Trials / Completed
CompletedNCT03327220
Treatment With Iovera° for Total Knee Arthroplasty (TKA) Post-Operative Pain
A Post-Market, Prospective, Randomized, Controlled Study To Evaluate The Iovera° Device In Treating Pain Associated With Total Knee Arthroplasty
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 124 (actual)
- Sponsor
- Pacira Pharmaceuticals, Inc · Industry
- Sex
- All
- Age
- 22 Years – 79 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | iovera° | 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. |
Timeline
- Start date
- 2017-11-06
- Primary completion
- 2019-03-27
- Completion
- 2019-03-27
- First posted
- 2017-10-31
- Last updated
- 2021-05-21
- Results posted
- 2021-05-21
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03327220. Inclusion in this directory is not an endorsement.