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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-05

Study Completion Date

2017-10-25

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).

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Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Cingal®

Single 4 ml intra-articular injection of Hyaluronic Acid plus Triamcinolone Hexacetonide

Group Type EXPERIMENTAL

Cingal® (Hyaluronic Acid plus Triamcinolone Hexacetonide)

Intervention Type DEVICE

Intra-articular injection

Monovisc®

Single 4 ml intra-articular injection of Sodium Hyaluronate

Group Type ACTIVE_COMPARATOR

Monovisc® (Sodium hyaluronate)

Intervention Type DEVICE

Intra-articular injection

Interventions

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Cingal® (Hyaluronic Acid plus Triamcinolone Hexacetonide)

Intra-articular injection

Intervention Type DEVICE

Monovisc® (Sodium hyaluronate)

Intra-articular injection

Intervention Type DEVICE

Other Intervention Names

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Cingal® Monovisc®

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No