Clinical trial: New Hydroxyethyl Cellulose Hydrogel for the Treatment of the Pain of Knee Arthrosis (NCT04061733)

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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 70 Years

Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment