NCT02993510

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Geistlich Pharma AG · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Cartilage Injury
• Osteochondritis Dissecans

Interventions

Type	Name	Description
PROCEDURE	Microfracture	Microfracture is a well-established arthroscopic surgical technique for cartilage repair which involves several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect, with resultant complete defect fill by a well-anchored clot
DEVICE	Chondro-Gide sutured	Implantation of Chondro-Gide membrane using atraumatic sutures following microfracture via mini-arthrotomy
DEVICE	Chondro-Gide glued	Implantation of Chondro-Gide membrane using Fibrin glue following microfracture via mini-arthrotomy

Timeline

• Start date: 2003-12-01
• Primary completion: 2015-12-01
• Completion: 2016-07-01
• First posted: 2016-12-15
• Last updated: 2017-02-23

Locations

7 sites across 1 country: Germany