Trial Outcomes & Findings for Vanguard TKA With KneeAlign 2 and Without KneeAlign 2 (NCT NCT02695329)

Last Updated: 2020-02-12

Results Overview

Proportion of subjects that have tibial alignment within 2 degrees from neutral and compare the accuracy of tibial component alignment between two groups.

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

Postoperative 6 months

Results posted on

2020-02-12

Participant Flow

Participant milestones

Participant milestones
Measure	Vanguard With KneeAlign 2 Having total knee arthroplasty surgery with the use of a navigation system KneeAlign 2. KneeAlign 2: Patients suffering non-severe varus deformity Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.	Vanguard Without KneeAlign 2 Having total knee arthroplasty surgery with the use of conventional surgical instruments, and without a navigation system KneeAlign 2.
Overall Study STARTED	50	50
Overall Study COMPLETED	45	45
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Vanguard With KneeAlign 2 Having total knee arthroplasty surgery with the use of a navigation system KneeAlign 2. KneeAlign 2: Patients suffering non-severe varus deformity Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.	Vanguard Without KneeAlign 2 Having total knee arthroplasty surgery with the use of conventional surgical instruments, and without a navigation system KneeAlign 2.
Overall Study Adverse Event	1	0
Overall Study Poor X-ray quality for measurement	4	5

Baseline Characteristics

Missing data on 6 KneeAlign group patients and 5 Conventional group patients. Failed to answer all questions on the form.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Postoperative 6 months

Proportion of subjects that have tibial alignment within 2 degrees from neutral and compare the accuracy of tibial component alignment between two groups.

Outcome measures

Outcome measures
Measure	Vanguard With KneeAlign 2 n=45 Participants Having total knee arthroplasty surgery with the use of a navigation system KneeAlign 2. KneeAlign 2: Patients suffering non-severe varus deformity Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.	Vanguard Without KneeAlign 2 n=45 Participants Having total knee arthroplasty surgery with the use of conventional surgical instruments, and without a navigation system KneeAlign 2.
Proportion of Subjects That Have Alignment Within 2 Degrees From Neutral on Tibia within 2 degrees (success)	41 Participants	31 Participants
Proportion of Subjects That Have Alignment Within 2 Degrees From Neutral on Tibia outlier (failure)	4 Participants	14 Participants

SECONDARY outcome

Timeframe: Postoperative 6 months

Deviation of tibial posterior slope angle from preoperative planned angle (within 2 degrees)

Outcome measures

Outcome measures
Measure	Vanguard With KneeAlign 2 n=45 Participants Having total knee arthroplasty surgery with the use of a navigation system KneeAlign 2. KneeAlign 2: Patients suffering non-severe varus deformity Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.	Vanguard Without KneeAlign 2 n=45 Participants Having total knee arthroplasty surgery with the use of conventional surgical instruments, and without a navigation system KneeAlign 2.
Number of Participants With Tibial Posterior Slope Alignment Within Predetermined Threshold within 2 degrees (success)	26 Participants	27 Participants
Number of Participants With Tibial Posterior Slope Alignment Within Predetermined Threshold outlier (failure)	19 Participants	18 Participants

SECONDARY outcome

Timeframe: Postoperative 6 months

Deviation of femoral valus/valgus angle from preoperative planned angle (within 2 degrees)

Outcome measures

Outcome measures
Measure	Vanguard With KneeAlign 2 n=45 Participants Having total knee arthroplasty surgery with the use of a navigation system KneeAlign 2. KneeAlign 2: Patients suffering non-severe varus deformity Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.	Vanguard Without KneeAlign 2 n=45 Participants Having total knee arthroplasty surgery with the use of conventional surgical instruments, and without a navigation system KneeAlign 2.
Number of Participants With Femoral Varus/Valgus Angle Within Predetermined Threshold within 2 degrees (success)	35 Participants	28 Participants
Number of Participants With Femoral Varus/Valgus Angle Within Predetermined Threshold outlier (failure)	10 Participants	17 Participants

SECONDARY outcome

Timeframe: Intra-operative and Post-operative 6 months

Number of participants, who experience adverse events and/or adverse device effects

Outcome measures

Outcome measures
Measure	Vanguard With KneeAlign 2 n=50 Participants Having total knee arthroplasty surgery with the use of a navigation system KneeAlign 2. KneeAlign 2: Patients suffering non-severe varus deformity Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.	Vanguard Without KneeAlign 2 n=50 Participants Having total knee arthroplasty surgery with the use of conventional surgical instruments, and without a navigation system KneeAlign 2.
Number of Participants With Adverse Events and/or Adverse Device Effects	1 Participants	0 Participants

Adverse Events

Vanguard With KneeAlign 2

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Vanguard Without KneeAlign 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vanguard With KneeAlign 2 n=50 participants at risk Having total knee arthroplasty surgery with the use of a navigation system KneeAlign 2. KneeAlign 2: Patients suffering non-severe varus deformity Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.	Vanguard Without KneeAlign 2 n=50 participants at risk Having total knee arthroplasty surgery with the use of conventional surgical instruments, and without a navigation system KneeAlign 2.
Musculoskeletal and connective tissue disorders Infection	2.0% 1/50 • Number of events 1 • From surgery to 6 month visit.	0.00% 0/50 • From surgery to 6 month visit.

Additional Information

Clinical Affairs Senior Manager

Zimmer Biomet G.K.

