Signature Personalised Patient Care System With the Vanguard Knee System Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Biomet, Inc.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01092312
First received: March 7, 2010
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Arthroplasty, Replacement, Knee
Device: Vanguard Knee System with Signature Knee Guide
Device: Vanguard Knee System with conventional Instruments

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study on the Signature Personalised Patient Care System With the Vanguard Knee System

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Mechanical Axial Alignment [ Time Frame: Prior to Discharge: 0-2 weeks ] [ Designated as safety issue: No ]
    Femoral and tibial component alignment, femoral and tibial rotational alignment, tibial posterior slope


Secondary Outcome Measures:
  • Clinical Outcome [ Time Frame: 6 months, 1 year ] [ Designated as safety issue: No ]
    American Knee Society Score, Oxford Knee Score


Estimated Enrollment: 628
Study Start Date: March 2010
Estimated Study Completion Date: May 2023
Estimated Primary Completion Date: May 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Signature Knee Guide
Vanguard Knee System with Signature Knee Guide
Device: Vanguard Knee System with Signature Knee Guide
Use of Signature Knee Guide
Active Comparator: Conventional Approach
Vanguard Complete Knee System with Conventional Approach
Device: Vanguard Knee System with conventional Instruments
Use of Conventional instruments

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01092312

Locations
United States, New York
Insall Scott Kelly Institute Enrolling by invitation
New York, New York, United States
Australia, Queensland
Logan Hospital Recruiting
Brisbane, Queensland, Australia, 4131
Contact: Iulian Nusem    07 32998235      
Principal Investigator: Iulian Nusem         
Australia, South Australia
The Queen Elizabeth Hospital Recruiting
Adelaide, South Australia, Australia, 5011
Contact: Graeme West    61 8 8222 8639      
Austria
The Orthopaedic Hospital Speising Recruiting
Vienna, Austria
Contact: Maggie Shen       maggie.shen@biomet.com   
General Hospital Kreuzschwestern Recruiting
Wels-Grieskirchen, Austria
Contact: Maggie Shen       maggie.shen@biomet.com   
Belgium
St Luc General Hospital Not yet recruiting
Brussels, Belgium
Contact: Maggie Shen       maggie.shen@biomet.com   
Denmark
Aalborg University Hospital Not yet recruiting
Aalborg, Denmark
Contact: Maggie Shen       maggie.shen@biomet.com   
France
Medipole de Savoie Recruiting
Chambery, France
Contact: Maggie She       maggie.shen@biomet.com   
Netherlands
Amphia Ziekenhuis Breda Not yet recruiting
Breda, Netherlands
Contact: Maggie Shen       maggie.shen@biomet.com   
Portugal
Torres Verdras Hospital Recruiting
Torres Verdras Hospital, Portugal
Contact: Maggie Shen       maggie.shen@biomet.com   
Sweden
Danderyd Hospital Not yet recruiting
Stockholm, Sweden
Contact: Maggie Shen       maggie.shen@biomet.com   
United Kingdom
Addenbrooke's Hospital Not yet recruiting
Cambridge, United Kingdom
Contact: Maggie Shen       maggie.shen@biomet.com   
Sponsors and Collaborators
Biomet, Inc.
Investigators
Principal Investigator: Gordon Morrison, MBChB The Queen Elizabeth Hospital
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01092312     History of Changes
Other Study ID Numbers: BMET AU02
Study First Received: March 7, 2010
Last Updated: March 17, 2014
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Biomet, Inc.:
knee
arthroplasty

ClinicalTrials.gov processed this record on October 01, 2014