Osteoarthritis Post-meniscectomy Clinical Trial
Official title:
Prospective, Randomized, Double-blind Clinical Trial to Investigate the Efficacy of Autologous Bone Marrow Aspirate Concentrate Post-Meniscectomy
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | December 31, 2025 |
| Est. primary completion date | November 30, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Rush University Medical Center | Chicago | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| Rush University Medical Center |
United States,
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Kim JD, Lee GW, Jung GH, Kim CK, Kim T, Park JH, Cha SS, You YB. Clinical outcome of autologous bone marrow aspirates concentrate (BMAC) injection in degenerative arthritis of the knee. Eur J Orthop Surg Traumatol. 2014 Dec;24(8):1505-11. doi: 10.1007/s00590-013-1393-9. Epub 2014 Jan 8. — View Citation
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | International Knee Documentation Committee (IKDC) Score | The primary outcome measure will be the IKDC score at one year follow-up | One Year | |
| Secondary | Patient reported outcomes throughout follow-up period | Patient reported outcomes will include change in scores from preoperative to Postoperative Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years | |
| Secondary | Synovial fluid analysis | To investigate any changes in synovial fluid markers of osteoarthritis. | 2 weeks, 6 weeks | |
| Secondary | Radiographic analysis | The degree of OA will be examined in all patients preoperatively and at subsequent follow-up visits at 1 and 2 years. | 1 year, 2 years | |
| Secondary | Patient reported outcomes throughout follow-up period (VAS) | Visual Analog Score (VAS) | 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years | |
| Secondary | Patient reported outcomes throughout follow-up period (IKDC) | International Knee Documentation Committee form (IKDC) | 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years | |
| Secondary | Patient reported outcomes throughout follow-up period (KOOS) | Knee injury and Osteoarthritis Outcome Score (KOOS) | 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years | |
| Secondary | Patient reported outcomes throughout follow-up period (SF-12) | (Short Form Health Survey) SF-12 | 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years |