Status:
COMPLETED
Treatment of Cartilage Lesions in Flanders Today
Lead Sponsor:
University Hospital, Ghent
Conditions:
Lesion of Joint Capsule of Knee Region
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief 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 avoid...
Eligibility Criteria
Inclusion
- 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
- 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 chondroitin sulphate, diacerein, capsaicin within two weeks of the baseline visit
- Corticosteroid therapy by systemic or intra-articular route within the last month of baseline or intramuscular or oral corticosteroids within the last two weeks of baseline
- Chronic use of anticoagulants
- Uncontrolled diabetes
- Any concomitant painful or disabling disease of the spine, hips or lower limbs that would interfere with evaluation of the afflicted knee
- Any clinically significant or symptomatic vascular or neurologic disorder of the lower extremities
- Any evidence of the following disease in the target joint: septic arthritis, inflammatory joint disease, hematochrosis, collagen gene mutations
- Current diagnosis of osteomyelitis
- A blood result showing liver enzymes more than two times the upper limit of normal or any other result that in the clinical investigator's mind is important clinically
- CRP level greater than 10g/l
- Unwilling to participate in post-operative rehabilitation protocol
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01421290
Start Date
January 1 2013
End Date
December 1 2015
Last Update
December 15 2022
Active Locations (1)
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1
University Hospital, Ghent
Ghent, Belgium