Knee Osteoarthritis
Conditions
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.
Detailed description
non-inferiority study of two HA products commercially availalble
Interventions
DEVICE3ml hyaluronic acid (DUROLANE)
DUROLANE Hyaluronic acid 20mg/ml
DEVICE2ml hyaluronic acid, (HYALGAN)
HYALGAN Hyaluronic acid 10mg/ml
Sponsors
Bioventus LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients assessment of WOMAC A1 pain when walking | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Patients assessment of WOMAC C function | 24 weeks |
| Patient global assessment | 24 weeks |
| OMERACT-OARSI responder rate | 24 weeks |
| Patients assessment of WOMAC A pain | 24 weeks |
| Minimal Clinically Important Improvement (MCII) | 24 weeks |
| Adverse events observed or spontaneously reported by patients for each treatment | 24 weeks |
| Patient Acceptable Symptom State (PASS) | 24 weeks |
Countries
France, Monaco
Outcome results
None listed