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

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ClinicalTrials.gov Identifier: NCT03909178
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Scott D Martin, Massachusetts General Hospital

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.


Condition or disease Intervention/treatment Phase
Acetabular Labrum Tear Femoro Acetabular Impingement Hip Arthroscopy Physical Therapy Osteoarthritis, Hip Procedure: Hip Arthroscopy Surgery with Acetabular Labral Repair Procedure: Physical Therapy Focused on the Hip and Hemi-pelvis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Arthroscopic Labral Repair Versus Physical Therapy for Tears of the Acetabular Labrum in Patients Age 40 and Older
Actual Study Start Date : October 21, 2013
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Hip Arthroscopy Surgery with Acetabular Labral Repair
Hip Arthroscopy Surgery with Acetabular Labral Repair
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.


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: 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.





Primary Outcome Measures :
  1. Change in mHHS Surveys from preoperative to various postoperative timepoints [ Time Frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months ]

    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

    Scoring of mHHS:

    Excellent: 90--100 Good: 80--89 Fair: 70--79 Poor: <70

    Higher score indicates better hip functionally.

    No subscores or subscales.



Secondary Outcome Measures :
  1. Change HOS Surveys from preoperative to various postoperative timepoints [ Time Frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months ]

    Full Name of Outcome: HOS--Hip Outcome Score, which consists of two subscores: Hip Outcome Score-Activity of Daily Living (HOS-ADL), Hip Outcome Score-Sports Sub-scale (HOS-SSS)

    Purpose: Validated Hip Patient Reported Outcome Measurements (PROMs) to assess the patient's functional outcomes post-surgery.

    Scale of HOS--ADL:

    Min: 0 Max: 68

    Converted to a percentage, by dividing patient's score by 68.

    No standardized scoring categories (i.e. excellent, good, fair, poor).

    Higher score indicates better hip functionally.

    Scale of HOS--SSS:

    Min: 0 Max: 36

    Converted to a percentage, by dividing patient's score by 36.

    No standardized scoring categories (i.e. excellent, good, fair, poor).

    Higher score indicates better hip functionally.


  2. Change NAHS Surveys from preoperative to various postoperative timepoints [ Time Frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months ]

    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.


  3. Change iHOT--33 Surveys from preoperative to various postoperative timepoints [ Time Frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months ]

    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


  4. Change LEFS Surveys from preoperative to various postoperative timepoints [ Time Frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months ]

    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: 80

    Converted to a percentage, by dividing patient's score by 80.

    No standardized scoring categories (i.e. excellent, good, fair, poor).

    Higher score indicates better hip functionally.

    No subscores or subscales


  5. Patient Satisfaction Questionnaires [ Time Frame: 12 months and 24 months ]

    Three Yes/No Questions:

    1. Are you satisfied with the treatment you received?
    2. Are you satisfied with the treatment regimen that you were given?
    3. If given the choice in the future, would you choose the same treatment?

  6. Degree of Improvement on Hip Strength [ Time Frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months ]

    At routine follow-up visits patients have a routine physical exam that will measure hip strength.

    Muscle Strength Testing is done using the resisted muscular contraction (RMC) scale:

    0—no muscle firing

    1. hip muscle contraction, no joint movement
    2. hip movement with gravity eliminated
    3. hip movement against gravity, but not against resistance
    4. hip movement against resistance, but not full strength
    5. full strength

  7. Degree of Improvement on Hip Range of Motion (ROM) [ Time Frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months ]

    At routine follow-up visits patients have a routine physical exam that will measure hip range of motion (ROM). ROM is measured in degrees.

    For reference:

    A right angle is 90 degrees. A straight line is 180 degrees.


  8. Degree of Improvement on Hip VAS Pain Score [ Time Frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months ]

    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


  9. Outerbridge Scoring [ Time Frame: Intra-operative ]

    Full Name of Outcome: Outerbridge Scoring

    Purpose: Scale of amount of osteoarthritic changes (cartilage wear) in hip joint based on arthroscopic visualization.

    Grading:

    Grade 0: Normal Grade 1: Cartilage with softening and swelling Grade 2: Partial-thickness defect with fissures on the surface that do not reach subchondral bone or exceed 1.5cm in diameter Grade 3: Fissuring to the level of subchondral bone in an area with a diameter more than 1.5cm Grade 4: Exposed subchondral bone head.

    Higher score indicates worse hip condition due to more osteoarthritic changes.

    No subscores or subscales.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03909178


Contacts
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Contact: Scott D Martin, MD 617-732-5329 sdmartin@partners.org
Contact: Mark R Nazal, MPH 617-643-0886 mnazal@mgh.harvard.edu

Locations
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United States, Massachusetts
MGH, Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Mark R Nazal, MPH    617-643-0886    mnazal@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Scott D Martin, MD Massachusetts General Hospital
Publications:
Alexander JW, Crawford MJ, Vega CE, Thompson MT, Miller AR, Noble PC. The impact of labral tears on the stability of the hip joint. Trans Orthop Res Soc. 2007; 32:71.
Kellgren JH, Jeffrey MR, Ball J. The Epidemiology of Chronic Rheumatism. Atlas of Standard Radiographs of Arthritis. Oxford, UK: Blackwell Scientific Publications; 1963:vii-11.
Cohen, J. Statistical power analysis for behavioral studies. (2nd ed). New Jersey: Lawrence Erlbaum.
Wilson, S.R. and I. Gordon, Calculating Sample Sizes in the Presence of Confounding Variables. J Royal Statisitical Soc, 1986. 35(2): p. 207-13.

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Responsible Party: Scott D Martin, Principal Investigator, Director, Joint Preservation Service, Director, MGH Sports Medicine Fellowship, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03909178    
Other Study ID Numbers: 2013P001442 /PHS
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Scott D Martin, Massachusetts General Hospital:
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
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Hip
Femoracetabular Impingement
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes