A Comparison Between Signature Personalised Patient Care to Conventional Total Knee Arthroplasty (TKA) and Computer Assisted Navigation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01145157
First received: June 15, 2010
Last updated: December 17, 2013
Last verified: December 2013

June 15, 2010
December 17, 2013
July 2010
April 2014   (final data collection date for primary outcome measure)
Mechanical Axial Alignment [ Time Frame: Six months post-operative ] [ Designated as safety issue: No ]
The primary radiological outcome will be tibial rotation
Same as current
Complete list of historical versions of study NCT01145157 on ClinicalTrials.gov Archive Site
Functional outcomes - Knee Society Score [ Time Frame: One year post-operative ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Comparison Between Signature Personalised Patient Care to Conventional Total Knee Arthroplasty (TKA) and Computer Assisted Navigation
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Joint Disease
  • Device: Signature Knee Guide
    Total Knee Arthroplasty performed using Signature Knee Guide
  • Device: Conventional Instrumentation
    Total Knee Arthroplasty performed using Conventional Instrumentation
  • Device: Computer Assisted Navigation
    Total Knee Arthroplasty performed using Computer Assisted Navigation
  • Experimental: Signature Knee Guide
    Total Knee Arthroplasty using the Signature Knee Guide with the Vanguard Knee System
    Intervention: Device: Signature Knee Guide
  • Active Comparator: Conventional Instrumentation
    Total Knee Arthroplasty will be performed using Conventional Instrumentation with the Vanguard Knee System
    Intervention: Device: Conventional Instrumentation
  • Active Comparator: Computer Assisted Navigation
    Total Knee Arthroplasty will be performed using Computer Assisted Navigation with the Vanguard Knee System
    Intervention: Device: Computer Assisted Navigation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
October 2014
April 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01145157
BMET AU03
No
Biomet, Inc.
Biomet, Inc.
Not Provided
Principal Investigator: Jegan Krishnan Flinders Medical Centre
Biomet, Inc.
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP