NCT05492851

Trial Comparing Three Single Dose Injections for Knee Osteoarthritis

A Double-blind, Randomized Trial Comparing Three Single Dose Injections for Knee Osteoarthritis

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 25 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is a 3-arm, double-blind, randomized trial comparing the clinical outcomes of Zilretta, Synvisc One, and Monovisc for knee OA.

Detailed description

Knee osteoarthritis (OA) is a leading cause of disability worldwide.1,2 Standard of care treatments for knee OA include activity modification, weight loss, therapeutic exercise and medications like non-steroidal anti-inflammatory drugs (NSAIDs). If these measures fail, injections like corticosteroids and hyaluronate (HA) can be helpful for pain control.3 The aforementioned injections have unique mechanisms of action. Steroid injections work through reducing joint inflammation, while HA works by lubricating and cushioning the joint. There are several varieties of steroids and HA injections that have been approved by the Food and Drug Administration for use in knee OA. Among these variations are extended-release triamcinolone (Zilretta), hylan GF-20 (synvisc one), and hyaluronan (monovisc). While each are FDA approved and commonly used in orthopedic and sports medicine clinics, they have never been directly compared in any study. Therefore, when selecting a treatment for a patient, it is largely based on provider preference, not clinical data. This study is a 3-arm, double-blind, randomized trial comparing the clinical outcomes of Zilretta, Synvisc One, and Monovisc for knee OA.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	Zilretta	Intra-articular injection to treat knee osteoarthritis
DRUG	Synvisc-One 48 MG in 6 ML Prefilled Syringe	Intra-articular injection to treat knee osteoarthritis
DRUG	Monovisc 88 MG Per 4 ML Prefilled Syringe	Intra-articular injection to treat knee osteoarthritis

Timeline

• Start date: 2022-08-02
• Primary completion: 2023-01-11
• Completion: 2023-01-11
• First posted: 2022-08-09
• Last updated: 2023-04-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study