NCT02539030

Comparison of Efficacy and Safety of Microfracture and Modified Microfracture

Random Clinical Trial for Comparison of Efficacy and Safety of Simple Microfracture and Modified Microfracture Using Collagen in the Patients With Knee Cartilage Defects

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (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 to prove the non-inferiority of the modified microfracture using collagen in patients with cartilage defects in their knees.

Detailed description

This study was an open-trial study. One hundred 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 centrally controlled randomization table. They were asked to follow the guidelines of the investigators during the study and to visit the hospital six times\*, including for screening. At each visit, the subjects underwent an examination with doctors, a blood test, an X-ray procedure, an MRI, an observation with the naked eyes, and arthroscopy to evaluate the safety and efficacy of the procedure. (\*If the screening date overlaps with the procedure date, the number of his or her visits would be five.)

Conditions

• Defect of Articular Cartilage
• Osteoarthritis
• Traumatic Arthritis

Interventions

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

Timeline

• Start date: 2013-02-01
• Primary completion: 2016-01-01
• Completion: 2017-06-01
• First posted: 2015-09-02
• Last updated: 2015-09-02

Locations

12 sites across 1 country: South Korea