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

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ClinicalTrials.gov Identifier: NCT01140815
Recruitment Status : Completed
First Posted : June 10, 2010
Results First Posted : August 4, 2014
Last Update Posted : August 4, 2014
Sponsor:
Collaborator:
Smith & Nephew, Inc.
Information provided by (Responsible Party):
Nancy Parks, Anderson Orthopaedic Research Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Knee Arthroplasty
Interventions Device: Total Knee Replacement
Device: Deuce
Enrollment 50
Recruitment Details Patients were recruited preoperatively in a clinical setting between 2007-2010.
Pre-assignment Details 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.
Arm/Group Title Total Deuce
Hide Arm/Group Description The Smith and Nephew Total Knee System The Journey Deuce Bicompartmental Knee System
Period Title: Overall Study
Started 25 25
Completed 25 25
Not Completed 0 0
Arm/Group Title Total (Control) Deuce (Study) Total
Hide Arm/Group Description

The Smith and Nephew Total Knee System

Total Knee Replacement: Smith and Nephew Total Knee Replacement

The Journey Deuce Bicompartmental Knee System

Deuce: Smith and Nephew Bicompartmental Knee Replacement

Total of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
58.3
(45 to 65)
60.3
(53 to 65)
59.3
(45 to 65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
19
  76.0%
16
  64.0%
35
  70.0%
Male
6
  24.0%
9
  36.0%
15
  30.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 25 participants 50 participants
25 25 50
Body Mass Index  
Mean (Full Range)
Unit of measure:  Lbs/square inches
Number Analyzed 25 participants 25 participants 50 participants
30
(25 to 35)
28.8
(23 to 34)
29.2
(23 to 35)
Knee Score  
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 25 participants 25 participants 50 participants
50
(15 to 78)
52.7
(20 to 90)
51.3
(15 to 90)
1.Primary Outcome
Title 2-Year Knee Society Score
Hide Description Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Deuce
Hide Arm/Group Description:
The Smith and Nephew Total Knee System
The Journey Deuce Bicompartmental Knee System
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: units on a scale 0-100
91.3  (9.6) 94.2  (5.6)
2.Primary Outcome
Title 6-Week Knee Society Score
Hide Description Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Deuce
Hide Arm/Group Description:
The Smith and Nephew Total Knee System
The Journey Deuce Bicompartmental Knee System
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: units on a scale 0-100
75  (15.7) 83.3  (15)
3.Primary Outcome
Title 4-Month Knee Society Score
Hide Description Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.
Time Frame 4 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Deuce
Hide Arm/Group Description:
The Smith and Nephew Total Knee System
The Journey Deuce Bicompartmental Knee System
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: units on a scale 0-100
87.1  (10.2) 91.3  (9)
4.Primary Outcome
Title 1-year Knee Society Score
Hide Description Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Deuce
Hide Arm/Group Description:
The Smith and Nephew Total Knee System
The Journey Deuce Bicompartmental Knee System
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: units on a scale 0-100
88.6  (14.6) 91.7  (9.2)
5.Secondary Outcome
Title 6-Week X-rays
Hide Description Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 6 weeks are reported.
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Deuce
Hide Arm/Group Description:
The Smith and Nephew Total Knee System
The Journey Deuce Bicompartmental Knee System
Overall Number of Participants Analyzed 25 25
Measure Type: Number
Unit of Measure: participants
0 0
6.Secondary Outcome
Title 4-month X-rays
Hide Description Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 4 months are reported.
Time Frame 4 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Deuce
Hide Arm/Group Description:
The Smith and Nephew Total Knee System
The Journey Deuce Bicompartmental Knee System
Overall Number of Participants Analyzed 25 25
Measure Type: Number
Unit of Measure: participants
0 0
7.Secondary Outcome
Title 1-year X-rays
Hide Description Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 1 year are reported.
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Deuce
Hide Arm/Group Description:
The Smith and Nephew Total Knee System
The Journey Deuce Bicompartmental Knee System
Overall Number of Participants Analyzed 25 25
Measure Type: Number
Unit of Measure: participants
2 3
8.Secondary Outcome
Title 2-year X-rays
Hide Description Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 2 years are reported.
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Deuce
Hide Arm/Group Description:
The Smith and Nephew Total Knee System
The Journey Deuce Bicompartmental Knee System
Overall Number of Participants Analyzed 25 25
Measure Type: Number
Unit of Measure: participants
6 4
9.Secondary Outcome
Title 2-year Patient Surveys
Hide Description Serial patient evaluation of function will be assessed using the Oxford Knee Outcome Questionnaire. The Oxford Questionnaire consists of 12 questions, each with a value of 0 (bad) to 4(good). The results are summed for a total score of 0(bad) to 48(good).
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who were not revised within 2 years and were able to complete a questionnaire did so.
Arm/Group Title Total (Control) Deuce (Study)
Hide Arm/Group Description:

