Clinical Trials Logo

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
Status Completed
Phase Phase 3
Start date December 2003
Completion date July 2016

See also
  Status Clinical Trial Phase
Recruiting NCT03479775 - Muscle Function and Traumatic Knee Injury in Sports
Recruiting NCT03321812 - Clinical Study of Decalcification Bone Scaffold for Cartilage Lesions of the Knee N/A
Recruiting NCT04889443 - Spontaneous Healing of ARticular Cartilage (SHARC)
Enrolling by invitation NCT04118023 - 7T MRI to Evaluate Cartilage Defects in the Knee
Active, not recruiting NCT01458782 - ACI-C Versus AMIC. A Randomized Trial Comparing Two Methods for Repair of Cartilage Defects in the Knee N/A
Recruiting NCT03477942 - Impact of Mesenchymal Stem Cells in Knee Osteoarthritis Phase 1
Active, not recruiting NCT01473199 - BioPoly RS Knee Registry Study for Cartilage Defect Replacement N/A
Recruiting NCT04739930 - Autologous Bone Marrow Concentrate in Knee Osteochondral Allograft Transplantation N/A
Recruiting NCT03873545 - Prospective Evaluation of ProChondrix CR for Repair of Articular Cartilage Defects on Femoral Condyle and Patella
Recruiting NCT04184687 - The Treatment of Cartilaginous Lesions and Concomitant Anterior Cruciate Ligament Reconstruction N/A
Not yet recruiting NCT02430558 - Second Line Treatment of Knee Osteochondral Lesion With Treated Osteochondral Graft Phase 1/Phase 2
Recruiting NCT04301258 - ProChondrix® CR Articular Cartilage Restoration Evaluation (PACE) Registry
Recruiting NCT02696876 - Synovium Brushing to Augmented Microfracture for Improved Cartilage Repair N/A
Recruiting NCT02637505 - Norwegian Cartilage Project - Microfracture N/A
Active, not recruiting NCT04135950 - Prospective Registry of Anterior Cruciate Ligament Reconstructions
Completed NCT03024801 - Effectiveness of Autologous Platelet-rich Plasma on Knee Cartilage Injury N/A
Completed NCT01041001 - Study to Compare Efficacy and Safety of Cartistem and Microfracture in Patients With Knee Articular Cartilage Injury Phase 3
Recruiting NCT04537013 - Clinical Study of Chondro-Gide® for Large Chondral Lesions in the Knee N/A
Not yet recruiting NCT04953572 - Treatment of Cartilage Defects With Peripheral Blood Stem Cells Phase 1
Recruiting NCT03962270 - Effect of Extracorporeal Shock Wave in the Treatment of Knee Osteoarthritis N/A