Clinical trial: Efficacy and Safety of Hymovis ONE® (32mg/4ml) Intrarticular Injection in Active Patients With Knee Overuse Syndrome (NCT04661111)

Eligibility criteria:
Inclusion Criteria:

          1. Male or female higher than 18 and less or equal to 65 years of age

          2. an active life-style, professional or regular casual sport player (people who plays
             sport or trains themselves at least 2-3 times per week).

          3. diagnosis of knee osteoarthritis will be based upon a standing weight bearing knee
             X-ray at Screening or an X-ray performed within 6 months prior to screening. The
             radiograms must be classified as a Kellgren and Lawrence Grade I-III for
             osteoarthritis of the knee.

          4. a knee VAS pain score, within 48 hours before the visit.

          5. patients must have had all analgesic/anti-inflammatory drugs discontinued for 2 weeks
             prior to Baseline except for acetaminophen.

        Exclusion Criteria:

          1. Major injury to the contralateral knee or other weight-bearing joint if it would
             interfere with the study assessments.

          2. Surgical procedure of the studied joint within the previous 12 months prior to
             Screening.

          3. Ligament reconstruction in the target knee within 1 year

          4. Inflammatory arthropathies such as rheumatoid arthritis, lupus, or psoriatic arthritis

          5. Intra-articular or local peri-articular corticosteroid injections to the study
             joint/knee within the previous 3 months prior to screening or to any other joint
             (beside the study joint) or soft tissue area within the previous month prior to
             Screening.

          6. Any corticosteroid within the previous month. Steroid inhalants are permitted if the
             patient has been on a stable regimen for the past month prior to Screening and remains
             on this regimen throughout the course of the trial.

          7. Intra-articular hyaluronan in the studied joint within the previous 6 months prior to
             Screening.

          8. History of allergic reaction to an intra-articular Hyaluronic acid injection

          9. Use of glucosamine- or chondroitin sulfate-containing products unless the patient is
             on stable doses for at least 4 months prior to Screening and willing to remain on
             these stable doses throughout the course of the trial.

         10. Patients with X-ray findings of acute fractures, severe loss of bone density,
             avascular necrosis and/or severe deformity.

         11. Axial deviation of the lower limbs higher than 20 degrees in valgus or varus on
             standing X-ray.

         12. Symptomatic osteoarthritis of either hip, contralateral knee or spine that may
             interfere with functional assessment of the signal knee.

         13. Clinically significant medio-lateral and/or anterior-posterior instability.

         14. Osteonecrosis of either knee.

         15. If patients are receiving or performing physical therapy at Screening, this physical
             therapy regimen has not been stable during the one-month preceding Screening and the
             patient is not willing to maintain the same regimen throughout the course of the
             trial.

         16. Patients with Kellgren-Lawrence Stage IV osteoarthritis of the knee (i.e.,in grade IV
             large osteophytes, marked narrowing, severe sclerosis, and definite deformity).

         17. Hemiparesis of the lower limbs
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 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