Osteoarthritis, Knee
Conditions
Brief summary
It is a post-license, multicenter, randomized, single blind, controlled study comparing a single injection of Cingal® (study arm) with a single injection of Monovisc® (control arm).
Interventions
DEVICECingal® (Hyaluronic Acid plus Triamcinolone Hexacetonide)
Intra-articular injection
DEVICEMonovisc® (Sodium hyaluronate)
Intra-articular injection
Sponsors
Pharmascience Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years of age * Diagnosed with osteoarthritis of the knee * Candidate for an intra-articular injection (single joint, unilateral) of Monovisc® or Cingal® as part of their routine clinical care and in accordance with the locally approved label
Exclusion criteria
* Previous intra-articular injection within the last 6 months from enrolment * Known hypersensitivity to cortico-steroids, hyaluronic acid or any component of Cingal® or Monovisc® * Infectious, traumatic or neoplasic component of knee pathology * Surgery of the knee within the last 6 months or scheduled surgery in the next two months from enrolment * Patients with impaired cardio-renal function, endocrine, or other diseases or conditions that use of corticosteroid is warned. * Patients with known bleeding disorders * Patient currently treated with oral steroids or opioids * Patients that, in the investigators' opinion, are unlikely to comply with protocol * Pregnant or nursing women or women who suspect they might be pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare the local pain reduction after a single injection of Cingal® or Monovisc® over a 6 weeks period in patients with osteoarthritis of the knee assessed with the Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 6 weeks post injection | Western Ontario and McMaster Universities Arthritis Index (WOMAC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in stiffness and physical function | 6 weeks post injection | Western Ontario and McMaster Universities Arthritis Index (WOMAC) |
| Compare the maximum pain reduction by treatment arm | 6 weeks post injection | Western Ontario and McMaster Universities Arthritis Index (WOMAC) |
| Compare the time to maximum pain reduction by treatment arm | 6 weeks post injection | Western Ontario and McMaster Universities Arthritis Index (WOMAC) |
| Overall change of WOMAC score | 6 weeks post injection | Western Ontario and McMaster Universities Arthritis Index (WOMAC) |
| Time to maximum WOMAC score reduction | 6 weeks post injection | Western Ontario and McMaster Universities Arthritis Index (WOMAC) |
Countries
Canada
Outcome results
None listed