Clinical Study of Chondro-Gide® for Large Chondral Lesions in the Knee

Exclusion Criteria

• •1. BMI ≥ 30 kg/m2
• •2. Symptomatic contralateral knee
• •3. Diagnosis of radiographic osteoarthritis with Kellgren-Lawrence grade 3 or more
• •4. Prior surgical treatment of the cartilage using microfracture, mosaicplasty, or autologous chondrocyte implantation (debridement and lavage are acceptable if the procedure was at least 3 months prior to enrollment)
• •5. Patella dysplasia
• •6. Chronic inflammatory arthritis or infectious arthritis
• •7. History of autoimmune disease or immunodeficiency
• •8. History of connective tissue disease
• •9. Intra-articular steroid use within the 3 months prior to enrollment
• •10. Other intra-articular injections (e.g. hyaluronic acid) within 3 months prior to enrollment
• •11. The patient is currently being treated with radiation, chemotherapy, immunosuppression or systemic steroid therapy with a dose equivalent to more than 5 mg prednisolone
• •12. Pregnancy or lack of adequate contraceptives if a female of child-bearing potential
• •13. Enrolled in another study, involved in the study (as a researcher/investigator/sponsor), or relative of someone directly involved in the study
• •14. Active infection of the index knee
• •15. Previous diagnosis of osteoporosis as diagnosed by DEXA, bone densitometry or CT scan
• •16. Any disorder or impairment that would interfere with evaluation of outcomes measures, such as neurological, degenerative muscular, psychiatric, or cognitive conditions
• •17. History or current substance or alcohol abuse as defined by the DSM-V
• •18. Any other medical condition that the investigator determines would interfere with the validity of the study
• •19. Known allergy to porcine collagen
• •20. Symptom duration greater than 36 months