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New treatment option for Osteochondral Defect
Official title Evaluating Cryopreserved Osteochondral Allograft Cores for the Treatment of Osteochondral Lesions in the Knee
ClinicalTrials.gov ID: NCT06216756
What this study is testing
- What it's testing
- 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.
- Time commitment: about 60 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 60
You may be able to join 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...
- 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.
You likely can't join if
- Bipolar articular cartilage involvement (kissing lesions) of the ipsilateral compartment (i.e., \> than ICRS Grade 2 on the opposing articular...
- 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)...
- Clinical and/or radiographic disease in the affected joint that includes generalized osteoarthritis, gout or a history of gout or pseudo-gout.
See the full eligibility 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...
- 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- Redwood City, California, United States
- San Francisco, California, United States
- Aurora, Illinois, United States
- Lexington, Kentucky, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 60 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Los Angeles, California, United States; Redwood City, California, United States; San Francisco, California, United States; Aurora, Illinois, United States; Lexington, Kentucky, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.