Clinical trial NCT05924763: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Articular Cartilage Disorder of Knee
Lead sponsor: BioGend Therapeutics Co.Ltd
Sponsor class: INDUSTRY
First posted: 2023-06-29
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 If during surgery the size of lesion is found to meet exclusion criteria, the subject will be considered withdrawn (screen failure) from the trial.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

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

Primary outcomes:
measure: International Knee Documentation Committee-2000 Subjective Knee Evaluation
timeFrame: 24 months after operation
measure: International Knee Documentation Committee-2000 Knee Examination Form
timeFrame: 24 months after operation
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 24 months after operation
measure: Pain (visual analogue scale;VAS)
timeFrame: 24 months after operation
measure: Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scale
timeFrame: 24 months after operation
Secondary outcomes:
measure: International Knee Documentation Committee-2000 Subjective Knee Evaluation
timeFrame: 12 months after operation
measure: International Knee Documentation Committee-2000 Knee Examination Form
timeFrame: 12 months after operation
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 12 months after operation
measure: Pain (visual analogue scale;VAS)
timeFrame: 12 months after operation
measure: Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scale
timeFrame: 12 months after operation
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: En Chu Kong Hospital
Study officials:
affiliation: BioGend Therapeutics Co.Ltd
name: Gwen Chang
role: STUDY_DIRECTOR
References: