NCT04261049

Effect of Zilretta Injection

Effect of ZILRETTA Injection on Neuromuscular Function, Gait Biomechanics and Physical Performance

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the pre-post effects of a single ZILRETTA knee injection on physiological measures of self-reported pain and disability, physical performance, and physical activity in individuals with knee osteoarthritis (OA). The investigators will recruit 35 symptomatic knee OA patients for this study. All data will be collected prior to injection (baseline), as well as at 4 (post 1) and 8-week follow-ups (post 2).

Detailed description

Individuals with knee osteoarthritis (OA) demonstrate significant physical disability which leads to diminished physical activity, a lesser quality of life, as well as a higher risk of inactivity related comorbidities including mortality. This is thought to be caused by an inability to voluntarily activate your quadriceps muscle due, in part, to knee joint swelling and joint-related pain. Incomplete muscle activation causes quadriceps weakness. Individuals with quadriceps weakness exhibit changes in their walking biomechanics which is associated with diminished physical function and lesser physical activity in those with knee OA. Therefore, it is critical to develop interventions that target mechanisms causing decreased quadriceps activation in order to restore optimal walking biomechanics and improve physical activity. The ZILRETTA knee injection is an FDA approved, extended release corticosteroid for in patients with knee osteoarthritis and has been shown to reduced knee pain for 3 months in approximately 70% of patients. Currently, there are no studies that have examined ZILRETTA's objective effectiveness on physical activity, biomechanics, and performance tests in patients who have received an injection. The overall purpose of the current study is to examine the effect of a ZILRETTA knee injection on functional and performance tests including quadriceps neuromuscular activation, quadriceps strength, walking gait biomechanics, and a battery of physical performance outcomes at 4 and 8-weeks following injection in 35 individuals with knee OA.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	Triamcinolone Acetonide Extended-Release Injectable Suspension	A single ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) intra-articular knee injection.

Timeline

• Start date: 2020-08-01
• Primary completion: 2022-01-10
• Completion: 2022-01-10
• First posted: 2020-02-07
• Last updated: 2022-05-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study