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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

Tracking Information
First Submitted Date  ICMJE March 7, 2010
First Posted Date  ICMJE March 24, 2010
Last Update Posted Date September 5, 2017
Actual Study Start Date  ICMJE March 2010
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2010)
Mechanical Axial Alignment [ Time Frame: Prior to Discharge: 0-2 weeks ]
Femoral and tibial component alignment, femoral and tibial rotational alignment, tibial posterior slope
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2010)
Clinical Outcome [ Time Frame: 6 months, 1 year ]
American Knee Society Score, Oxford Knee Score
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Signature Personalised Patient Care System With the Vanguard Knee System Study
Official Title  ICMJE Study on the Signature Personalised Patient Care System With the Vanguard Knee System
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Arthroplasty, Replacement, Knee
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 31, 2017)
325
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2010)
40
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Denmark,   France,   Netherlands,   Portugal,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01092312
Other Study ID Numbers  ICMJE GBMET.CR.G4
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zimmer Biomet
Study Sponsor  ICMJE Zimmer Biomet
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gordon Morrison, MBChB The Queen Elizabeth Hospital
PRS Account Zimmer Biomet
Verification Date August 2017

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