A Prospective, Open Label, Single-Arm, Multi-Center Study Evaluating Cryopreserved Osteochondral Allograft Cores for the Treatment of Osteochondral Lesions in the Knee
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteochondral Defect
- Sponsor
- AlloSource
- Enrollment
- 68
- Locations
- 6
- Primary Endpoint
- International Knee Documentation Committee (IKDC) score
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
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 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.
Investigators
Eligibility Criteria
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/m
- •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.
Outcomes
Primary Outcomes
International Knee Documentation Committee (IKDC) score
Time Frame: 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months post procedure
Change of physical functioning and pain from baseline as assessed by the subjective International Knee Documentation Committee (IKDC) score. Scores are reported on a 0-100 scale, with low scores indicating worse outcomes and higher scores indicating better outcomes.
Secondary Outcomes
- 12-item Veterans RAND (VR-12)(3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months post procedure)
- Graft incorporation(12 months, 24 months and 60 months post procedure)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months)
- Revision surgery(60 months post-procedure)
- Assessment of repair cartilage structure(12 months, 24 months and 60 months post procedure)