Signature Personalised Patient Care System With the Vanguard Knee System Study

August 31, 2017 updated by: Zimmer Biomet

Study on the Signature Personalised Patient Care System With the Vanguard Knee System

The purpose of this study is to determine whether the percentage cases which have ideal mechanical axial alignment using the Vanguard total Knee implant with the Signature cutting blocks is higher than those without the use of Signature when measured immediately post-operatively.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to determine whether the percentage cases which have ideal mechanical axial alignment using the Vanguard total Knee implant with the Signature cutting blocks is higher than those without the use of Signature when measured immediately post-operatively. Other outcomes will include knee assessments and patient questionnaires.

Study Type

Interventional

Enrollment (Actual)

325

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
    • Queensland
      • Brisbane, Queensland, Australia, 4131
        • Logan Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5011
        • The Queen Elizabeth Hospital
  • Austria
      • Vienna, Austria
        • The Orthopaedic Hospital Speising
    • Wels
      • Grieskirchen, Wels, Austria
        • General Hospital Kreuzschwestern
  • Belgium
      • Brussels, Belgium
        • St Luc General Hospital
  • Denmark
      • Aalborg, Denmark
        • Aalborg University Hospital
  • France
      • Chambery, France
        • Médipôle de Savoie
  • Netherlands
      • Breda, Netherlands
        • Amphia Ziekenhuis Breda
  • Portugal
    • Lisbon
      • Torres Vedras, Lisbon, Portugal
        • Torres Verdras Hospital
  • Sweden
      • Stockholm, Sweden
        • Danderyd Hospital
  • United Kingdom
      • Cambridge, United Kingdom
        • Addenbrooke's Hospital
  • United States
    • New York
      • New York, New York, United States, 10065
        • Insall Scott Kelly Institute

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:

  • painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more of the knee compartments are involved
  • correction of varus, valgus or posttraumatic deformity
  • correction or revision of unsuccessful osteotomy (wedge cut from bone to improve alignment), or arthrodesis (fusion)
  • need to obtain pain relief and improve function
  • ability and willingness to follow instructions, including control of weight and activity level.
  • a good nutritional state
  • must have reached full skeletal maturity
  • able and willing to undergo an MRI scan

Exclusion Criteria:

  • infection
  • sepsis
  • osteomyelitis
  • failure of a previous joint replacement

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
Vanguard Knee System with Signature Knee Guide
Procedure: Vanguard Knee System with Signature Knee Guide
Use of Signature Knee Guide
Active Comparator: Conventional Approach
Vanguard Complete Knee System with Conventional Approach
Procedure: Vanguard Knee System with conventional Instruments
Vanguard Knee System with conventional Instruments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mechanical Axial Alignment
Time Frame: Prior to Discharge: 0-2 weeks
Femoral and tibial component alignment, femoral and tibial rotational alignment, tibial posterior slope
Prior to Discharge: 0-2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Outcome
Time Frame: 6 months, 1 year
American Knee Society Score, Oxford Knee Score
6 months, 1 year

Collaborators and Investigators

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

Sponsor

Zimmer Biomet

Investigators

  • Principal Investigator: Gordon Morrison, MBChB, The Queen Elizabeth Hospital

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 (Actual)

March 1, 2010

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

March 7, 2010

First Submitted That Met QC Criteria

March 23, 2010

First Posted (Estimate)

March 24, 2010

Study Record Updates

Last Update Posted (Actual)

September 5, 2017

Last Update Submitted That Met QC Criteria

August 31, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GBMET.CR.G4

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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