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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03909178
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Massachusetts General Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Scott D Martin, MD
Principal Investigator Affiliation Massachusetts General Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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

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 6 months and 12 months. Secondary outcomes include changes in other outcomes measures (LEFS, HOS, NAHS, iHOT-33), patient satisfaction, and degree of improvement on physical exam, and the influence of OA severity (Outerbridge scoring) and location on the aforementioned outcome measures.

Arms & Interventions

Arms

Active Comparator: Hip Arthroscopy Surgery with Acetabular Labral Repair

Hip Arthroscopy Surgery with Acetabular Labral Repair

Active Comparator: Physical Therapy Focused on the Hip and Hemi-pelvis

Physical Therapy focusing on the hemipelvis strengthening, including the lower back, lower abdominal core, quadriceps, hamstrings, and gluteal muscles.

Interventions

Procedure: - Hip Arthroscopy Surgery with Acetabular Labral Repair

The research coordinator will, perform a baseline assessment, and randomize the patients into the study at this visit. Randomization will be assigned utilizing an electronic randomization program. Patients are prospectively identified and randomized into one of two study arms: arthroscopic surgery (AS) or physical therapy (PT). A third study arm, dependent upon improvement with PT, was created as patients crossed over (CO) from PT to AS after a lack of improvement after a minimum of 8 weeks of PT. AS consisted of labral repair. Any subject randomized to surgery will be seen by Dr. Martin to be consented separately for the arthroscopic procedure, which is standard of care. Those receiving surgical management will be scheduled for the post-operative physical therapy protocol within 2 weeks of their operative date, once a surgical date has been scheduled.

Procedure: - Physical Therapy Focused on the Hip and Hemi-pelvis

The research coordinator will, perform a baseline assessment, and randomize the patients into the study at this visit. Randomization will be assigned utilizing an electronic randomization program. Patients are prospectively identified and randomized into one of two study arms: arthroscopic surgery (AS) or physical therapy (PT). A third study arm, dependent upon improvement with PT, was created as patients crossed over (CO) from PT to AS after a lack of improvement after a minimum of 8 weeks of PT. AS consisted of labral repair or debridement, if repair was not possible, and PT consisted of a uniform, comprehensive PT protocol guided by selected physical therapists. Those randomized to the physical therapy side will be referred to PT. Those receiving conservative management will be scheduled for physical therapy.

Contact a Trial Team

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MGH, Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

MGH, Massachusetts General Hospital

Boston, Massachusetts, 02114

Site Contact

Mark R Nazal, MPH

[email protected]

617-643-0886