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Triathlon Total Stabilizer (TS) Outcomes Study

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00958789
First Posted: August 13, 2009
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stryker Orthopaedics
Results First Submitted: April 11, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Arthroplasty, Replacement, Knee
Intervention: Device: Triathlon TS 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
228 participants/knees were enrolled in the study. 47 participants/knees were censored from the main cohort for reasons such as, did not receive surgery under the protocol, did not receive a study device, inclusion/exclusion deviation, etc. Therefore, 181 participants/knees are followed and applicable data is reflected in this record.

Reporting Groups
  Description
Triathlon TS Knee Triathlon TS Knee System: Total knee replacement for revision cases

Participant Flow:   Overall Study
    Triathlon TS Knee
STARTED   181 
COMPLETED   130 [1] 
NOT COMPLETED   51 
Death                3 
Lost to Follow-up                7 
Withdrawal by Subject                16 
No 2 yr. Knee Society Score data                12 
2 yr. Knee Society Score not calculable                2 
Subject terminated                3 
Revision                8 
[1] Participant status at the 2 year primary outcome interval determined Completed/Not Completed counts.



  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 are not included in baseline analysis.

Reporting Groups
  Description
Triathlon TS Knee Triathlon TS Knee System: Total knee replacement for revision cases

Baseline Measures
   Triathlon TS Knee 
Overall Participants Analyzed 
[Units: Participants]
 181 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.24  (9.56) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      100  55.2% 
Male      81  44.8% 


  Outcome Measures

1.  Primary:   Knee Society Score (KSS) Change From Preoperative Time Point to 2 Years   [ Time Frame: pre-op, 2 years ]

2.  Secondary:   The Effect of Joint Line Restoration on Post-op Stability, Anterior Knee Pain & Functional Performance.   [ Time Frame: 2 years, 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   SF-36 Health Survey Change From Pre-op to Post-op Visits   [ Time Frame: pre-op, 1, 2, 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Radiographic Stability   [ Time Frame: 1, 2, 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Revision Rates   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits   [ Time Frame: pre-op, 1, 2, 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   HSS Patella Score Change From Pre-op to Post-op Visits   [ Time Frame: pre-op, 1, 2, 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Secondary:   Lower Extremity Activity Scale Score Change From Pre-op to Post-op Visits   [ Time Frame: pre-op, 1, 2, 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Secondary:   Knee Society Score (KSS) Change From Pre-op to Post-op Visits   [ Time Frame: pre-op, 1, 5 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
No text entered.


  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.


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



Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT00958789     History of Changes
Other Study ID Numbers: 65
First Submitted: August 11, 2009
First Posted: August 13, 2009
Results First Submitted: April 11, 2017
Results First Posted: May 19, 2017
Last Update Posted: July 2, 2017