Autologous Bone Marrow Aspirate Concentrate in Patients Undergoing Meniscectomy
Trial Parameters
Brief Summary
The proposed research study aims to evaluate the effects of autologous bone marrow aspirate concentrate (BMAC) on the development and progression of osteoarthritis (OA) in patients undergoing meniscectomy. This prospective, randomized, double-blind clinical trial will compare patient-reported outcomes, specifically IKDC scores between patients who receive BMAC post-meniscectomy and those who receive a saline control injection. The study will also compare physical examination, MRI, radiographs, and synovial fluid analysis. Our hypothesis is that those who receive the autologous BMAC injection after the procedure will have better outcomes than those who do not.
Eligibility Criteria
Inclusion Criteria: * Subject is greater than 18 years old * Written informed consent is obtained * Subject is determined to have a symptomatic meniscal tear requiring a meniscectomy * Meniscal pathology is confirmed through MRI and arthroscopically * Subject agrees to all follow-up evaluations * Osteoarthritis Kellen-Lawrence grade 1-3 on flexion PA and extension AP views Exclusion Criteria: * Any subject lacking decisional capability * Unwillingness to participate in the necessary follow-up * Subject is pregnant or may become pregnant * History of diabetes mellitus * History of rheumatoid arthritis or other autoimmune disorder * History of solid organ or hematologic transplantation * Diagnosis of a non-basal cell malignancy within the preceding 5 years * Infection requiring antibiotic treatment within the preceding 3 months * Osteoarthritis Kellen-Lawrence grade 4 on flexion posterior-anterior (PA) or extension anteroposterior (AP) views * Prior surgery on the index meniscus * Concom