Own Cartilage Cells Transplantation: validation of the therapy protocol for Cartilage Lesions

Not Applicable

Recruiting

• Conditions: C05.550.091; Articular pain/knee; C05.550.114.606.500; A02.165.407

• Registration Number: RBR-6fgy76
• Lead Sponsor: Hospital Israelita Albert Einstein

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-05
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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