Study Stopped
post transfer of company ownership from Smith \& Nephew to Bioventus LLC
Effectiveness of Two Hyaluronic Acids in Osteoarthritis of the Knee
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.
1 other identifier
interventional
290
2 countries
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable knee-osteoarthritis
Started Feb 2012
Typical duration for not_applicable knee-osteoarthritis
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 20, 2012
CompletedFirst Posted
Study publicly available on registry
March 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedFebruary 12, 2016
February 1, 2016
2 years
February 20, 2012
February 11, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Patients assessment of WOMAC A1 pain when walking
24 weeks
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (2)
Single injection hyaluronic acid
ACTIVE COMPARATOR3ml hyaluronic acid (DUROLANE)
Three injection hyaluronic acid
ACTIVE COMPARATOR2ml hyaluronic acid (HYALGAN)
Interventions
DUROLANE Hyaluronic acid 20mg/ml
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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, would be a contraindication for an intra-articular injection
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bioventus LLClead
Study Sites (17)
Cabinet Médical
Argeles, France
Centre Hospitalier de Belfort-Montbeliard
Belfort, France
Cabinet Médical
Billère, France
Cabinet Médical
Cabestany, France
Cabinet Médical Cabinet Médical
Cornebarrieu, France
Chu Henri Mondor
Créteil, France
Cabinet Médical
Lyon, France
Cabinet Médical
Metz, France
Hopital de Meulan-les-Mureaux
Meulan-en-Yvelines, France
Polyclinique Saint Odilon
Moulins, France
Centre Médical Europe
Paris, France
Institut de l'Appareil Locomoteur - Nollet
Paris, France
Hopitaux de Saint Marice
Saint-Maurice, France
Cabinet Médical
Strasbourg, France
Cabinet Medical
Valence, France
Cabinet Médical
Villeurbanne, France
Hospital Princesse Grace de Monaco
Monaco, Monaco
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thierry Conrozier, MD
Lyon University Hospital (HCL)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2012
First Posted
March 5, 2012
Study Start
February 1, 2012
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
February 12, 2016
Record last verified: 2016-02