NCT02519881

the Efficacy and Safety of a Modified Microfracture Using Collagen Compared to Those of a Simple Microfracture in Ankle

This Clinical Trial Evaluated the Efficacy and Safety of a Modified Microfracture Using Collagen Compared to Those of a Simple Microfracture in Patients With Cartilage Defects in Their Ankles.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Cellontech Co., Ltd. · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Accepted

Summary

This study was designed to evaluate the efficacy and safety of a modified microfracture using collagen, and to compare them with those of a simple microfracture in patients with cartilage defects in their ankles.

Detailed description

This study was an open-trial study. Sixty subjects participated in it. The study was explained to the subjects and they voluntarily agreed to participate in it. Their eligibility to participate in the study was checked, and they were randomized either into the simple microfracture group or the modified microfracture group using collagen based on a randomization table. They were asked to follow the guidelines of the investigators during the study and to visit the hospital five times, including for screening. At each visit, the subjects underwent an examination with doctors and MRI to evaluate the efficacy of the procedure. (\*If the subject began the first visit on the screening date, the total number of his or her visits was four.)

Conditions

• Defect of Articular Cartilage

Interventions

Type	Name	Description
PROCEDURE	Microfracture	simple microfracture of ankle
DEVICE	CartiFill	add collagen when doing microfracture

Timeline

• Start date: 2014-02-17
• Primary completion: 2018-01-23
• Completion: 2018-01-23
• First posted: 2015-08-11
• Last updated: 2026-04-07

Locations

3 sites across 1 country: South Korea