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
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.
- 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.
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