Clinical trial NCT04061733: New Hydroxyethyl Cellulose Hydrogel for the Treatment of the Pain of Knee Arthrosis
Official title: New Hydroxyethyl Cellulose Hydrogel for the Treatment of the Pain of Knee Arthrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Pain
Keywords: osteoarthritis
pain
knee
Lead sponsor: Promedon
Sponsor class: INDUSTRY
First posted: 2019-08-20
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multicenter
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain assessment: Percentage of pain reduction using a visual analogue scale
timeFrame: Change from Baseline at postoperative 12 months follow-up
Secondary outcomes:
measure: Improvement of Quality of life: KOOS
timeFrame: Baseline, and postoperative at 1, 3, 6 and 12 months follow-up
measure: Improvement of Health status
timeFrame: Change from Baseline at postoperative at 1, 3, 6 and 12 months follow-up
measure: Patient Global Impression
timeFrame: Change from Baseline, up to three days after injection, postoperative at 1, 3, 6 and 12 months follow-up
measure: Rate of Adverse Events
timeFrame: At injection, at three days after injection, postoperative at 1, 3, 6 and 12 months follow-up
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: CEMIC
city: Buenos Aires
country: Argentina
facility: DOM Centro de Reumatología
city: Buenos Aires
country: Argentina
facility: IADT
Study officials:
affiliation: IADT
name: Fernando E. Barclay, Dr.
role: PRINCIPAL_INVESTIGATOR
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