At a glance
ClinicalIndex Comparison RecordN/ACompleted· 150 enrolled
Drug / intervention
iovera° +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Post-Market, Multi-Center, Prospective, Double-Blind, Randomized, Controlled Study to Evaluate the Iovera° Device in Treating Pain Associated With Total Knee Arthroplasty
In Brief
A clinical study evaluating iovera° and iovera° Sham for Arthritis of the Knee. Completed, enrolled 150 participants across 8 sites.
Detailed Summary
This study will evaluate the iovera° device in treating pain associated with total knee arthroplasty (TKA). This study will also assess if overall pain medication is reduced following TKA and will investigate the relationship between patients treated with the iovera° device and length of hospital stay, pain, patient satisfaction and improved rehabilitation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthritis of the Knee
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 2014
Enrollment StartDec 2014
Primary CompletionMay 2016
Study CompletionJun 2016
TodayJul 2026
First PostedNov 5, 2014
Enrollment StartDec 1, 2014
Primary CompletionMay 1, 2016
Study CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 11.7 years ago
Interventions
iovera°device
Use of iovera° device to administer treatment Focused Cold Therapy
iovera° Shamdevice
iovera° device used for sham treatment