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Functional Performance of the Journey Deuce Bicompartmental Versus the Genesis II Total Knee System (Deuce)

This study has been completed.
Sponsor:
Collaborator:
Smith & Nephew, Inc.
Information provided by (Responsible Party):
Nancy Parks, Anderson Orthopaedic Research Institute
ClinicalTrials.gov Identifier:
NCT01140815
First received: May 28, 2010
Last updated: July 10, 2014
Last verified: July 2014
History of Changes
Results First Received: November 25, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Knee Arthroplasty
Interventions: Device: Total Knee Replacement
Device: Deuce

  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
Patients were recruited preoperatively in a clinical setting between 2007-2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients with only unicondylar arthritis were excluded and underwent unicondylar arthroplasty. Patients with arthritis in the lateral compartment were excluded and underwent total knee arthroplasty.

Reporting Groups
  Description
Total The Smith and Nephew Total Knee System
Deuce The Journey Deuce Bicompartmental Knee System

Participant Flow:   Overall Study
    Total     Deuce  
STARTED     25     25  
COMPLETED     25     25  
NOT COMPLETED     0     0  



  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.
Preoperative osteoarthritis of the knee in medial and patellofemoral joints. BMI less than or equal to 35, Age less than or equal to 65. No previous knee surgery.

Reporting Groups
  Description
Total (Control)

The Smith and Nephew Total Knee System

Total Knee Replacement: Smith and Nephew Total Knee Replacement
Deuce (Study)

The Journey Deuce Bicompartmental Knee System

Deuce: Smith and Nephew Bicompartmental Knee Replacement
Total Total of all reporting groups

Baseline Measures
    Total (Control)     Deuce (Study)     Total  
Number of Participants  
[units: participants]
 		  25     25     50  
Age  
[units: years]
Mean (Full Range) 		  58.3  
  (45 to 65)   		  60.3  
  (53 to 65)   		  59.3  
  (45 to 65)  
Gender  
[units: participants]
 		     
Female     19     16     35  
Male     6     9     15  
Region of Enrollment  
[units: participants]
 		     
United States     25     25     50  
Body Mass Index  
[units: lbs/square inches]
Mean (Full Range) 		  30  
  (25 to 35)   		  28.8  
  (23 to 34)   		  29.2  
  (23 to 35)  
Knee Score  
[units: units on a scale]
Mean (Full Range) 		  50  
  (15 to 78)   		  52.7  
  (20 to 90)   		  51.3  
  (15 to 90)  



  Outcome Measures
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1.  Primary:   2-Year Knee Society Score   [ Time Frame: 2 years ]
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2.  Primary:   6-Week Knee Society Score   [ Time Frame: 6 weeks ]
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3.  Primary:   4-Month Knee Society Score   [ Time Frame: 4 months ]
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4.  Primary:   1-year Knee Society Score   [ Time Frame: 1 year ]
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5.  Secondary:   6-Week X-rays   [ Time Frame: 6 weeks ]
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6.  Secondary:   4-month X-rays   [ Time Frame: 4 months ]
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7.  Secondary:   1-year X-rays   [ Time Frame: 1 year ]
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8.  Secondary:   2-year X-rays   [ Time Frame: 2 years ]
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9.  Secondary:   2-year Patient Surveys   [ Time Frame: 2 years ]
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10.  Secondary:   6-week Functional Testing   [ Time Frame: 6 weeks ]
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11.  Secondary:   4-month Functional Testing   [ Time Frame: 4 months ]
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12.  Secondary:   1-year Functional Testing   [ Time Frame: 1 year ]
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13.  Secondary:   2-year Functional Testing   [ Time Frame: 2 years ]
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  Serious Adverse Events
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  Other Adverse Events
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  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
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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 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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Knee Research Director
Organization: AORI
phone: 7036194423
e-mail: nancylparks@gmail.com



Responsible Party: Nancy Parks, Anderson Orthopaedic Research Institute
ClinicalTrials.gov Identifier: NCT01140815     History of Changes
Other Study ID Numbers: AORI2010-0103
Study First Received: May 28, 2010
Results First Received: November 25, 2013
Last Updated: July 10, 2014
Health Authority: United States: Institutional Review Board