Evaluating Cryopreserved Osteochondral Allograft Cores for the Treatment of Osteochondral Lesions in the Knee
- Conditions
- Osteochondral Defect
- Registration Number
- NCT06216756
- Lead Sponsor
- AlloSource
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Patient is =12 years and = 60 years of age at the time of surgery.<br><br> - Symptomatic patient presenting with moderate to severe pain in the index knee -<br> unresponsive to conservative treatment (i.e., medication, bracing, physical therapy)<br> and/or previous surgical intervention OR unsalvageable lesion that requires<br> transplantation at the discretion of the treating physician.<br><br> - Radiographically diagnosed, by MRI, or through arthroscopy, to have a cartilage<br> defect on the femoral condyle between 2.0-8.0 cm2 in size.<br><br> - Will be having an osteochondral transplant procedure.<br><br> - Has a mechanically stable knee or can be mechanically stabilized in the same<br> procedure.<br><br> - Has a normally aligned knee as confirmed by anatomic comparison to contralateral<br> limb, or <5° varus or valgus malalignment that has been corrected or will be<br> corrected in same procedure.<br><br> - Ipsilateral knee compartment has intact menisci or requires partial meniscectomy =<br> 50% resulting in stable menisci.<br><br> - MRI or CT scan obtained pre-operatively within 90 days of surgery.<br><br> - Willingness to follow standardized rehabilitation procedures.<br><br> - Has the ability to understand the requirements of the study, to provide written<br> informed consent, and to comply with the study protocol.<br><br>Exclusion Criteria:<br><br> - Bipolar articular cartilage involvement (kissing lesions) of the ipsilateral<br> compartment (i.e., > than ICRS Grade 2 on the opposing articular surface).<br><br> - Cystic changes present in the underlying subchondral bone >12 mm requiring osseous<br> repair.<br><br> - Has had a prior osteochondral allograft transplant procedure in the same knee.<br><br> - Will be receiving a meniscus allograft transplantation in the same procedure.<br><br> - Body Mass Index (BMI)of = 35 kg/m2.<br><br> - Active malignancy: undergoing treatment for tumor or boney traumatic injury or a<br> history of any invasive malignancy (except non-melanoma skin cancer) unless the<br> patient has been treated with curative intent and there have been no clinical signs<br> or symptoms of the malignancy for at least 5 years.<br><br> - Clinical and/or radiographic disease in the affected joint that includes generalized<br> osteoarthritis, gout or a history of gout or pseudo-gout.<br><br> - Active local microbial infection or a systemic infection, including prior or pending<br> treatment for HIV, syphilis, Hepatitis B or Hepatitis C.<br><br> - Currently immunologically suppressed or immunocompromised, or a medical condition<br> requiring radiation and/or chemotherapy.<br><br> - Unstable cardiovascular, renal, hepatic, endocrine and/or pulmonary disease, cancer,<br> or uncontrolled diabetes.<br><br> - Has a history of any inflammatory joint arthropathy.<br><br> - Currently using/chronic on oral corticosteroids.<br><br> - Received interarticular corticosteroid injection = 90 days prior to surgery<br><br> - Received hyaluronic acid injections into the joint space = 45 days prior to surgery.<br><br> - Is a female patient who is pregnant.<br><br> - Physically or mentally compromised (i.e., being currently treated for a psychiatric<br> disorder, senile dementia, Alzheimer's disease) in a manner that would compromise<br> his/her ability to participate in the clinical study.<br><br> - Has a history of substance abuse- (including but not limited to recreational drugs,<br> alcohol) or has been treated in the last 6 months before enrollment for alcohol<br> and/or drug abuse in an inpatient substance abuse program.<br><br> - Patients who, in the opinion of the Investigator, would not be able or willing to<br> comply with the protocol.<br><br> - Is currently involved in a study of another investigational product for similar<br> purpose or has been in the previous 90 days.<br><br> - Has any contraindications for MRI.<br><br> - Is having the procedure as part of a Worker's Compensation claim.<br><br> - Is a ward of the state, prisoner, or transient.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method International Knee Documentation Committee (IKDC) score
- Secondary Outcome Measures
Name Time Method Knee Injury and Osteoarthritis Outcome Score (KOOS);Assessment of repair cartilage structure;Graft incorporation;12-item Veterans RAND (VR-12);Revision surgery