Clinical Trials Directory

Trials / Completed

CompletedNCT02695329

Vanguard TKA With KneeAlign 2 and Without KneeAlign 2

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
100 (actual)
Sponsor
Zimmer Biomet · Industry
Sex
All
Age
20 Years
Healthy volunteers
Not accepted

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

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DEVICEKneeAlign 2Patients 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.

Timeline

Start date
2016-05-24
Primary completion
2018-10-03
Completion
2018-10-26
First posted
2016-03-01
Last updated
2020-02-12
Results posted
2019-10-03

Locations

1 site across 1 country: Japan

Source: ClinicalTrials.gov record NCT02695329. Inclusion in this directory is not an endorsement.