Trial Outcomes & Findings for Stryker Triathlon Total Knee System for Total Knee Arthroplasty Implanted Using ShapeMatch® Cutting Guides: Sub-Study B (NCT NCT02527161)
NCT ID: NCT02527161
Last Updated: 2020-09-18
Results Overview
Implant location and limb alignment is assessed using CT scan 3 months after surgery. The mean deviation of the postoperative femoral and tibial alignment from the preoperative plan is measured in degrees.
COMPLETED
NA
205 participants
3 months Post-Operatively
2020-09-18
Participant Flow
Patients were assessed and then placed in either Part A or Part B. Patients in Part B were invited to participate in the extension follow-up to 5-years.
Participant milestones
| Measure |
ShapeMatch® Cutting Guides With Triathlon®
Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
|
|---|---|
|
Overall Study
STARTED
|
205
|
|
Overall Study
COMPLETED
|
73
|
|
Overall Study
NOT COMPLETED
|
132
|
Reasons for withdrawal
| Measure |
ShapeMatch® Cutting Guides With Triathlon®
Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
|
|---|---|
|
Overall Study
Failed MRI
|
52
|
|
Overall Study
Withdrawal by Subject
|
19
|
|
Overall Study
Delay in or unfit for surgery
|
16
|
|
Overall Study
MRI contraindication
|
6
|
|
Overall Study
Consent violation
|
4
|
|
Overall Study
Only Recruited to Part A
|
27
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
6
|
Baseline Characteristics
Stryker Triathlon Total Knee System for Total Knee Arthroplasty Implanted Using ShapeMatch® Cutting Guides: Sub-Study B
Baseline characteristics by cohort
| Measure |
ShapeMatch Cutting Guides With Triathlon
n=96 Participants
Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
|
|---|---|
|
Age, Continuous
|
68.04 years
STANDARD_DEVIATION 8.30 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
96 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months Post-OperativelyPopulation: Participants with available data. Participants=knees.
Implant location and limb alignment is assessed using CT scan 3 months after surgery. The mean deviation of the postoperative femoral and tibial alignment from the preoperative plan is measured in degrees.
Outcome measures
| Measure |
ShapeMatch Cutting Guides With Triathlon
n=95 Participants
Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
|
|---|---|
|
Implant Location/Assessment of Alignment
Femoral deviation pre-op to post-op
|
1.70 degrees
Standard Deviation 1.46
|
|
Implant Location/Assessment of Alignment
Tibial deviation pre-op to post-op
|
1.91 degrees
Standard Deviation 1.58
|
SECONDARY outcome
Timeframe: Pre-operative to 5 years post-operativePopulation: Participants with available data. Participants=knees.
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 |
ShapeMatch Cutting Guides With Triathlon
n=100 Participants
Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
|
|---|---|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_Pain
Pre-op KOOS Pain score
|
36.18 units on a scale
Standard Deviation 17.64
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_Pain
6 weeks KOOS Pain score
|
66.23 units on a scale
Standard Deviation 16.88
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_Pain
3 months KOOS Pain score
|
74.96 units on a scale
Standard Deviation 18.55
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_Pain
6 months KOOS Pain score
|
80.03 units on a scale
Standard Deviation 18.12
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_Pain
1 year KOOS Pain score
|
85.11 units on a scale
Standard Deviation 16.69
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_Pain
2 years KOOS Pain score
|
87.00 units on a scale
Standard Deviation 18.18
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_Pain
5 years KOOS Pain score
|
89.58 units on a scale
Standard Deviation 14.24
|
SECONDARY outcome
Timeframe: Pre-operative to 5 years post-operativePopulation: Participants with available data. Participants=knees
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 |
ShapeMatch Cutting Guides With Triathlon
n=100 Participants
Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
|
|---|---|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_Symptoms
Pre-op KOOS Symptoms
|
40.94 units on a scale
Standard Deviation 20.85
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_Symptoms
6 weeks KOOS Symptoms
|
64.78 units on a scale
Standard Deviation 16.01
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_Symptoms
3 months KOOS Symptoms
|
71.12 units on a scale
Standard Deviation 18.60
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_Symptoms
6 months KOOS Symptoms
|
75.16 units on a scale
Standard Deviation 18.54
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_Symptoms
1 year KOOS Symptoms
|
83.12 units on a scale
Standard Deviation 15.33
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_Symptoms
2 years KOOS Symptoms score
|
84.49 units on a scale
Standard Deviation 17.07
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_Symptoms
5 years KOOS Symptoms
|
87.90 units on a scale
Standard Deviation 13.13
|
SECONDARY outcome
Timeframe: Pre-operative to 5 years post-operativePopulation: Participants with available data. Participants=knees.
