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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. ;


Study Design


Related Conditions & MeSH terms


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

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