Trial Outcomes & Findings for Triathlon® Posteriorly Stabilized (PS) Total Knee System - Outcomes Study (NCT NCT00957021)
NCT ID: NCT00957021
Last Updated: 2017-01-25
Results Overview
The primary outcome of this study is to compare active range of motion values for the Triathlon PS Total Knee System.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
409 participants
Primary outcome timeframe
2 years
Results posted on
2017-01-25
Participant Flow
409 participants/500 knees enrolled - 55 participants/65 knees censored = 354 participants/435 knees followed.
Participant milestones
| Measure |
Triathlon® PS Total Knee System
If both knees were replaced, but only one knee completed the study, the participant is counted as completed.
|
|---|---|
|
Overall Study
STARTED
|
354
|
|
Overall Study
COMPLETED
|
237
|
|
Overall Study
NOT COMPLETED
|
117
|
Reasons for withdrawal
| Measure |
Triathlon® PS Total Knee System
If both knees were replaced, but only one knee completed the study, the participant is counted as completed.
|
|---|---|
|
Overall Study
Death
|
5
|
|
Overall Study
Lost to Follow-up
|
8
|
|
Overall Study
Withdrawal by Subject
|
34
|
|
Overall Study
No 2 yr ROM data
|
35
|
|
Overall Study
Revised study component by 2 yr visit
|
8
|
|
Overall Study
Site Termination by the 2 yr visit
|
16
|
|
Overall Study
Surgery Cancelled
|
9
|
|
Overall Study
Termination due to language issue
|
2
|
Baseline Characteristics
Triathlon® Posteriorly Stabilized (PS) Total Knee System - Outcomes Study
Baseline characteristics by cohort
| Measure |
Triathlon® PS Total Knee System
n=351 Participants
Participants who were not censored from analysis.
|
|---|---|
|
Age, Continuous
|
65.12 years
STANDARD_DEVIATION 8.59 • n=5 Participants
|
|
Gender
Female
|
200 Participants
n=5 Participants
|
|
Gender
Male
|
151 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
351 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Participants can have both knees replaced. Range of motion is measured for each knee, as such the number of knees evaluated can be greater than the number of participants.
The primary outcome of this study is to compare active range of motion values for the Triathlon PS Total Knee System.
Outcome measures
| Measure |
Triathlon® PS Total Knee System
n=291 Knees
Includes participants who received the Triathlon® PS Total Knee System. Participants may have bilateral Triathlon® PS Total Knee replacement (TKR), with surgery occurring on different dates. Participants can therefore have a different status for each knee. If one knee has completed the study (i.e. has 2 year ROM data), the participant is counted in the study complete category.
|
|---|---|
|
Range of Motion
|
124 degrees
Standard Deviation 9.98
|
SECONDARY outcome
Timeframe: 1,2 and 5 yearsPopulation: Maximum number of knees evaluated at any interval.
The Knee Society Scores (KSS) at 1, 2, and 5-year visits will be compared. Additionally, comparison of scores at each post-surgery visit with baseline will be tested to see if any improvement is seen at each time point. 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® PS Total Knee System
n=340 knees
Includes participants who received the Triathlon® PS Total Knee System. Participants may have bilateral Triathlon® PS Total Knee replacement (TKR), with surgery occurring on different dates. Participants can therefore have a different status for each knee. If one knee has completed the study (i.e. has 2 year ROM data), the participant is counted in the study complete category.
|
|---|---|
|
Patient Outcome Knee Society Score
Pain/Motion 1 Yr (N=335)
|
93.77 units on a scale
Standard Deviation 9.03
|
|
Patient Outcome Knee Society Score
Pain/Motion 1 Yr difference from Baseline (N=333)
|
57.36 units on a scale
Standard Deviation 16.80
|
|
Patient Outcome Knee Society Score
Function 1 Yr (N=340)
|
86.26 units on a scale
Standard Deviation 15.50
|
|
Patient Outcome Knee Society Score
Function 1 Yr difference from Baseline (N=340)
|
30.99 units on a scale
Standard Deviation 17.43
|
|
Patient Outcome Knee Society Score
Pain/Motion 2 Yr (N=281)
|
93.96 units on a scale
Standard Deviation 8.45
|
|
Patient Outcome Knee Society Score
Pain/Motion 2 Yr difference from Baseline (N=279)
|
57.76 units on a scale
Standard Deviation 17.20
|
|
Patient Outcome Knee Society Score
Function 2 Yr (N=284)
|
87.38 units on a scale
Standard Deviation 16.40
|
|
Patient Outcome Knee Society Score
Function 2 Yr difference from Baseline (N=284)
|
32.55 units on a scale
Standard Deviation 18.89
|
|
Patient Outcome Knee Society Score
Pain/Motion 5 Yr (N=230)
|
94.61 units on a scale
Standard Deviation 7.62
|
|
Patient Outcome Knee Society Score
Pain/Motion 5 Yr difference from Baseline (N=229)
|
58.56 units on a scale
Standard Deviation 16.35
|
|
Patient Outcome Knee Society Score
Function 5 Yr (N=232)
|
82.07 units on a scale
Standard Deviation 20.74
|
|
Patient Outcome Knee Society Score
Function 5 Yr difference from Baseline (N=232)
|
27.33 units on a scale
Standard Deviation 22.59
|
SECONDARY outcome
Timeframe: 1,2,3,4 and 5 yearsPopulation: Maximum number of knees evaluated at any interval.
