Pivotal Study to Evaluate the Safety and Efficacy of GelrinC for Treatment of Cartilage Defects (NCT03262909) | Clinical Trial Compass
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Pivotal Study to Evaluate the Safety and Efficacy of GelrinC for Treatment of Cartilage Defects
United States181 participantsStarted 2017-11-14
Plain-language summary
Multicenter, open-label, controlled, non-randomized, double arm trial with a prospective treatment arm (GelrinC). This study compares the efficacy and safety of GelrinC to a historical control arm (microfracture) in the treatment of cartilage defects in 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.
Main Inclusion Criteria:
* Age between 18 and 50.
* Single contained symptomatic lesion located on the femoral condyle of the femur graded as ICRS III or IV with less than 5 mm of bone loss below the subchondral plate.
* Lesion size between 1 and 5 cm2 post debridement, less than or equal to 2.5 cm in diameter.
* BMI ≤35
* Contralateral knee is asymptomatic, stable, fully functional and not medically treated.
Main Exclusion Criteria:
* Presence of an additional grade III or IV symptomatic lesion.
* Recent Osteochondritis Dissecans within 1 year of baseline visit.
* Untreated ACL and/or PCL deficiency or Complex ligamentous instability of the knee.
* Patient is excluded if presenting untreated current meniscal tear or if previous menisci resection was within the last 6 months.
* Previous tendon repair or ligament reconstruction within the last 6 months.
* Failed Mosaicplasty or ACI or MACI or any other cartilage repair product.
* Microfracture performed less than 1 year before baseline visit.
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
The change of physical functioning as assessed by patient reported outcome measure (Knee injury and Osteoarthritis Outcome Score (KOOS).
Timeframe: 24 months post-surgery
2
The change of physical pain as assessed by patient reported outcome measure (Knee injury and Osteoarthritis Outcome Score (KOOS).