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Visionaire Health Economics Study Comparing Economic Outcomes Between Visionaire and Standard Instrumentation

NCT02158819 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2019-01-08

No results posted yet for this study

Summary

The purpose and primary objective of this study is to compare health economic outcomes between the use of a patient-matched cutting guide (Visionaire) versus the use of standard instrumentation in Total Knee Arthroplasty(TKA). Data will be collected pre-operatively, intra-operatively and post operatively up until and including the six week post-operative assessment. The secondary objectives of the study are to compare safety and early readmission rates between the two techniques. The study hypothesis is that there is no difference in the cost of the episode of care from hospital admission to discharge, including pre-operative radiology costs and cost of resources, with the Visonaire patient-matched cutting guide compared to standard instrumentation.

Conditions

  • Osteoarthritis, Knee

Interventions

DEVICE

Total knee arthroplasty with Visionaire

Patient Specific Instrumentation

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Andrew Baker · Private Practice

  • Lieth Stewart · Life Claremont Hospital

  • Willem Tollig · Pretoria East Hospital

  • Michael Barrow · Sunninghill Hospital

  • Dan Potgieter · Life Bay View Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-09
Primary Completion
2017-05-15
Completion
2017-05-15

Countries

  • South Africa

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 NCT02158819 on ClinicalTrials.gov