Trial Outcomes & Findings for Triathlon PSR Outcomes Study (NCT NCT04618770)
NCT ID: NCT04618770
Last Updated: 2023-12-11
Results Overview
The SF-36 is a 36-item patient completed questionnaire to measure general health and well-being. It includes physical and mental status component sub scores; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.
TERMINATED
NA
37 participants
pre-operative, 6 weeks, 1 year
2023-12-11
Participant Flow
Participant milestones
| Measure |
Triathlon PSR Tibial Insert
Cases receiving a Triathlon Total Knee with the Triathlon PSR Tibial Insert
Triathlon PSR Tibial Insert: The Triathlon PSR Tibial Insert is intended to be used as a component in primary TKA and is designed to reduce rotational constraint at deep flexion.
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|---|---|
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Overall Study
STARTED
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37
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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37
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Reasons for withdrawal
| Measure |
Triathlon PSR Tibial Insert
Cases receiving a Triathlon Total Knee with the Triathlon PSR Tibial Insert
Triathlon PSR Tibial Insert: The Triathlon PSR Tibial Insert is intended to be used as a component in primary TKA and is designed to reduce rotational constraint at deep flexion.
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|---|---|
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Overall Study
Censored from Analysis
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12
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Overall Study
Early Termination
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25
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Baseline Characteristics
Triathlon PSR Outcomes Study
Baseline characteristics by cohort
| Measure |
Triathlon PSR Tibial Insert
n=25 Participants
Cases receiving a Triathlon Total Knee with the Triathlon PSR Tibial Insert
Triathlon PSR Tibial Insert: The Triathlon PSR Tibial Insert is intended to be used as a component in primary TKA and is designed to reduce rotational constraint at deep flexion.
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|---|---|
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Age, Continuous
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65.96 years
STANDARD_DEVIATION 6.22 • n=5 Participants
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Sex: Female, Male
Female
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9 Participants
n=5 Participants
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Sex: Female, Male
Male
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16 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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25 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
Black or African American
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4 Participants
n=5 Participants
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Race (NIH/OMB)
White
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21 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Region of Enrollment
United States
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25 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: pre-operative, 6 weeks, 1 yearPopulation: Subjects data collection through 1 year as study was early terminated.
The SF-36 is a 36-item patient completed questionnaire to measure general health and well-being. It includes physical and mental status component sub scores; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.
Outcome measures
| Measure |
Triathlon PSR Tibial Insert
n=25 Participants
Cases receiving a Triathlon Total Knee with the Triathlon PSR Tibial Insert
Triathlon PSR Tibial Insert: The Triathlon PSR Tibial Insert is intended to be used as a component in primary TKA and is designed to reduce rotational constraint at deep flexion.
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|---|---|
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Mean SF-36 Physical Component Score
Physical SF-36-Preop
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34.17 score on a scale
Standard Deviation 8.45
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Mean SF-36 Physical Component Score
Physical SF-36-6 weeks
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34.10 score on a scale
Standard Deviation 9.10
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Mean SF-36 Physical Component Score
Physical SF-36-1 year
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41.85 score on a scale
Standard Deviation 10.14
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Mean SF-36 Physical Component Score
Mental SF-36-Preop
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55.87 score on a scale
Standard Deviation 9.72
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Mean SF-36 Physical Component Score
Mental SF-36-6 weeks
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54.40 score on a scale
Standard Deviation 9.07
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Mean SF-36 Physical Component Score
Mental SF-36-1 year
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53.44 score on a scale
Standard Deviation 9.59
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SECONDARY outcome
Timeframe: PreOp, 6 week, 1 yearPopulation: Subjects data collection through 1 year as study was early terminated.
The EuroQol-5 Dimension (EQ-5D) is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas; EQ-5D descriptive system and the visual analogue scale (VAS). The EQ-5D descriptive system comprises the following five dimensions: mobility self care, usual activities, pain/comfort and anxiety/depression. Each dimension has 3 levels indicating no problems, some problems or extreme problems. The index values on a scale between -1 (low) and 1 (high) are showing the average health status according to the 5 dimensions: A low score shows worse health and a high score shows better health. With the EQ VAS the respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
Outcome measures
| Measure |
Triathlon PSR Tibial Insert
n=25 Participants
Cases receiving a Triathlon Total Knee with the Triathlon PSR Tibial Insert
Triathlon PSR Tibial Insert: The Triathlon PSR Tibial Insert is intended to be used as a component in primary TKA and is designed to reduce rotational constraint at deep flexion.
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|---|---|
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EuroQol-5 Dimension (EQ-5D)
Descriptive EQ-5D-PreOp
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0.71 score on a scale
Standard Deviation 0.14
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EuroQol-5 Dimension (EQ-5D)
Descriptive EQ-5D-6 weeks
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0.76 score on a scale
Standard Deviation 0.11
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EuroQol-5 Dimension (EQ-5D)
Descriptive EQ-5D-1 year
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0.80 score on a scale
Standard Deviation 0.13
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EuroQol-5 Dimension (EQ-5D)
VAS EQ-5D-PreOp
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80.00 score on a scale
Standard Deviation 14.35
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EuroQol-5 Dimension (EQ-5D)
VAS EQ-5D-6 weeks
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81.50 score on a scale
Standard Deviation 12.50
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EuroQol-5 Dimension (EQ-5D)
VAS EQ-5D-1 year
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88.33 score on a scale
Standard Deviation 9.56
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SECONDARY outcome
Timeframe: PreOp, 6 weeks, 1 yearPopulation: Subjects data collection through 1 year as study was early terminated.
Range of Motion evaluates how much the knee can be bent and straightened. The normal range of motion is typically 0 to 135 degrees.
Outcome measures
| Measure |
Triathlon PSR Tibial Insert
n=25 Participants
Cases receiving a Triathlon Total Knee with the Triathlon PSR Tibial Insert
Triathlon PSR Tibial Insert: The Triathlon PSR Tibial Insert is intended to be used as a component in primary TKA and is designed to reduce rotational constraint at deep flexion.
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|---|---|
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Range of Motion
ROM-PreOp
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116.32 degrees
Standard Deviation 7.92
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Range of Motion
ROM-6 weeks
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111.08 degrees
Standard Deviation 10.70
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Range of Motion
ROM-1 year
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122.00 degrees
Standard Deviation 5.70
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SECONDARY outcome
Timeframe: 1 YearPopulation: At timepoint of termination, all enrolled and active subjects had the study device implanted.
All-cause survivorship of the Triathlon PSR Tibial Insert will be evaluated through 10 year.
Outcome measures
| Measure |
Triathlon PSR Tibial Insert
n=25 Participants
Cases receiving a Triathlon Total Knee with the Triathlon PSR Tibial Insert
Triathlon PSR Tibial Insert: The Triathlon PSR Tibial Insert is intended to be used as a component in primary TKA and is designed to reduce rotational constraint at deep flexion.
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|---|---|
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Survivorship of Triathlon PSR Insert
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25 Participants
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Adverse Events
Triathlon PSR Tibial Insert
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
Restriction type: LTE60