Articular pain/knee
Conditions
Interventions
There will only be one group with 3 participants. All participants will be submitted to a single intervention: there will be surgery to implant a porcine collagen membrane inside the knee containing c
Procedure/surgery
A11.329.171
Sponsors
Hospital Israelita Albert Einstein
Hospital Israelita Albert Einstein
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Male; age between 18 and 40 years; with or without anterior cruciate ligament (ACL) injury; lesion of the articular cartilage in the femur or patella; degrees 2 or 3 of the International Cartilage Repair Society (ICRS) classification; diameter greater than 2 cm; symptomatic; without improvement with conservative treatment based on physical therapy, weight loss and medications
Exclusion criteria
Exclusion criteria: Superficial chondral lesion (classification ICRS grade 1); Subchondral bone lesion (ICRS grade 4); Osteoarthritis (Kellgren-Lawrence rating greater than 1); Misalignment of the mechanical axis of the lower limb in the frontal plane; Multiple ligament lesions; Previous surgeries in the affected knee; Meniscal lesions not sutured; Systemic inflammatory diseases; Inability to adhere to the rehabilitation protocol; Functional limitations due to pain in the spine or hips; Claustrophobia; Metal implants that ensure the performance of magnetic resonance; Obesity (BMI greater than 30); Smoking; Gestation; Cognitive changes with inability to read, understand and sign the EHIC.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety of the procedure by the method of observation of the incidence and severity of complications according to version 4.0 of the NCI-CTCAE (National Cancer Institute-Common Terminology Criteria for Adverse Events). We will observe the absence of serious adverse events in the period one year | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of the surgery by measuring the WOMAC scales validated for the Portuguese language, IKDC validated for the Portuguese language and MOCART, from the observation of a variation of at least 10 points for less than WOMAC and 10 points for more of the IKDC and MOCART, in the mean of the scales in the pre- and post-intervention measurements | — |
Countries
Brazil
Contacts
Public ContactAlessandro;Mario Zorzi;Ferretti
Hospital Israelita Albert Einstein;Hospital Israelita Albert Einstein
Outcome results
None listed