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Not Yet Recruiting NCT07909928

Biologic Augmentation of Osteochondral Allograft Transplantation in the Knee

Conditions: Osteochondral Defect, Articular Cartilage Defect

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 10
Sponsor: University of Minnesota

Location: M Health Fairview Clinics and Surgery Center, 909 Fulton Street SE Minneapolis Minnesota

Summary

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.

Eligibility Criteria

Inclusion Criteria: * Adults 18 years of age or older. * Scheduled to undergo osteochondral allograft transplantation of the knee with Dr. Jeffrey Macalena or Dr. Bradley Nelson. * Medial or lateral femoral condyle osteochondral lesion deemed appropriate for treatment with osteochondral allograft transplantation. * Able to understand and provide informed consent. * Willing and able to comply with all study procedures and follow-up requirements. Exclusion Criteria: * Younger than 18 years of age. * Unable to provide informed consent, including individuals with absent, diminished, or fluctuating decision-making capacity. * Unwilling or unable to comply with study procedures or follow-up requirements. * Medical, psychiatric, or social condition that, in the opinion of the investigator, would interfere with study participation or interpretation of study results. * Participation in another research study that could affect study outcomes, at the discretion of the investigator. * Non-English-speaking individuals. * Prisoners. * Employees or students of the researcher.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07909928). StuddyBuddy aggregates publicly available trial information.