Using bone marrow concentrate to improve outcomes after meniscus surgery
Prospective, Randomized, Double-blind Clinical Trial to Investigate the Efficacy of Autologous Bone Marrow Aspirate Concentrate Post-Meniscectomy
This study is testing whether using a special treatment from your own bone marrow can help people feel better and have less knee pain after meniscus surgery compared to a saline solution.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rush University Medical Center Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT02582489 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of autologous bone marrow aspirate concentrate (BMAC) on osteoarthritis progression in patients undergoing meniscectomy. It is a prospective, randomized, double-blind study comparing patient-reported outcomes between those receiving BMAC and a saline control. The study will also assess physical examinations, MRI results, radiographs, and synovial fluid analysis to determine the efficacy of BMAC in improving knee function and reducing osteoarthritis symptoms. The hypothesis is that patients receiving BMAC will show better outcomes than those receiving the control treatment.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with symptomatic meniscal tears and osteoarthritis grades 1-3.
Not a fit: Patients with advanced osteoarthritis (grade 4) or those with autoimmune disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery and long-term outcomes for patients undergoing meniscectomy.
How similar studies have performed: While previous studies on BMAC have shown promise, this is the first to rigorously evaluate its effects in a controlled, randomized setting.
Eligibility criteria
Show full inclusion / exclusion 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 * Concomitant surgery such as ligament surgery or cartilage repair or restoration * Infection * Prior cortisone/viscosupplementation/ (platelet rich plasma) PRP injection within 6 weeks
Where this trial is running
Chicago, Illinois
- Rush University Medical Center — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Brian J Cole, MD, MBA — Midwest Orthopaedics at Rush
- Study coordinator: Carla Edwards, PhD
- Email: carla_edwards@rush.edu
- Phone: 312-563-5735
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.