The Clinical Outcome of BiCRI in the Treatment of Chondral and Osteochondral Lesions

Study Overview
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Brief Summary
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Based on the previous successful experiences, the investigators like to extend our patient population. In this study, the investigators aim to determine the safety and effectiveness of the Biphasic Cartilage Repair Implant (BiCRI) in the treatment of chondral and osteochondral lesions of the knee, including but not limited to more than one (1) lesion and the lesion that had been treated with microfracture or mosaicplasty but failed.

Detailed Description
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Patients who qualify for this trial and who are interested in participating will be consented using an Institutional Review Board (IRB) approved Informed Consent. Once a patient has signed the Informed Consent Form he/she is considered enrolled in the trial. If during surgery the size of lesion is found to meet exclusion criteria, the subject will be considered withdrawn (screen failure) from the trial. Clinical trial eligibility should be determined by confirmation that the patient meets the criteria included in the Protocol. Standard arthroscopic technique should be used to fully assess the joint and determine if the chondral or osteochondral defect is appropriate for inclusion in the study. Through arthroscopic examination after initial debridement, the investigator should use his best judgment to estimate the size of the lesion, and the number of BiCRI to be applied. Plain radiographs and MRI prior to 6-month (inclusive) visit will be performed according to routine clinical practice; however, 12-month and 24-monthpostoperative images should be done for study outcome evaluation

Official Title
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The Clinical Outcome of the Biphasic Cartilage Repair Implant (BiCRI) in the Treatment of Chondral and Osteochondral Lesions of the Knee.

Conditions
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Articular Cartilage Disorder of Knee

Intervention / Treatment
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* Device: Biphasic Cartilage Repair Implant (BiCRI)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BiCRI<br>Biphasic Cartilage Repair Implant | Device: Biphasic Cartilage Repair Implant (BiCRI)<br>* The Biphasic Cartilage Repair Implant (BiCRI) is a two-phase scaffold composed of poly(lactic-co-glycolic acid) (PLGA) and β-triCalcium phosphate (TCP).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Knee Documentation Committee-2000 Subjective Knee Evaluation | International Knee Documentation Committee-2000 Subjective Knee Evaluation compare to baseline | 24 months after operation | 
| International Knee Documentation Committee-2000 Knee Examination Form | International Knee Documentation CommitteeC-2000 Knee Examination Form compare to baseline | 24 months after operation | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Knee Injury and Osteoarthritis Outcome Score (KOOS) compare to baseline | 24 months after operation | 
| Pain (visual analogue scale;VAS) | Pain (visual analogue scale;VAS) compare to baseline | 24 months after operation | 
| Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scale | Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scale | 24 months after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Knee Documentation Committee-2000 Subjective Knee Evaluation | International Knee Documentation Committee-2000 Subjective Knee Evaluation compare to baseline | 12 months after operation | 
| International Knee Documentation Committee-2000 Knee Examination Form | International Knee Documentation CommitteeC-2000 Knee Examination Form compare to baseline | 12 months after operation | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Knee Injury and Osteoarthritis Outcome Score (KOOS) compare to baseline | 12 months after operation | 
| Pain (visual analogue scale;VAS) | Pain (visual analogue scale;VAS) compare to baseline | 12 months after operation | 
| Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scale | Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scale | 12 months after operation |