Back to resultsArthroscopic Labral Repair Versus Physical Therapy for Tears of the Acetabular Labrum
Primary Purpose
Acetabular Labrum Tear, Femoro Acetabular Impingement, Hip Arthroscopy
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hip Arthroscopy Surgery with Acetabular Labral Repair (SPT group)
Physical Therapy Focused on the Hip and Hemi-pelvis (PT group)
Sponsored by
About this trial
This is an interventional treatment trial for Acetabular Labrum Tear focused on measuring Acetabular Labrum Tear, Femoro Acetabular Impingement, Osteoarthritis, Hip Arthroscopy, Prospective, PROMs, mHHS, HOS, NAHS, LEFS, iHOT-33, RCT, Randomized Control Trial, Physical Therapy, PT, Osteoarthritis, Hip, Tonnis, Outerbridge, Older than 40 years old
Eligibility Criteria
Inclusion Criteria:
- Age 40 or greater: higher likelihood or undetectable OA on imaging
- 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.
- 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.
- Availability of hip radiographs and MRI: needed to assess eligibility
- Evidence on MRI of a tear of the acetabular labrum: documentation of acetabular labrum tear
- Willingness to undergo randomization and ability to understand and sign informed consent document: ability to understand study and consent willingly
Exclusion Criteria:
- 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
- Developmental dysplasia of the hip: distorted acetabular anatomy and biomechanics
- 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
- 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
- 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
- Same site surgery: complex anatomy
- 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
- 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
- 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
- Bilateral tears of the acetabular labrum: difficult to gauge patient progress after treatment
- Contraindication to surgery or physical therapy: cannot tolerate either treatment grouping
- Alternate form of PT for greater than 6 weeks: will negatively augment results. May affect recruitment.
Sites / Locations
- MGH, Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Hip Arthroscopy Surgery with Acetabular Labral Repair
Physical Therapy Focused on the Hip and Hemi-pelvis
Arm Description
Hip Arthroscopy Surgery with Acetabular Labral Repair
Physical Therapy focusing on the hemipelvis strengthening, including the lower back, lower abdominal core, quadriceps, hamstrings, and gluteal muscles.
Outcomes
Primary Outcome Measures
Change in mHHS Surveys From Preoperative to Various Postoperative Timepoints
Full Name of Outcome: modified Harris Hip Score (mHHS)
Purpose: Validated Hip Patient Reported Outcome Measurements (PROMs) to assess the patient's functional outcomes post-surgery.
Scale of mHHS:
Min: 0 Max: 100
Higher score indicates better hip functionally.
No subscores or subscales.
The mean changes in scores required to achieve a minimically clinically important difference is 6.9.
Secondary Outcome Measures
Change HOS Surveys From Preoperative to Various Postoperative Timepoints
Full Name of Outcome: HOS--Hip Outcome Score.
Purpose: Validated Hip Patient Reported Outcome Measurements (PROMs) to assess the patient's functional outcomes post-surgery.
Scale of HOS:
Min: 0 Max: 100
No standardized scoring categories (i.e. excellent, good, fair, poor).
Higher score indicates better hip functionally.
The mean change in HOS score required to achieve a minimally clinically important difference is 8.8.
Change NAHS Surveys From Preoperative to Various Postoperative Timepoints
Full Name of Outcome: Non-Arthritic Hip Score (NAHS)
Purpose: Validated Hip Patient Reported Outcome Measurements (PROMs) to assess the patient's functional outcomes post-surgery:
Scale of NAHS:
Min: 0 Max: 100
No standardized scoring categories (i.e. excellent, good, fair, poor).
Higher score indicates better hip functionally.
No subscores or subscales.
No specific score to indicate a minimally clinically important difference.
Change iHOT--33 Surveys From Preoperative to Various Postoperative Timepoints
Full Name of Outcome: International Hip Outcome Tool--33 Questions
Purpose: Validated Hip Patient Reported Outcome Measurements (PROMs) to assess the patient's functional outcomes post-surgery.
Scale of iHOT-33:
Min: 0 Max: 100
No standardized scoring categories (i.e. excellent, good, fair, poor).
Higher score indicates better hip functionally.
No subscores or subscales
The mean changes in iHOT-33 scores required to achieve minimally clinically important difference is 15.1.
Change LEFS Surveys From Preoperative to Various Postoperative Timepoints
Full Name of Outcome: Lower Extremity Functional Scale (LEFS)
Purpose: Validated Hip Patient Reported Outcome Measurements (PROMs) to assess the patient's functional outcomes post-surgery.
Scale of LEFS:
Min: 0 Max: 100
No standardized scoring categories (i.e. excellent, good, fair, poor).
Higher score indicates better hip functionally.
There is no designated improvement that is deemed to be a minimally clinically important difference
Degree of Improvement on Hip VAS Pain Score
At routine follow-up visits patients will be asked to rate hip pain using the VAS (Visual Analog Scale) Score
Min: 0--no pain Max: 10--worst pain experienced in their life
Increments of 1.
Categories:
1--3: mild pain 4--6: moderate pain 7--10: severe pain
There is no reduction in VAS score that is considered a minimally clinically important difference.