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 |
ShapeMatch Cutting Guides With Triathlon
n=100 Participants
Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
|
|---|---|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_ADL
Pre-op KOOS ADL
|
38.08 units on a scale
Standard Deviation 20.12
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_ADL
6 weeks KOOS ADL
|
71.98 units on a scale
Standard Deviation 17.58
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_ADL
3 months KOOS ADL
|
78.75 units on a scale
Standard Deviation 18.20
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_ADL
6 months KOOS ADL
|
82.37 units on a scale
Standard Deviation 17.90
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_ADL
1 year KOOS ADL
|
88.14 units on a scale
Standard Deviation 14.39
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_ADL
2 years KOOS ADL score
|
89.60 units on a scale
Standard Deviation 15.46
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_ADL
5 years KOOS ADL score
|
88.80 units on a scale
Standard Deviation 15.09
|
SECONDARY outcome
Timeframe: Pre-operative to 5 years Post-OperativePopulation: Participants with available data. Participants=knees
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 |
ShapeMatch Cutting Guides With Triathlon
n=100 Participants
Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
|
|---|---|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_S&R
Pre-op KOOS S&R
|
14.45 units on a scale
Standard Deviation 20.98
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_S&R
1 year KOOS S&R
|
65.05 units on a scale
Standard Deviation 25.48
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_S&R
2 years KOOS S&R
|
65.92 units on a scale
Standard Deviation 27.28
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_S&R
5 years KOOS S&R
|
64.78 units on a scale
Standard Deviation 27.00
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_S&R
6 weeks KOOS S&R
|
39.06 units on a scale
Standard Deviation 32.49
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_S&R
3 months KOOS S&R
|
48.58 units on a scale
Standard Deviation 28.74
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_S&R
6 months KOOS S&R
|
58.70 units on a scale
Standard Deviation 29.09
|
SECONDARY outcome
Timeframe: Pre-operative to 5 years post-operativePopulation: Participants with available data. Participants=knees.
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 |
ShapeMatch Cutting Guides With Triathlon
n=100 Participants
Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
|
|---|---|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_QOL
Pre-op KOOS QOL
|
19.92 unit of a scale
Standard Deviation 17.63
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_QOL
6 weeks KOOS QOL score
|
51.87 unit of a scale
Standard Deviation 22.12
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_QOL
3 months KOOS QOL score
|
61.51 unit of a scale
Standard Deviation 21.14
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_QOL
6 months KOOS QOL
|
69.44 unit of a scale
Standard Deviation 25.39
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_QOL
1 year KOOS QOL
|
77.09 unit of a scale
Standard Deviation 20.78
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_QOL
2 years KOOS QOL score
|
79.82 unit of a scale
Standard Deviation 22.53
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)_QOL
5 years KOOS QOL
|
80.19 unit of a scale
Standard Deviation 21.73
|
SECONDARY outcome
Timeframe: Pre-operative to 5 years Post-OperativePopulation: Participants with available data. Participants=knees.
SF-12 provides a summary measure of health status after combining the physical health score (PCS) and mental health score (MCS). The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health and well-being. It includes a physical and mental status component score: each ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good health state.
Outcome measures
| Measure |
ShapeMatch Cutting Guides With Triathlon
n=100 Participants
Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
|
|---|---|
|
Short Form Health Survey 12 v2 (SF-12)_Physical Component Summary (PCS)
SF12 PCS Preop
|
34.36 units on a scale
Standard Deviation 7.69
|
|
Short Form Health Survey 12 v2 (SF-12)_Physical Component Summary (PCS)
SF12 PCS 6 weeks
|
40.27 units on a scale
Standard Deviation 6.98
|
|
Short Form Health Survey 12 v2 (SF-12)_Physical Component Summary (PCS)
SF12 PCS 3 months
|
45.99 units on a scale
Standard Deviation 8.09
|
|
Short Form Health Survey 12 v2 (SF-12)_Physical Component Summary (PCS)
SF12 PCS 6 months
|
47.35 units on a scale
Standard Deviation 8.89
|
|
Short Form Health Survey 12 v2 (SF-12)_Physical Component Summary (PCS)
SF12 PCS 1 year
|
48.27 units on a scale
Standard Deviation 8.88
|
|
Short Form Health Survey 12 v2 (SF-12)_Physical Component Summary (PCS)
SF12 PCS 2 years
|
49.90 units on a scale
Standard Deviation 8.64
|
|
Short Form Health Survey 12 v2 (SF-12)_Physical Component Summary (PCS)
SF12 PCS 5 years
|
46.96 units on a scale
Standard Deviation 8.66
|
SECONDARY outcome
Timeframe: Pre-Operative to 5 years Post-OperativePopulation: Participants with available data. Participants=knees.
