Autologous Bone Marrow Aspirate Concentrate in Patients Undergoing Meniscectomy (NCT02582489) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Autologous Bone Marrow Aspirate Concentrate in Patients Undergoing Meniscectomy
United States100 participantsStarted 2017-12-22
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
International Knee Documentation Committee (IKDC) Score