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Effectiveness of Two Hyaluronic Acids in Osteoarthritis of the Knee

This study has suspended participant recruitment.
(Temporarily suspended-French Reg reqt post transfer of company ownership from Smith & Nephew to Bioventus LLC.)
Sponsor:
Information provided by (Responsible Party):
Bioventus LLC
ClinicalTrials.gov Identifier:
NCT01543737
First received: February 20, 2012
Last updated: July 11, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Knee Osteoarthritis
Device: 3ml hyaluronic acid (DUROLANE)
Device: 2ml hyaluronic acid, (HYALGAN)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:


Further study details as provided by Bioventus LLC:

Primary Outcome Measures:
  • Patients assessment of WOMAC A1 pain when walking [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patients assessment of WOMAC A pain [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Patients assessment of WOMAC C function [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Patient global assessment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • OMERACT-OARSI responder rate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Patient Acceptable Symptom State (PASS) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Minimal Clinically Important Improvement (MCII) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Adverse events observed or spontaneously reported by patients for each treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 290
Study Start Date: February 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Single injection hyaluronic acid Device: 3ml hyaluronic acid (DUROLANE)
DUROLANE Hyaluronic acid 20mg/ml
Active Comparator: Three injection hyaluronic acid Device: 2ml hyaluronic acid, (HYALGAN)
HYALGAN Hyaluronic acid 10mg/ml

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01543737

Locations
France
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
Monaco
Hospital Princesse Grace de Monaco
Monaco, Monaco
Sponsors and Collaborators
Bioventus LLC
Investigators
Principal Investigator: Thierry Conrozier, MD Lyon University Hospital (HCL)
  More Information

No publications provided

Responsible Party: Bioventus LLC
ClinicalTrials.gov Identifier: NCT01543737     History of Changes
Other Study ID Numbers: SNOF EC 01/2010
Study First Received: February 20, 2012
Last Updated: July 11, 2013
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on November 20, 2014