Cartilage Injury
Conditions
Brief summary
The goal of this study is to establish if mesenchymal stem cell augmentation improves graft incorporation and to analyze the cytokine environment of the joint after osteochondral allograft transplantation (OCA) with and without intra-articular bone marrow aspirate concentrate (BMAC) injection. Information learned from this study can be used to biochemically compare treatment response and to assess emerging therapeutic options that may positively alter the biochemical environment in patients who suffer from articular cartilage disorders.
Detailed description
Articular cartilage injuries in the knee continue to grow in number as detection and treatment options have advanced. Treatment options, including microfracture, autologous chondrocyte (cells that make cartilage) implantation, osteochondral grafting and meniscus transplantation can hopefully deter the progression of degeneration and have promise to function as disease modifying solutions. Osteochondral allograft transplantation (OCA) has emerged as a preferred method of treating large focal chondral defects as it structurally replaces the cartilage and often involved sub-chondral bone with native hyaline cartilage and bone. The results of OCA are successful with greater than 85% survival at 5-year follow-up. Failure can occur due to a lack of boney integration or low chondrocyte viability. Therefore, anything to enhance the graft augmentation process may be useful in preventing failure. The purpose of this prospective, randomized study is to determine the effect of bone marrow aspirate concentrate (BMAC) containing bone marrow derived mesenchymal stem cells on improving graft incorporation and preventing failure. The effect of BMAC on the graft and intra-articular knee environment will be evaluated using 3 techniques: computed tomography (CT) imaging, synovial fluid cytokine analysis, and serum biomarker analysis. Information learned from this study can be used to biochemically compare treatment response and to assess emerging therapeutic options that may positively alter the biochemical environment in patients undergoing osteochondral allograft transplantation.
Interventions
PROCEDUREAutologous bone marrow aspirate will be harvested and concentrated to a bone marrow aspirate concentrate (BMAC) containing bone marrow derived mesenchymal stem cells and delivered to site of operation
Autologous bone marrow aspirate will be processed and concentrated to a bone marrow aspirate concentrate (BMAC) containing bone marrow derived mesenchymal stem cells and delivered to the site of operation in the treatment group
PROCEDUREControl group incision
0.5cm sham incision over the iliac crest
Sponsors
Joint Restoration Foundation
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The control group will receive a 0.5cm sham incision over the iliac crest, but bone marrow aspiration will not be performed.
Intervention model description
Prospective, Randomized, Single Blind Clinical Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
• Patients aged 18-50 with a cartilage defect indicated for treatment with osteochondral allograft
Exclusion criteria
* Patients with known rheumatoid arthritis, any other inflammatory arthropathy or synovial tissue disorder. * Patients with known bipolar osteoarthritis of the knee as determined by the treating physician, greater than Kellegren-Lawrence Grade 3 on x-ray imaging * Patient with a known infection or history of infection in the affected knee
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Synovial Fluid Cytokine Measurement | Up to 52 weeks | To measure the amount of cytokines and cartilage biomarkers in the synovial fluid of patients undergoing osteochondral allograft transplantation with and without BMAC augmentation at different time points |
Other
| Measure | Time frame | Description |
|---|---|---|
| Radiographic analysis | Day 1, Post-operative 2 weeks, 6 weeks, 12, weeks, 24 weeks, 52 weeks | Changes in graft status will be analysed using radiographic analysis |
| Computed Tomography (CT) analysis | Post-operative 24 weeks | Changes in graft status will be analysed using Computed Tomography (CT) analysis |
Countries
United States
Outcome results
None listed