A Randomized Controlled Trial Comparing Chondro-Gide® to Microfracture Alone for Treatment of Knee Cartilage Defects.
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|ClinicalTrials.gov Identifier: NCT02993510|
Recruitment Status : Completed
First Posted : December 15, 2016
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cartilage Injury Osteochondritis Dissecans||Procedure: Microfracture Device: Chondro-Gide sutured Device: Chondro-Gide glued||Phase 3|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomised Multi-Center Study: Microfracturing With Chondro-Gide® for the Treatment of Isolated Cartilage Defects in the Knee Project-Nr.: 10830-003|
|Study Start Date :||December 2003|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||July 2016|
Active Comparator: microfracture
Microfracture is an arthroscopic surgical technique involving placement of microfracture penetrations within the cartilage defect to provide stem cells and growth factors from the bone marrow to aid cartilage repair
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
Experimental: Microfracture with Chondro-Gide sutured
Microfracture covered with a collagen membrane (Chondro-Gide®) using atraumatic sutures in a one-step mini-arthrotomy procedure
Device: Chondro-Gide sutured
Implantation of Chondro-Gide membrane using atraumatic sutures following microfracture via mini-arthrotomy
Experimental: Microfracture with Chondro-Gide glued
Microfracture covered with a collagen membrane (Chondro-Gide®) using fibrin glue in a one-step mini-arthrotomy procedure
Device: Chondro-Gide glued
Implantation of Chondro-Gide membrane using Fibrin glue following microfracture via mini-arthrotomy
- Histological evaluation of structural repair of evaluable biopsies harvested from the core of the index lesion during arthroscopy at 2 years [ Time Frame: 2 years post-surgery ]The macroscopically assessed integration, surface properties and extent of filling of the defect and the microscopically assessed using the International Cartilage Repair Society (ICRS) score
- MRI (magnetic resonance imaging) assessment of structural repair parameters. [ Time Frame: 6 months and 1,2 and 5 years post-surgery ]Structural repair is assessed with magnetic resonance imaging (MRI, 1.5T) by an independent and blinded radiologist, with a focus on the extent, signal intensity and surface of the defect filling, integration to adjacent cartilage, and bone marrow lesion (BML).
- Change from Baseline in the patient's evaluation of overall knee condition using the Modified Cincinnati Knee Rating System. [ Time Frame: 6 months and 1,2 and 5 years post-surgery ]The Change from Baseline will be evaluated.
- Change from Baseline in the patient's evaluation of pain using the Visual Analog Scale (VAS). [ Time Frame: 6 months and 1,2 and 5 years post-surgery ]The Change from Baseline will be evaluated.
- Change from Baseline in the patient's evaluation of overall knee condition using the International Cartilage Repair Society (ICRS) "Cartilage Injury Evaluation Package". [ Time Frame: 6 months and 1,2 and 5 years post-surgery ]The Change from Baseline will be evaluated.
- Adverse Events (AE) Review [ Time Frame: 5 years post-surgery ]The incidence, timing, severity, and relationship to treatment of all Adverse Events (AE), will be collected for all participants.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02993510
|University of Regensburg|
|Bad Abbach, Germany|
|University of Schleswig-Holstein|
|Principal Investigator:||Sven Anders, MD||University of Regensburg|