Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-03-06 @ 7:57 AM
Study NCT ID:
NCT02941120
Status:
COMPLETED
Last Update Posted:
2019-12-03
First Post:
2016-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-interventional Study With NOVOCART® Inject in the Reconstruction of the Knee Cartilage Defects
Sponsor:
Tetec AG
Organization:
Study Overview
Official Title:
Retrospective Observational Study for Reconstruction of Localized, Full-thickness Cartilage Defects in the Knee Joint With In-situ Polymerizable and Chondrocyte Populated Biomaterial (NOVOCART® Inject)
Status:
COMPLETED
Status Verified Date:
2019-01
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:
RENOVO
Brief Summary:
Retrospective non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with full-thickness cartilage defects in the knee joint.
Detailed Description:
Retrospective and multicenter non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with localized full-thickness cartilage defects in the knee joint.
Safety: Measuring the number of adverse drug reactions/serious adverse drug reactions since treatment and up to the present time.
Efficacy: Evaluate symptoms and functional status at the present time using IKDC 2000 (International Knee Documentation Committee) and KOOS (Knee injury osteoarthritis outcome score).
Safety: Measuring the number of adverse drug reactions/serious adverse drug reactions since treatment and up to the present time.
Efficacy: Evaluate symptoms and functional status at the present time using IKDC 2000 (International Knee Documentation Committee) and KOOS (Knee injury osteoarthritis outcome score).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: