Knee Osteoarthritis
Conditions
Keywords
Osteoarthritis, Knee, Hyaluronan, Hyaluronic Acid, Viscoelastic, Hydrogel
Brief summary
Purpose: The purpose of this study is to demonstrate if the intra-articular injection of a new viscoelastic Hydrogel (Hymovis) is superior to Placebo (phosphate buffered saline \[PBS\] in subjects with symptomatic osteoarthritis of the knee.
Interventions
DEVICEHymovis Intra-articular Injection
Hymovis Intra-articular injection
PROCEDUREPhosphate Buffered Saline Injection
Placebo Intra-articular injection
Sponsors
Fidia Farmaceutici s.p.a.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female ambulant outpatients ≥ 40 years of age with an active lifestyle: 2. Has a medical history of OA symptoms confirmed at least 3 months prior to the screening visit with radiographic evidence of OA, Kellgren-Lawrence grade 2-3 3. Discontinuation of any analgesic/NSAID therapy prior to baseline with no intent to resume during study
Exclusion criteria
1. Clinically significant apparent large effusion of the target knee; 2. Clinically significant valgus/varus deformities, ligamentous laxity or meniscal instability as assessed by the Investigator; 3. Any musculoskeletal condition affecting the target knee that would impair assessment of the effectiveness in the target knee such as Paget's disease 4. Medical history of anaphylactic reactions 5. History of septic arthritis in any joint 6. Females who are pregnant or breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain sub-score | 26 weeks | WOMAC A Pain sub-score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| WOMAC Function | 26 Weeks | WOMAC C Function sub-score |
| Visual Analog Scale (VAS) WOMAC Pain | 26 Weeks | Question A1 of WOMAC Pain sub-score |
| WOMAC Global Score | 26 Weeks | — |
| WOMAC Stiffness sub-score | 26 Weeks | WOMAC C stiffness sub-score |
| Responder Analysis | 26 weeks | Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI) Criteria |
| Patient Global Analysis | 26 Weeks | — |
| Clinician Responder Analysis | 26 Weeks | — |
| SF Health Outcome | 26 Weeks | — |
| Rescue Medication Usage Pill Count, Failure Outcome | 26 Weeks | — |
Countries
Puerto Rico, United States
Outcome results
None listed