Using a new implant to treat knee cartilage damage
The Clinical Outcome of the Biphasic Cartilage Repair Implant (BiCRI) in the Treatment of Chondral and Osteochondral Lesions of the Knee.
This study is testing a new implant to see if it can help people with knee cartilage damage feel better, especially those who haven't had success with other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 16 Years to 65 Years |
| Sex | All |
| Sponsor | BioGend Therapeutics Co.Ltd Industry-sponsored |
| Locations | 1 site (New Taipei City) |
| Trial ID | NCT05924763 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and effectiveness of the Biphasic Cartilage Repair Implant (BiCRI) for treating chondral and osteochondral lesions in the knee. It focuses on patients with symptomatic lesions, including those with multiple lesions or those who have previously undergone unsuccessful treatments like microfracture or mosaicplasty. Participants will undergo arthroscopic evaluation to confirm eligibility, and imaging will be performed at various intervals to assess outcomes. The study seeks to expand the patient population based on prior successful experiences with the BiCRI.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16 to 65 with symptomatic chondral or osteochondral lesions of the knee requiring surgical intervention.
Not a fit: Patients with inflammatory arthritis, severe lesions requiring multiple implants, or other significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery and outcomes for patients with knee cartilage damage.
How similar studies have performed: Previous studies have shown success with similar cartilage repair approaches, suggesting potential for positive outcomes in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New Taipei City
- En Chu Kong Hospital — New Taipei City, Taiwan (Recruiting)
Study contacts
- Study coordinator: Gwen Chang
- Email: gwen.chang@biogend.com.tw
- Phone: +886226558366
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.