A Phase 3 interventional study of Microfracture and Chondro-Gide sutured in Cartilage Injury and Osteochondritis Dissecans, sponsored by Geistlich Pharma AG. Completed at 7 sites in Germany. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-23.
Sponsored by Geistlich Pharma AG · Phase 3, Interventional, and Treatment
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.
30 studies on the registry are indexed under Osteochondritis Dissecans; 7 are open to participants now.
This study's enrollment of 67 is above the median of 45 across 17 interventional studies indexed under Osteochondritis Dissecans.
Browse Osteochondritis Dissecans studies →Geistlich Pharma AG is the lead sponsor of 13 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Procedure: Microfracture
Microfracture covered with a collagen membrane (Chondro-Gide®) using atraumatic sutures in a one-step mini-arthrotomy procedure
Device: Chondro-Gide sutured
Microfracture covered with a collagen membrane (Chondro-Gide®) using fibrin glue in a one-step mini-arthrotomy procedure
Device: Chondro-Gide glued
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
Implantation of Chondro-Gide membrane using atraumatic sutures following microfracture via mini-arthrotomy
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
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
Time frame: 2 years post-surgery
MRI (magnetic resonance imaging) assessment of structural repair parameters.
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).
Time frame: 6 months and 1,2 and 5 years post-surgery
Change from Baseline in the patient's evaluation of overall knee condition using the Modified Cincinnati Knee Rating System.
The Change from Baseline will be evaluated.
Time frame: 6 months and 1,2 and 5 years post-surgery
Change from Baseline in the patient's evaluation of pain using the Visual Analog Scale (VAS).
The Change from Baseline will be evaluated.
Time frame: 6 months and 1,2 and 5 years post-surgery
Change from Baseline in the patient's evaluation of overall knee condition using the International Cartilage Repair Society (ICRS) "Cartilage Injury Evaluation Package".
The Change from Baseline will be evaluated.
Time frame: 6 months and 1,2 and 5 years post-surgery
Adverse Events (AE) Review
The incidence, timing, severity, and relationship to treatment of all Adverse Events (AE), will be collected for all participants.
Time frame: 5 years post-surgery
Plan to share: No
The record gives a start of Dec 2003, a primary completion of Dec 2015 and a completion of Jul 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Geistlich Pharma AG