Trial Outcomes & Findings for Triathlon Total Stabilizer (TS) Outcomes Study (NCT NCT00958789)
NCT ID: NCT00958789
Last Updated: 2021-10-22
Results Overview
KSS Pain score, KSS Function score, Total Combined KSS The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome. Additionally, the KSS Pain subscore and KSS Function subscore are added together to obtain a total combined score (minimum score 0, maximum score 200).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
180 participants
Primary outcome timeframe
pre-op, 2 years
Results posted on
2021-10-22
Participant Flow
226 participants/228 knees were enrolled in the study. 47 participants/47 knees were censored from the main cohort. One bilateral participant had one knee censored and one knee included in study so this participant counts in the total. Therefore, 180 participants/181 knees are followed and applicable data is reflected in this record.
Participant milestones
| Measure |
Triathlon TS Knee
Triathlon TS Knee System: Total knee replacement for revision cases
|
|---|---|
|
Overall Study
STARTED
|
180
|
|
Overall Study
COMPLETED
|
130
|
|
Overall Study
NOT COMPLETED
|
50
|
Reasons for withdrawal
| Measure |
Triathlon TS Knee
Triathlon TS Knee System: Total knee replacement for revision cases
|
|---|---|
|
Overall Study
Death
|
5
|
|
Overall Study
Lost to Follow-up
|
14
|
|
Overall Study
Withdrawal by Subject
|
17
|
|
Overall Study
No 2 yr. Knee Society Score data
|
4
|
|
Overall Study
2 yr. Knee Society Score not calculable
|
1
|
|
Overall Study
Subject terminated
|
2
|
|
Overall Study
Revision
|
7
|
Baseline Characteristics
Triathlon Total Stabilizer (TS) Outcomes Study
Baseline characteristics by cohort
| Measure |
Triathlon TS Knee
n=180 Participants
Triathlon TS Knee System: Total knee replacement for revision cases
|
|---|---|
|
Age, Continuous
|
67.25 years
STANDARD_DEVIATION 9.59 • n=5 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: pre-op, 2 yearsPopulation: KSS Function Score at 2 years - One case had a calculable score for Function and not for Pain/Motion. Therefore, the case was not included in the Combined KSS Score and Participant Flow completed total of 130.
KSS Pain score, KSS Function score, Total Combined KSS The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome. Additionally, the KSS Pain subscore and KSS Function subscore are added together to obtain a total combined score (minimum score 0, maximum score 200).
Outcome measures
| Measure |
Triathlon TS Knee
n=178 knees
Triathlon TS Knee System: Total knee replacement for revision cases
|
Joint Line Restoration (JLR) > 5 mm
The Joint Line Restoration (JLR) is a measure in mm that the joint line was restored to the physiological joint line postoperative.
|
|---|---|---|
|
Knee Society Score (KSS) Change From Preoperative Time Point to 2 Years
KSS Pain/motion score preoperative
|
39.81 units on a scale
Standard Deviation 21.12
|
—
|
|
Knee Society Score (KSS) Change From Preoperative Time Point to 2 Years
KSS Pain/motion score 2 yrs.
|
83.97 units on a scale
Standard Deviation 15.95
|
—
|
|
Knee Society Score (KSS) Change From Preoperative Time Point to 2 Years
KSS Function score preoperative
|
41.43 units on a scale
Standard Deviation 23.09
|
—
|
|
Knee Society Score (KSS) Change From Preoperative Time Point to 2 Years
KSS Function score 2 yrs.
|
72.90 units on a scale
Standard Deviation 25.12
|
—
|
|
Knee Society Score (KSS) Change From Preoperative Time Point to 2 Years
Combined KSS score preoperative
|
82.96 units on a scale
Standard Deviation 34.96
|
—
|
|
Knee Society Score (KSS) Change From Preoperative Time Point to 2 Years
Combined KSS score 2 yrs.
|
157.05 units on a scale
Standard Deviation 36.13
|
—
|
SECONDARY outcome
Timeframe: 2 years, 5 yearsPopulation: Data based on knees with available radiographic and clinical data at 2 years and 5 years postoperative.
This outcome measure shows the results of the KSS Functional Score for the groupings of the Joint Line Restoration (JLR). The 2 groups of JLR were stratified by the amount in mm that the joint line was restored to the physiological joint line postoperative. One group was those that were restored to ≤ 5 mm and the other was those that were restored to \> 5mm. The Functional Score of the Knee Society Clinical Rating System ranges from a potential minimum score of 0 to a maximum score of 100 points. It is based on points assigned to ability to walk, climb stairs and the use of ambulatory aids. A higher value represents a better outcome.
