Femoral condyles single lesion from trauma or osteochondritis dissequans with invalidant signs
Conditions
Interventions
Product Name: CARTIPATCH®
Product Code: CARTIPATCH®
Pharmaceutical Form: Implant
INN or Proposed INN: CARTIPATCH®
Concentration unit: million organisms/ml million organisms/millilitre
Concentration ty
Sponsors
TBF
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: • • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 • Arthroscopic results of the lesion 18 months post surgery (ICRS) • Percentage of hyaline cartilage at 18 months post operative (histological ICRS comparison) • Comparison of the treated cartilaginous surfaces 18 months post surgery using MRI • Failure rate between the 2 arms (Is considered as a failure: a score lower than 70) ;Primary end point(s): Compare at 18 months the clinical improvement of the IKDC subjective score between the two groups | — |
Countries
Belgium
Outcome results
None listed