Trial Outcomes & Findings for Analysis of Competitive Posterior Cruciate Retaining (PCR) and Posterior Stabilized (PS) Total Knee Arthroplasty (TKA) (NCT NCT04321356)
NCT ID: NCT04321356
Last Updated: 2023-11-28
Results Overview
Anterior Posterior (AP) translations, in mm, of medial femoral condyle during deep knee bend activity. Positive values indicate anterior motion of the medial femoral condyle, and negative values indicate posterior motion of the medial femoral condyle.
Recruitment status
COMPLETED
Target enrollment
100 participants
Primary outcome timeframe
3 months post-operative
Results posted on
2023-11-28
Participant Flow
Participant milestones
| Measure |
Stryker Triathlon PCR TKA
Subjects implanted with a Stryker Triathlon PCR TKA
Triathlon PCR TKA: Total Knee Arthroplasty System
|
Stryker Triathlon PS TKA
Subjects implanted with a Stryker Triathlon PS TKA
Triathlon PS TKA: Total Knee Arthroplasty System
|
Zimmer Persona PCR TKA
Subjects implanted with a Zimmer Persona PCR TKA
Persona PCR TKA: Total Knee Arthroplasty System
|
Zimmer Persona PS TKA
Subjects implanted with a Zimmer Persona PS TKA
Persona PS TKA: Total Knee Arthroplasty System
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
26
|
29
|
14
|
|
Overall Study
COMPLETED
|
31
|
26
|
29
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Stryker Triathlon PCR TKA
n=31 Participants
Subjects implanted with a Stryker Triathlon PCR TKA
Triathlon PCR TKA: Total Knee Arthroplasty System
|
Stryker Triathlon PS TKA
n=26 Participants
Subjects implanted with a Stryker Triathlon PS TKA
Triathlon PS TKA: Total Knee Arthroplasty System
|
Zimmer Persona PCR TKA
n=29 Participants
Subjects implanted with a Zimmer Persona PCR TKA
Persona PCR TKA: Total Knee Arthroplasty System
|
Zimmer Persona PS TKA
n=14 Participants
Subjects implanted with a Zimmer Persona PS TKA
Persona PS TKA: Total Knee Arthroplasty System
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=31 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=100 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=31 Participants
|
26 Participants
n=26 Participants
|
29 Participants
n=29 Participants
|
14 Participants
n=14 Participants
|
100 Participants
n=100 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=31 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=100 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=31 Participants
|
12 Participants
n=26 Participants
|
17 Participants
n=29 Participants
|
8 Participants
n=14 Participants
|
49 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=31 Participants
|
14 Participants
n=26 Participants
|
12 Participants
n=29 Participants
|
6 Participants
n=14 Participants
|
51 Participants
n=100 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
31 participants
n=31 Participants
|
26 participants
n=26 Participants
|
29 participants
n=29 Participants
|
14 participants
n=14 Participants
|
100 participants
n=100 Participants
|
PRIMARY outcome
Timeframe: 3 months post-operativeAnterior Posterior (AP) translations, in mm, of medial femoral condyle during deep knee bend activity. Positive values indicate anterior motion of the medial femoral condyle, and negative values indicate posterior motion of the medial femoral condyle.
Outcome measures
| Measure |
Stryker Triathlon PCR TKA
n=31 Participants
Subjects implanted with a Stryker Triathlon PCR TKA
Triathlon PCR TKA: Total Knee Arthroplasty System
|
Stryker Triathlon PS TKA
n=26 Participants
Subjects implanted with a Stryker Triathlon PS TKA
Triathlon PS TKA: Total Knee Arthroplasty System
|
Zimmer Persona PCR TKA
n=29 Participants
Subjects implanted with a Zimmer Persona PCR TKA
Persona PCR TKA: Total Knee Arthroplasty System
|
Zimmer Persona PS TKA
n=14 Participants
Subjects implanted with a Zimmer Persona PS TKA
Persona PS TKA: Total Knee Arthroplasty System
|
|---|---|---|---|---|
|
Medial AP Translations, in mm, During Deep Knee Bend (DKB) Activity
|
4.2 millimeters
Standard Deviation 3.6
|
-0.4 millimeters
Standard Deviation 3.4
|
-0.5 millimeters
Standard Deviation 2.1
|
-3.3 millimeters
Standard Deviation 4.8
|
PRIMARY outcome
Timeframe: 3 months post-operativeAnterior Posterior (AP) translations, in mm, of lateral femoral condyle during deep knee bend activity. Positive values indicate anterior motion of the lateral femoral condyle, and negative values indicate posterior motion of the lateral femoral condyle.
