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NOT YET RECRUITING
NCT07909928
NA

Biologic Augmentation of Osteochondral Allograft Transplantation in the Knee

Sponsor: University of Minnesota

View on ClinicalTrials.gov

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.

Official title: Biologic Augmentation for Osteochondral Allograft Transplantation: A Prospective Case-Series

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2026-11-20

Completion Date

2028-07-20

Last Updated

2026-11-02

Healthy Volunteers

No

Interventions

PROCEDURE

Biologically Augmented Osteochondral Allograft Transplantation

Participants will undergo osteochondral allograft transplantation of the knee with biologic augmentation. Bone marrow will be aspirated from the tibial tubercle and processed to obtain bone marrow aspirate concentrate (BMAC). BMAC will be mixed with Arthrex AlloSync Pure to create a biologic slurry. This mixture will be applied to the base of the recipient socket and along the walls of the graft plug before implantation of the osteochondral allograft. Participants will receive routine postoperative care and complete scheduled follow-up assessments.

Locations (1)

M Health Fairview Clinics and Surgery Center, 909 Fulton Street SE

Minneapolis, Minnesota, United States