At a glance

ClinicalIndex Comparison Record

N/ACompleted· 100 enrolled

Drug / intervention

KneeAlign 2device

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/NCT02695329

NCT02695329N/ACompleted

Compare CT.gov

Randomized Controlled Study Comparing Vanguard With KneeAlign2 Navigational System Versus Vanguard Conventional

Zimmer Biomet·interventional·Posted Mar 1, 2016·Updated Feb 12, 2020

In Brief

A clinical study evaluating KneeAlign 2 for Osteoarthritis, Knee. Completed, enrolled 100 participants across 1 site.

Detailed Summary

Purpose of this study is to determine the effectiveness of the KneeAlign 2 system in terms of precise implant alignment by demonstrating that KneeAlign 2 provides better tibial alignment compared to conventional instruments

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsOsteoarthritis, Knee

CountriesJapan

Collaborators--

Timeline

N/ACompletedFinished

20162017201820192020202120222023202420252026

First PostedMar 2016

Enrollment StartMay 2016

Primary CompletionOct 2018

Study CompletionOct 2018

TodayJul 2026

First PostedMar 1, 2016

Enrollment StartMay 24, 2016

Primary CompletionOct 3, 2018

Study CompletionOct 26, 2018

TodayJul 2, 2026

Enrollment to primary: 2.4 yearsPosted 10.3 years ago

Interventions

KneeAlign 2device

Patients suffering non-severe varus deformity 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.