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ACTIVE NOT RECRUITING

NCT03909178

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

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2013-10-21

Completion Date

2030-06

Last Updated

2025-11-10

Healthy Volunteers

Conditions

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

Interventions

PROCEDURE

Hip Arthroscopy Surgery with Acetabular Labral Repair (SPT group)

Patients randomized to the SPT group provided consent for arthroscopic acetabular labral repair with femoroacetabular osteoplasty. As previously described in various technique publications from our group, the senior surgeon's (S.D.M.) hip arthroscopy technique includes intra-articular fluid distension for initial portal placement, puncture capsulotomy, autograft capsular augmentation if insufficient or degenerative labral tissue is encountered, intermittent traction, sparing use of electrocautery, and preservation of the chrondrolabral junction. All SPT patients underwent a standardized postoperative physical therapy protocol developed jointly by the senior author (a sports medicine fellowship-trained orthopaedic surgeon) and the physical therapists. Patients were kept weightbearing as tolerated on crutches for 6 weeks to maintain a level pelvis without lurching when walking and were instructed to avoid impact loading exercises for 6 months.

PROCEDURE

Physical Therapy Focused on the Hip and Hemi-pelvis (PT group)

PTA patients were assigned a standardized, 24-week course of supervised, core-based PT. This course was designed in concert with physical therapists within our institution to help address symptoms of labral tear in patients older than 40 who had mild to moderate OA. Weeks 1 and 2 focused on normalizing gait, and weeks 3 through 24 focused on optimizing range of motion (ROM) while slowly integrating strength training. Unlike the prerandomization PT protocol, the PTA protocol was predominantly physical therapist-supervised (at least 1 in-person visit per week).

Inclusion Criteria: 1. Age 40 or greater: higher likelihood or undetectable OA on imaging 2. Symptoms consistent with a tear of the acetabular labrum (at least one: catching, clicking, popping, pain with sitting, episodic pain, pain with hip flexion, adduction, and/or internal rotation): asymptomatic labral tears do exist in the general population however there is not definitive evidence to suggest treatment of asymptomatic tears is beneficial. 3. Symptoms not due to some other acute process in or around the hip (including septic arthritis, osteonecrosis, hemarthrosis, iliotibial band syndrome, fractures of the femoral neck or head, fractures of the acetabulum, greater trochanteric pain syndrome, sacroiliac joint pain, piriformis syndrome, low back pain associated with hip pain and not knee nor acute low back injury): certain conditions are not treatable by either arthroscopy or physical therapy. Some of these conditions can be managed with physical therapy but not arthroscopy. 4. Availability of hip radiographs and MRI: needed to assess eligibility 5. Evidence on MRI of a tear of the acetabular labrum: documentation of acetabular labrum tear 6. Willingness to undergo randomization and ability to understand and sign informed consent document: ability to understand study and consent willingly Exclusion Criteria: 1. Less than 2 mm of joint space on standing plain anterior-posterior radiographs of the hip: indicative of severe osteoarthritic disease and the patient would benefit more from a total hip replacement 2. Developmental dysplasia of the hip: distorted acetabular anatomy and biomechanics 3. Kellgren-Lawrence Grade 4 changes: classified as large osteophytes, marked narrowing of joint space, severe sclerosis, and definite deformity of bone contour; indicative of severe OA 4. Tonnis Grade 3 changes: classified as large cysts in the head or acetabulum, severe narrowing or obliteration of the joint space, severe deformity of the head, and necrosis; indicative of OA 5. Unexpected pathology at the time of arthroscopy: source of pain less likely to due dysfunction of the labrum and more likely due to aberrant extra-articular biology 6. Same site surgery: complex anatomy 7. Back pain greater than hip pain or back pain associated with leg symptoms below the knee: source of pain less likely to be originating from the hip and more likely to be referred from the back/spine 8. Back pain associated with positive neural tension signs e.g. positive slump test, positive SLR (straight leg raise), positive reflex changes or drop foot: source of pain less likely to be originating from the hip and more likely to be referred from the back/spine 9. Knee pain greater than hip pain: source of pain less likely to be originating from the hip and more likely to referred from the knee 10. Bilateral tears of the acetabular labrum: difficult to gauge patient progress after treatment 11. Contraindication to surgery or physical therapy: cannot tolerate either treatment grouping 12. Alternate form of PT for greater than 6 weeks: will negatively augment results. May affect recruitment.

Locations (1)

MGH, Massachusetts General Hospital

Boston, Massachusetts, United States