A Randomized Controlled Trial Comparing Chondro-Gide® to Microfracture Alone for Treatment of Kne… (NCT02993510) | Clinical Trial Compass
CompletedPhase 3
A Randomized Controlled Trial Comparing Chondro-Gide® to Microfracture Alone for Treatment of Knee Cartilage Defects.
Germany67 participantsStarted 2003-12
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female between 18 and 50
* One or two cartilage defects Grade III or IV according to Outerbridge classification
* Defect size between 2 and 10 cm2 (inclusive)
* Intact normal surrounding cartilage to suture the Chondro-Gide® membrane
* Informed consent
* Patient willing to fulfill a strict postoperative physiotherapy scheme
Exclusion Criteria:
* More than 2 defects
* Defects on both knees
* X-ray signs of osteoarthritis
* Bone lesion \> 0.7 cm in the defect
* Knee instability, varus or valgus deformation, status after complete meniscus resection, status after mosaicplasty, patella dysplasia
* Rheumatoid, infectious disease
* Skin lesion on the operated knee
* Treatment with cartilage building medication
* Drug and alcohol abuse
* Chronic heart disease, endocrine or metabolic disease, Haemophilia A/B
* Pregnancy or lactation
* Collagen allergy
* Participation in other Trials
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Histological evaluation of structural repair of evaluable biopsies harvested from the core of the index lesion during arthroscopy at 2 years
Timeframe: 2 years post-surgery
2
MRI (magnetic resonance imaging) assessment of structural repair parameters.
Timeframe: 6 months and 1,2 and 5 years post-surgery