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

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: July 24, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Joint Disease
Device: Signature Knee Guide
Device: Conventional Instrumentation
Device: Computer Assisted Navigation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Mechanical Axial Alignment [ Time Frame: Six months post-operative ] [ Designated as safety issue: No ]
    The primary radiological outcome will be tibial rotation


Secondary Outcome Measures:
  • Functional outcomes - Knee Society Score [ Time Frame: One year post-operative ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: July 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01145157

Locations
Australia, South Australia
Repatriation General Hospital (RGH)
Daw Park, South Australia, Australia, 5041
Sponsors and Collaborators
Biomet, Inc.
Investigators
Principal Investigator: Jegan Krishnan Flinders Medical Centre
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01145157     History of Changes
Other Study ID Numbers: BMET AU03
Study First Received: June 15, 2010
Last Updated: July 24, 2014
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Biomet, Inc.:
knee
arthroplasty

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 16, 2014