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

Prospective PROMs Outcomes in Arthroscopic Acetabular Labral Repair With and Without Application of Platelet-Rich Plasma (PRP) Harvested From the Body of the Ilium

This study is testing whether using bone marrow concentrate during hip surgery can help people with labral tears and hip impingement feel better and prevent further joint problems.

Quick facts

• Study type: Observational
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Massachusetts General Hospital (other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT03909139 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with symptoms indicative of an acetabular labrum tear.

Not a fit: Patients with hip pain due to conditions unrelated to labral tears or those with acute hip processes may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved joint function and reduced progression of osteoarthritis in patients with labral tears.

How similar studies have performed: While the use of BMAC in other joints has shown promise, this specific application in hip arthroscopy is relatively novel and has not been extensively tested.

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.

Where this trial is running

Boston, Massachusetts

• 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

Conditions: Acetabular Labrum Tear, Femoro Acetabular Impingement, Chondral Defect, Bone Marrow Aspirate Concentrate, Mesenchymal Stromal Cell, Chondrolabral Junction, Osteoarthritis, Femoroacetabuloplasty