Outcome measures
| Measure |
Stryker Triathlon PCR TKA
n=31 Participants
Subjects implanted with a Stryker Triathlon PCR TKA
Triathlon PCR TKA: Total Knee Arthroplasty System
|
Stryker Triathlon PS TKA
n=26 Participants
Subjects implanted with a Stryker Triathlon PS TKA
Triathlon PS TKA: Total Knee Arthroplasty System
|
Zimmer Persona PCR TKA
n=29 Participants
Subjects implanted with a Zimmer Persona PCR TKA
Persona PCR TKA: Total Knee Arthroplasty System
|
Zimmer Persona PS TKA
n=14 Participants
Subjects implanted with a Zimmer Persona PS TKA
Persona PS TKA: Total Knee Arthroplasty System
|
|---|---|---|---|---|
|
Lateral AP Translations, in mm, During Deep Knee Bend (DKB) Activity
|
0.7 millimeters
Standard Deviation 3.6
|
-3.3 millimeters
Standard Deviation 3.5
|
0.6 millimeters
Standard Deviation 2.3
|
-5.2 millimeters
Standard Deviation 4.8
|
PRIMARY outcome
Timeframe: 3 months post-operativeMaximum weight-bearing flexion, in degrees, during deep knee bend activity
Outcome measures
| Measure |
Stryker Triathlon PCR TKA
n=31 Participants
Subjects implanted with a Stryker Triathlon PCR TKA
Triathlon PCR TKA: Total Knee Arthroplasty System
|
Stryker Triathlon PS TKA
n=26 Participants
Subjects implanted with a Stryker Triathlon PS TKA
Triathlon PS TKA: Total Knee Arthroplasty System
|
Zimmer Persona PCR TKA
n=29 Participants
Subjects implanted with a Zimmer Persona PCR TKA
Persona PCR TKA: Total Knee Arthroplasty System
|
Zimmer Persona PS TKA
n=14 Participants
Subjects implanted with a Zimmer Persona PS TKA
Persona PS TKA: Total Knee Arthroplasty System
|
|---|---|---|---|---|
|
Maximum Flexion, in Degrees, During Deep Knee Bend Activity
|
107 degrees
Standard Deviation 11
|
101 degrees
Standard Deviation 16
|
107 degrees
Standard Deviation 11
|
114 degrees
Standard Deviation 17
|
PRIMARY outcome
Timeframe: 3 months post-operativeAxial rotation (AR), in degrees, during deep knee bend activity. Positive values indicate external femorotibial axial rotation, and negative values indicate internal femorotibial axial rotation.
Outcome measures
| Measure |
Stryker Triathlon PCR TKA
n=31 Participants
Subjects implanted with a Stryker Triathlon PCR TKA
Triathlon PCR TKA: Total Knee Arthroplasty System
|
Stryker Triathlon PS TKA
n=26 Participants
Subjects implanted with a Stryker Triathlon PS TKA
Triathlon PS TKA: Total Knee Arthroplasty System
|
Zimmer Persona PCR TKA
n=29 Participants
Subjects implanted with a Zimmer Persona PCR TKA
Persona PCR TKA: Total Knee Arthroplasty System
|
Zimmer Persona PS TKA
n=14 Participants
Subjects implanted with a Zimmer Persona PS TKA
Persona PS TKA: Total Knee Arthroplasty System
|
|---|---|---|---|---|
|
Axial Rotation, in Degrees, During Deep Knee Bend Activity
|
4.3 degrees
Standard Deviation 4.4
|
3.6 degrees
Standard Deviation 3.7
|
-1.5 degrees
Standard Deviation 4.0
|
2.8 degrees
Standard Deviation 4.7
|
Adverse Events
Stryker Triathlon PCR TKA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stryker Triathlon PS TKA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Zimmer Persona PCR TKA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Zimmer Persona PS 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place