Unilateral Primary Osteoarthritis of Knee Clinical Trial
Official title:
An Open Label,Multicentre, Randomized Trial to Determine the Efficacy of Periarticular Parecoxib Sodium In A Multimodal Cocktail vs Intravenous Parecoxib Sodium for Pain Management in Total Knee Arthroplasty
Primary Research Objective:
The primary objective of this study is to determine efficacy of periarticular parecoxib
sodium in a multimodal cocktail versus intravenous parecoxib injections for pain management
in total knee arthroplasty
Secondary Research Objective:
- To determine if perioperative use of parecoxib sodium was associated with improved
clinical outcomes
- To evaluate the safety, in terms of adverse events; serious adverse events and
tolerability of parecoxib sodium in periarticular injections in a multimodal cocktail
This is a multi-center, open label, parallel randomized trial designed to evaluate the
efficacy and safety of periarticular parecoxib sodium compared to intravenous parecoxib
sodium.
125 patients with primary knee osteoarthritis from 4 participating sites who meet
inclusion/exclusion criteria will be enrolled into the trial. After initial screening,
patients will attend clinic for baseline examination. Subjects will then randomly allocated
to periarticular parecoxib sodium or intravenous sodium in ratio of 1:1. patients are
observed at post-operative 6, 12, 24 hours, subsequently daily for 4 days and finally at 2
week follow-up
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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