The SF-36 score at 1, 2, 3, 4 and 5-year visits will be compared at each post-surgery visit with baseline to see if any improvement is seen for each time point.The SF-36 includes a physical component and a mental component and is completed by the participant. Physical component and mental component scores were calculated on a scale ranging from 0 to 100. Low values represented a poor health state and high values represented a good health state.
Outcome measures
| Measure |
Triathlon® PS Total Knee System
n=335 knees
Includes participants who received the Triathlon® PS Total Knee System. Participants may have bilateral Triathlon® PS Total Knee replacement (TKR), with surgery occurring on different dates. Participants can therefore have a different status for each knee. If one knee has completed the study (i.e. has 2 year ROM data), the participant is counted in the study complete category.
|
|---|---|
|
Patient Outcome SF-36
SF36 Physical Component 1 Yr (N=335)
|
48.16 units on a scale
Standard Deviation 8.50
|
|
Patient Outcome SF-36
SF36 Physical 1 Yr difference from Baseline(N=332)
|
15.32 units on a scale
Standard Deviation 9.28
|
|
Patient Outcome SF-36
SF36 Mental Component 1 Yr (N=335)
|
55.21 units on a scale
Standard Deviation 8.02
|
|
Patient Outcome SF-36
SF36 Mental 1Yr difference from Baseline(N=332)
|
2.58 units on a scale
Standard Deviation 11.06
|
|
Patient Outcome SF-36
SF36 Physical Component 2Yr (N=290)
|
47.34 units on a scale
Standard Deviation 9.57
|
|
Patient Outcome SF-36
SF36 Physical 2 Yr difference from Baseline(N=288)
|
14.54 units on a scale
Standard Deviation 9.75
|
|
Patient Outcome SF-36
SF36 Mental Component 2 Yr (N=290)
|
55.04 units on a scale
Standard Deviation 8.10
|
|
Patient Outcome SF-36
SF36 Mental 2Yr difference from Baseline(N=288)
|
2.04 units on a scale
Standard Deviation 10.90
|
|
Patient Outcome SF-36
SF36 Physical Component 3Yr (N=259)
|
47.23 units on a scale
Standard Deviation 9.31
|
|
Patient Outcome SF-36
SF36 Physical 3 Yr difference from Baseline(N=257)
|
14.45 units on a scale
Standard Deviation 9.58
|
|
Patient Outcome SF-36
SF36 Mental Component 3 Yr (N=259)
|
54.30 units on a scale
Standard Deviation 9.68
|
|
Patient Outcome SF-36
SF36 Mental 3 Yr difference from Baseline(N=257)
|
1.93 units on a scale
Standard Deviation 11.06
|
|
Patient Outcome SF-36
SF36 Physical Component 4 Yr (N=254)
|
46.26 units on a scale
Standard Deviation 10.05
|
|
Patient Outcome SF-36
SF36 Physical 4 Yr difference from Baseline(N=253)
|
13.58 units on a scale
Standard Deviation 10.54
|
|
Patient Outcome SF-36
SF36 Mental Component 4 Yr (N=254)
|
54.49 units on a scale
Standard Deviation 8.74
|
|
Patient Outcome SF-36
SF36 Mental 4 Yr difference from Baseline(N=253)
|
1.93 units on a scale
Standard Deviation 10.88
|
|
Patient Outcome SF-36
SF36 Physical Component 5 Yr (N=243)
|
46.33 units on a scale
Standard Deviation 9.72
|
|
Patient Outcome SF-36
SF36 Physical 5 Yr difference from Baseline(N=242)
|
13.65 units on a scale
Standard Deviation 10.82
|
|
Patient Outcome SF-36
SF36 Mental Component 5 Yr (N=243)
|
54.82 units on a scale
Standard Deviation 7.97
|
|
Patient Outcome SF-36
SF36 Mental 5 Yr difference from Baseline(N=242)
|
2.25 units on a scale
Standard Deviation 11.06
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: The number of knees evaluated at 5 years.
