Trial Outcomes & Findings for Kinematic Analysis: Posterior Stabilized, Fixed Bearing Total Knee Arthroplasty With Attune Knee System - Phase 2 (NCT NCT02613338)

NCT ID: NCT02613338

Last Updated: 2019-11-12

Results Overview

Amount of anterior sliding (positive) and/or posterior rollback (negative) of the lateral condyle during DKB, gait, and ramp down

• Recruitment status: COMPLETED
• Target enrollment: 30 participants
• Primary outcome timeframe: 3 months post-operative
• Results posted on: 2019-11-12

Participant Flow

Participant milestones

Measure	DePuy Attune PS FB Knee System Patients implanted with a DePuy Attune posterior stabilizing fixed bearing knee system DePuy Attune posterior stabilizing fixed bearing knee system: Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system at least three months post-operative.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	DePuy Attune PS FB Knee System n=30 Participants Patients implanted with a DePuy Attune posterior stabilizing fixed bearing knee system DePuy Attune posterior stabilizing fixed bearing knee system: Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system at least three months post-operative.
Age, Categorical <=18 years	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=30 Participants
Age, Categorical >=65 years	23 Participants n=30 Participants
Age, Continuous	68.48 years STANDARD_DEVIATION 5.16 • n=30 Participants
Sex: Female, Male Female	15 Participants n=30 Participants
Sex: Female, Male Male	15 Participants n=30 Participants
Region of Enrollment United States	30 Participants n=30 Participants

PRIMARY outcome

Timeframe: 3 months post-operative

Amount of anterior sliding (positive) and/or posterior rollback (negative) of the lateral condyle during DKB, gait, and ramp down

Outcome measures

Measure	DePuy Attune PS FB Knee System n=30 Participants Patients implanted with a DePuy Attune posterior stabilizing fixed bearing knee system DePuy Attune posterior stabilizing fixed bearing knee system: Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system at least three months post-operative.
Femoro-tibial Kinematics - Lateral Anterior/Posterior Motion Deep Knee Bend	-5.81 mm Standard Deviation 3.12
Femoro-tibial Kinematics - Lateral Anterior/Posterior Motion Gait	-0.1 mm Standard Deviation 1.57
Femoro-tibial Kinematics - Lateral Anterior/Posterior Motion Ramp Down	0.58 mm Standard Deviation 1.71

PRIMARY outcome

Timeframe: 3 months post-operative

Amount of anterior sliding (positive) and/or posterior rollback (negative) of the medial condyle during DKB, gait, and ramp down

Outcome measures

Measure	DePuy Attune PS FB Knee System n=30 Participants Patients implanted with a DePuy Attune posterior stabilizing fixed bearing knee system DePuy Attune posterior stabilizing fixed bearing knee system: Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system at least three months post-operative.
Femoro-tibial Kinematics - Medial Anterior/Posterior Motion Gait	-0.07 mm Standard Deviation 1.82
Femoro-tibial Kinematics - Medial Anterior/Posterior Motion Deep Knee Bend	-1.81 mm Standard Deviation 2.04
Femoro-tibial Kinematics - Medial Anterior/Posterior Motion Ramp Down	-0.14 mm Standard Deviation 1.39

PRIMARY outcome

Timeframe: 3 months post-operative

Amount of axial rotation of the femoral component with respect to the tibial component during DKB, gait, and ramp down. Positive indicated external rotation of femur wrt tibia.

Outcome measures

Measure	DePuy Attune PS FB Knee System n=30 Participants Patients implanted with a DePuy Attune posterior stabilizing fixed bearing knee system DePuy Attune posterior stabilizing fixed bearing knee system: Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system at least three months post-operative.
Femoro-tibial Kinematics - Axial Rotation Deep Knee Bend	5.4 degrees Standard Deviation 4.04
Femoro-tibial Kinematics - Axial Rotation Gait	0.17 degrees Standard Deviation 2.46
Femoro-tibial Kinematics - Axial Rotation Ramp Down	0.88 degrees Standard Deviation 4.36

PRIMARY outcome

Timeframe: 3 months post-operative

Amount of weight-bearing flexion during DKB, gait, and ramp down. All numbers are positive, indicating magnitude.

Outcome measures

Measure	DePuy Attune PS FB Knee System n=30 Participants Patients implanted with a DePuy Attune posterior stabilizing fixed bearing knee system DePuy Attune posterior stabilizing fixed bearing knee system: Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system at least three months post-operative.
Femoro-tibial Kinematics - Weight-bearing Flexion Deep Knee Bend	110.27 degrees Standard Deviation 20.40
Femoro-tibial Kinematics - Weight-bearing Flexion Gait	28.5 degrees Standard Deviation 9.85
Femoro-tibial Kinematics - Weight-bearing Flexion Ramp Down	33.8 degrees Standard Deviation 8.38

SECONDARY outcome

Timeframe: 3 months post-operative

Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the activity was normalized with respect to participant's body weight and has been termed "maximum reaction force."

Outcome measures

Measure	DePuy Attune PS FB Knee System n=30 Participants Patients implanted with a DePuy Attune posterior stabilizing fixed bearing knee system DePuy Attune posterior stabilizing fixed bearing knee system: Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system at least three months post-operative.
Max Ground Reaction Force - Deep Knee Bend	0.83 proportion of body weight Standard Deviation 0.17

SECONDARY outcome

Timeframe: 3 months post-operative

Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the activity.

was normalized with respect to participant's body weight and has been termed "maximum reaction force."

Outcome measures

Measure	DePuy Attune PS FB Knee System n=30 Participants Patients implanted with a DePuy Attune posterior stabilizing fixed bearing knee system DePuy Attune posterior stabilizing fixed bearing knee system: Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system at least three months post-operative.
Max Ground Reaction Force - Gait	1.09 proportion of body weight Standard Deviation 0.23

SECONDARY outcome

Timeframe: 3 months post-operative

Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the activity.

was normalized with respect to participant's body weight and has been termed "maximum reaction force."

Outcome measures

Measure	DePuy Attune PS FB Knee System n=30 Participants Patients implanted with a DePuy Attune posterior stabilizing fixed bearing knee system DePuy Attune posterior stabilizing fixed bearing knee system: Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system at least three months post-operative.
Max Ground Reaction Force - Ramp Down	1.06 proportion of body weight Standard Deviation 0.21

Adverse Events

DePuy Attune PS FB Knee System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Adrija Sharma, Principal Investigator

University of Tennessee

Phone: 8659747684

Email: adrija.sharma@utk.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place