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

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ClinicalTrials.gov Identifier: NCT00894361
Recruitment Status : Completed
First Posted : May 7, 2009
Results First Posted : May 7, 2009
Last Update Posted : July 30, 2013
Sponsor:
Collaborator:
Depuy, Inc.
Information provided by (Responsible Party):
Terence J. Gioe, M.D., Minneapolis Veterans Affairs Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   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
Enrollment 400
Recruitment Details October 1, 2001 to January 1, 2007 recruitment period from the Minneapolis VAMC Orthopaedic Clinic
Pre-assignment Details Patients that were recruited but not enrolled either failed the inclusion criteria or elected not to participate
Arm/Group Title Rotating-platform Design Total Knee Arthroplasty (TKA) All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)
Hide Arm/Group Description patients who were randomized to receive the rotating platform mobile-bearing TKA design patients who were randomized to receive the all-polyethylene tibial component design
Period Title: Overall Study
Started 200 200
Completed 176 136
Not Completed 24 64
Reason Not Completed
deaths and less than 2 yr followup             24             64
Arm/Group Title Rotating-platform Design Total Knee Arthroplasty (TKA) All-polyethylene Tibia Design Total Knee Arthroplasty (TKA) Total
Hide Arm/Group Description patients who were randomized to receive the rotating platform mobile-bearing total knee arthroplasty (TKA) design patients who were randomized to receive the all-polyethylene tibial component design Total of all reporting groups
Overall Number of Baseline Participants 200 200 400
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 200 participants 400 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
79
  39.5%
74
  37.0%
153
  38.3%
>=65 years
121
  60.5%
126
  63.0%
247
  61.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 200 participants 400 participants
Female
5
   2.5%
7
   3.5%
12
   3.0%
Male
195
  97.5%
193
  96.5%
388
  97.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 200 participants 200 participants 400 participants
200 200 400
range of motion of knee  
Mean (Standard Deviation)
Unit of measure:  Degrees
Number Analyzed 200 participants 200 participants 400 participants
113.7  (1.0) 111.9  (1.1) 112.8  (1.2)
1.Primary Outcome
Title Knee Postoperative Range of Motion (ROM) at 2 Years
Hide Description range of motion of the knee postoperatively at 2 years
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rotating-platform Design Total Knee Arthroplasty (TKA) All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)
Hide Arm/Group Description:
patients who were randomized to receive the rotating platform mobile-bearing TKA design
patients who were randomized to receive the all-polyethylene tibial component design
Overall Number of Participants Analyzed 176 136
Mean (Standard Deviation)
Unit of Measure: degrees
110.4  (0.8) 111.9  (0.9)
2.Secondary Outcome
Title Survival of the Implants to Subject Death or Implant Removal
Hide Description [Not Specified]
Time Frame 10 or more years
Outcome Measure Data Not Reported
Time Frame 2 Years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rotating-platform Design Total Knee Arthroplasty (TKA) All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)
Hide Arm/Group Description patients who were randomized to receive the rotating platform mobile-bearing total knee arthroplasty (TKA) design patients who were randomized to receive the all-polyethylene tibial component design
All-Cause Mortality
Rotating-platform Design Total Knee Arthroplasty (TKA) All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Rotating-platform Design Total Knee Arthroplasty (TKA) All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/200 (0.00%)   0/200 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rotating-platform Design Total Knee Arthroplasty (TKA) All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/200 (0.00%)   0/200 (0.00%) 
Mean 43 month followup with minimum 2 year followup; survival analysis will follow at long-term followup; multiple outcome measures also recorded other than range of motion (ROM)
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
Layout table for Results Point of Contact information
Name/Title: Terence J. Gioe, M.D.
Organization: Minneapolis Veterans Affairs Medical Center (VAMC)
Phone: 612-467-1780
EMail: tjgioe@gmail.com
Layout table for additonal information
Responsible Party: Terence J. Gioe, M.D., Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT00894361     History of Changes
Other Study ID Numbers: MVA-3028
First Submitted: March 24, 2009
First Posted: May 7, 2009
Results First Submitted: March 24, 2009
Results First Posted: May 7, 2009
Last Update Posted: July 30, 2013