Actively Recruiting
Evaluating Cryopreserved Osteochondral Allograft Cores for the Treatment of Osteochondral Lesions in the Knee
Led by AlloSource · Updated on 2025-11-25
68
Participants Needed
6
Research Sites
325 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluating Cryopreserved Osteochondral Allograft Cores for the Treatment of Osteochondral Lesions in the Knee
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 12 to 60 years at the time of surgery
- Symptomatic moderate to severe knee pain unresponsive to conservative treatment or previous surgery, or an unsalvageable lesion requiring transplant
- Cartilage defect on the femoral condyle between 0.9 and 8.0 cm2 confirmed by MRI, CT scan, or arthroscopy
- Scheduled for an osteochondral transplant procedure
- Mechanically stable knee or able to be stabilized during the same surgery
- Normally aligned knee or less than 5° varus or valgus malalignment corrected or to be corrected during surgery
- Ipsilateral knee compartment has intact menisci or requires partial meniscectomy of 50% or less resulting in stable menisci
- Confirmation imaging obtained within 90 days before surgery
- Willing to follow standardized rehabilitation
- Able to understand study requirements, provide informed consent, and comply with protocol
You will not qualify if you...
- Bipolar articular cartilage involvement (kissing lesions) greater than ICRS Grade 2 on the opposing surface in the same knee compartment
- Prior osteochondral allograft transplant in the same knee
- Receiving meniscus allograft transplantation in the same procedure
- Body Mass Index (BMI) of 35 kg/m2 or higher
- Active malignancy or history of invasive malignancy unless treated with no signs for at least 5 years
- Generalized osteoarthritis, gout, or history of gout or pseudo-gout in the affected joint
- Active local or systemic infections including HIV, syphilis, Hepatitis B or C
- Immunosuppressed or immunocompromised condition or undergoing radiation/chemotherapy
- Unstable cardiovascular, renal, hepatic, endocrine, pulmonary disease, cancer, or uncontrolled diabetes
- History of inflammatory joint arthropathy
- Current or chronic use of oral corticosteroids
- Interarticular corticosteroid injection within 90 days before surgery
- Hyaluronic acid injection into the joint within 45 days before surgery
- Pregnancy
- Physically or mentally compromised impacting study participation
- History of substance abuse or treatment for substance abuse within 6 months
- Unable or unwilling to comply with the study protocol
- Participation in another investigational product study within 90 days
- Contraindications for MRI
- Procedure as part of a Worker's Compensation claim
- Being a ward of the state, prisoner, or transient
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Banner- University Medical Center- Phoenix Orthopedic and Sports Medicine Institute
Phoenix, Arizona, United States, 85006
Actively Recruiting
2
Cedars-Sinai Kerlan Jobe Institute
Los Angeles, California, United States, 90045
Not Yet Recruiting
3
Stanford Medicine-Orthopaedics and Sports Medicine in Redwood City
Redwood City, California, United States, 94063
Actively Recruiting
4
University of California San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
5
Rush Copley Medical Center
Aurora, Illinois, United States, 60504
Actively Recruiting
6
University of Kentucky Research Foundation
Lexington, Kentucky, United States, 40506
Actively Recruiting
Research Team
E
Elizabeth Esterl, DNP, MS, RN
CONTACT
P
Paige McHenry, MS, ATC, CCRA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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