Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years and Over|
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Massachusetts General Hospital|
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|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Acetabular Labrum Tear, Femoro Acetabular Impingement, Hip Arthroscopy, Physical Therapy, Osteoarthritis, Hip|
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.
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.
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.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.