Effectiveness of Two Hyaluronic Acids in Osteoarthritis of the Knee

NCT ID: NCT01543737

Last Updated: 2016-02-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 290 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-02-28

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.

Detailed Description

non-inferiority study of two HA products commercially availalble

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Single injection hyaluronic acid

3ml hyaluronic acid (DUROLANE)

Group Type: ACTIVE_COMPARATOR

3ml hyaluronic acid (DUROLANE)

Intervention Type: DEVICE

DUROLANE Hyaluronic acid 20mg/ml

Three injection hyaluronic acid

2ml hyaluronic acid (HYALGAN)

Group Type: ACTIVE_COMPARATOR

2ml hyaluronic acid, (HYALGAN)

Intervention Type: DEVICE

HYALGAN Hyaluronic acid 10mg/ml

Interventions

3ml hyaluronic acid (DUROLANE)

DUROLANE Hyaluronic acid 20mg/ml

Intervention Type: DEVICE

2ml hyaluronic acid, (HYALGAN)

HYALGAN Hyaluronic acid 10mg/ml

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bioventus LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thierry Conrozier, MD

Role: PRINCIPAL_INVESTIGATOR

Lyon University Hospital (HCL)

Locations

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

Countries

France; Monaco

Other Identifiers

SNOF EC 01/2010

Identifier Type: -

Identifier Source: org_study_id