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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Osteoarthritis, Knee, Pain

Intervention / Treatment
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* Device: Hydrogel injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, multicenter
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Subjects who will receive an injection of the hydrogel | Device: Hydrogel injection<br>* Hydrogel injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment: Percentage of pain reduction using a visual analogue scale | Percentage of pain reduction using a visual analogue scale (Wong-Baker scale) where Face 0: does not hurt at all and Face 10: hurts as much as you can imagine | Change from Baseline at postoperative 12 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of Quality of life: KOOS | Quality of life (QoL-Status) - defined as improvement of the QoL of the subjects, compared to the baseline values for KOOS (Knee injury and Osteoarthritis Outcome Score) questionnaire. The KOOS questionnaire was developed as an instrument to assess the patient's opinion about their knee and associated problems.The KOOS questionnaire measures 5 subscales: pain referred by the patient, other specific symptoms of the disease, function in daily life activities, function in sport and recreation and quality of life related to the knee. All items have 5 possible response options (from 0 to 4) where 0 indicates no problems and 4 indicates extreme problems, and each of those 5 scores is calculated as the sum of the included items. The scores are transformed on a scale of 0 to 100, which 0 represents extreme knee problems and 100 indicates no symptoms. The score ranges from 0 to 100, separately for each sub-scale. A change of 10 points or more is considered a clinically significant change. | Baseline, and postoperative at 1, 3, 6 and 12 months follow-up | 
| Improvement of Health status | Health Status assessed with 12-Item Short-Form Health Survey (SF-12). It consists of 12 items (grouped in 8 health concepts: physical function, physical role, bodily pain, general health, vitality, social function, emotional role and mental health) from which two summaries are constructed: physical and mental. The higher the score on the scales indicates the better health. | Change from Baseline at postoperative at 1, 3, 6 and 12 months follow-up | 
| Patient Global Impression | Patient Global Impression with the his/her osteoarthritis will be evaluated with a visual analogue scale (Wong-Baker scale) where Face 0: represents an inactive osteoarthritis, that is, without symptoms and Face 10: represents a very active osteoarthritis, that is, with severe symptoms. | Change from Baseline, up to three days after injection, postoperative at 1, 3, 6 and 12 months follow-up | 
| Rate of Adverse Events | All adverse events will be registered. | At injection, at three days after injection, postoperative at 1, 3, 6 and 12 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, pain, knee