The Western Ontario and McMaster Osteoarthritis Index (WOMAC) scores at 1, 2, 3, 4 and 5-year visits will be compared between groups, when data is available. Additionally, comparison of scores at each post-surgery visit with baseline will be tested to see if any improvement is seen for each time point. The WOMAC collects information specific to osteoarthritis outcomes. The questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and physical findings. Pain is scored from 0 to 100 for each set of factors, with 0 indicating no pain and 100 indicating extreme pain. Total WOMAC scores range from 0 to 300. Lower values represent better outcomes. Data for the WOMAC is only available at the 5 year interval due to typographical errors noted on earlier interval forms rendering them invalid for comparison.
Outcome measures
| Measure |
Triathlon® PS Total Knee System
n=236 knees
Includes participants who received the Triathlon® PS Total Knee System. Participants may have bilateral Triathlon® PS Total Knee replacement (TKR), with surgery occurring on different dates. Participants can therefore have a different status for each knee. If one knee has completed the study (i.e. has 2 year ROM data), the participant is counted in the study complete category.
|
|---|---|
|
Patient Outcome WOMAC
|
45.11 units on a scale
Standard Deviation 53.96
|
SECONDARY outcome
Timeframe: 1,2,3,4 and 5 yearsPopulation: Maximum number of knees available at any interval.
The Lower-Extremity Activity Scale (LEAS) score at 1, 2, 3, 4 and 5-year intervals will be compared at each post-surgery visit with baseline to see if any improvement is seen for each time point.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. A level of 1 indicated that the subject was confined to bed all day while a level of 18 indicated that the subject was up and about at will inside and outside of the house, and also participated in vigorous physical activity, such as competitive level sports, on a daily basis.
Outcome measures
| Measure |
Triathlon® PS Total Knee System
n=339 knees
Includes participants who received the Triathlon® PS Total Knee System. Participants may have bilateral Triathlon® PS Total Knee replacement (TKR), with surgery occurring on different dates. Participants can therefore have a different status for each knee. If one knee has completed the study (i.e. has 2 year ROM data), the participant is counted in the study complete category.
|
|---|---|
|
Patient Outcome Lower-Extremity Activity Scale
LEAS 1 Year (N=339)
|
11.22 units on a scale
Standard Deviation 2.62
|
|
Patient Outcome Lower-Extremity Activity Scale
LEAS 1 Year difference from Baseline (N=339)
|
1.97 units on a scale
Standard Deviation 2.84
|
|
Patient Outcome Lower-Extremity Activity Scale
LEAS 2 Year (N=291)
|
11.04 units on a scale
Standard Deviation 2.63
|
|
Patient Outcome Lower-Extremity Activity Scale
LEAS 2 Year difference from Baseline (N=291)
|
1.86 units on a scale
Standard Deviation 2.98
|
|
Patient Outcome Lower-Extremity Activity Scale
LEAS 3 Year (N=266)
|
11.15 units on a scale
Standard Deviation 2.87
|
|
Patient Outcome Lower-Extremity Activity Scale
LEAS 3 Year difference from Baseline (N=266)
|
1.95 units on a scale
Standard Deviation 3.12
|
|
Patient Outcome Lower-Extremity Activity Scale
LEAS 4 Year (N=262)
|
10.97 units on a scale
Standard Deviation 2.76
|
|
Patient Outcome Lower-Extremity Activity Scale
LEAS 4 Year difference from Baseline (N=262)
|
1.87 units on a scale
Standard Deviation 3.03
|
|
Patient Outcome Lower-Extremity Activity Scale
LEAS 5 Year (N=244)
|
11.02 units on a scale
Standard Deviation 2.93
|
|
Patient Outcome Lower-Extremity Activity Scale
LEAS 5 Year difference from Baseline (N=244)
|
1.89 units on a scale
Standard Deviation 3.14
|
SECONDARY outcome
Timeframe: 1,2 and 5 yearsPopulation: Maximum number of knees evaluable at any interval.
