Biologic Augmentation for Articular Cartilage Injury
What You Need to Know Before You Apply
What is the purpose of this trial?
This prospective, single-center pilot study will evaluate biologic augmentation during osteochondral allograft transplantation of the knee using a combination of bone marrow aspirate concentrate (BMAC) and Arthrex AlloSync Pure.
Approximately 10 adults undergoing osteochondral allograft transplantation for focal osteochondral defects of the medial or lateral femoral condyle will be enrolled. During surgery, BMAC will be collected from the tibial tubercle and mixed with Arthrex AlloSync Pure. The mixture will be applied to the recipient socket and graft plug before allograft implantation.
The primary objective is to assess osteochondral allograft incorporation using magnetic resonance imaging (MRI) at 6 months after surgery. Secondary outcomes include MRI-based graft incorporation at 12 weeks and, when clinically indicated, 12 months; knee function and pain measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS) and Visual Analog Scale (VAS); radiographic graft healing; and postoperative complications and adverse events during one year of follow-up.
Who Is on the Research Team?
Jeffrey Macalena, MD
Principal Investigator
University of Minnesota
Are You a Good Fit for This Trial?
This trial is for adults who need knee surgery to repair a specific area of damaged cartilage and bone (osteochondral defect) in the femoral condyle. Participants must be eligible for osteochondral allograft transplantation.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Biologically Augmented Osteochondral Allograft Transplantation
Trial Overview
The study tests whether adding a mix of bone marrow cells (BMAC) and Arthrex AlloSync Pure during knee cartilage transplant surgery helps the graft heal better. About 10 patients will receive this biologic-augmented treatment, with follow-up scans and assessments over one year.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All participants will undergo osteochondral allograft transplantation of the knee with biologic augmentation using bone marrow aspirate concentrate (BMAC) and Arthrex AlloSync Pure. Bone marrow will be aspirated from the tibial tubercle and processed to obtain BMAC. The BMAC will be combined with AlloSync Pure and applied to the recipient socket and graft plug before allograft implantation. Participants will complete postoperative imaging and clinical outcome assessments over one year.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor
Arthrex, Inc.
Industry Sponsor
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