Trial Outcomes & Findings for Functional Performance of the Journey Deuce Bicompartmental Versus the Genesis II Total Knee System (NCT NCT01140815)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

2 years

Results posted on

2014-08-04

Participant Flow

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

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.

Participant milestones

Participant milestones
Measure	Total The Smith and Nephew Total Knee System	Deuce The Journey Deuce Bicompartmental Knee System
Overall Study STARTED	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total (Control) n=25 Participants The Smith and Nephew Total Knee System Total Knee Replacement: Smith and Nephew Total Knee Replacement	Deuce (Study) n=25 Participants The Journey Deuce Bicompartmental Knee System Deuce: Smith and Nephew Bicompartmental Knee Replacement	Total n=50 Participants Total of all reporting groups
Age, Continuous	58.3 years n=5 Participants	60.3 years n=7 Participants	59.3 years n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	16 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants
Body Mass Index	30 lbs/square inches n=5 Participants	28.8 lbs/square inches n=7 Participants	29.2 lbs/square inches n=5 Participants
Knee Score	50 units on a scale n=5 Participants	52.7 units on a scale n=7 Participants	51.3 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 2 years

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.

Outcome measures

Outcome measures
Measure	Total n=25 Participants The Smith and Nephew Total Knee System	Deuce n=25 Participants The Journey Deuce Bicompartmental Knee System
2-Year Knee Society Score	91.3 units on a scale 0-100 Standard Deviation 9.6	94.2 units on a scale 0-100 Standard Deviation 5.6

PRIMARY outcome

Timeframe: 6 weeks

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.

Outcome measures

Outcome measures
Measure	Total n=25 Participants The Smith and Nephew Total Knee System	Deuce n=25 Participants The Journey Deuce Bicompartmental Knee System
6-Week Knee Society Score	75 units on a scale 0-100 Standard Deviation 15.7	83.3 units on a scale 0-100 Standard Deviation 15

PRIMARY outcome

Timeframe: 4 months

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.

Outcome measures

Outcome measures
Measure	Total n=25 Participants The Smith and Nephew Total Knee System	Deuce n=25 Participants The Journey Deuce Bicompartmental Knee System
4-Month Knee Society Score	87.1 units on a scale 0-100 Standard Deviation 10.2	91.3 units on a scale 0-100 Standard Deviation 9

PRIMARY outcome

Timeframe: 1 year

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.

Outcome measures

Outcome measures
Measure	Total n=25 Participants The Smith and Nephew Total Knee System	Deuce n=25 Participants The Journey Deuce Bicompartmental Knee System
1-year Knee Society Score	88.6 units on a scale 0-100 Standard Deviation 14.6	91.7 units on a scale 0-100 Standard Deviation 9.2

SECONDARY outcome

Timeframe: 6 weeks

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.

Outcome measures

Outcome measures
Measure	Total n=25 Participants The Smith and Nephew Total Knee System	Deuce n=25 Participants The Journey Deuce Bicompartmental Knee System
6-Week X-rays	0 participants	0 participants

SECONDARY outcome

Timeframe: 4 months

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.

Outcome measures

Outcome measures
Measure	Total n=25 Participants The Smith and Nephew Total Knee System	Deuce n=25 Participants The Journey Deuce Bicompartmental Knee System
4-month X-rays	0 participants	0 participants

SECONDARY outcome

Timeframe: 1 year

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.

Outcome measures

Outcome measures
Measure	Total n=25 Participants The Smith and Nephew Total Knee System	Deuce n=25 Participants The Journey Deuce Bicompartmental Knee System
1-year X-rays	2 participants	3 participants

SECONDARY outcome

Timeframe: 2 years

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.

Outcome measures

Outcome measures
Measure	Total n=25 Participants The Smith and Nephew Total Knee System	Deuce n=25 Participants The Journey Deuce Bicompartmental Knee System
2-year X-rays	6 participants	4 participants

SECONDARY outcome

Timeframe: 2 years

Population: Patients who were not revised within 2 years and were able to complete a questionnaire did so.

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).

Outcome measures

Outcome measures
Measure	Total n=23 Participants The Smith and Nephew Total Knee System	Deuce n=23 Participants The Journey Deuce Bicompartmental Knee System
2-year Patient Surveys	41 units on a scale 0-48 Interval 24.0 to 48.0	43 units on a scale 0-48 Interval 32.0 to 47.0

SECONDARY outcome

Timeframe: 6 weeks

Population: Patients who were not revised and were able to make an appointment and complete the testing did so.

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.

Outcome measures

Outcome measures
Measure	Total n=24 Participants The Smith and Nephew Total Knee System	Deuce n=25 Participants The Journey Deuce Bicompartmental Knee System
6-week Functional Testing	36.5 seconds Standard Deviation 10.7	35.1 seconds Standard Deviation 15.6

SECONDARY outcome

Timeframe: 4 months

Population: Patients who were not revised and were able to make an appointment and complete the testing did so.

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.

Outcome measures

Outcome measures
Measure	Total n=24 Participants The Smith and Nephew Total Knee System	Deuce n=24 Participants The Journey Deuce Bicompartmental Knee System
4-month Functional Testing	25.5 seconds Standard Deviation 3.7	26.7 seconds Standard Deviation 4.8

SECONDARY outcome

Timeframe: 1 year

Population: Patients who were not revised and were able to make an appointment and complete the testing did so.

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.

Outcome measures

Outcome measures
Measure	Total n=23 Participants The Smith and Nephew Total Knee System	Deuce n=22 Participants The Journey Deuce Bicompartmental Knee System
1-year Functional Testing	25 seconds Standard Deviation 5.6	23.9 seconds Standard Deviation 3.4

SECONDARY outcome

Timeframe: 2 years

Population: Patients who were not revised and were able to make an appointment and complete the testing did so.

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.

Outcome measures

Outcome measures
Measure	Total n=23 Participants The Smith and Nephew Total Knee System	Deuce n=23 Participants The Journey Deuce Bicompartmental Knee System
2-year Functional Testing	25.1 seconds Standard Deviation 2.9	23.3 seconds Standard Deviation 3.7

Adverse Events

Total (Control)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Deuce (Study)

Serious events: 3 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Total (Control) n=25 participants at risk The Smith and Nephew Total Knee System Total Knee Replacement: Smith and Nephew Total Knee Replacement	Deuce (Study) n=25 participants at risk The Journey Deuce Bicompartmental Knee System Deuce: Smith and Nephew Bicompartmental Knee Replacement
Surgical and medical procedures Revision knee arthroplasty	4.0% 1/25	12.0% 3/25

Other adverse events

Other adverse events
Measure	Total (Control) n=25 participants at risk The Smith and Nephew Total Knee System Total Knee Replacement: Smith and Nephew Total Knee Replacement	Deuce (Study) n=25 participants at risk The Journey Deuce Bicompartmental Knee System Deuce: Smith and Nephew Bicompartmental Knee Replacement
Musculoskeletal and connective tissue disorders Knee stiff	12.0% 3/25	4.0% 1/25

Additional Information

Knee Research Director

AORI

Phone: 7036194423

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60