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

AlloSource

Status: Not yet enrolling

Conditions: Osteochondral Defect

Treatments: Procedure: osteochondral transplant on the femoral condyle

Study type: Interventional

Funder types: Industry

Identifiers

NCT06216756

COCA-OCA-001

Details and patient eligibility

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.

Full 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 2.0-8.0 cm2 in size, and cystic changes requiring osseous repair present in less than or equal to 12 mm of subchondral bone, as confirmed by Magnetic Resonance Imaging (MRI) 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.

Enrollment: 68 estimated patients

Sex: All

Ages: 12 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is ≥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 through arthroscopy, to have a cartilage defect on the femoral condyle between 2.0-8.0 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.
• MRI or CT scan 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).
• Cystic changes present in the underlying subchondral bone >12 mm requiring osseous repair.
• 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 prior or pending treatment for 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 inpatient 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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68 participants in 1 patient group

Osteochondral transplant on the femoral condyle

Experimental group

Description:

Eligible and enrolled patients will receive one or more cryopreserved osteochondral allograft core as part of their osteochondral transplant procedure

Treatment:

Procedure: osteochondral transplant on the femoral condyle