Phone: +81-6402-6777

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Vanguard With KneeAlign 2 n=50 Participants Having total knee arthroplasty surgery with the use of a navigation system KneeAlign 2. KneeAlign 2: Patients suffering non-severe varus deformity Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.	Vanguard Without KneeAlign 2 n=50 Participants Having total knee arthroplasty surgery with the use of conventional surgical instruments, and without a navigation system KneeAlign 2.	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=100 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=50 Participants	4 Participants n=50 Participants	5 Participants n=100 Participants
Age, Categorical >=65 years	49 Participants n=50 Participants	46 Participants n=50 Participants	95 Participants n=100 Participants
Age, Continuous	75.8 years STANDARD_DEVIATION 5.2 • n=50 Participants	74.0 years STANDARD_DEVIATION 6.6 • n=50 Participants	74.9 years STANDARD_DEVIATION 6.0 • n=100 Participants
Sex: Female, Male Female	39 Participants n=50 Participants	40 Participants n=50 Participants	79 Participants n=100 Participants
Sex: Female, Male Male	11 Participants n=50 Participants	10 Participants n=50 Participants	21 Participants n=100 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=100 Participants
Race (NIH/OMB) Asian	50 Participants n=50 Participants	50 Participants n=50 Participants	100 Participants n=100 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=100 Participants
Race (NIH/OMB) Black or African American	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=100 Participants
Race (NIH/OMB) White	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=100 Participants
Race (NIH/OMB) More than one race	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=100 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=100 Participants
Region of Enrollment Japan	50 participants n=50 Participants	50 participants n=50 Participants	100 participants n=100 Participants
Body Mass Index	26.3 kg/m^2 STANDARD_DEVIATION 4.2 • n=50 Participants	27.3 kg/m^2 STANDARD_DEVIATION 4.3 • n=50 Participants	26.8 kg/m^2 STANDARD_DEVIATION 4.3 • n=100 Participants
EQ-5D-3L	0.553 point STANDARD_DEVIATION 0.117 • n=44 Participants • Missing data on 6 KneeAlign group patients and 5 Conventional group patients. Failed to answer all questions on the form.	0.582 point STANDARD_DEVIATION 0.091 • n=45 Participants • Missing data on 6 KneeAlign group patients and 5 Conventional group patients. Failed to answer all questions on the form.	0.568 point STANDARD_DEVIATION 0.105 • n=89 Participants • Missing data on 6 KneeAlign group patients and 5 Conventional group patients. Failed to answer all questions on the form.
KSS-Objective Score	37.4 point STANDARD_DEVIATION 19.1 • n=41 Participants • Missing data on 9 KneeAlign2 patients and on 9 Conventional patients. Failed to obtain data.	35.9 point STANDARD_DEVIATION 19.3 • n=41 Participants • Missing data on 9 KneeAlign2 patients and on 9 Conventional patients. Failed to obtain data.	36.6 point STANDARD_DEVIATION 19.1 • n=82 Participants • Missing data on 9 KneeAlign2 patients and on 9 Conventional patients. Failed to obtain data.
KSS-Patient Satisfaction	11.2 point STANDARD_DEVIATION 6.1 • n=45 Participants • Missing data, 5 KneeAlign2 patients and 5 conventional patients. Failed to answer all questions on the form.	13.1 point STANDARD_DEVIATION 6.0 • n=45 Participants • Missing data, 5 KneeAlign2 patients and 5 conventional patients. Failed to answer all questions on the form.	12.1 point STANDARD_DEVIATION 6.1 • n=90 Participants • Missing data, 5 KneeAlign2 patients and 5 conventional patients. Failed to answer all questions on the form.
KSS-Function Score	33.5 point STANDARD_DEVIATION 16.5 • n=42 Participants • Missing data on 8 KneeAlign2 patients and 12 Conventional patients. Failed to answer all questions on the form.	43.6 point STANDARD_DEVIATION 18.4 • n=38 Participants • Missing data on 8 KneeAlign2 patients and 12 Conventional patients. Failed to answer all questions on the form.	38.3 point STANDARD_DEVIATION 18.0 • n=80 Participants • Missing data on 8 KneeAlign2 patients and 12 Conventional patients. Failed to answer all questions on the form.
KSS-Patient Expectation	9.1 point STANDARD_DEVIATION 2.1 • n=34 Participants • Missing data on 16 KneeAlign2 patients and 13 conventional patients. Failed to answer all questions on the form	9.6 point STANDARD_DEVIATION 2.6 • n=37 Participants • Missing data on 16 KneeAlign2 patients and 13 conventional patients. Failed to answer all questions on the form	9.3 point STANDARD_DEVIATION 2.4 • n=71 Participants • Missing data on 16 KneeAlign2 patients and 13 conventional patients. Failed to answer all questions on the form
Oxford Knee Score	20.7 point STANDARD_DEVIATION 8.0 • n=43 Participants • Missing data on 7 KneeAlign2 patients and 3 Conventional patients. Failed to answer all questions on the form.	24.0 point STANDARD_DEVIATION 7.9 • n=47 Participants • Missing data on 7 KneeAlign2 patients and 3 Conventional patients. Failed to answer all questions on the form.	22.4 point STANDARD_DEVIATION 8.1 • n=90 Participants • Missing data on 7 KneeAlign2 patients and 3 Conventional patients. Failed to answer all questions on the form.