Effectiveness of Two Hyaluronic Acids in Osteoarthritis of the Knee

Bioventus

Status

Terminated

Conditions

Knee Osteoarthritis

Treatments

Device: 2ml hyaluronic acid, (HYALGAN)

Device: 3ml hyaluronic acid (DUROLANE)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01543737

SNOF EC 01/2010

Details and patient eligibility

About

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.

Full description

non-inferiority study of two HA products commercially availalble

Enrollment

290 patients

Sex

All

Ages

40 to 85 years old

Volunteers

No Healthy Volunteers

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