Full Information
NCT ID
NCT03909178
First Posted
June 12, 2018
Last Updated
August 25, 2023
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03909178
Brief Title
Arthroscopic Labral Repair Versus Physical Therapy for Tears of the Acetabular Labrum
Official Title
Arthroscopic Labral Repair Versus Physical Therapy for Tears of the Acetabular Labrum in Patients Age 40 and Older
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 21, 2013 (Actual)
Primary Completion Date
June 20, 2020 (Actual)
Study Completion Date
June 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acetabular Labrum Tear, Femoro Acetabular Impingement, Hip Arthroscopy, Physical Therapy, Osteoarthritis, Hip
Keywords
Acetabular Labrum Tear, Femoro Acetabular Impingement, Osteoarthritis, Hip Arthroscopy, Prospective, PROMs, mHHS, HOS, NAHS, LEFS, iHOT-33, RCT, Randomized Control Trial, Physical Therapy, PT, Osteoarthritis, Hip, Tonnis, Outerbridge, Older than 40 years old
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hip Arthroscopy Surgery with Acetabular Labral Repair
Arm Type
Active Comparator
Arm Description
Hip Arthroscopy Surgery with Acetabular Labral Repair
Arm Title
Physical Therapy Focused on the Hip and Hemi-pelvis
Arm Type
Active Comparator
Arm Description
Physical Therapy focusing on the hemipelvis strengthening, including the lower back, lower abdominal core, quadriceps, hamstrings, and gluteal muscles.
Intervention Type
Procedure
Intervention Name(s)
Hip Arthroscopy Surgery with Acetabular Labral Repair (SPT group)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Physical Therapy Focused on the Hip and Hemi-pelvis (PT group)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in mHHS Surveys From Preoperative to Various Postoperative Timepoints
Description
Full Name of Outcome: modified Harris Hip Score (mHHS)
Purpose: Validated Hip Patient Reported Outcome Measurements (PROMs) to assess the patient's functional outcomes post-surgery.
Scale of mHHS:
Min: 0 Max: 100
Higher score indicates better hip functionally.
No subscores or subscales.
The mean changes in scores required to achieve a minimically clinically important difference is 6.9.
Time Frame
Baseline (pre-operative), 3 months, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Change HOS Surveys From Preoperative to Various Postoperative Timepoints
Description
Full Name of Outcome: HOS--Hip Outcome Score.
Purpose: Validated Hip Patient Reported Outcome Measurements (PROMs) to assess the patient's functional outcomes post-surgery.
Scale of HOS:
Min: 0 Max: 100
No standardized scoring categories (i.e. excellent, good, fair, poor).
Higher score indicates better hip functionally.
The mean change in HOS score required to achieve a minimally clinically important difference is 8.8.
Time Frame
Baseline (pre-operative), 3 months, 6 months, 12 months
Title
Change NAHS Surveys From Preoperative to Various Postoperative Timepoints
Description
Full Name of Outcome: Non-Arthritic Hip Score (NAHS)
Purpose: Validated Hip Patient Reported Outcome Measurements (PROMs) to assess the patient's functional outcomes post-surgery:
Scale of NAHS:
Min: 0 Max: 100
No standardized scoring categories (i.e. excellent, good, fair, poor).
Higher score indicates better hip functionally.
No subscores or subscales.
No specific score to indicate a minimally clinically important difference.
Time Frame
Baseline (pre-operative), 3 months, 6 months, 12 months
Title
Change iHOT--33 Surveys From Preoperative to Various Postoperative Timepoints
Description
Full Name of Outcome: International Hip Outcome Tool--33 Questions
Purpose: Validated Hip Patient Reported Outcome Measurements (PROMs) to assess the patient's functional outcomes post-surgery.
Scale of iHOT-33:
Min: 0 Max: 100
No standardized scoring categories (i.e. excellent, good, fair, poor).
Higher score indicates better hip functionally.
No subscores or subscales
The mean changes in iHOT-33 scores required to achieve minimally clinically important difference is 15.1.
Time Frame
Baseline (pre-operative), 3 months, 6 months, 12 months
Title
Change LEFS Surveys From Preoperative to Various Postoperative Timepoints
Description
Full Name of Outcome: Lower Extremity Functional Scale (LEFS)
Purpose: Validated Hip Patient Reported Outcome Measurements (PROMs) to assess the patient's functional outcomes post-surgery.
Scale of LEFS:
Min: 0 Max: 100
No standardized scoring categories (i.e. excellent, good, fair, poor).
Higher score indicates better hip functionally.
There is no designated improvement that is deemed to be a minimally clinically important difference
Time Frame
Baseline (pre-operative), 3 months, 6 months, 12 months
Title
Degree of Improvement on Hip VAS Pain Score
Description
At routine follow-up visits patients will be asked to rate hip pain using the VAS (Visual Analog Scale) Score
Min: 0--no pain Max: 10--worst pain experienced in their life
Increments of 1.
Categories:
1--3: mild pain 4--6: moderate pain 7--10: severe pain
There is no reduction in VAS score that is considered a minimally clinically important difference.
Time Frame
Baseline (pre-operative), 3 months, 6 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 40 or greater: higher likelihood or undetectable OA on imaging
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.
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.
Availability of hip radiographs and MRI: needed to assess eligibility
Evidence on MRI of a tear of the acetabular labrum: documentation of acetabular labrum tear
Willingness to undergo randomization and ability to understand and sign informed consent document: ability to understand study and consent willingly
Exclusion Criteria:
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
Developmental dysplasia of the hip: distorted acetabular anatomy and biomechanics
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
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
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
Same site surgery: complex anatomy
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
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
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
Bilateral tears of the acetabular labrum: difficult to gauge patient progress after treatment
Contraindication to surgery or physical therapy: cannot tolerate either treatment grouping
Alternate form of PT for greater than 6 weeks: will negatively augment results. May affect recruitment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott D Martin, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
MGH, Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Arthroscopic Labral Repair Versus Physical Therapy for Tears of the Acetabular Labrum
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