopic surgical labral repair and physical therapy. The investigators anticipate that pain, range of motion, activity level, and functional performance, as judged by validated outcome measures and serial physical exams, will improve when compared to baseline. The investigators also anticipate that the level of response will be greater in the surgical treatment group than in the physical therapy group at 12 months.

Our Primary Outcome is change in the modified Harris Hip Score at 12 months. Secondary outcomes include changes in other outcomes measures (LEFS, HOS, NAHS, iHOT-33), patient satisfaction, degree of improvement on physical exam, longer-term functional outcomes (i.e., at 2, 5, and 10 years), and the influence of OA severity (Outerbridge scoring) and location on the aforementioned outcome measures. ;

Related Conditions & MeSH terms

• Acetabular Labrum Tear
• Femoracetabular Impingement
• Femoro Acetabular Impingement
• Hip Arthroscopy
• Osteoarthritis
• Osteoarthritis, Hip
• Physical Therapy

• NCT number: NCT03909178
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 21, 2013
• Completion date: June 2030