Effectiveness of Two Hyaluronic Acids in Osteoarthritis of the Knee
Study Details
Study Description
Brief Summary
The purpose of this study is to assess whether a single injection hyaluronic acid (HA) product is not inferior to a 3 injection HA product at 24 weeks (6 months), in terms of effectiveness in reducing pain when walking in patients suffering from symptomatic tibiofemoral osteoarthritis of the knee.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
non-inferiority study of two HA products commercially availalble
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Single injection hyaluronic acid 3ml hyaluronic acid (DUROLANE) |
Device: 3ml hyaluronic acid (DUROLANE)
DUROLANE Hyaluronic acid 20mg/ml
|
| Active Comparator: Three injection hyaluronic acid 2ml hyaluronic acid (HYALGAN) |
Device: 2ml hyaluronic acid, (HYALGAN)
HYALGAN Hyaluronic acid 10mg/ml
|
Outcome Measures
Primary Outcome Measures
- Patients assessment of WOMAC A1 pain when walking [24 weeks]
Secondary Outcome Measures
- Patients assessment of WOMAC A pain [24 weeks]
- Patients assessment of WOMAC C function [24 weeks]
- Patient global assessment [24 weeks]
- OMERACT-OARSI responder rate [24 weeks]
- Patient Acceptable Symptom State (PASS) [24 weeks]
- Minimal Clinically Important Improvement (MCII) [24 weeks]
- Adverse events observed or spontaneously reported by patients for each treatment [24 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥ 40 and < 85
-
Tibiofemoral osteoarthritis of the knee according to the American College of Rheumatology clinical criteria, in the Kellgren-Lawrence (KL) stages II-III, confirmed by radiology (< 3 months)
-
Unilateral symptomatic osteoarthritis of the knee causing pain when walking (WOMAC A1 scale), assessed over the previous 24 hours on a scale of 0 to 10: Pain when walking: ≤ 3 and < 8
-
Bilateral osteoarthritis of the knee, if pain in the other knee is < 3 (10-point numerical scale)
-
Patient: outpatient, capable of walking 50 metres without a walking stick, crutches or a walker, capable of reading, understanding, signing and dating the patient information sheet
-
Patient with social security cover
Exclusion Criteria:
-
Osteoarthritis of the knee in Kellgren-Lawrence (KL) stages I and IV
-
Bilateral symptomatic osteoarthritis of the knee causing pain when walking (WOMAC A1 scale), assessed on a scale of 0 to 10: Pain when walking > 3, in both knees
-
Predominant symptomatic patellofemoral osteoarthritis of the knee
-
Congestive manifestation of osteoarthritis of the knee defined according to the Knee Osteoarthritis Flare-Ups Score (KOFUS) criteria
-
Last viscosupplementation of the affected knee < 6 months before, last injection of corticosteroids < 2 months before
-
Known hypersensitivity to avian proteins and hyaluronic acids;
-
History of joint replacement or major surgery in the affected knee in the last six months
-
History of arthroscopy or surgery in the affected knee in the last three months
-
Symptomatic hip disease on the same side or other side of the body
-
Joint replacement or any other surgery planned in the next six months
-
History of septic arthritis of the affected knee
-
Skin complaint affecting the knee at the injection site
-
Haemorrhagic disease contraindicating, in the doctor's opinion, any intra-articular injection
-
In order to respect the pragmatic nature of the study:
-
Any medical and / or pathological condition that, in the investigator's opinion, makes the subject unsuitable for inclusion
-
Any medical and / or pathological condition that, in the investigator's opinion, would be a contraindication for an intra-articular injection
-
Any other complaint that, in the investigator's opinion, would impede the assessment of the effectiveness of the affected knee
-
Any treatment administered to the patient that may interfere with the interpretation of the study results
-
Use of glucocorticosteroids (except inhaled corticosteroids) during the previous month
-
Treatment with diacerein, avocado and soya unsaponifiables, glucosamine sulphate or chondroitin sulphate, started in the previous 3 months, or irregular doses over the previous 3 months
-
Hard of hearing (not being able to follow a telephone conversation properly)
-
Patient without a telephone
-
Pregnant women or nursing mothers
-
Participation in other clinical studies, within 30 days before inclusion
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cabinet Médical | Argeles-sur-Mer | France | ||
| 2 | Centre Hospitalier de Belfort-Montbeliard | Belfort | France | ||
| 3 | Cabinet Médical | Billere | France | ||
| 4 | Cabinet Médical | Cabestany | France | ||
| 5 | Cabinet Médical Cabinet Médical | Cornebarrieu | France | ||
| 6 | Chu Henri Mondor | Creteil | France | ||
| 7 | Cabinet Médical | Lyon | France | ||
| 8 | Cabinet Médical | Metz | France | ||
| 9 | Hopital de Meulan-les-Mureaux | Meulan | France | ||
| 10 | Polyclinique Saint Odilon | Moulins | France | ||
| 11 | Centre Médical Europe | Paris | France | ||
| 12 | Institut de l'Appareil Locomoteur - Nollet | Paris | France | ||
| 13 | Hopitaux de Saint Marice | Saint-Maurice | France | ||
| 14 | Cabinet Médical | Strasbourg | France | ||
| 15 | Cabinet Medical | Valence | France | ||
| 16 | Cabinet Médical | Villeurbanne | France | ||
| 17 | Hospital Princesse Grace de Monaco | Monaco | Monaco |
Sponsors and Collaborators
- Bioventus LLC
Investigators
- Principal Investigator: Thierry Conrozier, MD, Lyon University Hospital (HCL)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SNOF EC 01/2010