BiPhasic Cartilage Repair Implant (BiCRI) IDE Clinical Trial - Taiwan
Taiwan92 participantsStarted 2011-10
Plain-language summary
The purpose of this trial is to evaluate the safety and effectiveness of the Biphasic Cartilage Repair Implant (BiCRI) compared to marrow stimulation in the treatment of chondral and osteochondral lesions located on the medial femoral condyle, lateral femoral condyle, or trochlea of the knee. The hypothesis is that the BiCRI provides an improvement in pain and function as compared to baseline, that is no worse than marrow stimulation at 1 year.
Who can participate
Age range55 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female presenting with a single, symptomatic chondral or osteochondral lesion of the medial or lateral femoral condyles or the trochlea requiring primary surgical intervention
✓. Skeletally mature (epiphyses are confirmed to be closed on x-ray)
✓. Lesion size requires no more than 2 implants (assuming patient were to be randomized to the treatment group). Lesion size will be assessed at the time of the study procedure for all subjects. If the size of the lesion is appropriate for 1 or 2 implants the patient will be randomized. If the lesion is found to be too large the patient will not be included in the trial, but will be treated according to standard of care. Lesion sizes that are considered appropriate include the following:
✓. Willing and able to refrain from taking pain medications (including: narcotic and non-steroidal anti-inflammatory drugs) for 7 days prior to the baseline preoperative visit and for 7 days prior to the 12-month postoperative visit (i.e., a "wash out" period)
✓. Willing and able to return for follow-up over a one year post-operative period
✓. Willing and able to comply with all postoperative guidelines
Exclusion criteria
✕. ≥ 55 years old
✕. Lesions \> grade II on the articular surface of the tibia or patella
✕. Kissing lesions (defined as an opposing lesion \> grade II on the surface of the tibia or patella). Lesion ≤ grade II on opposing surface would be acceptable.
✕. Lesion would require more than 2 implants (assuming patient were to be randomized to the treatment group). Lesion sizes that are not considered appropriate include the following:
✕. Lesion will require bone grafting
✕. Rheumatoid arthritis and other inflammatory arthritis