NCT01145157

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2010

Completed
15 days until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

August 2, 2017

Status Verified

August 1, 2017

Enrollment Period

4.4 years

First QC Date

June 15, 2010

Last Update Submit

August 1, 2017

Conditions

Joint Disease

Keywords

kneearthroplasty

Outcome Measures

Primary Outcomes (1)

  • Mechanical Axial Alignment

    The primary radiological outcome will be tibial rotation

    Six months post-operative

Secondary Outcomes (1)

  • Functional outcomes - Knee Society Score

    One year post-operative

Study Arms (3)

Signature Knee Guide

EXPERIMENTAL

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

Device: Signature Knee Guide

Conventional Instrumentation

ACTIVE COMPARATOR

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

Device: Conventional Instrumentation

Computer Assisted Navigation

ACTIVE COMPARATOR

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

Device: Computer Assisted Navigation

Interventions

Signature Knee GuideDEVICE

Total Knee Arthroplasty performed using Signature Knee Guide

Signature Knee Guide
Conventional InstrumentationDEVICE

Total Knee Arthroplasty performed using Conventional Instrumentation

Conventional Instrumentation
Computer Assisted NavigationDEVICE

Total Knee Arthroplasty performed using Computer Assisted Navigation

Computer Assisted Navigation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Repatriation General Hospital (RGH)

Daw Park, South Australia, 5041, Australia

Location

Related Publications (1)

  • 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.

    PMID: 27652687DERIVED

MeSH Terms

Conditions

Joint Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

  • Jegan Krishnan

    Flinders Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2010

First Posted

June 16, 2010

Study Start

July 1, 2010

Primary Completion

December 1, 2014

Study Completion

February 1, 2015

Last Updated

August 2, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

There is no plan to share Individual Patient Data

Locations

AU(1)