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

NCT06216756 | Recruiting

• 1 other identifier: COCA-OCA-001
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Osteochondral Defect

Outcome Measures

Primary Outcomes (1)

• International Knee Documentation Committee (IKDC) score

  Change of physical functioning and pain from baseline as assessed by the subjective International Knee Documentation Committee (IKDC) score. Scores are reported on a 0-100 scale, with low scores indicating worse outcomes and higher scores indicating better outcomes.

  3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months post procedure

Secondary Outcomes (5)

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

• Assessment of repair cartilage structure

  12 months, 24 months and 60 months post procedure

• Graft incorporation

  12 months, 24 months and 60 months post procedure

• 12-item Veterans RAND (VR-12)

  3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months post procedure

• Revision surgery

  60 months post-procedure

Study Arms (1)

Osteochondral transplant on the femoral condyle

EXPERIMENTAL

Eligible and enrolled patients will receive one or more cryopreserved osteochondral allograft core as part of their osteochondral transplant procedure

Procedure: osteochondral transplant on the femoral condyle

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.

Osteochondral transplant on the femoral condyle

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients are ≥12 years and ≤ 60 years of age at the time of surgery.
• Symptomatic patient presenting with moderate to severe pain in the index knee - unresponsive to conservative treatment (i.e., medication, bracing, physical therapy) and/or previous surgical intervention OR unsalvageable lesion that requires transplantation at the discretion of the treating physician.
• Radiographically diagnosed, by MRI or CT scans, or through arthroscopy, to have a cartilage defect on the femoral condyle between 0.9-8.0 cm2 in size.
• Will be having an osteochondral transplant procedure.
• Has a mechanically stable knee or can be mechanically stabilized in the same procedure.
• Has a normally aligned knee as confirmed by anatomic comparison to contralateral limb, or \<5° varus or valgus malalignment that has been corrected or will be corrected in same procedure.
• Ipsilateral knee compartment has intact menisci or requires partial meniscectomy ≤ 50% resulting in stable menisci.
• Confirmation MRI, CT scan, or arthroscopy obtained pre-operatively within 90 days of surgery
• Willingness to follow standardized rehabilitation procedures.
• Has the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.

You may not qualify if:

• Bipolar articular cartilage involvement (kissing lesions) of the ipsilateral compartment (i.e., \> than ICRS Grade 2 on the opposing articular surface).
• Has had a prior osteochondral allograft transplant procedure in the same knee.
• Will be receiving a meniscus allograft transplantation in the same procedure.
• Body Mass Index (BMI)of ≥ 35 kg/m2.
• Active malignancy: undergoing treatment for tumor or boney traumatic injury or a history of any invasive malignancy (except non-melanoma skin cancer) unless the patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years.
• Clinical and/or radiographic disease in the affected joint that includes generalized osteoarthritis, gout or a history of gout or pseudo-gout.
• Active local microbial infection or a systemic infection, including HIV, syphilis, Hepatitis B or Hepatitis C.
• Currently immunologically suppressed or immunocompromised, or a medical condition requiring radiation and/or chemotherapy.
• Unstable cardiovascular, renal, hepatic, endocrine and/or pulmonary disease, cancer, or uncontrolled diabetes.
• Has a history of any inflammatory joint arthropathy.
• Currently using/chronic on oral corticosteroids.
• Received interarticular corticosteroid injection ≤ 90 days prior to surgery.
• Received hyaluronic acid injections into the joint space ≤ 45 days prior to surgery.
• Is a female patient who is pregnant.
• Physically or mentally compromised (i.e., being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease) in a manner that would compromise his/her ability to participate in the clinical study.

Sponsors & Collaborators

• AlloSource: lead

Study Sites (6)

Banner- University Medical Center- Phoenix Orthopedic and Sports Medicine Institute

Phoenix, Arizona, 85006, United States

RECRUITING

Cedars-Sinai Kerlan Jobe Institute

Los Angeles, California, 90045, United States

NOT YET RECRUITING

Stanford Medicine-Orthopaedics and Sports Medicine in Redwood City

Redwood City, California, 94063, United States

RECRUITING

University of California San Francisco

San Francisco, California, 94158, United States

RECRUITING

Rush Copley Medical Center

Aurora, Illinois, 60504, United States

RECRUITING

University of Kentucky Research Foundation

Lexington, Kentucky, 40506, United States

RECRUITING

Central Study Contacts

Elizabeth Esterl, DNP, MS, RN

CONTACT

7207326231; eesterl@allosource.org

Paige McHenry, MS, ATC, CCRA

CONTACT

2154997062; pmchenry@allosource.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 22, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2031
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)