Resumen

Prospective, multicenter study, unmasked, single-arm, to study the safety and efficacy of a new hydroxyethyl cellulose hydrogel for the treatment of the knee pain caused by osteoarthritis.

Descripción detallada

Prospective, multicenter study, unmasked, single-arm, to study the safety and efficacy of a new hydroxyethyl cellulose hydrogel for the treatment of the knee pain caused by osteoarthritis. The working hypothesis is that the effect of hydrogel use on the study population will result in a reduction in pain in the knees affected by symptomatic OA. The general objective of this study is to generate clinical evidence of the safety and efficacy of the new hydrogel used as a treatment of symptomatic knee osteoarthritis. The patient's perception of the pain caused by osteoarthritis in the knee joint before and after the treatment under evaluation will be quantify. Subjects' quality of life before and after treatment will also be evaluated. Monitoring of the adverse events associated with the use of the device under evaluation will be determined. Subjects will be follow-up for 12 months.

Elegibilidad

Edad mínima: 40 YearsEdad máxima: 70 YearsSexo: ALL

Criterios de inclusión

BMI (Kg/m²) 20-32
Subjects diagnosed with osteoarthritis of unilateral or bilateral knee osteoarthritis who meet the criteria defined by the American College of Rheumatology for at least 4 months prior to the study. In bilateral knee osteoarthritis, only the knee with more symptoms will be treated.
Arthrosis grade 2 or 3 according to the Kellgren - Lawrence Classification System (radiological classification)
Persistence of symptoms despite conservative treatment (NSAIDS, Physical Therapy, lifestyle changes, etc.) for more than 4 months
Subjects aged between 40 and 70 years
For female subjects: postmenopausal women with at least 1 year documented in the medical record.

Criterios de exclusión

Arthrosis grade 0 or 4 according to the Kellgren - Lawrence Classification
History of allergy to any of the Hydrogel components
History of previous treatment with corticosteroid injections less than 4 months prior to entry into this clinical study
History of previous treatment with hyaluronic acid viscosupplementation
History of open or arthroscopic surgery in the knee to be treated less than 9 months
Severe chronic progressive disease
Insulin-requiring diabetes
Rheumatic diseases (rheumatoid arthritis, psoriasis, gout, pseudo-gout, fibromyalgia)
History of septic arthritis
History of psychiatric illness that makes it impossible to understand and sign the informed consent
History or presence of severe peripheral vascular disease
Deseje over 15° valgus or varus movement
Pregnant or breastfeeding women
BMI (kg/m²)\> 32

New Hydroxyethyl Cellulose Hydrogel for the Treatment of the Pain of Knee Arthrosis

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Hydrogel injection

Ubicaciones

CEMIC

DOM Centro de Reumatología

IADT

Patrocinadores