Effectiveness of Two Hyaluronic Acids in Osteoarthritis of the Knee
This study is currently recruiting participants.
Verified July 2012 by Smith & Nephew, Inc.
Sponsor:
Smith & Nephew, Inc.
Information provided by (Responsible Party):
Smith & Nephew, Inc.
ClinicalTrials.gov Identifier:
NCT01543737
First received: February 20, 2012
Last updated: July 31, 2012
Last verified: July 2012
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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 Smith & Nephew, Inc.:
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 Primary Completion Date: | June 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543737
Contacts
| Contact: Alexandra Fursy | +33 1 56 38 27 07 | afursy@axonal.fr |
Locations
| France | |
| Cabinet Médical | Active, not recruiting |
| Argeles-sur-Mer, France | |
| Cabinet Médical | Withdrawn |
| Bayonne, France | |
| Centre Hospitalier de Belfort-Montbeliard | Not yet recruiting |
| Belfort, France | |
| Contact: Jean-Charles Balblanc | |
| Sub-Investigator: Marie Bossert | |
| Sub-Investigator: Anne Lohse | |
| Cabinet Médical | Active, not recruiting |
| Billere, France | |
| Cabinet Médical | Not yet recruiting |
| Cabestany, France | |
| Contact: Sophie Cantogrel | |
| Sub-Investigator: Jean-Luc Dajon | |
| Cabinet Médical Cabinet Médical | Recruiting |
| Cornebarrieu, France | |
| Contact: Benoit Loze | |
| Sub-Investigator: Frédérique Bertrand Latour | |
| Chu Henri Mondor | Recruiting |
| Creteil, France | |
| Contact: Xavier Chevalier | |
| Sub-Investigator: Natacha Thelier | |
| Sub-Investigator: Majali Meyer | |
| Sub-Investigator: Claire Eymard | |
| Sub-Investigator: Sandra Guignard | |
| Cabinet Médical | Recruiting |
| Lyon, France | |
| Contact: Thierry Conrozier | |
| Sub-Investigator: Yves Mornand | |
| Sub-Investigator: Frederic Colson | |
| Cabinet Médical | Active, not recruiting |
| Metz, France | |
| Hopital de Meulan-les-Mureaux | Active, not recruiting |
| Meulan, France | |
| Polyclinique Saint Odilon | Recruiting |
| Moulins, France | |
| Contact: Bernard Maillet | |
| Sub-Investigator: Marc Laine | |
| Institut de l'Appareil Locomoteur - Nollet | Recruiting |
| Paris, France | |
| Contact: Thierry Boyer | |
| Sub-Investigator: Virginie Legre | |
| Institut de l'Appareil Locomoteur - Nollet | Withdrawn |
| Paris, France | |
| Cabinet Médical Cabinet Médical | Withdrawn |
| Paris, France | |
| Centre Médical Europe | Not yet recruiting |
| Paris, France | |
| Contact: Arthur Wulwik | |
| Sub-Investigator: Marc Stomboni | |
| Hopitaux de Saint Marice | Not yet recruiting |
| Saint-Maurice, France | |
| Contact: Jacques De Lecluse de Longraye | |
| Sub-Investigator: Caroline Herbin | |
| Cabinet Médical | Recruiting |
| Strasbourg, France | |
| Contact: Dominique Kieffer | |
| Sub-Investigator: Philippe Niederberger | |
| Sub-Investigator: Janine Ribaut | |
| Cabinet Medical | Active, not recruiting |
| Valence, France | |
| Cabinet Médical | Active, not recruiting |
| Villeurbanne, France | |
| Monaco | |
| Hospital Princesse Grace de Monaco | Recruiting |
| Monaco, Monaco | |
| Contact: Olivier Brocq | |
| Sub-Investigator: Philippe Brunner | |
Sponsors and Collaborators
Smith & Nephew, Inc.
Investigators
| Principal Investigator: | Thierry Conrozier, MD | Lyon University Hospital (HCL) |
More Information
No publications provided
| Responsible Party: | Smith & Nephew, Inc. |
| ClinicalTrials.gov Identifier: | NCT01543737 History of Changes |
| Other Study ID Numbers: | SNOF EC 01/2010 |
| Study First Received: | February 20, 2012 |
| Last Updated: | July 31, 2012 |
| 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 Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013