NCT02158819

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

A Prospective, Randomised Pilot Study to Compare Health Economic Outcomes Using a Patient-matched Cutting Guide Versus Standard Instrumentation in Total Knee Arthroplasty.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, randomised pilot study comparing the health economic outcomes between TKA using standard instrumentation and TKA using a patient-matched cutting guide. The primary indication for this study is degenerative arthritis of the knee requiring unilateral primary total knee arthroplasty. Patients requiring TKA who are eligible and have consented to participate will be randomised to TKA with The Genesis II™ Total Knee Implant System or the Legion™ Primary Total Knee System using either Visionaire™ patient-matched cutting guides or standard instrumentation. The study will recruit for 1 year and patients will have a final follow up at the six week post-operative assessment. The primary objective of this study will evaluate the cost of the episode of care from hospital admission to discharge. This will include pre-operative costs, anesthetic costs, operative and theatre costs, costs of instruments and resources. The study will also measure length of stay as well as blood transfusion requirements. The secondary objectives of this study are to compare the safety and early readmission rates between the two techniques, by measuring the complication rates intra-operatively and post-operatively as well as the number of patients readmitted to hospital prior to the six week post-operative assessment.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	Total knee arthroplasty with Visionaire	Patient Specific Instrumentation

Timeline

• Start date: 2014-07-09
• Primary completion: 2017-05-15
• Completion: 2017-05-15
• First posted: 2014-06-09
• Last updated: 2019-01-08

Locations

5 sites across 1 country: South Africa