CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 93 enrolled
Drug / intervention
Persona Knee System +2 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.

Search/NCT03227692
NCT03227692N/ACompleted
CompareCT.gov

Randomized Controlled Study Comparing iASSIST Knee System Versus Conventional Instrumentation

Zimmer Biomet·interventional·Posted Jul 24, 2017·Updated Jul 2, 2020

In Brief

A clinical study evaluating Persona Knee System, Total Knee Arthroplasty, and 1 other intervention for Osteoarthritis, Knee. Completed, enrolled 93 participants across 3 sites.

Detailed Summary

The purpose of this study is to compare the accuracy of knee component alignment between patients operated with iASSIST Knee (Investigational group) versus patients operated without iASSIST Knee (Control group) using the same implant system.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Knee
CountriesJapan
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJul 24, 2017
Enrollment StartAug 18, 2017
Primary CompletionNov 14, 2019
Study CompletionDec 2, 2019
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 8.9 years ago

Interventions

Persona Knee Systemdevice

Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.

Total Knee Arthroplastyprocedure

Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.

iAssist Kneedevice

Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.