Effectiveness of Two Hyaluronic Acids in Osteoarthritis of the Knee

February 11, 2016 updated by: Bioventus LLC

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

non-inferiority study of two HA products commercially availalble

Study Type

Interventional

Enrollment (Actual)

290

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Argeles-sur-Mer, France
        • Cabinet Medical
      • Belfort, France
        • Centre Hospitalier de Belfort-Montbéliard
      • Billere, France
        • Cabinet Medical
      • Cabestany, France
        • Cabinet Medical
      • Cornebarrieu, France
        • Cabinet Médical Cabinet Médical
      • Creteil, France
        • Chu Henri Mondor
      • Lyon, France
        • Cabinet Medical
      • Metz, France
        • Cabinet Medical
      • Meulan, France
        • Hopital de Meulan-les-Mureaux
      • Moulins, France
        • Polyclinique Saint Odilon
      • Paris, France
        • Centre Médical Europe
      • Paris, France
        • Institut de l'Appareil Locomoteur - Nollet
      • Saint-Maurice, France
        • Hopitaux de Saint Marice
      • Strasbourg, France
        • Cabinet Medical
      • Valence, France
        • Cabinet Medical
      • Villeurbanne, France
        • Cabinet Medical
  • Monaco
      • Monaco, Monaco
        • Hospital Princesse Grace de Monaco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patients assessment of WOMAC A1 pain when walking
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Patients assessment of WOMAC A pain
Time Frame: 24 weeks
24 weeks
Patients assessment of WOMAC C function
Time Frame: 24 weeks
24 weeks
Patient global assessment
Time Frame: 24 weeks
24 weeks
OMERACT-OARSI responder rate
Time Frame: 24 weeks
24 weeks
Patient Acceptable Symptom State (PASS)
Time Frame: 24 weeks
24 weeks
Minimal Clinically Important Improvement (MCII)
Time Frame: 24 weeks
24 weeks
Adverse events observed or spontaneously reported by patients for each treatment
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bioventus LLC

Investigators

  • Principal Investigator: Thierry Conrozier, MD, Lyon University Hospital (HCL)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

February 20, 2012

First Submitted That Met QC Criteria

March 2, 2012

First Posted (Estimate)

March 5, 2012

Study Record Updates

Last Update Posted (Estimate)

February 12, 2016

Last Update Submitted That Met QC Criteria

February 11, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNOF EC 01/2010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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