Using bone marrow concentrate with hip arthroscopy for labral tears and impingement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the use of bone marrow aspirate concentrate (BMAC) in conjunction with hip arthroscopy to treat femoro-acetabular impingement (FAI) and acetabular labrum tears. The approach aims to restore the native anatomy and biomechanics of the hip joint, potentially mitigating the progression of osteoarthritis associated with labral injuries. By focusing on the repair of labral pathology and addressing underlying bony lesions, the study seeks to improve patient outcomes and reduce the need for more invasive procedures. The research will assess the feasibility and efficacy of BMAC in treating chondral defects within the hip joint.

Why it matters

Who can join: the full rules

Inclusion Criteria and Rationale:

1. Age 18 or older: patients of any age have the capacity to potentially benefit from labral repair
2. Symptoms consistent with a tear of the acetabular labrum (i.e., 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 magnetic resonance imaging (MRI and/or MRA): needed to assess eligibility
5. Evidence of labral tear on MRI and/or MRA: documentation of acetabular labrum tear
6. Willingness to participate and ability to understand and sign informed consent document: ability to understand study and consent willingly
7. Returning subjects enrolled in protocol 2017P001391/PHS

Exclusion Criteria and Rationale:

1. Non-English speaking subjects: PROMs are only validated in English.
2. Systemic infection: surgery is generally contraindicated when systemic infection is present.
3. Systemic heparinization: the vascularity of the bone and adjacent tissues is significant, posing a potential problem for bleeding when the patient is anti-coagulated.
4. Pregnant women/fetuses: although surgery can be performed on pregnant women, pregnant women are excluded under federal regulations.

Where it's running

• MGH, Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Scott D Martin, MD — Massachusetts General Hospital
• Study coordinator: Scott D Martin, MD
• Email: sdmartin@partners.org
• Phone: 617-732-5329

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.