At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Post-Market, Prospective, Randomized, Controlled Study To Evaluate The Iovera° Device In Treating Pain Associated With Total Knee Arthroplasty
In Brief
A clinical study evaluating iovera° for Total Knee Arthroplasty. Completed, enrolled 124 participants across 1 site.
Detailed Summary
This study is designed to investigate whether iovera° treatment prior to TKA decreases cumulative participant opioid use over the course of 6 weeks following TKA while maintaining similar levels of pain relief. The study will also investigate whether there is a relationship between participants treated with iovera° and participant reported pain and function as measured by knee injury and osteoarthritis outcomes score (KOOS JR), numeric rating scale (NRS) for pain; use of hospital services post-TKA and improved physical rehabilitation as measured by range of motion.
Study Details
Timeline
Interventions
The iovera° device applies cold to a target nerve to cause a temporary peripheral nerve block based on a process called Wallerian degeneration (2nd degree axonotmesis) without disrupting connective nerve tissue.