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

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

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.

Study Overview

• Status: Completed
• Conditions: Articular Cartilage Disorder of Knee
• Intervention / Treatment: Device: Biphasic Cartilage Repair Implant (BiCRI)

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 If during surgery the size of lesion is found to meet exclusion criteria, the subject will be considered withdrawn (screen failure) from the trial.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

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan
    • En Chu Kong Hospital
  • New Taipei City, Taiwan
    • Ministry of Health and Welfare Shuang-Ho Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BiCRI; Biphasic Cartilage Repair Implant	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 β-triCalcium phosphate (TCP).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: BioGend Therapeutics Co.Ltd
• Investigators: Study Director: Gwen Chang, BioGend Therapeutics Co.Ltd

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Actual): June 10, 2022
• Study Completion (Actual): August 18, 2022

Study Registration Dates

• First Submitted: May 25, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Estimated): September 25, 2025
• Last Update Submitted That Met QC Criteria: September 21, 2025
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Cartilage Diseases
• Other Study ID Numbers: CR18-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No