Ignite Creation Date:
2024-05-06 @ 1:23 AM
Last Modification Date:
2024-10-26 @ 11:03 AM
Study NCT ID:
NCT01791062
Status:
COMPLETED
Last Update Posted:
2016-11-21
First Post:
2013-02-11
Brief Title:
Safety and Efficacy Study of HYTOP in the Treatment of Focal Chondral Defects
Sponsor:
TRB Chemedica AG
Organization:
TRB Chemedica AG
Study Overview
Official Title:
Safety and Efficacy of a Novel Cell-free Cartilage Repair Construct in the Treatment of Focal Chondral Defects Involving the Femoro-tibial Compartment of the Knee Joint
Status:
COMPLETED
Status Verified Date:
2016-11
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:
The two-layer bioresorbable HYTOP matrix consists of an upper layer of highly purified porcine splint-skin which contains natural pores and a lower layer of highly purified collagen fleece containing hyaluronan HA
In this study the medical device will be used and evaluated in a one-step procedure combining microfracturing with surgical implantation of HYTOP HYTOP will support haemostasis in the articular cartilage defect act as a support for cell growth and as a three-dimensional scaffold for cell differentiation HYTOP will protect the underlying tissue after cartilage debridement andor microfracturing of the subchondral bone
The primary working hypothesis is that HYTOP is safe and suitable as a cell-free matrix to support haemostasis as a cover for the cartilage lesion and eventually to enhance cartilage regeneration in a one-step surgical procedure
In this study the medical device will be used and evaluated in a one-step procedure combining microfracturing with surgical implantation of HYTOP HYTOP will support haemostasis in the articular cartilage defect act as a support for cell growth and as a three-dimensional scaffold for cell differentiation HYTOP will protect the underlying tissue after cartilage debridement andor microfracturing of the subchondral bone
The primary working hypothesis is that HYTOP is safe and suitable as a cell-free matrix to support haemostasis as a cover for the cartilage lesion and eventually to enhance cartilage regeneration in a one-step surgical procedure
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None