Status:
UNKNOWN
New Hydroxyethyl Cellulose Hydrogel for the Treatment of the Pain of Knee Arthrosis
Lead Sponsor:
Promedon
Conditions:
Osteoarthritis, Knee
Pain
Eligibility:
All Genders
40-70 years
Phase:
NA
Brief Summary
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.
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- BMI (Kg/m²) 20-32
- For female subjects: postmenopausal women with at least 1 year documented in the medical record.
Exclusion
- 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
Key Trial Info
Start Date :
September 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04061733
Start Date
September 30 2019
End Date
July 31 2024
Last Update
December 29 2022
Active Locations (3)
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1
CEMIC
Buenos Aires, Argentina
2
DOM Centro de Reumatología
Buenos Aires, Argentina
3
IADT
Buenos Aires, Argentina