Synvisc One for Osteoarthritis

Phase 4

Waitlist Available

Led By Michael Baria

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 month, 6 month

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares three types of injections (Zilretta, Synvisc One, and Monovisc) for treating knee osteoarthritis. It targets people with knee osteoarthritis who need more relief than standard treatments provide. Zilretta helps by reducing inflammation, while Synvisc One and Monovisc help by lubricating and cushioning the knee joint. Cingal, a combination of sodium hyaluronate and triamcinolone hexacetonide, has shown greater pain reduction in knee osteoarthritis compared to sodium hyaluronate alone.

Eligible Conditions

Osteoarthritis of the Knee
Osteoarthritis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 month, 6 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 month, 6 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 month, 6 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Knee injury and Osteoarthritis Outcome Score (KOOS) Pain patient reported outcome questionnaire

Secondary study objectives

Knee injury and Osteoarthritis Outcome Score (KOOS) Function in Sport and Recreation (Sport/Rec) patient reported outcome

Knee injury and Osteoarthritis Outcome Score (KOOS) Function in daily living (ADL) patient reported outcome

Knee

+2 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Active Control

Group I: Synvisc OneActive Control1 Intervention

Generic Name: Hylan G-F 20 Synvisc-One combines the three doses of SYNVISC (hylan G-F 20) which consists of hylan A (average molecular weight6,000,000 daltons) and hylan B hydrated gel in a buffered physiological sodium chloride solution, pH 7.2. Each 10 mL syringe of Synvisc-One combines the three 2-mL doses (16 mg each) of a complete SYNVISC treatment regimen (48 mg). Synvisc-One belongs to a class of drugs called Intra-Articular Agents; Rheumatologics, Other. 10mL of Hylan G-F 20 administered as a 1 dose parapatellar intra-articular injection.

Group II: ZilrettaActive Control1 Intervention

Generic Name: Triamcinolone acetonide Zilretta is an extended-release synthetic corticosteroid indicated as an intra-articular injection for the management ofosteoarthritis pain of the knee. 5mL suspension of 32 mg of triamsinolone administered as a 1 dose parapatellar intra-articular injection.

Group III: MonoviscActive Control1 Intervention

Generic Name: Hyaluronan The Monovisc™ device is a proprietary high molecular weight hyaluronic acid (HA) viscosupplementation intended for the treatment of pain in patients with moderate osteoarthritis (OA) of the knee who have failed conservative non-pharmacological therapy and simple analgesics. The device is administered by a single injection via the para-patellar approach under sterile conditions. 4mL injection of Hyaluronan administered as a 1 dose parapatellar intra-articular injection.

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