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A Comparison Between Signature Total Knee Arthroplasty (TKA) to Conventional TKA and Computer Assisted TKA

Primary Purpose

Joint Disease

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Signature Knee Guide
Conventional Instrumentation
Computer Assisted Navigation
Sponsored by
Zimmer Biomet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Joint Disease focused on measuring knee, arthroplasty

Eligibility Criteria

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

Inclusion Criteria:

  • Patient is of legal age and skeletally mature
  • Patient requires primary total knee arthroplasty due to non- inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, a vascular necrosis, dysplasia/DDH) or inflammatory joint disease (e.g., Rheumatoid arthritis).
  • Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, haematological, etc., conditions that would pose excessive operative risk
  • The patient will be available for follow up throughout the duration of the study.

Exclusion Criteria:

  • Patient is unable to have an MRI scan due to the following conditions:

    • Cardiac pacemaker
    • Surgical clips in head (aneurysm clips)
    • Some artificial heart valves
    • Electronic inner ear implants
    • Metal fragments in eyes
    • Electronic stimulators
    • Implanted pumps
  • Patient has active infection or sepsis (treated or untreated)
  • Patient has any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery.
  • Patient is female of child-bearing age and not taking contraceptive precautions.
  • Patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia).
  • Patient has known moderate to severe renal insufficiency.
  • Patient has a known or suspected metal sensitivity.
  • Patient is immunosuppressed or receiving high doses of corticosteroids.
  • Patient has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, or drug, alcohol abuse.
  • Patient has BMI >40.

Sites / Locations

  • Repatriation General Hospital (RGH)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Signature Knee Guide

Conventional Instrumentation

Computer Assisted Navigation

Arm Description

Total Knee Arthroplasty using the Signature Knee Guide with the Vanguard Knee System

Total Knee Arthroplasty will be performed using Conventional Instrumentation with the Vanguard Knee System

Total Knee Arthroplasty will be performed using Computer Assisted Navigation with the Vanguard Knee System

Outcomes

Primary Outcome Measures

Mechanical Axial Alignment
The primary radiological outcome will be tibial rotation

Secondary Outcome Measures

Functional outcomes - Knee Society Score
The Knee Score consists of points given for pain, range of motion, and stability in both the coronal and sagittal planes, with deductions for fixed deformity, and extensor lag. The Function Score consists of points given for the ability to walk on level surfaces, and the ability to ascend and descend stairs, with deductions for the use of external supporting devices.

Full Information

First Posted
June 15, 2010
Last Updated
August 1, 2017
Sponsor
Zimmer Biomet
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1. Study Identification

Unique Protocol Identification Number
NCT01145157
Brief Title
A Comparison Between Signature Total Knee Arthroplasty (TKA) to Conventional TKA and Computer Assisted TKA
Official Title
A Comparison Between 'Signature™ Personalised Patient Care' to Conventional Total Knee Arthroplasty and Computer Assisted Navigation and a Cost Benefit Analysis for the Australian Market
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective, randomised clinical outcomes study comparing the Signature Personalised Patient Care, Conventional Total Knee Arthroplasty and Computer Assisted Navigation, using Vanguard Knee System. The aim of the study is to evaluate the safety and efficacy of TKA using Signature Personalised Patient Care compared to Conventional TKA and Computer Assisted Navigation.
Detailed Description
The objective of this study is to report and compare on the outcomes from patients undergoing total knee arthroplasty utilizing 'SignatureTM Personalised Patient Care', Conventional Total Knee Arthroplasty and Computer Assisted Navigation. The 'SignatureTM Personalised Patient Care' is a system that uses a patient's Magnetic Resonance Imaging (MRI) and X-ray design to build surgical instruments customized for a patient's unique knee anatomy. Cutting positioning guides are produced to match the outer shape of the individual's distal femur and proximal tibia. The cutting positioning guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Joint Disease
Keywords
knee, arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Signature Knee Guide
Arm Type
Experimental
Arm Description
Total Knee Arthroplasty using the Signature Knee Guide with the Vanguard Knee System
Arm Title
Conventional Instrumentation
Arm Type
Active Comparator
Arm Description
Total Knee Arthroplasty will be performed using Conventional Instrumentation with the Vanguard Knee System
Arm Title
Computer Assisted Navigation
Arm Type
Active Comparator
Arm Description
Total Knee Arthroplasty will be performed using Computer Assisted Navigation with the Vanguard Knee System
Intervention Type
Device
Intervention Name(s)
Signature Knee Guide
Intervention Description
Total Knee Arthroplasty performed using Signature Knee Guide
Intervention Type
Device
Intervention Name(s)
Conventional Instrumentation
Intervention Description
Total Knee Arthroplasty performed using Conventional Instrumentation
Intervention Type
Device
Intervention Name(s)
Computer Assisted Navigation
Intervention Description
Total Knee Arthroplasty performed using Computer Assisted Navigation
Primary Outcome Measure Information:
Title
Mechanical Axial Alignment
Description
The primary radiological outcome will be tibial rotation
Time Frame
Six months post-operative
Secondary Outcome Measure Information:
Title
Functional outcomes - Knee Society Score
Description
The Knee Score consists of points given for pain, range of motion, and stability in both the coronal and sagittal planes, with deductions for fixed deformity, and extensor lag. The Function Score consists of points given for the ability to walk on level surfaces, and the ability to ascend and descend stairs, with deductions for the use of external supporting devices.
Time Frame
One year post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is of legal age and skeletally mature Patient requires primary total knee arthroplasty due to non- inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, a vascular necrosis, dysplasia/DDH) or inflammatory joint disease (e.g., Rheumatoid arthritis). Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, haematological, etc., conditions that would pose excessive operative risk The patient will be available for follow up throughout the duration of the study. Exclusion Criteria: Patient is unable to have an MRI scan due to the following conditions: Cardiac pacemaker Surgical clips in head (aneurysm clips) Some artificial heart valves Electronic inner ear implants Metal fragments in eyes Electronic stimulators Implanted pumps Patient has active infection or sepsis (treated or untreated) Patient has any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery. Patient is female of child-bearing age and not taking contraceptive precautions. Patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia). Patient has known moderate to severe renal insufficiency. Patient has a known or suspected metal sensitivity. Patient is immunosuppressed or receiving high doses of corticosteroids. Patient has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, or drug, alcohol abuse. Patient has BMI >40.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jegan Krishnan
Organizational Affiliation
Flinders Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Repatriation General Hospital (RGH)
City
Daw Park
State/Province
South Australia
ZIP/Postal Code
5041
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share Individual Patient Data
Citations:
PubMed Identifier
27652687
Citation
Cundy WJ, Theodoulou A, Ling CM, Krishnan J, Wilson CJ. Blood Loss in Total Knee Arthroplasty. J Knee Surg. 2017 Jun;30(5):452-459. doi: 10.1055/s-0036-1592147. Epub 2016 Sep 21.
Results Reference
derived

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A Comparison Between Signature Total Knee Arthroplasty (TKA) to Conventional TKA and Computer Assisted TKA

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