drugset / Trial / NCT05058209

Effect of ZILRETTA Versus CELESTONE on Quality of Life, Pain, Neuromuscular Function, and Physical Performance

NCT05058209

Phase 4 Completed 20 enrolled ROC Foundation
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to examine the pre, post, and follow up effects of a single ZILRETTA knee injection vs a single CELESTONE SOLUSPAN knee injection on physiological measure of self-reported quality of life, pain, physical function, and physical performance in individuals with osteoarthritis (OA) knee pain. The Primary Investigator (PI) will recruit 20 symptomatic knee OA patients for this study. Patients will be randomized into one of two treatment arms, Arm 1 (ZILRETTA injection) or Arm 2 (CELESTONE SOLUSPAN injection). Patients in Arm 1 will receive a single 5 mL IV injection of 32 mg ZILRETTA into the affected knee joint. Patients in Arm 2 will receive a 5ml IV injection of 6mg/ml CELESTONE SOLUSPAN into the affected knee joint. Each study arm will include 10 patients. All data will be collected prior to injection (baseline), as well as at 6-week (post 1) and 12-week follow-ups (post 2). Patients will blinded to treatment arm until after they complete their 12-week follow up.

Timeline

Start
2020-11-30
Primary completion
2021-04-28
Completion
2021-04-28

Drugs

EvaluationDrugModalityDoseRoute
Comparator Betamethasone Other / unclassified 6 mg/ml Other
Comparator Triamcinolone Acetonide Other / unclassified 32 mg Other

Indications