Early Effect of Cingal® Compared to Monovisc® in Patients With Osteoarthritis of the Knee

Study Overview
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Brief Summary
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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).

Official Title
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Early Effect of Cingal® Compared to Monovisc® in Patients With Osteoarthritis of the Knee (EEFFEK Study)

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: Cingal® (Hyaluronic Acid plus Triamcinolone Hexacetonide)
* Device: Monovisc® (Sodium hyaluronate)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cingal®<br>Single 4 ml intra-articular injection of Hyaluronic Acid plus Triamcinolone Hexacetonide | Device: Cingal® (Hyaluronic Acid plus Triamcinolone Hexacetonide)<br>* Intra-articular injection<br>* Other names: Cingal®;|
| Active Comparator: Monovisc®<br>Single 4 ml intra-articular injection of Sodium Hyaluronate | Device: Monovisc® (Sodium hyaluronate)<br>* Intra-articular injection<br>* Other names: Monovisc®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 6 weeks post injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the maximum pain reduction by treatment arm | Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 6 weeks post injection | 
| Compare the time to maximum pain reduction by treatment arm | Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 6 weeks post injection | 
| Change in stiffness and physical function | Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 6 weeks post injection | 
| Overall change of WOMAC score | Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 6 weeks post injection | 
| Time to maximum WOMAC score reduction | Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 6 weeks post injection |