Observational Study on the Treatment of Knee Osteochondral Lesions of Grade III-IV (NCT01554878) | Clinical Trial Compass
CompletedNot Applicable
Observational Study on the Treatment of Knee Osteochondral Lesions of Grade III-IV
Italy20 participantsStarted 2012-01
Plain-language summary
The purpose of the study is to evaluate prospectively the outcome of treatment interventions of knee osteochondral lesions Outerbridge grade III and IV.
Who can participate
Age range
30 Years – 60 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:
patients referred to the participating centers for symptomatic treatment of degenerative lesions of the knee, which meet the following inclusion criteria:
* symptomatic osteochondral lesions of grade III or IV (according to classification of Outerbridge;
* Axial deviation with chondral damage, correct or not;
* Consent to the processing of personal data, signed and dated by patient;
* Patients of both sexes and aged between 30 and 60 years;
* Patients willing to participate actively in the rehabilitation program and to attend post-operative follow-up visits.
Exclusion criteria:
* Patients with synovitis;
* BMI\> 30;
* Allergy to collagen or calcium phosphate;
* Patients with neoplastic disease;
* Patients with metabolic disorders, thyroid diseases, immune system disorders.
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
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score