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

Launched by MASSACHUSETTS GENERAL HOSPITAL · Apr 8, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a treatment approach for patients with certain hip problems, particularly those suffering from a tear in the acetabular labrum, a structure that helps stabilize the hip joint. The researchers are looking at the use of a substance called Bone Marrow Aspirate Concentrate (BMAC) alongside a surgical procedure known as hip arthroscopy. This combination aims to improve the repair of the labrum and potentially prevent further joint damage, which could lead to conditions like osteoarthritis.

To be eligible for participation, individuals should be 18 years or older and have symptoms that suggest a labral tear, such as pain and catching sensations in the hip. They should also have imaging tests, like MRI, showing evidence of a tear. Participants will undergo the hip arthroscopy procedure and have the chance to receive the BMAC treatment. It’s important to note that individuals with certain medical conditions, language barriers, or who are pregnant are not able to participate. This trial could offer hope for those dealing with painful hip issues by exploring innovative ways to help their recovery.

Gender

ALL

Eligibility criteria

• 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.