Outcome measures
| Measure |
Triathlon TS Knee
n=49 Knees
Triathlon TS Knee System: Total knee replacement for revision cases
|
Joint Line Restoration (JLR) > 5 mm
n=32 Knees
The Joint Line Restoration (JLR) is a measure in mm that the joint line was restored to the physiological joint line postoperative.
|
|---|---|---|
|
Knee Society Score (KSS) Functional Results Stratified by Joint Line Restoration Groups at 2 and 5 Years Postoperative
KSS Function Score at 2yr
|
75.31 units on a scale
Standard Deviation 22.81
|
70.00 units on a scale
Standard Deviation 25.02
|
|
Knee Society Score (KSS) Functional Results Stratified by Joint Line Restoration Groups at 2 and 5 Years Postoperative
KSS Function Score at 5yr
|
66.82 units on a scale
Standard Deviation 23.31
|
71.36 units on a scale
Standard Deviation 26.78
|
SECONDARY outcome
Timeframe: 2 year and 5 year postoperativePopulation: Data based on knees with available radiographic and clinical data at 2 years and 5 years postoperative.
Measures the knee stability results for the groupings of the Joint Line Restoration (JLR). The 2 groups of JLR were stratified by amount in mm that the joint line was restored to physiological joint line postoperative. One group were restored to ≤ 5 mm and the other were restored to \> 5mm. Knee stability is evaluated in the anterior-posterior (AP) and medial-lateral (ML) planes. AP drawer test determines instability in mm of the tibia. It was done in the AP plane in both JLR groupings (≤ 5mm and \> 5mm) at 2 years and 5 years. The AP measurements were sub categorized into 5mm and 5-10mm. ML is tested with a varus valgus stress test to determine any instability as measured in degrees. The ML measurements were done in both JLR groupings (≤ 5mm and \> 5mm) at 2 years and 5 years with all results in only one category of \< 5 degrees. The higher the number of degrees or mm measured the more instability in the knee.
Outcome measures
| Measure |
Triathlon TS Knee
n=49 Knees
Triathlon TS Knee System: Total knee replacement for revision cases
|
Joint Line Restoration (JLR) > 5 mm
n=32 Knees
The Joint Line Restoration (JLR) is a measure in mm that the joint line was restored to the physiological joint line postoperative.
|
|---|---|---|
|
Knee Stability Results Stratified by Joint Line Restoration Groups at 2 and 5 Year Postoperative
Knee Stability AP < 5mm at 2 years
|
47 Knees
|
29 Knees
|
|
Knee Stability Results Stratified by Joint Line Restoration Groups at 2 and 5 Year Postoperative
Knee Stability AP 5-10mm at 2 years
|
2 Knees
|
3 Knees
|
|
Knee Stability Results Stratified by Joint Line Restoration Groups at 2 and 5 Year Postoperative
Knee Stability AP < 5mm at 5 years
|
30 Knees
|
21 Knees
|
|
Knee Stability Results Stratified by Joint Line Restoration Groups at 2 and 5 Year Postoperative
Knee Stability AP 5-10mm at 5 years
|
1 Knees
|
1 Knees
|
|
Knee Stability Results Stratified by Joint Line Restoration Groups at 2 and 5 Year Postoperative
Knee Stability ML< 5 degrees at 2 years
|
49 Knees
|
32 Knees
|
|
Knee Stability Results Stratified by Joint Line Restoration Groups at 2 and 5 Year Postoperative
Knee Stability ML < 5 degrees at 5 years
|
31 Knees
|
22 Knees
|
SECONDARY outcome
Timeframe: 2 year and 5 year postoperativePopulation: Data based on knees with available radiographic and clinical data at 2 years and 5 years postoperative. There was an one more anterior knee pain evaluation as compared to knee stability and KSS Function as there was one missing value on those two evaluations.
Measures the presence or absence of anterior knee pain in the groupings of the Joint Line Restoration (JLR). The 2 groups of JLR were stratified by the amount in mm that the joint line was restored to the physiological joint line postoperative. One group was those that were restored to ≤ 5 mm and the other was those that were restored to \> 5mm. Anterior knee pain is determined by clinical examination with patient and clinician whether it is present or absent.
