The Clinical Outcome of BiCRI in the Treatment of Chondral and Osteochondral Lesions
Articular Cartilage Disorder of Knee
About this trial
This is an interventional treatment trial for Articular Cartilage Disorder of Knee
Eligibility Criteria
Inclusion Criteria: - Age between 16~65 (inclusive) years old presenting with either symptomatic chondral or osteochondral lesion of knee requiring primary surgical intervention. The lesions may include but not limited to following conditions: multiple lesions lesion that had been treated with microfracture or mosaicplasty but failed. The index lesion is ICRS grade 3-4 lesion, Outerbridge grade 4, or OCD grades 3-4 Willing and able to consent in wiring to participate in the study Exclusion Criteria: 1. Rheumatoid arthritis and other inflammatory arthritis 2. The index cartilage lesion requires more than 3 (exclusive) implants 3. Skeletally immature (epiphyses are not closed based on x-ray) 4. Concomitant comorbidities 5. Local or systemic infection, not including asymptomatic urinary tract infection if treated with antibiotics preoperatively 6. Pregnancy or breast feeding 7. Prisoner 8. Patient is actively participating in another medical device, drug, or biologic investigation (active defines as within the last 30 days prior to signing the consent form) 9. Any condition that is not suitable to participate in the study based on the physician's judgement
Sites / Locations
- En Chu Kong HospitalRecruiting
Arms of the Study
Arm 1
Experimental
BiCRI
Biphasic Cartilage Repair Implant