New Hydroxyethyl Cellulose Hydrogel for the Treatment of the Pain of Knee Arthrosis (PROMGEL-OA)

Promedon

Status: Active, not recruiting

Conditions: Pain; Osteoarthritis, Knee

Treatments: Device: Hydrogel injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT04061733

PROMGEL-OA-2018

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. Arthrosis grade 2 or 3 according to the Kellgren - Lawrence Classification System (radiological classification)
3. Persistence of symptoms despite conservative treatment (NSAIDS, Physical Therapy, lifestyle changes, etc.) for more than 4 months
4. Subjects aged between 40 and 70 years
5. BMI (Kg/m²) 20-32
6. For female subjects: postmenopausal women with at least 1 year documented in the medical record.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Experimental

Experimental group

Description:

Subjects who will receive an injection of the hydrogel

Treatment:

Device: Hydrogel injection