Acetabular Labrum TearNCT03909178
Arthroscopic Labral Repair Versus Physical Therapy for Tears of the Acetabular Labrum
A study testing Hip Arthroscopy Surgery with Acetabular Labral Repair (SPT group) and Physical Therapy Focused on the Hip and Hemi-pelvis (PT group) in people with Acetabular Labrum Tear and Femoro Acetabular Impingement, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acetabular Labrum Tear, Femoro Acetabular Impingement, Hip Arthroscopy
- What is being tested?
- Hip Arthroscopy Surgery with Acetabular Labral Repair (SPT group) and Physical Therapy Focused on the Hip and Hemi-pelvis (PT group)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2013to Jun 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
MGH, Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Arthroscopic Labral Repair Versus Physical Therapy for Tears of the Acetabular Labrum in Patients Age 40 and Older
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.
Read the 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 12 months. Secondary outcomes include changes in other outcomes measures (LEFS, HOS, NAHS, iHOT-33), patient satisfaction, degree of improvement on physical exam, longer-term functional outcomes (i.e., at 2, 5, and 10 years), and the influence of OA severity (Outerbridge scoring) and location on the aforementioned outcome measures.
- Conditions
- Acetabular Labrum Tear, Femoro Acetabular Impingement, Hip Arthroscopy, Physical Therapy, Osteoarthritis, Hip
- Being tested
- Hip Arthroscopy Surgery with Acetabular Labral Repair (SPT group), Physical Therapy Focused on the Hip and Hemi-pelvis (PT group)
- 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
- Medical subject headings
- Femoracetabular Impingement, Osteoarthritis, Hip, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip Arthroscopy Surgery with Acetabular Labral Repair (SPT group)Procedure or surgery
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.
Physical Therapy Focused on the Hip and Hemi-pelvis (PT group)Procedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Hip Arthroscopy Surgery with Acetabular Labral Repair | Active comparator | Hip Arthroscopy Surgery with Acetabular Labral Repair Receives: Procedure: Hip Arthroscopy Surgery with Acetabular Labral Repair (SPT group) |
| Physical Therapy Focused on the Hip and Hemi-pelvis | Active comparator | Physical Therapy focusing on the hemipelvis strengthening, including the lower back, lower abdominal core, quadriceps, hamstrings, and gluteal muscles. Receives: Procedure: Physical Therapy Focused on the Hip and Hemi-pelvis (PT group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-operative), 3 months, 6 months, 12 months
Secondary outcomes (5)
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.
Measured: Baseline (pre-operative), 3 months, 6 months, 12 months
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.
Measured: Baseline (pre-operative), 3 months, 6 months, 12 months
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.
Measured: Baseline (pre-operative), 3 months, 6 months, 12 months
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
Measured: Baseline (pre-operative), 3 months, 6 months, 12 months
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.
Measured: Baseline (pre-operative), 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start21 Oct 2013
- Primary completion20 Jun 2020
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (64)Papers the sponsor has linked to this study.
- Other trials for Acetabular Labrum TearStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott D Martin, Massachusetts General Hospital
- Investigators
- Scott D Martin, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909178
- Sponsor's protocol ID
- 2013P001442
- Status last verified
- Nov 2025
- First submitted
- 12 Jun 2018
- Last updated
- 10 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Register B, Pennock AT, Ho CP, Strickland CD, Lawand A, Philippon MJ. Prevalence of abnormal hip findings in asymptomatic participants: a prospective, blinded study. Am J Sports Med. 2012 Dec;40(12):2720-4. doi: 10.1177/0363546512462124. Epub 2012 Oct 25.
PubMed 23104610Vawklang N, Lertwanich P. Prevalence of acetabular labral tears and sublabral sulci: a cadaveric study. J Med Assoc Thai. 2012 Sep;95 Suppl 9:S104-9.
PubMed 23326991Alexander 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.
Crawford MJ, Dy CJ, Alexander JW, Thompson M, Schroder SJ, Vega CE, Patel RV, Miller AR, McCarthy JC, Lowe WR, Noble PC. The 2007 Frank Stinchfield Award. The biomechanics of the hip labrum and the stability of the hip. Clin Orthop Relat Res. 2007 Dec;465:16-22. doi: 10.1097/BLO.0b013e31815b181f.
PubMed 17906586Song Y, Ito H, Kourtis L, Safran MR, Carter DR, Giori NJ. Articular cartilage friction increases in hip joints after the removal of acetabular labrum. J Biomech. 2012 Feb 2;45(3):524-30. doi: 10.1016/j.jbiomech.2011.11.044. Epub 2011 Dec 15.
PubMed 22176711Haemer JM, Carter DR, Giori NJ. The low permeability of healthy meniscus and labrum limit articular cartilage consolidation and maintain fluid load support in the knee and hip. J Biomech. 2012 May 11;45(8):1450-6. doi: 10.1016/j.jbiomech.2012.02.015. Epub 2012 Mar 3.
PubMed 22391467Samora JB, Ng VY, Ellis TJ. Femoroacetabular impingement: a common cause of hip pain in young adults. Clin J Sport Med. 2011 Jan;21(1):51-6. doi: 10.1097/JSM.0b013e318205dfde.
PubMed 21200171Byrd JW. The role of hip arthroscopy in the athletic hip. Clin Sports Med. 2006 Apr;25(2):255-78, viii. doi: 10.1016/j.csm.2005.12.007.
PubMed 16638490Enseki KR, Martin RL, Draovitch P, Kelly BT, Philippon MJ, Schenker ML. The hip joint: arthroscopic procedures and postoperative rehabilitation. J Orthop Sports Phys Ther. 2006 Jul;36(7):516-25. doi: 10.2519/jospt.2006.2138.
PubMed 16881468McCarthy JC, Lee J. Hip arthroscopy: indications and technical pearls. Clin Orthop Relat Res. 2005 Dec;441:180-7. doi: 10.1097/01.blo.0000195057.27653.93.
PubMed 16331001Groh MM, Herrera J. A comprehensive review of hip labral tears. Curr Rev Musculoskelet Med. 2009 Jun;2(2):105-17. doi: 10.1007/s12178-009-9052-9. Epub 2009 Apr 7.
PubMed 19468871Khanduja V, Villar RN. Arthroscopic surgery of the hip: current concepts and recent advances. J Bone Joint Surg Br. 2006 Dec;88(12):1557-66. doi: 10.1302/0301-620X.88B12.18584.
PubMed 17159164Kelly BT, Weiland DE, Schenker ML, Philippon MJ. Arthroscopic labral repair in the hip: surgical technique and review of the literature. Arthroscopy. 2005 Dec;21(12):1496-504. doi: 10.1016/j.arthro.2005.08.013.
PubMed 16376242Stevens MS, Legay DA, Glazebrook MA, Amirault D. The evidence for hip arthroscopy: grading the current indications. Arthroscopy. 2010 Oct;26(10):1370-83. doi: 10.1016/j.arthro.2010.07.016.
PubMed 20887936Longo UG, Franceschetti E, Maffulli N, Denaro V. Hip arthroscopy: state of the art. Br Med Bull. 2010;96:131-57. doi: 10.1093/bmb/ldq018. Epub 2010 Jul 6.
PubMed 20605889