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Signature Personalised Patient Care System With the Vanguard Knee System Study

This study has been terminated.
(No difference in outcome between the two groups)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01092312
First Posted: March 24, 2010
Last Update Posted: September 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zimmer Biomet
March 7, 2010
March 24, 2010
September 4, 2017
March 2010
September 2016   (Final data collection date for primary outcome measure)
Mechanical Axial Alignment [ Time Frame: Prior to Discharge: 0-2 weeks ]
Femoral and tibial component alignment, femoral and tibial rotational alignment, tibial posterior slope
Same as current
Complete list of historical versions of study NCT01092312 on ClinicalTrials.gov Archive Site
Clinical Outcome [ Time Frame: 6 months, 1 year ]
American Knee Society Score, Oxford Knee Score
Same as current
Not Provided
Not Provided
 
Signature Personalised Patient Care System With the Vanguard Knee System Study
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Arthroplasty, Replacement, Knee
  • Procedure: Vanguard Knee System with Signature Knee Guide
    Use of Signature Knee Guide
  • Procedure: Vanguard Knee System with conventional Instruments
    Vanguard Knee System with conventional Instruments
  • Experimental: Signature Knee Guide
    Vanguard Knee System with Signature Knee Guide
    Intervention: Procedure: Vanguard Knee System with Signature Knee Guide
  • Active Comparator: Conventional Approach
    Vanguard Complete Knee System with Conventional Approach
    Intervention: Procedure: Vanguard Knee System with conventional Instruments
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
325
September 2016
September 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   Denmark,   France,   Netherlands,   Portugal,   Sweden,   United Kingdom,   United States
 
 
NCT01092312
GBMET.CR.G4
No
Not Provided
Not Provided
Zimmer Biomet
Zimmer Biomet
Not Provided
Principal Investigator: Gordon Morrison, MBChB The Queen Elizabeth Hospital
Zimmer Biomet
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP