Status:
RECRUITING
Evaluating Cryopreserved Osteochondral Allograft Cores for the Treatment of Osteochondral Lesions in the Knee
Lead Sponsor:
AlloSource
Conditions:
Osteochondral Defect
Eligibility:
All Genders
12-60 years
Phase:
NA
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.
Detailed 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 mechanica...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Has a history of substance abuse- (including but not limited to recreational drugs, alcohol) or has been treated in the last 6 months before enrollment for alcohol and/or drug abuse in an in-patient substance abuse program.
- Patients who, in the opinion of the Investigator, would not be able or willing to comply with the protocol.
- Is currently involved in a study of another investigational product for similar purpose or has been in the previous 90 days.
- Has any contraindications for MRI.
- Is having the procedure as part of a Worker's Compensation claim.
- Is a ward of the state, prisoner, or transient.
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2031
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT06216756
Start Date
December 1 2024
End Date
March 1 2031
Last Update
November 25 2025
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Banner- University Medical Center- Phoenix Orthopedic and Sports Medicine Institute
Phoenix, Arizona, United States, 85006
2
Cedars-Sinai Kerlan Jobe Institute
Los Angeles, California, United States, 90045
3
Stanford Medicine-Orthopaedics and Sports Medicine in Redwood City
Redwood City, California, United States, 94063
4
University of California San Francisco
San Francisco, California, United States, 94158