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

NCT ID: NCT05924763

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-20
• Study Completion Date: 2022-08-18

Brief 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.

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 If during surgery the size of lesion is found to meet exclusion criteria, the subject will be considered withdrawn (screen failure) from the trial.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

Conditions

Articular Cartilage Disorder of Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BiCRI

Biphasic Cartilage Repair Implant

Group Type: EXPERIMENTAL

Biphasic Cartilage Repair Implant (BiCRI)

Intervention Type: DEVICE

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

Interventions

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 β-triCalcium phosphate (TCP).

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioGend Therapeutics Co.Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gwen Chang

Role: STUDY_DIRECTOR

BioGend Therapeutics Co.Ltd

Locations

En Chu Kong Hospital

New Taipei City, , Taiwan

Ministry of Health and Welfare Shuang-Ho Hospital

New Taipei City, , Taiwan

Countries

Taiwan

Other Identifiers

CR18-001

Identifier Type: -

Identifier Source: org_study_id