Outcome measures
| Measure |
Triathlon TS Knee
n=50 Knees
Triathlon TS Knee System: Total knee replacement for revision cases
|
Joint Line Restoration (JLR) > 5 mm
n=32 Knees
The Joint Line Restoration (JLR) is a measure in mm that the joint line was restored to the physiological joint line postoperative.
|
|---|---|---|
|
Anterior Knee Pain Results Stratified by Joint Line Restoration Groups at 2 and 5 Years Postoperative
Anterior Knee Pain Absent at 2 yrs
|
45 Knees
|
28 Knees
|
|
Anterior Knee Pain Results Stratified by Joint Line Restoration Groups at 2 and 5 Years Postoperative
Anterior Knee Pain Present at 2 yrs.
|
5 Knees
|
4 Knees
|
|
Anterior Knee Pain Results Stratified by Joint Line Restoration Groups at 2 and 5 Years Postoperative
Anterior Knee Pain Absent at 5 yrs.
|
26 Knees
|
20 Knees
|
|
Anterior Knee Pain Results Stratified by Joint Line Restoration Groups at 2 and 5 Years Postoperative
Anterior Knee Pain Present at 5 yrs.
|
7 Knees
|
2 Knees
|
SECONDARY outcome
Timeframe: pre-op, 1, 2, 5 yearsPopulation: Participants/knees with available data. Overall number of participants and units analyzed is based upon the preoperative population.
The SF-36 Health Survey is a 36-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.
Outcome measures
| Measure |
Triathlon TS Knee
n=179 Knees
Triathlon TS Knee System: Total knee replacement for revision cases
|
Joint Line Restoration (JLR) > 5 mm
The Joint Line Restoration (JLR) is a measure in mm that the joint line was restored to the physiological joint line postoperative.
|
|---|---|---|
|
Short Form Health Survey (SF-36) Health Survey Change From Pre-op to Post-op Visits
SF-36 Physical Score Preoperative
|
32.43 units on a scale
Standard Deviation 8.07
|
—
|
|
Short Form Health Survey (SF-36) Health Survey Change From Pre-op to Post-op Visits
SF-36 Physical Score 2 year
|
40.55 units on a scale
Standard Deviation 11.60
|
—
|
|
Short Form Health Survey (SF-36) Health Survey Change From Pre-op to Post-op Visits
SF-36 Physical Score 5 year
|
38.42 units on a scale
Standard Deviation 10.44
|
—
|
|
Short Form Health Survey (SF-36) Health Survey Change From Pre-op to Post-op Visits
SF-36 Mental Score Preoperative
|
45.85 units on a scale
Standard Deviation 14.81
|
—
|
|
Short Form Health Survey (SF-36) Health Survey Change From Pre-op to Post-op Visits
SF-36 Mental Score 1 year
|
52.57 units on a scale
Standard Deviation 12.33
|
—
|
|
Short Form Health Survey (SF-36) Health Survey Change From Pre-op to Post-op Visits
SF-36 Mental Score 2 year
|
52.42 units on a scale
Standard Deviation 11.99
|
—
|
|
Short Form Health Survey (SF-36) Health Survey Change From Pre-op to Post-op Visits
SF-36 Mental Score 5 years
|
54.07 units on a scale
Standard Deviation 11.81
|
—
|
|
Short Form Health Survey (SF-36) Health Survey Change From Pre-op to Post-op Visits
SF-36 Physical Score 1 year
|
41.30 units on a scale
Standard Deviation 10.49
|
—
|
SECONDARY outcome
Timeframe: 1, 2, 5 yearsPopulation: Data based on knees with available data at 1, 2 and 5 years postoperative at the tibial and femoral component interface.
The scoring system was based on the Knee Society guidelines and determined by measuring the width of the radiolucent lines for each of the zones of the implant components in millimeters. The total widths are added for each zone which produces a numerical score. Radiolucency in at least 50% of a zone and measuring at least 1 mm in width is defined as radiolucency present. Failure is defined as a score of 10 or greater, regardless of symptoms and considered as radiographic instability.
