Visionaire Health Economics Study Comparing Economic Outcomes Between Visionaire and Standard Instrumentation (VISHE13)

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: Total knee arthroplasty with Visionaire

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Cape Town
    • Mossel Bay, Cape Town, South Africa, 6506
      • Life Bay View Hospital
  • Gauteng
    • Johannesburg, Gauteng, South Africa
      • Sunninghill Hospital
    • Pretoria, Gauteng, South Africa
      • Pretoria East Hospital
  • Kwazulu Natal
    • Durban, Kwazulu Natal, South Africa, 4001
      • Private Practice
  • Western Cape
    • Cape Town, Western Cape, South Africa
      • Life Claremont Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Degenerative arthritis of the knee requiring unilateral primary Total Knee Arthroplasty in subjects for whom the use of patient-matched cutting guides or standard instrumentation are, in the surgeon's opinion, clinically appropriate and acceptable forms of treatment;
• Patient is of legal age to consent and is skeletally mature;
• The patient is able to fully understand the purpose of the trial, and his/her role as a participant in the study
• The patient consents to his/her inclusion in the study after the nature, scope and possible consequences of the study have been explained in an understandable form.

Exclusion Criteria:

• Patient is known to have poor bone stock making a Total Knee Arthroplasty unjustifiable.
• Patient is immuno-suppressed.
• Patient has physical, emotional or neurological conditions that would compromise the subject's compliance with postoperative rehabilitation and follow-up.
• Patient is pregnant or may become pregnant during the course of the study, or is lactating.
• Patient has a history of prior ipsilateral major knee surgery (e.g. arthroplasty, high tibial osteotomy, or tibial plateau fracture). Minor prior procedures such as Anterior Cruciate Ligament repair, meniscectomy, or arthroscopy are not excluded.
• Patient has active, localized or systemic infection.
• Patient is severely overweight (BMI >40).
• Patient is a prisoner.
• Patient has a significant MRI (magnetic resonance imaging) exclusion or contraindication.
• Patient has had a total joint arthroplasty of the contralateral limb in the last 12 months.
• Patient presently identified with future need for bilateral TKA within the next twenty-four months.
• Patient has a known or suspected hypersensitivity/allergy to foreign materials contained in the implant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: TKA with standard instrumentation; This arm consists of the Genesis II Total knee implant system or the Legion Primary total knee system with standard instrumentation
Active Comparator: Total knee arthroplasty with Visionaire; This arm will consist of the Genesis II Total Knee Implant System or Legion Primary Total Knee System with the Visionaire patient-matched instrumentation	Device: Total knee arthroplasty with Visionaire; Patient Specific Instrumentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost of the episode of care from admission to hospital to discharge	The cost of the episode of care from admission to hospital to discharge , including pre-operative radiology costs and costs associated with Visionaire and will incorporate the costs of time, number of instruments utilised, blood transfusion requirements, length of stay and pre-operative xray and MRI costs.	up to 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients that experience short term complications and/or early readmissions	Percentage of patients experiencing intra-operative complications, post operative complications, post discharge complications or readmissions prior to the 6 week post-operative assessment.	up to 6 weeks

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Principal Investigator: Andrew Baker, Private Practice; Principal Investigator: Lieth Stewart, Life Claremont Hospital; Principal Investigator: Willem Tollig, Pretoria East Hospital; Principal Investigator: Michael Barrow, Sunninghill Hospital; Principal Investigator: Dan Potgieter, Life Bay View Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2014
• Primary Completion (Actual): May 15, 2017
• Study Completion (Actual): May 15, 2017

Study Registration Dates

• First Submitted: June 5, 2014
• First Submitted That Met QC Criteria: June 5, 2014
• First Posted (Estimate): June 9, 2014

Study Record Updates

• Last Update Posted (Actual): January 8, 2019
• Last Update Submitted That Met QC Criteria: January 7, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: total knee arthroplasty; Health Economics; Visionaire; Degenerative arthritis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: VISHE.13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No