Effectiveness of Two Hyaluronic Acids in Osteoarthritis of the Knee

Not Applicable

Terminated

• Conditions: Knee Osteoarthritis
• Interventions: Device: 3ml hyaluronic acid (DUROLANE); Device: 2ml hyaluronic acid, (HYALGAN)

• Registration Number: NCT01543737
• Lead Sponsor: 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.

Detailed Description

non-inferiority study of two HA products commercially availalble

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-20
• Study First Submitted QC: 2012-03-02
• Study First Posted: 2012-03-05
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-11
• Last Update Posted: 2016-02-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 290

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single injection hyaluronic acid	3ml hyaluronic acid (DUROLANE)	3ml hyaluronic acid (DUROLANE)
Three injection hyaluronic acid	2ml hyaluronic acid, (HYALGAN)	2ml hyaluronic acid (HYALGAN)

Primary Outcome Measures

Name	Time	Method
Patients assessment of WOMAC A1 pain when walking	24 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (11)

Centre Hospitalier de Belfort-Montbeliard; 🇫🇷 Belfort, France

Hopital de Meulan-les-Mureaux; 🇫🇷 Meulan, France

Centre Médical Europe; 🇫🇷 Paris, France

Chu Henri Mondor; 🇫🇷 Creteil, France

Hopitaux de Saint Marice; 🇫🇷 Saint-Maurice, France

Cabinet Médical Cabinet Médical; 🇫🇷 Cornebarrieu, France

Cabinet Médical; 🇫🇷 Villeurbanne, France

Institut de l'Appareil Locomoteur - Nollet; 🇫🇷 Paris, France

Cabinet Medical; 🇫🇷 Valence, France

Polyclinique Saint Odilon; 🇫🇷 Moulins, France

Hospital Princesse Grace de Monaco; 🇲🇨 Monaco, Monaco