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Evaluating Cryopreserved Osteochondral Allograft Cores for the Treatment of Osteochondral Lesions in the Knee

Osteochondral Defect Clinical Trial

Official title:
A Prospective, Open Label, Single-Arm, Multi-Center Study Evaluating Cryopreserved Osteochondral Allograft Cores for the Treatment of Osteochondral Lesions in the Knee

Clinical Trial Summary

The primary objective of this study is to obtain evidence of the effectiveness of Cryopreserved Osteochondral Allograft Core in the treatment of osteochondral lesions on the femoral condyle.

Clinical Trial Description

Patients between the ages of ≥12 years and ≤ 60 years who have a symptomatic full-thickness cartilage lesion (Grade 3 or 4) on the femoral condyle, in a mechanically stable knee, or is being mechanically stabilized in the same procedure, between 2.0-8.0 cm2 in size, and cystic changes requiring osseous repair present in less than or equal to 12 mm of subchondral bone, as confirmed by Magnetic Resonance Imaging (MRI) or arthroscopy, and undergoing an osteochondral transplant procedure will be eligible for enrollment. Patients will receive one or more cryopreserved osteochondral allograft core transplants to replace damaged cartilage. Patients will be followed for up to 60 months post-procedure (6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months) to evaluate short and long-term outcomes of the procedure using the cryopreserved osteochondral allograft cores. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06216756
Study type Interventional
Source AlloSource
Contact Elizabeth Esterl, DNP, MS, RN
Phone 720-732-6231
Email eesterl@allosource.org
Status Not yet recruiting
Phase N/A
Start date March 2024
Completion date March 2031
View Details
See also
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