Triathlon® Posteriorly Stabilized (PS) Total Knee System - Outcomes Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT00957021
First received: August 10, 2009
Last updated: November 12, 2013
Last verified: November 2013
Results First Received: September 5, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Arthroplasty, Replacement, Knee
Intervention: Device: Triathlon® PS Total Knee System

  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
409 participants/500 knees enrolled - 55 participants/65 knees censored = 354 participants/435 knees followed.

Reporting Groups
  Description
Triathlon® PS Total Knee System If both knees were replaced, but only one knee completed the study, the participant is counted as completed.

Participant Flow:   Overall Study
    Triathlon® PS Total Knee System  
STARTED     354  
COMPLETED     237  
NOT COMPLETED     117  
Death                 5  
Lost to Follow-up                 8  
Withdrawal by Subject                 34  
No 2 yr ROM data                 35  
Revision of study component                 8  
Site Termination                 16  
Surgery Cancelled                 9  
Termination due to language issue                 2  



  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.
Participants who were censored protocol violations or who were enrolled, but did not have surgery and age data was not available, are not included in the baseline analysis.

Reporting Groups
  Description
Triathlon® PS Total Knee System Participants who were not censored from analysis.

Baseline Measures
    Triathlon® PS Total Knee System  
Number of Participants  
[units: participants]
  351  
Age [1]
[units: years]
Mean ± Standard Deviation
  65.12  ± 8.59  
Gender  
[units: participants]
 
Female     200  
Male     151  
Region of Enrollment  
[units: participants]
 
United States     351  
[1]

For bilateral total knee replacement participants, the age at the time of the initial knee replacement surgery is used.

3 participants did not have demographic data which would allow calculation of age; these participants did not recieve the Triathlon® PS Total Knee System and are part of the "surgery cancelled" participant flow category.




  Outcome Measures

1.  Primary:   Range of Motion   [ Time Frame: 2 years ]

2.  Secondary:   Patient Outcome Knee Society Score   [ Time Frame: 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Patient Outcome SF-36   [ Time Frame: 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Patient Outcome WOMAC   [ Time Frame: 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Patient Outcome Lower-Extremity Activity Scale   [ Time Frame: 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Radiographic Outcome   [ Time Frame: 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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
No text entered.  


Results Point of Contact:  
Name/Title: Director of Clinical Research
Organization: Stryker Orthopaedics
phone: 201-831-5401
e-mail: Ellen.Axelson@Stryker.com


No publications provided


Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT00957021     History of Changes
Other Study ID Numbers: 55
Study First Received: August 10, 2009
Results First Received: September 5, 2013
Last Updated: November 12, 2013
Health Authority: United States: Institutional Review Board