Ignite Creation Date:
2024-05-06 @ 7:12 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05924763
Status:
RECRUITING
Last Update Posted:
2023-06-29
First Post:
2023-05-25
Brief Title:
The Clinical Outcome of BiCRI in the Treatment of Chondral and Osteochondral Lesions
Sponsor:
BioGend Therapeutics CoLtd
Organization:
BioGend Therapeutics CoLtd
Study Overview
Official Title:
The Clinical Outcome of the Biphasic Cartilage Repair Implant BiCRI in the Treatment of Chondral and Osteochondral Lesions of the Knee
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 heshe 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in the trial If during surgery the size of lesion is found to meet exclusion criteria the subject will be considered withdrawn screen failure from the trial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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None