Effects of Hymovis® injections in patients with osteoarthritis of the knee

Not Applicable

Completed

• Conditions: Knee osteoarthritis; Musculoskeletal Diseases; Osteoarthritis

• Registration Number: ISRCTN12227846
• Lead Sponsor: Fidia Farmaceutici Spa

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31215422 (added 20/06/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-11
• Study Completion: 2017-06-30
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1. Age 40–75 years old
2. Monolateral (unless contralateral knee is grade I and asymptomatic) femorotibial knee osteoarthritis associated or not with femoropatellar knee osteoarthritis
3. Clinical and radiological criteria of the American College of Rheumatology
4. Symptomatic for more than 6 months in the most painful knee
5. Radiological Kellgren and Lawrence grade II or III in radiographs from less than 12 months ago
6. Mean knee pain score of the most painful knee at rest over the past 24 hours on the Visual Analogue Scale (0–100) of at least 40 with a washout period for Paracetamol and oral non-steroidal anti-inflammatory drugs depending on the half-life of the drug
7. Able to follow the instructions of the study
8. Signed an informed consent form

Exclusion Criteria

1. Bilateral (except asymptomatic and grade I) osteoarthritis of the knee
2. Radiological Kellgren and Lawrence grade I or IV
3. Chondromatosis or villonodular synovitis of the knee
4. Recent trauma (<1 month) of the symptomatic knee
5. Acute inflammatory osteoarthritis
6. Articular disease resulting from articular dysplasia, aseptic osteonecrosis, acromegaly, Paget’s disease, haemophilia or haemochromatosis
7. Inflammatory disease
8. Pathologies interfering with the evaluation of osteoarthritis
9. Contraindications to Hymovis®: hypersensitivity to the product components and infections or skin diseases in the area of the injection site
10. Anticoagulants (coumarinic compounds) and heparin

Study & Design

• Study Type: Interventional
• Study Design: Not specified