Efficacy of OSTENIL PLUS (Hyaluronic Acid) Versus SYNVISC-ONE in Patients With Tibiofemoral Osteoarthritis

NCT ID: NCT03203408

Last Updated: 2017-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 290 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-21
• Study Completion Date: 2012-11-22

Brief Summary

The main objective of the study was to demonstrate the non-inferiority of the efficacy of a single intra-articular injection of OSTENIL PLUS compared to that of a single intra-articular injection of the reference product SYNVISC-ONE in the treatment of symptomatic tibiofemoral osteoarthritis. The primary endpoint was the change in mean score on the WOMAC pain scales from D0 to D180.

Detailed Description

After a period of washout-out for NSAIDs, the patients received a single intra-articular injection of OSTENIL PLUS or of SYNVISC-ONE in the most painful knee. The study involved a preselection visit at D-7 and five further visits: at D0 (baseline, evaluation before intra-articular injection), at D2 ± 2 days (injection), at D30 ± 15 days, at D90 ± 15 days and C5 at D180 ± 15 days.

To enrol the patients as quickly as possible, 129 sites, i.e. general medical or rheumatology practices, were open. After verifying the inclusion and exclusion criteria, the evaluating investigators assigned a randomisation number based on the chronological order of inclusion of patients at their site. The patient was then sent to the injecting investigator so that he/she could give the injection of the product corresponding to the randomisation number.

Conditions

Knee Osteoarthritis

Study Design

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

Study Groups

OSTENIL PLUS

A single intra-articular injection of sodium hyaluronate 40 mg/2.0 ml at Day 2, i.e. 2 days post Baseline (Day 0 = Week 0)

Group Type: EXPERIMENTAL

OSTENIL PLUS

Intervention Type: DEVICE

Injection into the joint cavity of the most painful knee

SYNVISC-ONE

A single intra-articular injection of hylan G-F 20 48 mg/6 ml at Day 2, i.e. 2 days post Baseline (Day 0 = Week 0)

Group Type: ACTIVE_COMPARATOR

SYNVISC-ONE

Intervention Type: DEVICE

Injection into the joint cavity of the most painful knee

Interventions

OSTENIL PLUS

Injection into the joint cavity of the most painful knee

Intervention Type: DEVICE

SYNVISC-ONE

Injection into the joint cavity of the most painful knee

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Male or female aged 40-85 years;
• Primary knee osteoarthritis complying with the American College or Rheumatology criteria;
• Radiographically defined osteoarthritis: joint space narrowing and osteophyte in X-ray taken less than one year previously and modified Kellgren-Lawrence grade Ib-III;
• Symptoms on one side only, with a mean WOMAC A of ≥40 mm. If knee osteoarthritis is bilateral, a difference for that score between the contralateral knee and the selected knee should be of at least 20 mm;
• Pain present on at least 15 days in the month before inclusion;
• Failure or intolerance of first line analgesics and NSAIDs;
• With health insurance;
• Understanding and following the study instructions;
• Signed the informed consent.

Exclusion Criteria

• Knee osteoarthritis that is not symptomatic or insufficiently symptomatic;
• Bilateral symptomatic knee osteoarthritis of the same severity on both sides;
• Post-traumatic secondary knee osteoarthritis;
• Knee osteoarthritis of radiographic grade I, Ia or IV;
• Exclusively patellofemoral osteoarthritis where the symptoms are principally of patellofemoral origin (Patellar syndrome);
• Symptomatic homolateral coxarthrosis;
• Varus or valgus deformation of the selected knee (deformation axis ≥15° in X-ray);
• Inflammatory rheumatism (rheumatoid arthritis, psoriatic rheumatism, articular chondrocalcinosis, gout, Paget's disease, ankylosing spondylitis, lupus, etc.);
• History of injury to the selected knee during the 6 months before inclusion;
• Venous or lymphatic stenosis of the lower limb;
• Femoral or sciatic nerve root pain of the lower limb to be tested;
• Tendinopathy (e.g. hip periarthritis);
• Treatment with intra-articular hyaluronic acid in the selected knee during the 6 months before inclusion;
• Intra-articular injection of corticosteroids in the selected knee during the 2 months before inclusion;
• Treatment with symptomatic slow-acting drugs for osteoarthritis and/or dietary supplements for osteoarthritis (chondroitin sulphate, diacerein, avocado and soybean unsaponifiables, oxaceprol, copper granions, glucosamine) which had been started less than 3 months previously or whose dose had been changed during the last 3 months before inclusion;
• Total knee replacement of the selected knee;
• Surgery of the other knee or of the hip or any other surgery scheduled during the period of the study;
• History of any surgical intervention, arthroscopy, osteotomy, etc. in the year before inclusion;
• Obesity: body mass index ≥30 kg/m2;
• History of autoimmune disease;
• Severe condition likely to interfere with the evaluation, such as neoplasia, malignant blood disease, kidney disease, liver disease or severe infection;
• Very marked hydrarthrosis (requiring puncture) at the time of inclusion;
• Wound or skin condition of the selected knee;
• Anticoagulant treatment with heparin or warfarin (platelet antiaggregants such as ASPIRIN ≤325 mg/d, ticlopidine or clopidogrel were allowed);
• Known hypersensitivity to hyaluronic acid and/or to avian proteins and/or paracetamol;
• Known hypersensitivity to mannitol;
• Participation in a clinical research study within the previous 3 months;
• Pregnancy, breast-feeding.

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

Sponsors

TRB Chemedica

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Renée Liliane Dreiser, Dr

Role: STUDY_CHAIR

APHP Bichat-Claude Bernard, Paris, France

Bernard Avouac, Dr

Role: STUDY_CHAIR

APHP Henri Mondor, Creteil, France

Thomas Bardin, Prof.

Role: PRINCIPAL_INVESTIGATOR

APHP Lariboisière, Paris, France

Other Identifiers

2011-A00258-33

Identifier Type: OTHER

Identifier Source: secondary_id

OSTP-EUR-10-01

Identifier Type: -

Identifier Source: org_study_id