The Smith and Nephew Total Knee System

Total Knee Replacement: Smith and Nephew Total Knee Replacement

The Journey Deuce Bicompartmental Knee System

Deuce: Smith and Nephew Bicompartmental Knee Replacement

Overall Number of Participants Analyzed 23 23
Mean (Full Range)
Unit of Measure: units on a scale 0-48
41
(24 to 48)
43
(32 to 47)
10.Secondary Outcome
Title 6-week Functional Testing
Hide Description A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result.
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who were not revised and were able to make an appointment and complete the testing did so.
Arm/Group Title Total (Control) Deuce (Study)
Hide Arm/Group Description:

The Smith and Nephew Total Knee System

Total Knee Replacement: Smith and Nephew Total Knee Replacement

The Journey Deuce Bicompartmental Knee System

Deuce: Smith and Nephew Bicompartmental Knee Replacement

Overall Number of Participants Analyzed 24 25
Mean (Standard Deviation)
Unit of Measure: seconds
36.5  (10.7) 35.1  (15.6)
11.Secondary Outcome
Title 4-month Functional Testing
Hide Description A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result.
Time Frame 4 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who were not revised and were able to make an appointment and complete the testing did so.
Arm/Group Title Total (Control) Deuce (Study)
Hide Arm/Group Description:

The Smith and Nephew Total Knee System

Total Knee Replacement: Smith and Nephew Total Knee Replacement

The Journey Deuce Bicompartmental Knee System

Deuce: Smith and Nephew Bicompartmental Knee Replacement

Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: seconds
25.5  (3.7) 26.7  (4.8)
12.Secondary Outcome
Title 1-year Functional Testing
Hide Description A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result.
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who were not revised and were able to make an appointment and complete the testing did so.
Arm/Group Title Total (Control) Deuce (Study)
Hide Arm/Group Description:

The Smith and Nephew Total Knee System

Total Knee Replacement: Smith and Nephew Total Knee Replacement

The Journey Deuce Bicompartmental Knee System

Deuce: Smith and Nephew Bicompartmental Knee Replacement

Overall Number of Participants Analyzed 23 22
Mean (Standard Deviation)
Unit of Measure: seconds
25  (5.6) 23.9  (3.4)
13.Secondary Outcome
Title 2-year Functional Testing
Hide Description A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result.
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who were not revised and were able to make an appointment and complete the testing did so.
Arm/Group Title Total (Control) Deuce (Study)
Hide Arm/Group Description:

The Smith and Nephew Total Knee System

Total Knee Replacement: Smith and Nephew Total Knee Replacement

The Journey Deuce Bicompartmental Knee System

Deuce: Smith and Nephew Bicompartmental Knee Replacement

Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: seconds
25.1  (2.9) 23.3  (3.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Total (Control) Deuce (Study)
Hide Arm/Group Description

The Smith and Nephew Total Knee System

Total Knee Replacement: Smith and Nephew Total Knee Replacement

The Journey Deuce Bicompartmental Knee System

Deuce: Smith and Nephew Bicompartmental Knee Replacement

All-Cause Mortality
Total (Control) Deuce (Study)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Total (Control) Deuce (Study)
Affected / at Risk (%) Affected / at Risk (%)
Total   1/25 (4.00%)   3/25 (12.00%) 
Surgical and medical procedures     
Revision knee arthroplasty [1]  1/25 (4.00%)  3/25 (12.00%) 
[1]
Implant revised for loosening
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Total (Control) Deuce (Study)
Affected / at Risk (%) Affected / at Risk (%)
Total   3/25 (12.00%)   1/25 (4.00%) 
Musculoskeletal and connective tissue disorders     
Knee stiff [1]  3/25 (12.00%)  1/25 (4.00%) 
[1]
Manipulation of the knee under anesthesia for stiffness
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.
Results Point of Contact
Name/Title: Knee Research Director
Organization: AORI
Phone: 7036194423
Responsible Party: Nancy Parks, Anderson Orthopaedic Research Institute
ClinicalTrials.gov Identifier: NCT01140815     History of Changes
Other Study ID Numbers: AORI2010-0103
First Submitted: May 28, 2010
First Posted: June 10, 2010
Results First Submitted: November 25, 2013
Results First Posted: August 4, 2014
Last Update Posted: August 4, 2014