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

Primary Purpose

Articular Cartilage Disorder of Knee

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Biphasic Cartilage Repair Implant (BiCRI)
Sponsored by
BioGend Therapeutics Co.Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Articular Cartilage Disorder of Knee

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • En Chu Kong HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BiCRI

Arm Description

Biphasic Cartilage Repair Implant

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 25, 2023
Last Updated
June 27, 2023
Sponsor
BioGend Therapeutics Co.Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05924763
Brief Title
The Clinical Outcome of BiCRI in the Treatment of Chondral and Osteochondral Lesions
Official Title
The Clinical Outcome of the Biphasic Cartilage Repair Implant (BiCRI) in the Treatment of Chondral and Osteochondral Lesions of the Knee.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2019 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioGend Therapeutics Co.Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Articular Cartilage Disorder of Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BiCRI
Arm Type
Experimental
Arm Description
Biphasic Cartilage Repair Implant
Intervention Type
Device
Intervention Name(s)
Biphasic Cartilage Repair Implant (BiCRI)
Intervention Description
The Biphasic Cartilage Repair Implant (BiCRI) is a two-phase scaffold composed of poly(lactic-co-glycolic acid) (PLGA) and β-triCalcium phosphate (TCP).
Primary Outcome Measure Information:
Title
International Knee Documentation Committee-2000 Subjective Knee Evaluation
Description
International Knee Documentation Committee-2000 Subjective Knee Evaluation compare to baseline
Time Frame
24 months after operation
Title
International Knee Documentation Committee-2000 Knee Examination Form
Description
International Knee Documentation CommitteeC-2000 Knee Examination Form compare to baseline
Time Frame
24 months after operation
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
Knee Injury and Osteoarthritis Outcome Score (KOOS) compare to baseline
Time Frame
24 months after operation
Title
Pain (visual analogue scale;VAS)
Description
Pain (visual analogue scale;VAS) compare to baseline
Time Frame
24 months after operation
Title
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scale
Description
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scale
Time Frame
24 months after operation
Secondary Outcome Measure Information:
Title
International Knee Documentation Committee-2000 Subjective Knee Evaluation
Description
International Knee Documentation Committee-2000 Subjective Knee Evaluation compare to baseline
Time Frame
12 months after operation
Title
International Knee Documentation Committee-2000 Knee Examination Form
Description
International Knee Documentation CommitteeC-2000 Knee Examination Form compare to baseline
Time Frame
12 months after operation
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
Knee Injury and Osteoarthritis Outcome Score (KOOS) compare to baseline
Time Frame
12 months after operation
Title
Pain (visual analogue scale;VAS)
Description
Pain (visual analogue scale;VAS) compare to baseline
Time Frame
12 months after operation
Title
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scale
Description
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scale
Time Frame
12 months after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gwen Chang
Phone
+886226558366
Ext
6373
Email
gwen.chang@biogend.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gwen Chang
Organizational Affiliation
BioGend Therapeutics Co.Ltd
Official's Role
Study Director
Facility Information:
Facility Name
En Chu Kong Hospital
City
New Taipei City
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang-Chin Wu
Phone
+886226723456
Email
dtorth65@yahoo.com.tw

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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