Outcome measures
| Measure |
Triathlon TS Knee
n=149 Knees
Triathlon TS Knee System: Total knee replacement for revision cases
|
Joint Line Restoration (JLR) > 5 mm
The Joint Line Restoration (JLR) is a measure in mm that the joint line was restored to the physiological joint line postoperative.
|
|---|---|---|
|
Number of Knees With Radiographic Stability at 1, 2 and 5 Years Postoperative
Radiographically unstable at 1 year
|
2 Knees
|
—
|
|
Number of Knees With Radiographic Stability at 1, 2 and 5 Years Postoperative
Radiographically unstable at 2 year
|
0 Knees
|
—
|
|
Number of Knees With Radiographic Stability at 1, 2 and 5 Years Postoperative
Radiographically unstable at 5 year
|
0 Knees
|
—
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Knees enrolled in the study.
Revision was defined as the removal of either the femoral component or the tibial baseplate component.
Outcome measures
| Measure |
Triathlon TS Knee
n=181 Knees
Triathlon TS Knee System: Total knee replacement for revision cases
|
Joint Line Restoration (JLR) > 5 mm
The Joint Line Restoration (JLR) is a measure in mm that the joint line was restored to the physiological joint line postoperative.
|
|---|---|---|
|
Number of Knees With a Revision of Femoral and/or Tibial Baseplate Component
Aseptic Loosening
|
5 Knees
|
—
|
|
Number of Knees With a Revision of Femoral and/or Tibial Baseplate Component
Septic Loosening
|
9 Knees
|
—
|
SECONDARY outcome
Timeframe: pre-op, 1, 2, 5 yearsPopulation: Knees with available data. Overall number of participants and units analyzed is based upon the preoperative population.
KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Outcome measures
| Measure |
Triathlon TS Knee
n=180 Knees
Triathlon TS Knee System: Total knee replacement for revision cases
|
Joint Line Restoration (JLR) > 5 mm
The Joint Line Restoration (JLR) is a measure in mm that the joint line was restored to the physiological joint line postoperative.
|
|---|---|---|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits
KOOS Pain Preoperative
|
41.51 units on a scale
Standard Deviation 18.91
|
—
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits
KOOS Pain 1 year
|
75.09 units on a scale
Standard Deviation 21.55
|
—
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits
KOOS Pain 2 year
|
74.67 units on a scale
Standard Deviation 21.36
|
—
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits
KOOS Pain 5 year
|
73.95 units on a scale
Standard Deviation 21.31
|
—
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits
KOOS Symptoms Preoperative
|
43.39 units on a scale
Standard Deviation 18.93
|
—
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits
KOOS Symptoms 1 year
|
73.02 units on a scale
Standard Deviation 21.02
|
—
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits
KOOS Symptoms 2 year
|
72.95 units on a scale
Standard Deviation 19.11
|
—
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits
KOOS Symptoms 5 year
|
75.88 units on a scale
Standard Deviation 17.25
|
—
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits
KOOS Daily Living Preoperative
|
45.56 units on a scale
Standard Deviation 20.41
|
—
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits
KOOS Daily Living 1 year
|
76.43 units on a scale
Standard Deviation 21.19
|
—
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits
KOOS Daily Living 2 year
|
76.17 units on a scale
Standard Deviation 21.83
|
—
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits
KOOS Daily Living 5 year
|
74.99 units on a scale
Standard Deviation 20.34
|
—
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits
KOOS Function Sports and Recreational Preoperative
|
12.56 units on a scale
Standard Deviation 19.95
|
—
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits
KOOS Function Sports and Recreational 1 year
|
44.10 units on a scale
Standard Deviation 34.39
|
—
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits
KOOS Function Sports and Recreational 2 year
|
41.86 units on a scale
Standard Deviation 33.26
|
—
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits
KOOS Function Sports and Recreational 5 year
|
42.77 units on a scale
Standard Deviation 43.41
|
—
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits
KOOS Quality of Life Preoperative
|
18.06 units on a scale
Standard Deviation 17.90
|
—
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits
KOOS Quality of Life 1 year
|
55.99 units on a scale
Standard Deviation 28.20
|
—
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits
KOOS Quality of Life 2 year
|
55.74 units on a scale
Standard Deviation 27.71
|
—
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits
KOOS Quality of Life 5 year
|
57.37 units on a scale
Standard Deviation 27.56
|
—
|
SECONDARY outcome
Timeframe: pre-op, 1, 2, 5 yearsPopulation: Participants/knees with available data. Overall number of participants and units analyzed is based upon the preoperative population.
The HSS Patella Score incorporates both subjective symptoms and objective data specific to the patellofemoral joint. It consists of one score from 0-100 with a score of 100 indicating no pain, no functional limitations, no tenderness or crepitus and normal quadriceps strength.
