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

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

Participant Flow

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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
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

Baseline Characteristics

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Arm/Group Title		Total (Control)	Deuce (Study)	Total
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
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)

Outcome Measures

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1. Primary Outcome

Title	2-Year Knee Society Score
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Total	Deuce
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Total	Deuce
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Total	Deuce
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Total	Deuce
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Total	Deuce
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Total	Deuce
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Total	Deuce
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Total	Deuce
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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)

Adverse Events

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Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Total (Control)	Deuce (Study)
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	--/--	--/--
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
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

Limitations and Caveats

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[Not Specified]

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.

Results Point of Contact

Name/Title: Knee Research Director

Organization: AORI

Phone: 7036194423

EMail: nancylparks@gmail.com

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