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Visionaire™ Versus Standard Instrumentation Safety and Efficacy in Total Knee Arthroplasty (TKA)

NCT01084772 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2020-04-03

Study results available
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Summary

The objective of this study is to assess outcomes following TKA, utilizing two surgical techniques. Patients will be randomized to one of two arms: TKA with standard instrumentation and TKA with VISIONAIRE™ patient-matched cutting blocks. Data will be collected at preoperative, operative/discharge, 3 months, 1 year and 2 years after TKA. The secondary objective of this study is to compare the safety, quality of life, and economic outcomes of TKA when these two techniques are utilized. This study does not involve treatment or investigational products, as all components are FDA cleared and are commercially available.

Conditions

  • Degenerative Arthritis of Knee

Interventions

OTHER

VISIONAIRE Total Knee Arthroplasty

TKA will be performed with VISIONAIRE instrumentation, depending on randomization assignment.

OTHER

Standard Total Knee Arthroplasty

TKA will be performed with standard instrumentation, depending on randomization assignment.

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Beate Hanson, MD, PhD · Smith & Nephew, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-21
Primary Completion
2014-04-15
Completion
2015-09-30

Countries

  • United States
  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01084772 on ClinicalTrials.gov