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NCT06216756NARecruiting

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

AlloSource

Start Date

12/1/2024

Completion Date

3/1/2031

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 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 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.

Eligibility Criteria

Age Range: 12 years to 60 years

Inclusion Criteria: * 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 Criteria: * 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.

Interventions

PROCEDURE

osteochondral transplant on the femoral condyle

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Conditions

Osteochondral Defect

Locations

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

Phoenix, Arizona 85006

United States

Cedars-Sinai Kerlan Jobe Institute

Los Angeles, California 90045

United States

Stanford Medicine-Orthopaedics and Sports Medicine in Redwood City

Redwood City, California 94063

United States

University of California San Francisco

San Francisco, California 94158

United States

Rush Copley Medical Center

Aurora, Illinois 60504

United States

University of Kentucky Research Foundation

Lexington, Kentucky 40506

United States