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

Zimmer Biomet1 site in 1 country100 target enrollmentMay 24, 2016

ConditionsOsteoarthritis, Knee

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteoarthritis, Knee
Sponsor: Zimmer Biomet
Enrollment: 100
Locations: 1
Primary Endpoint: Proportion of Subjects That Have Alignment Within 2 Degrees From Neutral on Tibia
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

May 24, 2016

End Date

October 26, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Zimmer Biomet

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Knee (either unilateral or bilateral) Osteoarthritis (varus deformity only)
•Subjects willing to return for follow-up evaluations

Exclusion Criteria

•Knee degenerative diseases other than Knee Osteoarthritis (such as necrosis / Rheumatoid Arthritis)
•Severe OA deformation (FTA: \>185 degrees or \<175 degrees)
•Active Infection (or within 6 weeks after infection)
•Osteomyelitis
•Any type of implant is inserted in the affected side of lower extremity
•Hip disease on the affected side
•Uncooperative patient or patient with neurologic disorders who are incapable of following directions
•diagnosed Osteoporosis or Osteomalacia
•Metabolic disorders which may impair bone formation
•Distant foci of infections which may spread to the implant site

Outcomes

Primary Outcomes

Proportion of Subjects That Have Alignment Within 2 Degrees From Neutral on Tibia

Time Frame: Postoperative 6 months

Proportion of subjects that have tibial alignment within 2 degrees from neutral and compare the accuracy of tibial component alignment between two groups.

Secondary Outcomes

Number of Participants With Tibial Posterior Slope Alignment Within Predetermined Threshold(Postoperative 6 months)
Number of Participants With Femoral Varus/Valgus Angle Within Predetermined Threshold(Postoperative 6 months)
Number of Participants With Adverse Events and/or Adverse Device Effects(Intra-operative and Post-operative 6 months)