PHASE III PROTOCOL COMPARING A MICROFRACTURE TREATMENT TO A CARTIPATCH® CHONDROCYTE GRAFT TREATMENT IN FEMORAL CONDYLE LESIONS - CARTIPATCH vs MICROFRACTURE
- Conditions
- Femoral condyles single lesion from trauma or osteochondritis dissequans with invalidant signs
- Registration Number
- EUCTR2007-003481-18-BE
- Lead Sponsor
- TBF
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 64
Patients presenting an osteocartilaginous femoral single lesion, with a traumatic etiology or an osteochondritis dissecans could be included in this trial only if all the following criteria are met:
•Patients of both sexes, active, between 18 and 45 years.
•Osteochondritis dissecans, type III or IV following the ICRS classification.
•Grade 3 or 4 lesion following the ICRS classification.
•Lesion’s surface (perpendicular measure: L x l) from 2.50 cm2 to 7.00 cm2 measured following debridment during the arthroscopy.
•Lesion’s depth should not be over 10 mm.
•Existence of invalidating symptoms, clinically significant (subjective IKDC score lower than 55).
•No prior surgical treatment of this lesion such as microfracture according to Pridie method or perforation > 4mm validated by MRI and osteochondral autografts or autologous chondrocytes implantation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
••Pregnant or breast-feeding women. It will then be required for women in age of giving birth to conduct a pregnancy test before recruiting for the study and to take contraception recognized as efficient.
•Anaphylactic reaction history to gentamicin and amphotericin B.
•Femoral osteocartilaginous lesion showing a kissing lesion on the tibial plateau or the patella.
•Knee varus or valgus > 6°
•Any symptomatic affection of the patella.
•Existence of an arthrosis, rheumatoid arthritis or any other articular knee affection (meniscal and ligamentary pathology), which, from the surgeon’s opinion, could potentially compromise the evolution of the treatement.
•Excessive laxity: Lachman higher than 3 (ICRS). History of one or several crossed ligaments rupture without correction (surgery performed more than 1 year before patient inclusion).
•Meniscal pathology history concerning 2/3 of meniscus without treatment (surgery performed more than 1 year before patient inclusion).
•Existence of an ulcerous pathology, tuberculosis, a psychiatrically evaluated pathology or a disease requiring a long-term treatment, including drugs acting on the joint or bone metabolism.
•Patients suffering present and passed bone, cartilage, muscle or adipose tissue cancer.
•Patients with positive serological tests for HIV, Hepatitis B and C, HTLV and Syphilis.
•Patients Body Mass Index higher than 30.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Compare the clinical improvement of the IKDC subjective score between the microfracture-treated group and the Cartipatch® chondrocyte graft-treated groups 18 months post-operatively;Secondary Objective: •Clinical examination of the knee (KOOS clinical score) and the correlation between IKDC and KOOS<br>•Arthroscopic results of the lesion 18 months post surgery (ICRS)<br>•Percentage of hyaline cartilage at 18 months post operative (histological ICRS comparison)<br>•Comparison of the treated cartilaginous surfaces 18 months post surgery using MRI<br>•Failure rate between the 2 arms (Is considered as a failure: a score lower than 70)<br>;Primary end point(s): Compare at 18 months the clinical improvement of the IKDC subjective score between the two groups
- Secondary Outcome Measures
Name Time Method