Study Summary
This trial will compare the outcomes of patients who receive BMAC after meniscectomy to those who don't, in terms of symptoms, physical examination, MRI, radiographs, and synovial fluid analysis. The hypothesis is that BMAC will improve outcomes.
Eligible Conditions
- Osteoarthritis After Meniscectomy
Treatment Effectiveness
Effectiveness Progress
Similar Trials
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: One Year
1 year, 2 years
Radiographic analysis
2 weeks, 6 weeks
Synovial fluid analysis
Year 2
Patient reported outcomes throughout follow-up period
One Year
International Knee Documentation Committee (IKDC) Score
Trial Safety
Safety Progress
Similar Trials
Trial Design
2 Treatment Groups
Meniscectomy with Bone Marrow Aspirate Concentrate (BMAC)
1 of 2
Meniscectomy with Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
100 Total Participants · 2 Treatment Groups
Primary Treatment: Bone Marrow Aspirate Concentrate · Has Placebo Group · N/A
Meniscectomy with Bone Marrow Aspirate Concentrate (BMAC)Experimental Group · 2 Interventions: Bone Marrow Aspirate Concentrate, Standard Meniscectomy · Intervention Types: Biological, Procedure
Meniscectomy with Placebo
Procedure
PlaceboComparator Group · 1 Intervention: Standard Meniscectomy · Intervention Types: ProcedureTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bone Marrow Aspirate Concentrate
2016
Completed Phase 4
~200
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: one year
Who is running the clinical trial?
Rush University Medical CenterLead Sponsor
389 Previous Clinical Trials
153,397 Total Patients Enrolled
Brian J Cole, MD, MBAPrincipal InvestigatorMidwest Orthopaedics at Rush
Eligibility Criteria
Age 18+ · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a meniscal tear of the knee that requires a meniscectomy.
Meniscal pathology is confirmed through MRI and arthroscopically.
References
- Vangsness, C. Thomas, Jack Farr, Joel Boyd, David T. Dellaero, C. Randal Mills, and Michelle LeRoux-Williams. 2014. “Adult Human Mesenchymal Stem Cells Delivered via Intra-articular Injection to the Knee Following Partial Medial Meniscectomy”. Journal of Bone and Joint Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/jbjs.m.00058.
- Gobbi, Alberto, Georgios Karnatzikos, Celeste Scotti, Vivek Mahajan, Laura Mazzucco, and Brunella Grigolo. 2011. “One-step Cartilage Repair with Bone Marrow Aspirate Concentrated Cells and Collagen Matrix in Full-thickness Knee Cartilage Lesions”. Cartilage. SAGE Publications. doi:10.1177/1947603510392023.
- Enea, D., S. Cecconi, S. Calcagno, A. Busilacchi, S. Manzotti, and A. Gigante. 2015. “One-step Cartilage Repair in the Knee: Collagen-covered Microfracture and Autologous Bone Marrow Concentrate. A Pilot Study”. The Knee. Elsevier BV. doi:10.1016/j.knee.2014.10.003.
- Fortier, Lisa A, Hollis G Potter, Ellen J Rickey, Lauren V Schnabel, Li Foong Foo, Leroy R Chong, Tracy Stokol, Jon Cheetham, and Alan J Nixon. 2010. “Concentrated Bone Marrow Aspirate Improves Full-thickness Cartilage Repair Compared with Microfracture in the Equine Model”. The Journal of Bone and Joint Surgery-american Volume. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/jbjs.i.01284.
- Centeno, Christopher, John Pitts, Hasan Al-Sayegh, and Michael Freeman. 2014. “Efficacy of Autologous Bone Marrow Concentrate for Knee Osteoarthritis with and Without Adipose Graft”. Biomed Research International. Hindawi Limited. doi:10.1155/2014/370621.
- Kim, Jae-Do, Gun Woo Lee, Gu Hee Jung, Cheung Kue Kim, Taehun Kim, Jin Hyung Park, Seong Sook Cha, and Young-Bin You. 2014. “Clinical Outcome of Autologous Bone Marrow Aspirates Concentrate (BMAC) Injection in Degenerative Arthritis of the Knee”. European Journal of Orthopaedic Surgery & Traumatology. Springer Science and Business Media LLC. doi:10.1007/s00590-013-1393-9.
- 2017. "Autologous Bone Marrow Aspirate Concentrate in Patients Undergoing Meniscectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02582489.
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Conditions
Cancer Related
Treatments