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

NCT03203408 | Completed DMC

• 2 other identifiers: OSTP-EUR-10-012011-A00258-33
• Study Type: interventional
• Target: 290
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change in WOMAC A

  Change from baseline in the pain subscore (section A) of the WOMAC score

  Day 0 to Day 180

Secondary Outcomes (6)

• Lequesne algofunctional index

  Day 0 to Day 180

• WOMAC B

  Day 0 to Day 180

• WOMAC C

  Day 0 to Day 180

• Patient's overall status score in relation to his/her knee osteoarthritis

  Day 0 to Day 180

• Assessment of overall treatment efficacy by the patient

  Day 30 to Day 180

Other Outcomes (6)

• Incidence of all adverse events

  Day 0 to Day 180

• Incidence of local adverse reactions

  Day 30

• Assessment of local treatment tolerability by the patient

  Day 30

Study Arms (2)

OSTENIL PLUS

EXPERIMENTAL

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)

Device: OSTENIL PLUS

SYNVISC-ONE

ACTIVE COMPARATOR

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)

Device: SYNVISC-ONE

Interventions

OSTENIL PLUS DEVICE

Injection into the joint cavity of the most painful knee

OSTENIL PLUS

SYNVISC-ONE DEVICE

Injection into the joint cavity of the most painful knee

SYNVISC-ONE

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Failure or intolerance of first line analgesics and NSAIDs;
• With health insurance;
• Understanding and following the study instructions;
• Signed the informed consent.

You may not qualify if:

• 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.);
• 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);
• 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;
• Obesity: body mass index ≥30 kg/m2;
• History of autoimmune disease;

Sponsors & Collaborators

• TRB Chemedica: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Renée Liliane Dreiser, Dr

  APHP Bichat-Claude Bernard, Paris, France

  STUDY CHAIR

• Bernard Avouac, Dr

  APHP Henri Mondor, Creteil, France

  STUDY CHAIR

• Thomas Bardin, Prof.

  APHP Lariboisière, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: To prevent the patients from knowing the nature of their treatment, the investigational products OSTENIL PLUS and SYNVISC-ONE were packed in identical neutral packs. OSTENIL PLUS and SYNVISC-ONE differ in appearance (product volume and viscosity, prefilled syringe) and were therefore readily identifiable by the investigator administering the investigational product (i.e. injecting investigator). The double-blind masking could be ensured thanks to the intervention of an observer who did not know the nature of the treatment, namely the evaluating investigator. The treatment was therefore administered blind to the evaluating investigator and the patient but not to the injecting investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study was a multicentre, prospective, double-blind, randomised, controlled non-inferiority study in two parallel groups of patients followed up for six months.

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: June 29, 2017
• Study Start: June 21, 2011
• Primary Completion: November 22, 2012
• Study Completion: November 22, 2012
• Last Updated: October 11, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share