Osteoarthritis Post-meniscectomy
Conditions
Keywords
Mesenchymal stem cells, Bone marrow aspirate concentrate
Brief 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.
Detailed description
Recent studies have demonstrated both the safety of BMAC intra-articular injection and improvements in subjective, patient reported outcomes in patients with existing knee OA. Unfortunately these studies were largely uncontrolled, underpowered, and/or retrospective in nature. Additionally, a recent prospective, randomized clinical study of allograft mesenchymal stem cells (MSCs) injected at a separate time point post surgical intervention has highlighted the ability of MSCs to increase meniscal volume and improve knee pain following injection. This will be the first study to examine the effects of autograft BMAC intra-articular injection in a single-stage procedure and in a prospective, randomized, double-blind fashion. The results of this study, if the null hypothesis is rejected, will have far-reaching implications for the standard of care in meniscal treatment and on OA progression in the knee. Additionally, if the results of this study are favorable in reduction of OA progression this study will change the surgical approach to all axial, synovial joints including the shoulder, elbow, wrist, hip, and ankle.
Interventions
BIOLOGICALBone Marrow Aspirate Concentrate
Subjects undergoing autologous bone marrow aspirate concentrate will receive an intra-articular injection into the affected knee.
PROCEDUREStandard Meniscectomy
All subjects will undergo either a partial or complete meniscectomy to treat the torn meniscus.
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Knee Documentation Committee (IKDC) Score | One Year | The primary outcome measure will be the IKDC score at one year follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported outcomes throughout follow-up period | 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years | Patient reported outcomes will include change in scores from preoperative to Postoperative Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |
| Synovial fluid analysis | 2 weeks, 6 weeks | To investigate any changes in synovial fluid markers of osteoarthritis. |
| Radiographic analysis | 1 year, 2 years | The degree of OA will be examined in all patients preoperatively and at subsequent follow-up visits at 1 and 2 years. |
| Patient reported outcomes throughout follow-up period (VAS) | 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years | Visual Analog Score (VAS) |
| Patient reported outcomes throughout follow-up period (IKDC) | 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years | International Knee Documentation Committee form (IKDC) |
| Patient reported outcomes throughout follow-up period (KOOS) | 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years | Knee injury and Osteoarthritis Outcome Score (KOOS) |
| Patient reported outcomes throughout follow-up period (SF-12) | 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years | (Short Form Health Survey) SF-12 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBrian J Cole, MD, MBA
Midwest Orthopaedics at Rush
Outcome results
None listed