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

Conditions

• Osteochondral Defect

Eligibility Criteria

Sex

ALL

Age

12 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• osteochondral transplant on the femoral condyle — PROCEDURE
  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 0.9-8.0 cm2 in size, and cystic changes requiring osseous repair, as confirmed by MRI , CT scan, or arthroscopy and will undergo a osteochondral transplant by removing the damaged cartilage and replacing that cartilage with a cryopreserved osteochondral allograft core.

Study Details

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.

Key Dates

Start date

Dec 1, 2024

Status verified

Nov 2025

Primary completion

Mar 31, 2031

Completion

Mar 31, 2031

Study Design

Enrollment

68 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Osteochondral transplant on the femoral condyle
  Eligible and enrolled patients will receive one or more cryopreserved osteochondral allograft core as part of their osteochondral transplant procedure

Primary Outcome Measure

International Knee Documentation Committee (IKDC) score [ Time Frame: 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months post procedure ]

Central Contacts

• Elizabeth Esterl, DNP, MS, RN
  7207326231
  [email protected]
• Paige McHenry, MS, ATC, CCRA
  2154997062
  [email protected]

Locations (6)

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