Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-03-07 @ 10:18 PM
Study NCT ID:
NCT03696394
Status:
UNKNOWN
Last Update Posted:
2019-04-04
First Post:
2018-10-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy of BioCartilage® Micronized Cartilage Matrix in Microfracture Treatment of Osteochondral Defects
Sponsor:
St. Paul's Hospital, Canada
Organization:
Study Overview
Official Title:
A Pilot Study to Evaluate the Efficacy of BioCartilage® Micronized Cartilage Matrix in Microfracture Treatment of Osteochondral Defects of the Talus
Status:
UNKNOWN
Status Verified Date:
2019-04
Last Known Status:
RECRUITING
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 study was designed by the principal investigator, Dr. Andrea Veljkovic, and the St. Paul's Hospital Foot and Ankle Research Group, who will conduct the study. The study is being funded by Arthrex, Inc., the manufacturer of the Health Canada approved BioCartilage® Micronized Cartilage Matrix.
The purpose of this study is to assess whether adding BioCartilage® to microfracture treatment of osteochondral defects of the talus improves osteochondral healing as well as improving pain and function.
Efficacy will be assessed primarily by outcomes scores as measure by the Ankle Osteoarthritis Scale (AOS) at the baseline and at multiple post-op followup visits. Additional outcomes scores will also be administered to compare general health and foot function between the two groups at baseline and at multiple post-op followup visits. X-rays and MRI will be used to assess the osteochondral healing rate.
The purpose of this study is to assess whether adding BioCartilage® to microfracture treatment of osteochondral defects of the talus improves osteochondral healing as well as improving pain and function.
Efficacy will be assessed primarily by outcomes scores as measure by the Ankle Osteoarthritis Scale (AOS) at the baseline and at multiple post-op followup visits. Additional outcomes scores will also be administered to compare general health and foot function between the two groups at baseline and at multiple post-op followup visits. X-rays and MRI will be used to assess the osteochondral healing rate.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| H18-00603 | OTHER | UBC Providence Health Care Research Ethics Board | View |