Visionaire Health Economics Study Comparing Economic Outcomes Between Visionaire and Standard Instrumentation (VISHE13)
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Total knee arthroplasty with Visionaire
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Visionaire, Health Economics, Degenerative arthritis, total knee arthroplasty
Eligibility Criteria
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
Sites / Locations
- Life Bay View Hospital
- Sunninghill Hospital
- Pretoria East Hospital
- Private Practice
- Life Claremont Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
TKA with standard instrumentation
Total knee arthroplasty with Visionaire
Arm Description
This arm consists of the Genesis II Total knee implant system or the Legion Primary total knee system with standard instrumentation
This arm will consist of the Genesis II Total Knee Implant System or Legion Primary Total Knee System with the Visionaire patient-matched instrumentation
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02158819
Brief Title
Visionaire Health Economics Study Comparing Economic Outcomes Between Visionaire and Standard Instrumentation
Acronym
VISHE13
Official Title
A Prospective, Randomised Pilot Study to Compare Health Economic Outcomes Using a Patient-matched Cutting Guide Versus Standard Instrumentation in Total Knee Arthroplasty.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
July 9, 2014 (Actual)
Primary Completion Date
May 15, 2017 (Actual)
Study Completion Date
May 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smith & Nephew, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Visionaire, Health Economics, Degenerative arthritis, total knee arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TKA with standard instrumentation
Arm Type
No Intervention
Arm Description
This arm consists of the Genesis II Total knee implant system or the Legion Primary total knee system with standard instrumentation
Arm Title
Total knee arthroplasty with Visionaire
Arm Type
Active Comparator
Arm Description
This arm will consist of the Genesis II Total Knee Implant System or Legion Primary Total Knee System with the Visionaire patient-matched instrumentation
Intervention Type
Device
Intervention Name(s)
Total knee arthroplasty with Visionaire
Intervention Description
Patient Specific Instrumentation
Primary Outcome Measure Information:
Title
Cost of the episode of care from admission to hospital to discharge
Description
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.
Time Frame
up to 1 week
Secondary Outcome Measure Information:
Title
Percentage of patients that experience short term complications and/or early readmissions
Description
Percentage of patients experiencing intra-operative complications, post operative complications, post discharge complications or readmissions prior to the 6 week post-operative assessment.
Time Frame
up to 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Baker
Organizational Affiliation
Private Practice
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lieth Stewart
Organizational Affiliation
Life Claremont Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Willem Tollig
Organizational Affiliation
Pretoria East Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Barrow
Organizational Affiliation
Sunninghill Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dan Potgieter
Organizational Affiliation
Life Bay View Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Life Bay View Hospital
City
Mossel Bay
State/Province
Cape Town
ZIP/Postal Code
6506
Country
South Africa
Facility Name
Sunninghill Hospital
City
Johannesburg
State/Province
Gauteng
Country
South Africa
Facility Name
Pretoria East Hospital
City
Pretoria
State/Province
Gauteng
Country
South Africa
Facility Name
Private Practice
City
Durban
State/Province
Kwazulu Natal
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Life Claremont Hospital
City
Cape Town
State/Province
Western Cape
Country
South Africa
12. IPD Sharing Statement
Plan to Share IPD
No
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Visionaire Health Economics Study Comparing Economic Outcomes Between Visionaire and Standard Instrumentation
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