Comparison of Efficacy and Safety of Microfracture and Modified Microfracture

Osteoarthritis Clinical Trial

Official title: 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 Active, not recruiting

Clinical Trial 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.

Clinical Trial 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.) ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cartilage Diseases
• Defect of Articular Cartilage
• Osteoarthritis
• Traumatic Arthritis

• NCT number: NCT02539030
• Study type: Interventional
• Source: Sewon Cellontech Co., Ltd.
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: February 2013
• Completion date: June 2017