Effectiveness of Two Hyaluronic Acids in Osteoarthritis of the Knee

Knee Osteoarthritis Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01543737
• Other study ID #: SNOF EC 01/2010
• Status: Terminated
• Phase: N/A
• First received: February 20, 2012
• Last updated: February 11, 2016
• Start date: February 2012
• Est. completion date: February 2014

Study information

• Verified date: February 2016
• Source: Bioventus LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

non-inferiority study of two HA products commercially availalble

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 290
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• 3ml hyaluronic acid (DUROLANE)
DUROLANE Hyaluronic acid 20mg/ml
• 2ml hyaluronic acid, (HYALGAN)
HYALGAN Hyaluronic acid 10mg/ml

Locations

Country	Name	City	State
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
Monaco	Hospital Princesse Grace de Monaco	Monaco

Sponsors (1)

Lead Sponsor	Collaborator
Bioventus LLC

Countries where clinical trial is conducted

France,  Monaco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients assessment of WOMAC A1 pain when walking		24 weeks	No
Secondary	Patients assessment of WOMAC A pain		24 weeks	No
Secondary	Patients assessment of WOMAC C function		24 weeks	No
Secondary	Patient global assessment		24 weeks	No
Secondary	OMERACT-OARSI responder rate		24 weeks	No
Secondary	Patient Acceptable Symptom State (PASS)		24 weeks	No
Secondary	Minimal Clinically Important Improvement (MCII)		24 weeks	No
Secondary	Adverse events observed or spontaneously reported by patients for each treatment		24 weeks	Yes