Trial Outcomes & Findings for Kinematic Analysis: Posterior Stabilized, Fixed Bearing Total Knee Arthroplasty With Attune Knee System (NCT NCT02204748)

NCT ID: NCT02204748

Last Updated: 2019-10-10

Results Overview

Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.

• Recruitment status: COMPLETED
• Target enrollment: 5 participants
• Primary outcome timeframe: 3 months post-operative
• Results posted on: 2019-10-10

Participant Flow

Participant milestones

Measure	DePuy Attune PS FB TKA Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative. DePuy Attune posterior stabilizing fixed bearing knee system
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Kinematic Analysis: Posterior Stabilized, Fixed Bearing Total Knee Arthroplasty With Attune Knee System

Baseline characteristics by cohort

Measure	DePuy Attune PS FB TKA n=5 Participants Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative. DePuy Attune posterior stabilizing fixed bearing knee system
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	66.2 years STANDARD_DEVIATION 8.07 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months post-operative

Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.

Outcome measures

Measure	DePuy Attune PS FB TKA n=5 Participants Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative. DePuy Attune posterior stabilizing fixed bearing knee system
Femoro-tibial Kinematics - Translation and Lift-off for Deep Knee Bend Lateral Anterior Posterior Deep Knee Bend	-4.89 mm Standard Deviation 3.57
Femoro-tibial Kinematics - Translation and Lift-off for Deep Knee Bend Medial Anterior Posterior Deep Knee Bend	-2.58 mm Standard Deviation 2.5

PRIMARY outcome

Timeframe: 3 months post-operative

Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during gait activity.

Outcome measures

Measure	DePuy Attune PS FB TKA n=5 Participants Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative. DePuy Attune posterior stabilizing fixed bearing knee system
Femoro-tibial Kinematics: Translation and Lift-off for Gait Lateral Anterior Posterior Gait	-0.8 mm Standard Deviation 1.89
Femoro-tibial Kinematics: Translation and Lift-off for Gait Medial Anterior Posterior Gait	0.24 mm Standard Deviation 0.67

PRIMARY outcome

Timeframe: 3 months post-operative

Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during ramp down activity.

Outcome measures

Measure	DePuy Attune PS FB TKA n=5 Participants Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative. DePuy Attune posterior stabilizing fixed bearing knee system
Femoro-tibial Kinematics: Translation and Lift-off for Ramp Down Lateral Anterior Posterior Ramp Down	-1.35 mm Standard Deviation 2.39
Femoro-tibial Kinematics: Translation and Lift-off for Ramp Down Medial Anterior Posterior Ramp Down	-0.58 mm Standard Deviation 1.72

PRIMARY outcome

Timeframe: 3 months post-operative

Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.

Outcome measures

Measure	DePuy Attune PS FB TKA n=5 Participants Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative. DePuy Attune posterior stabilizing fixed bearing knee system
Femoro-tibial Kinematics - Deep Knee Bend Axial Rotation Deep Knee Bend	2.99 degrees Standard Deviation 5.73
Femoro-tibial Kinematics - Deep Knee Bend Max weight-bearing flexion Deep knee bend	118.2 degrees Standard Deviation 20.96

PRIMARY outcome

Timeframe: 3 months post-operative

Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during gait activity.

Outcome measures

Measure	DePuy Attune PS FB TKA n=5 Participants Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative. DePuy Attune posterior stabilizing fixed bearing knee system
Femoro-tibial Kinematics - Gait Axial Rotation Gait	1.28 degrees Standard Deviation 2.76
Femoro-tibial Kinematics - Gait Max Weight-bearing flexion Gait	19.4 degrees Standard Deviation 4.72

PRIMARY outcome

Timeframe: 3 months post-operative

Degree of axial rotation and maximum weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during ramp down activity.

Outcome measures

Measure	DePuy Attune PS FB TKA n=5 Participants Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative. DePuy Attune posterior stabilizing fixed bearing knee system
Femoro-tibial Kinematics - Ramp Down Axial Rotation Ramp Down	0.97 degrees Standard Deviation 4.32
Femoro-tibial Kinematics - Ramp Down Max Weight-bearing flexion Ramp Down	28.6 degrees Standard Deviation 5.94

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 described activity, then normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed "maximum reaction force."

Outcome measures

Measure	DePuy Attune PS FB TKA n=5 Participants Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative. DePuy Attune posterior stabilizing fixed bearing knee system
Max Ground Reaction Force - Deep Knee Bend	75.3 percentage of body weight Standard Deviation 11.2

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 described activity, then normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed "maximum reaction force."

Outcome measures

Measure	DePuy Attune PS FB TKA n=5 Participants Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative. DePuy Attune posterior stabilizing fixed bearing knee system
Max Ground Reaction Force - Gait	106.0 percentage of body weight Standard Deviation 3.0

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 described activity was normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed "maximum reaction force."

Outcome measures

Measure	DePuy Attune PS FB TKA n=5 Participants Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative. DePuy Attune posterior stabilizing fixed bearing knee system
Max Ground Reaction Force - Ramp Down	97.2 percentage of body weight Standard Deviation 15.0

Adverse Events

DePuy Attune PS FB TKA

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, Ph. D.

The University of Tennessee

Phone: 8659742093

Email: asharma1@utk.edu

Results disclosure agreements

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