Outcome measures
| Measure |
Triathlon TS Knee
n=171 Knees
Triathlon TS Knee System: Total knee replacement for revision cases
|
Joint Line Restoration (JLR) > 5 mm
The Joint Line Restoration (JLR) is a measure in mm that the joint line was restored to the physiological joint line postoperative.
|
|---|---|---|
|
Hospital Special Surgery (HSS) Patella Score Change From Pre-op to Post-op Visits
HSS Patella Score Preoperative
|
45.09 units on a scale
Standard Deviation 18.43
|
—
|
|
Hospital Special Surgery (HSS) Patella Score Change From Pre-op to Post-op Visits
HSS Patella Score 2 year
|
80.08 units on a scale
Standard Deviation 19.31
|
—
|
|
Hospital Special Surgery (HSS) Patella Score Change From Pre-op to Post-op Visits
HSS Patella Score 5 year
|
78.56 units on a scale
Standard Deviation 20.24
|
—
|
|
Hospital Special Surgery (HSS) Patella Score Change From Pre-op to Post-op Visits
HSS Patella Score 1 year
|
76.68 units on a scale
Standard Deviation 21.48
|
—
|
SECONDARY outcome
Timeframe: pre-op, 1, 2, 5 yearsPopulation: Participants/knees with available data. Overall number of participants and units analyzed is based upon the preoperative population.
The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.
Outcome measures
| Measure |
Triathlon TS Knee
n=180 Knees
Triathlon TS Knee System: Total knee replacement for revision cases
|
Joint Line Restoration (JLR) > 5 mm
The Joint Line Restoration (JLR) is a measure in mm that the joint line was restored to the physiological joint line postoperative.
|
|---|---|---|
|
Lower Extremity Activity Scale (LEAS) Score Change From Pre-op to Post-op Visits
LEAS Score Preoperative
|
7.80 units on a scale
Standard Deviation 2.86
|
—
|
|
Lower Extremity Activity Scale (LEAS) Score Change From Pre-op to Post-op Visits
LEAS Score 1 year
|
9.65 units on a scale
Standard Deviation 3.18
|
—
|
|
Lower Extremity Activity Scale (LEAS) Score Change From Pre-op to Post-op Visits
LEAS Score 2 year
|
9.60 units on a scale
Standard Deviation 3.26
|
—
|
|
Lower Extremity Activity Scale (LEAS) Score Change From Pre-op to Post-op Visits
LEAS Score 5 year
|
9.75 units on a scale
Standard Deviation 3.39
|
—
|
SECONDARY outcome
Timeframe: pre-op, 1,2, 5 yearPopulation: Data based on knees with available data at 1,2 and 5 years postoperative.
The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, ROM and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.
Outcome measures
| Measure |
Triathlon TS Knee
n=178 Knees
Triathlon TS Knee System: Total knee replacement for revision cases
|
Joint Line Restoration (JLR) > 5 mm
The Joint Line Restoration (JLR) is a measure in mm that the joint line was restored to the physiological joint line postoperative.
|
|---|---|---|
|
Knee Society Score (KSS) Change From Pre-op to Post-op Visits
Pain Motion Mean Preoperative
|
39.81 units on a scale
Standard Deviation 21.12
|
—
|
|
Knee Society Score (KSS) Change From Pre-op to Post-op Visits
Pain Motion Mean 1 year
|
85.45 units on a scale
Standard Deviation 15.14
|
—
|
|
Knee Society Score (KSS) Change From Pre-op to Post-op Visits
Pain Motion Mean 2 year
|
83.97 units on a scale
Standard Deviation 15.95
|
—
|
|
Knee Society Score (KSS) Change From Pre-op to Post-op Visits
Pain Motion Mean 5 year
|
82.06 units on a scale
Standard Deviation 17.24
|
—
|
|
Knee Society Score (KSS) Change From Pre-op to Post-op Visits
Function Mean Preoperative
|
41.43 units on a scale
Standard Deviation 23.09
|
—
|
|
Knee Society Score (KSS) Change From Pre-op to Post-op Visits
Function Mean 1 year
|
74.18 units on a scale
Standard Deviation 24.00
|
—
|
|
Knee Society Score (KSS) Change From Pre-op to Post-op Visits
Function Mean 2 year
|
72.90 units on a scale
Standard Deviation 25.12
|
—
|
|
Knee Society Score (KSS) Change From Pre-op to Post-op Visits
Function Mean 5 year
|
70.71 units on a scale
Standard Deviation 26.51
|
—
|
Adverse Events
Operative Adverse Events
Serious events: 37 serious events
Other events: 59 other events
Deaths: 0 deaths
Non-Operative Adverse Events
Serious events: 40 serious events
Other events: 0 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Operative Adverse Events
n=181 participants at risk
Triathlon TS Knee System: Total knee replacement for revision cases
Operative site events are reported by knee because in the case of bilateral participants (this is when one participant has both knees enrolled in the study), an event can occur in one knee, both knees or the same knee at different times and are counted separately for this reason.
