Trial Outcomes & Findings for In Vivo Kinematics Comparison of Stryker or Zimmer Total Knee Arthroplasty (NCT NCT01864434)

Last Updated: 2019-10-10

Results Overview

Lateral Anterior Posterior (LAP) and Medial Anterior Posterior (MAP) translations, and Axial Rotation (AR) and maximum flexion of medial femoral condyles during deep knee bend (DKB) activity

Recruitment status

COMPLETED

Target enrollment

50 participants

Primary outcome timeframe

3 months post-operative

Results posted on

2019-10-10

Participant Flow

Participant milestones

Participant milestones
Measure	Patients With a Stryker Triathlon CR TKA Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty. Stryker PCR TKA	Patients With a Zimmer PCR TKA Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty. Zimmer PCR TKA
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

In Vivo Kinematics Comparison of Stryker or Zimmer Total Knee Arthroplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With a Stryker Triathlon CR TKA n=25 Participants Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty. Stryker PCR TKA	Patients With a Zimmer PCR TKA n=25 Participants Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty. Zimmer PCR TKA	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Age, Continuous	68.7 years STANDARD_DEVIATION 6.4 • n=5 Participants	70.6 years STANDARD_DEVIATION 9.4 • n=7 Participants	69.60 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	19 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	6 Participants n=7 Participants	29 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months post-operative

Lateral Anterior Posterior (LAP) and Medial Anterior Posterior (MAP) translations, and Axial Rotation (AR) and maximum flexion of medial femoral condyles during deep knee bend (DKB) activity

Outcome measures

Outcome measures
Measure	Patients With a Stryker Triathlon CR TKA n=25 Participants Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty. Stryker PCR TKA	Patients With a Zimmer PCR TKA n=25 Participants Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty. Zimmer PCR TKA
Kinematics - Deep Knee Bend Activity Lateral Anterior Posterior Deep Knee Bend	-0.43 mm Standard Deviation 3.43	-1.00 mm Standard Deviation 3.23
Kinematics - Deep Knee Bend Activity Medial Anterior Posterior Deep Knee Bend	3.51 mm Standard Deviation 2.68	-0.42 mm Standard Deviation 2.20
Kinematics - Deep Knee Bend Activity Axial Rotation Deep Knee Bend	5.20 mm Standard Deviation 3.93	0.75 mm Standard Deviation 5.12
Kinematics - Deep Knee Bend Activity Maximum Flexion Deep knee bend	107.80 mm Standard Deviation 8.50	107.20 mm Standard Deviation 11

PRIMARY outcome

Timeframe: 3 months post-operative

Lateral Anterior Posterior (LAP) \[during 3 moments - 0-33%, 33-66% and 66-100%\] and Medial Anterior Posterior (MAP) \[during 3 moments - 0-33%, 33-66% and 66-100%\] translations, and Axial Rotation (AR) \[during 3 moments - 0-33%, 33-66% and 66-100%\] of medial femoral condyles during ramp up activity

Outcome measures

Outcome measures
Measure	Patients With a Stryker Triathlon CR TKA n=25 Participants Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty. Stryker PCR TKA	Patients With a Zimmer PCR TKA n=25 Participants Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty. Zimmer PCR TKA
Kinematics - Ramp up Activity Lateral Anterior Posterior Translation 66% to 100%	-0.23 mm Standard Deviation 2.69	-0.07 mm Standard Deviation 2.70
Kinematics - Ramp up Activity Medial Anterior Posterior Translation 0% to 33%	-1.31 mm Standard Deviation 3.43	-1.88 mm Standard Deviation 2.07
Kinematics - Ramp up Activity Medial Anterior Posterior Translation 33% to 66%	-1.04 mm Standard Deviation 3.36	0.41 mm Standard Deviation 2.16
Kinematics - Ramp up Activity Medial Anterior Posterior Translation 66% to 100%	0.48 mm Standard Deviation 2.35	-0.09 mm Standard Deviation 1.63
Kinematics - Ramp up Activity Axial Rotation 0% to 33%	-1.33 mm Standard Deviation 4.03	-2.69 mm Standard Deviation 3.99
Kinematics - Ramp up Activity Axial Rotation 33% to 66%	-0.15 mm Standard Deviation 3.17	1.27 mm Standard Deviation 3.42
Kinematics - Ramp up Activity Lateral Anterior Posterior Translation 0% to 33%	-0.31 mm Standard Deviation 2.41	0.20 mm Standard Deviation 2.75
Kinematics - Ramp up Activity Lateral Anterior Posterior Translation 33% to 66%	-0.94 mm Standard Deviation 2.26	-0.61 mm Standard Deviation 2.42
Kinematics - Ramp up Activity Axial Rotation 66% to 100%	0.95 mm Standard Deviation 2.19	-0.03 mm Standard Deviation 3.96

PRIMARY outcome

Timeframe: 3 months post-operative

Outcome measures

Outcome measures
Measure	Patients With a Stryker Triathlon CR TKA n=25 Participants Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty. Stryker PCR TKA	Patients With a Zimmer PCR TKA n=25 Participants Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty. Zimmer PCR TKA
Kinematics - Ramp Down Activity Axial Rotation 0% to 33%	-0.44 mm Standard Deviation 2.76	0.24 mm Standard Deviation 3.19
Kinematics - Ramp Down Activity Axial Rotation 33% to 66%	0.67 mm Standard Deviation 3.09	1.22 mm Standard Deviation 3.97
Kinematics - Ramp Down Activity Axial Rotation 66% to 100%	0.59 mm Standard Deviation 3.39	-0.54 mm Standard Deviation 3.86
Kinematics - Ramp Down Activity Lateral Anterior Posterior Translation 0% to 33%	-0.57 mm Standard Deviation 2.33	-1.11 mm Standard Deviation 2.27
Kinematics - Ramp Down Activity Lateral Anterior Posterior Translation 33% to 66%	-1.25 mm Standard Deviation 1.86	-0.96 mm Standard Deviation 2.6
Kinematics - Ramp Down Activity Lateral Anterior Posterior Translation 66% to 100%	0.83 mm Standard Deviation 2.56	0.15 mm Standard Deviation 2.37
Kinematics - Ramp Down Activity Medial Anterior Posterior Translation 0% to 33%	-0.87 mm Standard Deviation 2.19	-0.92 mm Standard Deviation 1.95
Kinematics - Ramp Down Activity Medial Anterior Posterior Translation 33% to 66%	-.75 mm Standard Deviation 2.42	0 mm Standard Deviation 1.27
Kinematics - Ramp Down Activity Medial Anterior Posterior Translation 66% to 100%	1.29 mm Standard Deviation 2.34	-0.31 mm Standard Deviation 1.44

Adverse Events

Patients With a Stryker Triathlon CR TKA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Patients With a Zimmer PCR 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.

University of Tennessee

Phone: 8659742093

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place