Treatment of Cartilage Lesions in Flanders Today (NCT01421290) | Clinical Trial Compass
CompletedNot Applicable
Treatment of Cartilage Lesions in Flanders Today
Belgium40 participantsStarted 2013-01
Plain-language summary
The hypothesis of this study is to investigate whether surgical intervention is necessary for patients who suffer from cartilage lesions of the knee, or whether this surgical intervention can be avoided or postponed by using conservative treatment options such as physiotherapy, nutrition supplements, intra-articular injections, bracing.
Forty patients suffering from cartilage lesions in their knee joint will be selected preoperatively. All these patients fulfil certain inclusion- and exclusion criteria. They will be asked to respond to 3 different questionnaires. These questionnaires include the visual analogue scale to evaluate pain (VAS), the Knee injury and Osteoarthritis Outcome Score or KOOS and the International Knee Documentation Committee (IKDC) form to evaluate the effect of their cartilage lesion on activities in daily life. Six months later +/- 20 patients will have had surgery and +/- 20 patients will have had conservative treatment, both groups of patients will be asked to respond again to the 3 different questionnaires. The outcome of the results will tell us more of the evolution both between groups and in each group separately.
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:
* Symptomatic single cartilage lesions of the femur condyles
* Size of the lesion, determined by MRI:
between 1-2 cm² for the group who will receive conservative treatment between 2-5 cm² for the group who will have surgery
\- Mechanical joint pain, assessed by a 100 mm Visual Analogue Scale: \> 40 mm for the conservative group, \> 60 mm for the operative group
* Agree to stop using analgetics and NSAID's 2 weeks before the First respond of the surveys, and 2 weeks before the second respond of the surveys. Only paracetamol (4g/day) is allowed.
* men and women, women have to use contraceptive to avoid pregnancies.
* age between 18 - 50 years
Exclusion Criteria:
* participation in concurrent trials
* participation in previous trials within 3 months
* subjects with HIV, hepatitis, syphilis
* malignancy
* alcohol and drug abuse
* poor general health condition as judged by the investigator
* osteochondritis dissecans
* advanced osteoarthritis (kellgren 2-4)
* known allergy to penicillins and gentamicin or presence of multiple severe allergies
* complex ligamentous instability of the knee
* lateral meniscus lesion or more than 50% resection of medial meniscus
* Varus or valgus misalignment exceeding 3° (kissing lesions out)
* Mosaicplasty (OATS)
* Microfracture performed less than 1 year before baseline
* Received hyaluronic acid intra-articular injections into the afflicted knee within the last six months of baseline
* Taking specific OA drugs, such as ch…
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
Questionnaires to decide which intervention will be performed.