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

August 1, 2017 updated by: Zimmer Biomet

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Daw Park, South Australia, Australia, 5041
        • Repatriation General Hospital (RGH)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Signature Knee Guide
Total Knee Arthroplasty using the Signature Knee Guide with the Vanguard Knee System
Device: Signature Knee Guide
Total Knee Arthroplasty performed using Signature Knee Guide
Active Comparator: Conventional Instrumentation
Total Knee Arthroplasty will be performed using Conventional Instrumentation with the Vanguard Knee System
Device: Conventional Instrumentation
Total Knee Arthroplasty performed using Conventional Instrumentation
Active Comparator: Computer Assisted Navigation
Total Knee Arthroplasty will be performed using Computer Assisted Navigation with the Vanguard Knee System
Device: Computer Assisted Navigation
Total Knee Arthroplasty performed using Computer Assisted Navigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mechanical Axial Alignment
Time Frame: Six months post-operative
The primary radiological outcome will be tibial rotation
Six months post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional outcomes - Knee Society Score
Time Frame: One year post-operative
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.
One year post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Investigators

  • Principal Investigator: Jegan Krishnan, Flinders Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

June 15, 2010

First Submitted That Met QC Criteria

June 15, 2010

First Posted (Estimate)

June 16, 2010

Study Record Updates

Last Update Posted (Actual)

August 2, 2017

Last Update Submitted That Met QC Criteria

August 1, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMET AU03 (INT.CR.LAU3)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share Individual Patient Data

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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