Gamma Vacuum Foil (GVF) Versus Cross-linked Polyethylene in Total Knee Arthroplasty Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT00289133
First received: February 7, 2006
Last updated: May 31, 2016
Last verified: May 2016
Results First Received: May 30, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Osteoarthritis, Knee
Arthritis, Rheumatoid
Intervention: Device: total knee arthroplasty

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
GVF Poly Gamma Vacuum Foil polyethylene tibial component
XLK Poly Cross-linked polyethylene tibial component

Participant Flow:   Overall Study
    GVF Poly     XLK Poly  
STARTED     461     477  
COMPLETED     189     179  
NOT COMPLETED     272     298  
Non-study device implanted                 12                 0  
Protocol Violation                 32                 38  
Withdrawal by Subject                 9                 10  
Death                 5                 10  
Lost to Follow-up - Hurricane Katri                 73                 74  
Physician Decision                 41                 45  
Revision                 8                 6  
Lost to Follow-up                 92                 115  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Enrolled Subjects

Reporting Groups
  Description
GVF Poly

Gamma Vacuum Foil polyethylene tibial insert

total knee arthroplasty: Gamma Vacuum Foil polyethylene tibial insert

XLK Poly

Cross-linked polyethylene tibial insert

total knee arthroplasty: cross-linked polyethylene tibial insert

Total Total of all reporting groups

Baseline Measures
    GVF Poly     XLK Poly     Total  
Number of Participants  
[units: participants]
  449     477     926  
Age  
[units: years]
Mean (Standard Deviation)
  66.3  (8.5)     66.4  (8.5)     66.3  (8.5)  
Gender  
[units: participants]
     
Female     290     308     598  
Male     159     169     328  
Region of Enrollment  
[units: participants]
     
United States     449     477     926  



  Outcome Measures
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1.  Primary:   Survivorship (Revision of Any Component for Any Reason)   [ Time Frame: 5 years ]

2.  Secondary:   American Knee Society Evaluation - Total Score   [ Time Frame: 2 year ]

3.  Secondary:   American Knee Society Evaluation - Total Score   [ Time Frame: Minimum 5 years, up to 7.6 years ]

4.  Secondary:   Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score   [ Time Frame: 2 year ]

5.  Secondary:   Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score   [ Time Frame: Minimum 5 years, up to 7.6 years ]

6.  Secondary:   Radiographic Outcomes - Percentage of Knees With Femoral Radiolucencies (>2mm)   [ Time Frame: Minimum 5 years, up to 7.6 years ]

7.  Secondary:   Radiographic Outcomes - Percentage of Knees With Tibial Radiolucencies (>2mm)   [ Time Frame: Minimum 5 years, up to 7.6 years ]

8.  Secondary:   Radiographic Outcomes - Percentage of Knees With Femoral Osteolysis (>2mm)   [ Time Frame: Minimum 5 years, up to 7.6 years ]

9.  Secondary:   Radiographic Outcomes - Percentage of Knees With Tibial Osteolysis (>2mm)   [ Time Frame: Minimum 5 years, up to 7.6 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Serious adverse events were not collected in this study per the modern definition. All adverse events collected for this study will be reported in the 'Other Adverse Events' table. MedDRA was used to classify each AE into SOC, but not Preferred Term.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Clinical Portfolio Leader
Organization: DePuy Orthopaedics, Inc.
phone: 574-372-7231
e-mail: shimden@its.jnj.com



Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT00289133     History of Changes
Other Study ID Numbers: 03111
Study First Received: February 7, 2006
Results First Received: May 30, 2014
Last Updated: May 31, 2016
Health Authority: United States: Institutional Review Board