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A Study to Evaluate the Efficacy of BioCartilage® Micronized Cartilage Matrix in Microfracture Treatment of Osteochondral Defects

NCT03696394 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-04-04

No results posted yet for this study

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.

Conditions

  • Osteochondral Defect

Interventions

DEVICE

BioCartilage® Micronized Cartilage Matrix

BioCartilage® is a scaffold with Collagen Type II and cartilage matrix elements

Sponsors & Collaborators

  • Arthrex, Inc.

    collaborator INDUSTRY

  • St. Paul's Hospital, Canada

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-29
Primary Completion
2021-11-30
Completion
2023-11-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03696394 on ClinicalTrials.gov