A Randomized Controlled Trial Comparing Chondro-Gide® to Microfracture Alone for Treatment of Knee Cartilage Defects.

Cartilage Injury Clinical Trial

Official title: Randomised Multi-Center Study: Microfracturing With Chondro-Gide® for the Treatment of Isolated Cartilage Defects in the Knee Project-Nr.: 10830-003

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the safety and effectiveness of using Chondro-Gide® collagen membrane either sutured or glued compared to microfracture alone in the treatment of symptomatic cartilage defects of the knee.

Clinical Trial Description

• Prospective, randomized, active treatment-controlled, open-label multicenter study (up to 40 sites in the US and EU).

• All subjects that meet preoperative screening eligibility criteria will be randomized to treatment with Chondro-Gide® either sutured or glued or Microfracture alone.

• Eligible and consenting subjects are randomized in a 1:1:1 ratio using centralized randomization list to receive one of the following treatments: Group I: Microfracture alone; Group II: Microfracture covered with a Chondro-Gide® membrane glued with fibrin glue (AMIC glued); Group III: Microfracture covered with a Chondro-Gide® membrane sutured (AMIC sutured)

• All subjects will be assessed at intervals post-procedure (6 weeks, 3 months, and 1,2 and 5 years).

• Subjects will be required to follow a strict pre-specified post-surgery rehabilitation protocol specific to the defect location.

• Measures to assess effectiveness and safety will be conducted at all follow-ups.

• Safety will be assessed by the collection of adverse events at all timepoints. ;

Related Conditions & MeSH terms

• Cartilage Injury
• Osteochondritis
• Osteochondritis Dissecans

• NCT number: NCT02993510
• Study type: Interventional
• Source: Geistlich Pharma AG
• Status: Completed
• Phase: Phase 3
• Start date: December 2003
• Completion date: July 2016