NCT05924763

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 29, 2023

Completed
Last Updated

September 25, 2025

Status Verified

January 1, 2023

Enrollment Period

3.1 years

First QC Date

May 25, 2023

Last Update Submit

September 21, 2025

Conditions

Articular Cartilage Disorder of Knee

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (5)

  • International Knee Documentation Committee-2000 Subjective Knee Evaluation

    12 months after operation

  • International Knee Documentation Committee-2000 Knee Examination Form

    12 months after operation

  • Knee Injury and Osteoarthritis Outcome Score (KOOS)

    12 months after operation

  • Pain (visual analogue scale;VAS)

    12 months after operation

  • Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scale

    12 months after operation

Study Arms (1)

BiCRI

EXPERIMENTAL

Biphasic Cartilage Repair Implant

Device: Biphasic Cartilage Repair Implant (BiCRI)

Interventions

Biphasic Cartilage Repair Implant (BiCRI)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).

BiCRI

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

En Chu Kong Hospital

New Taipei City, Taiwan

Location

Ministry of Health and Welfare Shuang-Ho Hospital

New Taipei City, Taiwan

Location

Study Officials

  • Gwen Chang

    BioGend Therapeutics Co.Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2023

First Posted

June 29, 2023

Study Start

May 20, 2019

Primary Completion

June 10, 2022

Study Completion

August 18, 2022

Last Updated

September 25, 2025

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(2)