|
Non-Operative Adverse Events
n=180 participants at risk
Triathlon TS Knee System: Total knee replacement for revision cases
Non-Operative Site Events are reported by participant.
|
|---|---|---|
|
Cardiac disorders
Non-operative Site
|
—
0/0 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
6.1%
11/180 • Number of events 11 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
|
Gastrointestinal disorders
Non-operative Site
|
—
0/0 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
2.8%
5/180 • Number of events 5 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
|
General disorders
Non-operative site
|
—
0/0 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
1.1%
2/180 • Number of events 2 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
|
Infections and infestations
Operative Site
|
8.3%
15/181 • Number of events 17 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
—
0/0 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
|
Injury, poisoning and procedural complications
Operative Site
|
2.2%
4/181 • Number of events 4 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
—
0/0 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
|
Metabolism and nutrition disorders
Non-operative Site
|
—
0/0 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
0.56%
1/180 • Number of events 1 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Non-operative Site
|
—
0/0 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
5.6%
10/180 • Number of events 14 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-operative Site
|
—
0/0 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
1.7%
3/180 • Number of events 3 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
|
Nervous system disorders
Non-operative Site
|
—
0/0 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
1.1%
2/180 • Number of events 2 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
|
Psychiatric disorders
Non-operative Site
|
—
0/0 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
1.1%
2/180 • Number of events 2 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
|
Renal and urinary disorders
Non-operative Site
|
—
0/0 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
2.8%
5/180 • Number of events 6 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
|
Reproductive system and breast disorders
Non-operative Site
|
—
0/0 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
0.56%
1/180 • Number of events 2 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Non-operative Site
|
—
0/0 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
2.8%
5/180 • Number of events 9 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Non-operative Site
|
—
0/0 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
0.56%
1/180 • Number of events 1 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
|
Social circumstances
Non-operative Site
|
—
0/0 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
1.1%
2/180 • Number of events 2 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
|
Vascular disorders
Non-operative Site
|
—
0/0 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
2.8%
5/180 • Number of events 5 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
|
Infections and infestations
Non-operative Site
|
—
0/0 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
3.9%
7/180 • Number of events 8 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Operative Site
|
13.3%
24/181 • Number of events 25 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
—
0/0 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Operative Site
|
—
0/0 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
—
0/0 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
|
Nervous system disorders
Operative Site
|
—
0/0 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
—
0/0 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
|
Renal and urinary disorders
Operative Site
|
—
0/0 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
—
0/0 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
|
Blood and lymphatic system disorders
Non-operative Site
|
—
0/0 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
1.1%
2/180 • Number of events 2 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
Other adverse events
| Measure |
Operative Adverse Events
n=181 participants at risk
Triathlon TS Knee System: Total knee replacement for revision cases
Operative site events are reported by knee because in the case of bilateral participants (this is when one participant has both knees enrolled in the study), an event can occur in one knee, both knees or the same knee at different times and are counted separately for this reason.
|
Non-Operative Adverse Events
n=180 participants at risk
Triathlon TS Knee System: Total knee replacement for revision cases
Non-Operative Site Events are reported by participant.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Operative Site
|
32.6%
59/181 • Number of events 66 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
—
0/0 • This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
|
Additional Information
Ellen Axelson, Director, Clinical Operations
Stryker Orthopaedics
Phone: 201-831-5401
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Each investigator shall have privileges for their own center's results at the completion of the study.These manuscripts \& abstracts will be delayed until after the multi-center publication is submitted.All publications shall be submitted to the sponsor for review at least 60 days prior to the submission for publication.The sponsor shall not edit or otherwise influence the publications other than to ensure that confidential information is not disclosed and that the data is accurately represented.
- Publication restrictions are in place
Restriction type: OTHER