Radiographic success/failure at 1, 2, and 5-year visits will be assessed. Radiographic failure is defined as a score of 10 or greater according to the Knee Society Roentgenographic Scoring System, regardless of symptoms. A migrating or shifting prosthesis with or without the disappearance of radiolucent lines is also a failure regardless of score.
Outcome measures
| Measure |
Triathlon® PS Total Knee System
n=345 knees
Includes participants who received the Triathlon® PS Total Knee System. Participants may have bilateral Triathlon® PS Total Knee replacement (TKR), with surgery occurring on different dates. Participants can therefore have a different status for each knee. If one knee has completed the study (i.e. has 2 year ROM data), the participant is counted in the study complete category.
|
|---|---|
|
Radiographic Outcome
Radiographic failure at 1 Yr (N=347 knees)
|
1 knees
|
|
Radiographic Outcome
Radiographic failure at 2 Yrs (N=282 knees)
|
2 knees
|
|
Radiographic Outcome
Radiographic failure at 5 Yrs (N=217 knees)
|
3 knees
|
Adverse Events
Triathlon® PS Total Knee System
Serious events: 86 serious events
Other events: 194 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Triathlon® PS Total Knee System
n=354 participants at risk
All non-censored participants who received the Triathlon® PS Total Knee System.
|
|---|---|
|
Cardiac disorders
Non-operative site
|
4.2%
15/354 • Number of events 17 • This study requires that all operative site and systemic adverse events be reported from enrollment to 5 years postoperative. This includes any change from baseline status. Censored protocol violations were not included as at risk participants.
Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
|
|
Gastrointestinal disorders
Non-operative site
|
2.5%
9/354 • Number of events 10 • This study requires that all operative site and systemic adverse events be reported from enrollment to 5 years postoperative. This includes any change from baseline status. Censored protocol violations were not included as at risk participants.
Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
|
|
General disorders
Non-operative Site
|
0.56%
2/354 • Number of events 3 • This study requires that all operative site and systemic adverse events be reported from enrollment to 5 years postoperative. This includes any change from baseline status. Censored protocol violations were not included as at risk participants.
Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
|
|
Immune system disorders
Non-operative Site
|
0.28%
1/354 • Number of events 1 • This study requires that all operative site and systemic adverse events be reported from enrollment to 5 years postoperative. This includes any change from baseline status. Censored protocol violations were not included as at risk participants.
Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
|
|
Infections and infestations
Operative Site
|
2.3%
8/354 • Number of events 8 • This study requires that all operative site and systemic adverse events be reported from enrollment to 5 years postoperative. This includes any change from baseline status. Censored protocol violations were not included as at risk participants.
Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
|
|
Infections and infestations
Non-operative Site
|
0.85%
3/354 • Number of events 3 • This study requires that all operative site and systemic adverse events be reported from enrollment to 5 years postoperative. This includes any change from baseline status. Censored protocol violations were not included as at risk participants.
Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
|
|
Injury, poisoning and procedural complications
Operative Site
|
0.56%
2/354 • Number of events 2 • This study requires that all operative site and systemic adverse events be reported from enrollment to 5 years postoperative. This includes any change from baseline status. Censored protocol violations were not included as at risk participants.
Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
|
|
Metabolism and nutrition disorders
Non-operative Site
|
0.28%
1/354 • Number of events 1 • This study requires that all operative site and systemic adverse events be reported from enrollment to 5 years postoperative. This includes any change from baseline status. Censored protocol violations were not included as at risk participants.
Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
|
|
Musculoskeletal and connective tissue disorders
Operative Site
|
5.9%
21/354 • Number of events 22 • This study requires that all operative site and systemic adverse events be reported from enrollment to 5 years postoperative. This includes any change from baseline status. Censored protocol violations were not included as at risk participants.
Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
|
|
Musculoskeletal and connective tissue disorders
Non-operative Site
|
4.5%
16/354 • Number of events 19 • This study requires that all operative site and systemic adverse events be reported from enrollment to 5 years postoperative. This includes any change from baseline status. Censored protocol violations were not included as at risk participants.
Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-operative Site
|
2.5%
9/354 • Number of events 9 • This study requires that all operative site and systemic adverse events be reported from enrollment to 5 years postoperative. This includes any change from baseline status. Censored protocol violations were not included as at risk participants.
Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
|
|
Nervous system disorders
Non-operative Site
|
1.1%
4/354 • Number of events 4 • This study requires that all operative site and systemic adverse events be reported from enrollment to 5 years postoperative. This includes any change from baseline status. Censored protocol violations were not included as at risk participants.
Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
|
|
Psychiatric disorders
Non-operative Site
|
0.28%
1/354 • Number of events 1 • This study requires that all operative site and systemic adverse events be reported from enrollment to 5 years postoperative. This includes any change from baseline status. Censored protocol violations were not included as at risk participants.
Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
|
|
Renal and urinary disorders
Non-operative Site
|
0.85%
3/354 • Number of events 3 • This study requires that all operative site and systemic adverse events be reported from enrollment to 5 years postoperative. This includes any change from baseline status. Censored protocol violations were not included as at risk participants.
Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
|
|
Respiratory, thoracic and mediastinal disorders
Non-operative Site
|
3.4%
12/354 • Number of events 12 • This study requires that all operative site and systemic adverse events be reported from enrollment to 5 years postoperative. This includes any change from baseline status. Censored protocol violations were not included as at risk participants.
Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
|
|
Vascular disorders
Non-operative Site
|
0.85%
3/354 • Number of events 4 • This study requires that all operative site and systemic adverse events be reported from enrollment to 5 years postoperative. This includes any change from baseline status. Censored protocol violations were not included as at risk participants.
Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
|
|
Nervous system disorders
Operative Site
|
0.28%
1/354 • Number of events 1 • This study requires that all operative site and systemic adverse events be reported from enrollment to 5 years postoperative. This includes any change from baseline status. Censored protocol violations were not included as at risk participants.
Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
|
|
Ear and labyrinth disorders
Non-operative Site
|
0.28%
1/354 • Number of events 1 • This study requires that all operative site and systemic adverse events be reported from enrollment to 5 years postoperative. This includes any change from baseline status. Censored protocol violations were not included as at risk participants.
Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
|
|
Hepatobiliary disorders
Non-operative Site
|
0.28%
1/354 • Number of events 1 • This study requires that all operative site and systemic adverse events be reported from enrollment to 5 years postoperative. This includes any change from baseline status. Censored protocol violations were not included as at risk participants.
Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
|
Other adverse events
| Measure |
Triathlon® PS Total Knee System
n=354 participants at risk
All non-censored participants who received the Triathlon® PS Total Knee System.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Operative Site
|
25.4%
90/354 • Number of events 121 • This study requires that all operative site and systemic adverse events be reported from enrollment to 5 years postoperative. This includes any change from baseline status. Censored protocol violations were not included as at risk participants.
Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
|
|
Musculoskeletal and connective tissue disorders
Non-operative Site
|
31.4%
111/354 • Number of events 203 • This study requires that all operative site and systemic adverse events be reported from enrollment to 5 years postoperative. This includes any change from baseline status. Censored protocol violations were not included as at risk participants.
Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
|
|
Respiratory, thoracic and mediastinal disorders
Non-operative Site
|
8.2%
29/354 • Number of events 65 • This study requires that all operative site and systemic adverse events be reported from enrollment to 5 years postoperative. This includes any change from baseline status. Censored protocol violations were not included as at risk participants.
Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
|
|
Blood and lymphatic system disorders
Non-operative Site
|
8.8%
31/354 • Number of events 34 • This study requires that all operative site and systemic adverse events be reported from enrollment to 5 years postoperative. This includes any change from baseline status. Censored protocol violations were not included as at risk participants.
Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
|
|
Gastrointestinal disorders
Non-operative Site
|
7.6%
27/354 • Number of events 34 • This study requires that all operative site and systemic adverse events be reported from enrollment to 5 years postoperative. This includes any change from baseline status. Censored protocol violations were not included as at risk participants.
Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
|
|
Nervous system disorders
Non-operative Site
|
6.8%
24/354 • Number of events 29 • This study requires that all operative site and systemic adverse events be reported from enrollment to 5 years postoperative. This includes any change from baseline status. Censored protocol violations were not included as at risk participants.
Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
|
|
Renal and urinary disorders
Non-operative Site
|
6.2%
22/354 • Number of events 30 • This study requires that all operative site and systemic adverse events be reported from enrollment to 5 years postoperative. This includes any change from baseline status. Censored protocol violations were not included as at risk participants.
Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
|
|
Skin and subcutaneous tissue disorders
Non-operative Site
|
7.3%
26/354 • Number of events 42 • This study requires that all operative site and systemic adverse events be reported from enrollment to 5 years postoperative. This includes any change from baseline status. Censored protocol violations were not included as at risk participants.
Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
|
Additional Information
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 and 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 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