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Comparison of Mobile-Bearing and Fixed-Bearing All-Polyethylene Tibia Total Knee Designs

This study has been completed.
Sponsor:
Collaborator:
Depuy, Inc.
Information provided by:
Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00894361
First received: March 24, 2009
Last updated: May 15, 2009
Last verified: May 2009
History of Changes
Results First Received: March 24, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Osteoarthritis, Knee
Interventions: Procedure: TKA surgery with the rotating platform mobile-bearing knee design
Procedure: TKA surgery with the all-polyethylene tibia knee design

  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
October 1, 2001 to January 1, 2007 recruitment period from the Minneapolis VAMC Orthopaedic Clinic

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients that were recruited but not enrolled either failed the inclusion criteria or elected not to participate

Reporting Groups
  Description
Rotating-platform Design TKA patients who were randomized to receive the rotating platform mobile-bearing TKA design
All-polyethylene Tibia Design TKA patients who were randomized to receive the all-polyethylene tibial component design

Participant Flow:   Overall Study
    Rotating-platform Design TKA     All-polyethylene Tibia Design TKA  
STARTED     200     200  
COMPLETED     176     136  
NOT COMPLETED     24     64  
deaths and less than 2 yr followup                 24                 64  



  Baseline Characteristics
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Reporting Groups
  Description
Rotating-platform Design TKA patients who were randomized to receive the rotating platform mobile-bearing TKA design
All-polyethylene Tibia Design TKA patients who were randomized to receive the all-polyethylene tibial component design
Total Total of all reporting groups

Baseline Measures
    Rotating-platform Design TKA     All-polyethylene Tibia Design TKA     Total  
Number of Participants  
[units: participants]
 		  200     200     400  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     79     74     153  
>=65 years     121     126     247  
Gender  
[units: participants]
 		     
Female     5     7     12  
Male     195     193     388  
Region of Enrollment  
[units: participants]
 		     
United States     200     200     400  
range of motion of knee  
[units: degrees]
Mean ± Standard Deviation 		  113.7  ± 1.0     111.9  ± 1.1     112.8  ± 1.2  



  Outcome Measures

1.  Primary:   Knee Postoperative ROM at 2 Years   [ Time Frame: 2 years ]
  Show Outcome Measure 1

2.  Secondary:   Survival of the Implants to Subject Death or Implant Removal   [ Time Frame: 10 or more years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  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.


Limitations and Caveats
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
Mean 43 month followup with minimum 2 year followup; survival analysis will follow at long-term followup; multiple outcome measures also recorded other than ROM  


Results Point of Contact:  
Name/Title: Terence J. Gioe, M.D.
Organization: Minneapolis Veterans Affairs Medical Center (VAMC)
phone: 612-467-1780
e-mail: tjgioe@gmail.com


No publications provided


Responsible Party: Terence J. Gioe, M.D., Chief, Dept. of Orthopaedic Surgery, Minneapolis VAMC
ClinicalTrials.gov Identifier: NCT00894361     History of Changes
Other Study ID Numbers: MVA-3028
Study First Received: March 24, 2009
Results First Received: March 24, 2009
Last Updated: May 15, 2009
Health Authority: United States: Federal Government