Effectiveness of Two Hyaluronic Acids in Osteoarthritis of the Knee

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01543737
Recruitment Status : Terminated (post transfer of company ownership from Smith & Nephew to Bioventus LLC)
First Posted : March 5, 2012
Last Update Posted : February 12, 2016
Information provided by (Responsible Party):
Bioventus LLC

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
Knee Osteoarthritis Device: 3ml hyaluronic acid (DUROLANE) Device: 2ml hyaluronic acid, (HYALGAN) Not Applicable

Detailed Description:
non-inferiority study of two HA products commercially availalble

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Patients assessment of WOMAC A1 pain when walking [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Patients assessment of WOMAC A pain [ Time Frame: 24 weeks ]
  2. Patients assessment of WOMAC C function [ Time Frame: 24 weeks ]
  3. Patient global assessment [ Time Frame: 24 weeks ]
  4. OMERACT-OARSI responder rate [ Time Frame: 24 weeks ]
  5. Patient Acceptable Symptom State (PASS) [ Time Frame: 24 weeks ]
  6. Minimal Clinically Important Improvement (MCII) [ Time Frame: 24 weeks ]
  7. Adverse events observed or spontaneously reported by patients for each treatment [ Time Frame: 24 weeks ]

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01543737

Cabinet Médical
Argeles-sur-Mer, France
Centre Hospitalier de Belfort-Montbeliard
Belfort, France
Cabinet Médical
Billere, France
Cabinet Médical
Cabestany, France
Cabinet Médical Cabinet Médical
Cornebarrieu, France
Chu Henri Mondor
Creteil, France
Cabinet Médical
Lyon, France
Cabinet Médical
Metz, France
Hopital de Meulan-les-Mureaux
Meulan, 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
Sponsors and Collaborators
Bioventus LLC
Principal Investigator: Thierry Conrozier, MD Lyon University Hospital (HCL)

Responsible Party: Bioventus LLC Identifier: NCT01543737     History of Changes
Other Study ID Numbers: SNOF EC 01/2010
First Posted: March 5, 2012    Key Record Dates
Last Update Posted: February 12, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Protective Agents