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