Triathlon® Cruciate Retaining (CR) Total Knee System Outcomes Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT00957723
First received: August 10, 2009
Last updated: March 10, 2014
Last verified: March 2014
Results First Received: June 13, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Arthroplasty, Replacement, Knee
Intervention: Device: Triathlon® CR 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
467/500 participants/knees enrolled;48 participants/52 knees censored = 419/448 participants/knees followed

Reporting Groups
  Description
Triathlon® CR Total Knee System Participants who received the Triathlon® CR Total Knee System can have one or both knees replaced. If both knees were replaced, but only one knee completed the study, the participant is counted as having completed.

Participant Flow:   Overall Study
    Triathlon® CR Total Knee System  
STARTED     419  
COMPLETED     298 [1]
NOT COMPLETED     121  
Death                 3  
Revision/ Removal of Study Implant                 3  
Lost to Follow-up                 7  
Withdrawal by Subject                 23  
Did not undergo surgery                 3  
Investigative Site Terminated                 55  
Intercurrent Illness                 2  
2yr ROM Data Not Evaluable                 25  
[1] Number of participants with 2-year primary endpoint data



  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.
No text entered.

Reporting Groups
  Description
Triathlon® CR Total Knee System Participants who received the Triathlon® CR Total Knee System and were not censored from analysis.

Baseline Measures
    Triathlon® CR Total Knee System  
Number of Participants  
[units: participants]
  419  
Age  
[units: years]
Mean ± Standard Deviation
  65.6  ± 8.64  
Gender  
[units: participants]
 
Female     246  
Male     173  
Region of Enrollment  
[units: participants]
 
United States     419  



  Outcome Measures

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

2.  Primary:   Patellar Subluxation, Dislocation and Fracture Rate   [ Time Frame: 10 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Knee Society Score (KSS)   [ Time Frame: 10 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   SF-36 Health Survey   [ Time Frame: 10 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Western Ontario and McMaster Osteoarthritis Index (WOMAC)   [ Time Frame: 10 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Lower-Extremity Activity Scale (LEAS)   [ Time Frame: 10 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Patient Outcome Long Term Follow-up Questionnaire   [ Time Frame: 10 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Knee Society Total Knee Arthorplasty Roentgenographic Score   [ Time Frame: 10 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

9.  Secondary:   Adverse Event Rate   [ Time Frame: 10 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  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: NCT00957723     History of Changes
Other Study ID Numbers: 56
Study First Received: August 10, 2009
Results First Received: June 13, 2013
Last Updated: March 10, 2014
Health Authority: United States: Institutional Review Board