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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

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT02158819

First Posted

June 5, 2014

Last Updated

January 7, 2019

Sponsor

Smith & Nephew, Inc.

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

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

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: