Effectiveness of Two Hyaluronic Acids in Osteoarthritis of the Knee

Not Applicable

Terminated

• Conditions: Knee Osteoarthritis

• 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

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)

Cabinet Médical; 🇫🇷 Villeurbanne, France

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

Cabinet Médical Cabinet Médical; 🇫🇷 Cornebarrieu, France

Chu Henri Mondor; 🇫🇷 Creteil, 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 Medical; 🇫🇷 Valence, France

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