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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01145157
Recruitment Status : Completed
First Posted : June 16, 2010
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Tracking Information
First Submitted Date  ICMJE June 15, 2010
First Posted Date  ICMJE June 16, 2010
Last Update Posted Date August 2, 2017
Study Start Date  ICMJE July 2010
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2010)
Mechanical Axial Alignment [ Time Frame: Six months post-operative ]
The primary radiological outcome will be tibial rotation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2017)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2010)
Functional outcomes - Knee Society Score [ Time Frame: One year post-operative ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison Between Signature Total Knee Arthroplasty (TKA) to Conventional TKA and Computer Assisted TKA
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Joint Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 15, 2010)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01145157
Other Study ID Numbers  ICMJE BMET AU03 (INT.CR.LAU3)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is no plan to share Individual Patient Data
Responsible Party Zimmer Biomet
Study Sponsor  ICMJE Zimmer Biomet
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jegan Krishnan Flinders Medical Centre
PRS Account Zimmer Biomet
Verification Date August 2017

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