NCT03909178

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
49mo left

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Oct 2013Jun 2030

Study Start

First participant enrolled

October 21, 2013

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2018

Completed
10 months until next milestone

First Posted

Study publicly available on registry

April 9, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2020

Completed
11 months until next milestone

Results Posted

Study results publicly available

May 18, 2021

Completed
9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Expected
Last Updated

November 10, 2025

Status Verified

November 1, 2025

Enrollment Period

6.7 years

First QC Date

June 12, 2018

Results QC Date

March 3, 2021

Last Update Submit

November 5, 2025

Conditions

Keywords

Acetabular Labrum TearFemoro Acetabular ImpingementOsteoarthritisHip ArthroscopyProspectivePROMsmHHSHOSNAHSLEFSiHOT-33RCT, Randomized Control TrialPhysical Therapy, PTOsteoarthritis, HipTonnisOuterbridgeOlder than 40 years old

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline (pre-operative), 3 months, 6 months, 12 months

Secondary Outcomes (5)

  • Change HOS Surveys From Preoperative to Various Postoperative Timepoints

    Baseline (pre-operative), 3 months, 6 months, 12 months

  • Change NAHS Surveys From Preoperative to Various Postoperative Timepoints

    Baseline (pre-operative), 3 months, 6 months, 12 months

  • Change iHOT--33 Surveys From Preoperative to Various Postoperative Timepoints

    Baseline (pre-operative), 3 months, 6 months, 12 months

  • Change LEFS Surveys From Preoperative to Various Postoperative Timepoints

    Baseline (pre-operative), 3 months, 6 months, 12 months

  • Degree of Improvement on Hip VAS Pain Score

    Baseline (pre-operative), 3 months, 6 months, 12 months

Study Arms (2)

Hip Arthroscopy Surgery with Acetabular Labral Repair

ACTIVE COMPARATOR

Hip Arthroscopy Surgery with Acetabular Labral Repair

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.

Procedure: Physical Therapy Focused on the Hip and Hemi-pelvis (PT group)

Interventions

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.

Hip Arthroscopy Surgery with Acetabular Labral Repair

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).

Physical Therapy Focused on the Hip and Hemi-pelvis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MGH, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (64)

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  • Martin SD, Abraham PF, Varady NH, Nazal MR, Conaway W, Quinlan NJ, Alpaugh K. Hip Arthroscopy Versus Physical Therapy for the Treatment of Symptomatic Acetabular Labral Tears in Patients Older Than 40 Years: A Randomized Controlled Trial. Am J Sports Med. 2021 Apr;49(5):1199-1208. doi: 10.1177/0363546521990789. Epub 2021 Mar 3.

MeSH Terms

Conditions

Femoracetabular ImpingementOsteoarthritis, HipOsteoarthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsArthritisRheumatic Diseases

Limitations and Caveats

Crossover rates in this study were high. For ethical reasons, all randomized patients had to meet surgical eligibility, potentially increasing crossover rates because participants randomized to PTA were aware that they met surgical eligibility. Second, some patients may have had bias for either SPT or PTA. However, to minimize this bias, we imposed strict inclusion criteria to ensure that patients did not prefer one treatment arm and were fully committed to completing their assigned treatment.

Results Point of Contact

Title
Dr. Scott Martin
Organization
Massachusetts General Hospital

Study Officials

  • Scott D Martin, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Director, Joint Preservation Service, Director, MGH Sports Medicine Fellowship

Study Record Dates

First Submitted

June 12, 2018

First Posted

April 9, 2019

Study Start

October 21, 2013

Primary Completion

June 20, 2020

Study Completion (Estimated)

June 1, 2030

Last Updated

November 10, 2025

Results First Posted

May 18, 2021

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations