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Signature Personalised Patient Care System With the Vanguard Knee System Study

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ClinicalTrials.gov Identifier: NCT01092312
Recruitment Status : Terminated (No difference in outcome between the two groups)
First Posted : March 24, 2010
Last Update Posted : September 5, 2017
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Brief Summary:
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 or disease Intervention/treatment Phase
Arthroplasty, Replacement, Knee Procedure: Vanguard Knee System with Signature Knee Guide Procedure: Vanguard Knee System with conventional Instruments Not Applicable

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  (Clinical Trial)
Actual Enrollment : 325 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study on the Signature Personalised Patient Care System With the Vanguard Knee System
Actual Study Start Date : March 2010
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

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



Primary Outcome Measures :
  1. Mechanical Axial Alignment [ Time Frame: Prior to Discharge: 0-2 weeks ]
    Femoral and tibial component alignment, femoral and tibial rotational alignment, tibial posterior slope


Secondary Outcome Measures :
  1. Clinical Outcome [ Time Frame: 6 months, 1 year ]
    American Knee Society Score, Oxford Knee Score



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01092312


Locations
United States, New York
Insall Scott Kelly Institute
New York, New York, United States, 10065
Australia, Queensland
Logan Hospital
Brisbane, Queensland, Australia, 4131
Australia, South Australia
The Queen Elizabeth Hospital
Adelaide, South Australia, Australia, 5011
Austria
General Hospital Kreuzschwestern
Grieskirchen, Wels, Austria
The Orthopaedic Hospital Speising
Vienna, Austria
Belgium
St Luc General Hospital
Brussels, Belgium
Denmark
Aalborg University Hospital
Aalborg, Denmark
France
Medipole de Savoie
Chambery, France
Netherlands
Amphia Ziekenhuis Breda
Breda, Netherlands
Portugal
Torres Verdras Hospital
Torres Vedras, Lisbon, Portugal
Sweden
Danderyd Hospital
Stockholm, Sweden
United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom
Sponsors and Collaborators
Zimmer Biomet
Investigators
Principal Investigator: Gordon Morrison, MBChB The Queen Elizabeth Hospital

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01092312     History of Changes
Other Study ID Numbers: GBMET.CR.G4
First Posted: March 24, 2010    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: August 2017

Keywords provided by Zimmer Biomet:
knee
arthroplasty