Clinical trial NCT01543737: Effectiveness of Two Hyaluronic Acids in Osteoarthritis of the Knee
Official title: Single-blind Randomised Pragmatic Trial Comparing the Effectiveness of Two Hyaluronic Acid Viscosupplements, DUROLANE® (Single Injection) Versus HYALGAN® (Three Injections) for Symptomatic Tibiofemoral Osteoarthritis of the Knee.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Bioventus LLC
Sponsor class: INDUSTRY
First posted: 2012-03-05
Enrollment: 290
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Patients assessment of WOMAC A1 pain when walking
timeFrame: 24 weeks
Secondary outcomes:
measure: Patients assessment of WOMAC A pain
timeFrame: 24 weeks
measure: Patients assessment of WOMAC C function
timeFrame: 24 weeks
measure: Patient global assessment
timeFrame: 24 weeks
measure: OMERACT-OARSI responder rate
timeFrame: 24 weeks
measure: Patient Acceptable Symptom State (PASS)
timeFrame: 24 weeks
measure: Minimal Clinically Important Improvement (MCII)
timeFrame: 24 weeks
measure: Adverse events observed or spontaneously reported by patients for each treatment
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Argeles-sur-Mer
country: France
facility: Cabinet Médical
city: Belfort
country: France
facility: Centre Hospitalier de Belfort-Montbeliard
city: Billere
country: France
facility: Cabinet Médical
city: Cabestany
country: France
facility: Cabinet Médical
city: Cornebarrieu
country: France
facility: Cabinet Médical Cabinet Médical
city: Creteil
country: France
facility: Chu Henri Mondor
city: Lyon
country: France
facility: Cabinet Médical
city: Metz
country: France
facility: Cabinet Médical
city: Meulan
country: France
facility: Hopital de Meulan-les-Mureaux
city: Moulins
country: France
facility: Polyclinique Saint Odilon
city: Paris
country: France
facility: Centre Médical Europe
city: Paris
country: France
facility: Institut de l'Appareil Locomoteur - Nollet
city: Saint-Maurice
country: France
facility: Hopitaux de Saint Marice
city: Strasbourg
country: France
facility: Cabinet Médical
city: Valence
country: France
facility: Cabinet Medical
city: Villeurbanne
country: France
facility: Cabinet Médical
city: Monaco
country: Monaco
facility: Hospital Princesse Grace de Monaco
Study officials:
affiliation: Lyon University Hospital (HCL)
name: Thierry Conrozier, MD
role: PRINCIPAL_INVESTIGATOR
References: