Second Line Treatment of Knee Osteochondral Lesion With Treated Osteochondral Graft (NCT02430558) | Clinical Trial Compass
TerminatedPhase 1/2
Second Line Treatment of Knee Osteochondral Lesion With Treated Osteochondral Graft
Stopped: Low accrual rate
10 participantsStarted 2016-04-05
Plain-language summary
Patient with IKDC score \< 65, pretreated with mosaicplasty or ACI ( with matrix or not) within \> 18 months, with one or two osteochondral lesions are recruited to have treated osteochondral allografts in mosaicplasty.
Who can participate
Age range
18 Years – 55 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 and female patients between the ages of 18 and 55
* osteochondral lesions of the knee due to trauma or osteochondritis dissecans or removal treatment ( lesion post autograft)
* Osteochondral lesion \> grade II- ICRS
* One lesion or 2 concomitant lesions (tibial plateau, patella and condyles )at least one lesion has been pretreated by mosaicplasy or ACI. These treatment would have to have been made at least 18 months before inclusion
* Presence of disabling and clinically meaningful symptoms (subjective IKDC \< 65, no improvement for 3 months)
* No significant obesity (BMI \< 30)
* Accompanying ligamentous and meniscal lesions, joint malalignment and patella femoral instability are authorized and corrected concurrently.
* Patient able to understand, sign and date the informed consent form
* Patient affiliated with a national health insurance system or who is the beneficiary of such as system
* Women of childbearing age may not be included in the clinical trial unless their pregnancy test is negative. If this test is negative, they will be asked to use an effective birth control method during the entire the study.
Exclusion Criteria:
* \- Pregnant or breast feeding women: Women of childbearing age will be asked to undergo a pregnancy test before being enrolled into the study and to use an effective birth control method.
* Presence of osteoarthritis, rheumatoid arthritis, any other condition of knee joint that, in the surgeon's op…
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.