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

Articular Cartilage Disorder of Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05924763
• Other study ID #: CR18-001
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2023
• Source: BioGend Therapeutics Co.Ltd
• Contact: Gwen Chang
• Phone: +886226558366
• Email: gwen.chang[@]biogend.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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 If during surgery the size of lesion is found to meet exclusion criteria, the subject will be considered withdrawn (screen failure) from the trial.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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

Inclusion Criteria:

1. - 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.

2. The index lesion is ICRS grade 3-4 lesion, Outerbridge grade 4, or OCD grades 3-4

3. 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

Related Conditions & MeSH terms

• Articular Cartilage Disorder of Knee
• Cartilage Diseases

Intervention

Device:
• Biphasic Cartilage Repair Implant (BiCRI)
The Biphasic Cartilage Repair Implant (BiCRI) is a two-phase scaffold composed of poly(lactic-co-glycolic acid) (PLGA) and ß-triCalcium phosphate (TCP).

Locations

Country	Name	City	State
Taiwan	En Chu Kong Hospital	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
BioGend Therapeutics Co.Ltd

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Knee Documentation Committee-2000 Subjective Knee Evaluation	International Knee Documentation Committee-2000 Subjective Knee Evaluation compare to baseline	24 months after operation
Primary	International Knee Documentation Committee-2000 Knee Examination Form	International Knee Documentation CommitteeC-2000 Knee Examination Form compare to baseline	24 months after operation
Primary	Knee Injury and Osteoarthritis Outcome Score (KOOS)	Knee Injury and Osteoarthritis Outcome Score (KOOS) compare to baseline	24 months after operation
Primary	Pain (visual analogue scale;VAS)	Pain (visual analogue scale;VAS) compare to baseline	24 months after operation
Primary	Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scale	Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scale	24 months after operation
Secondary	International Knee Documentation Committee-2000 Subjective Knee Evaluation	International Knee Documentation Committee-2000 Subjective Knee Evaluation compare to baseline	12 months after operation
Secondary	International Knee Documentation Committee-2000 Knee Examination Form	International Knee Documentation CommitteeC-2000 Knee Examination Form compare to baseline	12 months after operation
Secondary	Knee Injury and Osteoarthritis Outcome Score (KOOS)	Knee Injury and Osteoarthritis Outcome Score (KOOS) compare to baseline	12 months after operation
Secondary	Pain (visual analogue scale;VAS)	Pain (visual analogue scale;VAS) compare to baseline	12 months after operation
Secondary	Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scale	Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scale	12 months after operation