Autologous Bone Marrow Aspirate Concentrate in Patients Undergoing Meniscectomy
Prospective, Randomized, Double-blind Clinical Trial to Investigate the Efficacy of Autologous Bone Marrow Aspirate Concentrate Post-Meniscectomy
Rush University Medical Center
100 participants
Dec 22, 2017
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria13
- 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
- Concomitant surgery such as ligament surgery or cartilage repair or restoration
- Infection
- Prior cortisone/viscosupplementation/ (platelet rich plasma) PRP injection within 6 weeks
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Subjects undergoing autologous bone marrow aspirate concentrate will receive an intra-articular injection into the affected knee.
All subjects will undergo either a partial or complete meniscectomy to treat the torn meniscus.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT02582489