Actively Recruiting

Age: 18Years +
All Genders
ID03909139

Prospective Outcomes of Arthroscopic Acetabular Labral Repair With and Without Bone Marrow Aspirate Concentrate Application

Led by Massachusetts General Hospital · Updated on 2025-10-27

400

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of bone marrow aspirate concentrate (BMAC) combined with hip arthroscopy to treat patients with femoro-acetabular impingement (FAI) and acetabular labral tears. FAI can damage the acetabular labrum and the chondrolabral junction, potentially accelerating hip osteoarthritis. This study aims to compare outcomes after arthroscopic labral repair with and without BMAC application to address early cartilage damage and improve joint biomechanics. The study involves adult patients diagnosed with labral tears and pincer or cam deformities who undergo arthroscopic labral repair using a capsular chondrolabral preservation technique. During surgery, the decision to apply BMAC, which involves aspirating bone marrow, concentrating mesenchymal stromal cells, and injecting them into the hip joint, is made based on intra-operative findings. Patients either receive BMAC treatment or standard arthroscopic repair without BMAC. Follow-up visits are scheduled at 3 months, 6 months, 12 months, and then annually to monitor progress. Participants will complete surveys measuring hip function and pain, such as iHOT-33, HOS, NAHS, LEFS, mHHS, RAND-36, and pain visual analog scales before surgery and at follow-up visits. Patient satisfaction questionnaires are collected at 12 months and annually. The study also involves standard diagnostic imaging and clinical exams for diagnosis and eligibility. The total duration of participation varies as patients are monitored long term after surgery to assess outcomes and safety.

CONDITIONS

Brief Title

Use of BMAC With Hip Arthroscopy Treatment of FAI and Labral Tear

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 or older
  • Symptoms consistent with acetabular labrum tear such as catching, clicking, popping, or hip pain
  • Symptoms not caused by other acute hip conditions like infection, fractures, or nerve pain
  • Availability of hip X-rays and MRI or MRA scans
  • Evidence of labral tear on MRI or MRA
  • Willingness and ability to understand and sign informed consent
  • Returning subjects from protocol 2017P001391/PHS
Not Eligible

You will not qualify if you...

  • Non-English speaking individuals
  • Presence of systemic infection
  • Use of systemic heparin or anticoagulant therapy
  • Pregnancy or pregnancy in fetus as per federal regulations for surgery exclusion

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of surgery and immediate recovery period

Participants undergo arthroscopic labral repair surgery with or without bone marrow aspirate concentrate (BMAC) application based on intra-operative findings.

1 surgery visit (in-person)

Post-operative Follow-up

Duration - Up to several years following surgery

Participants attend routine post-operative follow-up visits to monitor progress and recovery after surgery.

Visits at 3 months, 6 months, 12 months, and annually thereafter

Trial Site Locations

Total: 1 location

1

MGH, Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

S

Scott D Martin, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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