Pain at rest and pain during mobilization was measured using a 10 centimeter Visual analogue scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain.
Outcome measures
| Measure |
ShapeMatch Cutting Guides With Triathlon
n=100 Participants
Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
|
|---|---|
|
VAS Pain at Rest
VAS pain at rest_Preop
|
5.78 centimeters
Standard Deviation 2.49
|
|
VAS Pain at Rest
VAS pain at rest_6 weeks
|
3.09 centimeters
Standard Deviation 2.56
|
|
VAS Pain at Rest
VAS pain at rest_3 months
|
2.02 centimeters
Standard Deviation 2.14
|
|
VAS Pain at Rest
VAS pain at rest_6 months
|
1.45 centimeters
Standard Deviation 1.98
|
|
VAS Pain at Rest
VAS pain at rest_ 1 year
|
1.22 centimeters
Standard Deviation 1.84
|
|
VAS Pain at Rest
VAS pain at rest_ 2 years
|
1.09 centimeters
Standard Deviation 1.82
|
|
VAS Pain at Rest
VAS pain at rest_ 5 years
|
1.04 centimeters
Standard Deviation 1.65
|
SECONDARY outcome
Timeframe: Pre-Operative to 5 years post-operativePopulation: Participants with available data. Participants=knees.
Pain at rest and pain during mobilization was measured using a 10 centimeter Visual analogue scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain.
Outcome measures
| Measure |
ShapeMatch Cutting Guides With Triathlon
n=100 Participants
Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
|
|---|---|
|
VAS Pain Mobilised
VAS pain during mobilization_Preop
|
7.28 units of a scale
Standard Deviation 2.07
|
|
VAS Pain Mobilised
VAS pain during mobilization_6 weeks
|
3.47 units of a scale
Standard Deviation 2.74
|
|
VAS Pain Mobilised
VAS pain during mobilization_3 months
|
2.39 units of a scale
Standard Deviation 2.48
|
|
VAS Pain Mobilised
VAS pain during mobilization_6 months
|
1.83 units of a scale
Standard Deviation 2.23
|
|
VAS Pain Mobilised
VAS pain during mobilization_1 year
|
1.43 units of a scale
Standard Deviation 1.99
|
|
VAS Pain Mobilised
VAS pain during mobilization_2 years
|
1.41 units of a scale
Standard Deviation 2.19
|
|
VAS Pain Mobilised
VAS pain during mobilization_5 years
|
1.22 units of a scale
Standard Deviation 1.92
|
SECONDARY outcome
Timeframe: Pre-operative to 5 years Post-OperativePopulation: Participants with available data. Participants=knees.
SF-12 provides a summary measure of health status after combining the physical health score (PCS) and mental health score (MCS). The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health and well-being. It includes a physical and mental status component score: each ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good health state.
Outcome measures
| Measure |
ShapeMatch Cutting Guides With Triathlon
n=100 Participants
Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
|
|---|---|
|
Short Form Health Survey 12 (SF-12)_Mental Component Summary (MCS)
SF12 MCS Preop
|
47.02 units on a scale
Standard Deviation 12.49
|
|
Short Form Health Survey 12 (SF-12)_Mental Component Summary (MCS)
SF12 MCS 6 weeks
|
49.91 units on a scale
Standard Deviation 10.56
|
|
Short Form Health Survey 12 (SF-12)_Mental Component Summary (MCS)
SF12 MCS 3 months
|
52.18 units on a scale
Standard Deviation 9.96
|
|
Short Form Health Survey 12 (SF-12)_Mental Component Summary (MCS)
SF12 MCS 6 months
|
52.58 units on a scale
Standard Deviation 9.15
|
|
Short Form Health Survey 12 (SF-12)_Mental Component Summary (MCS)
SF12 MCS 1 year
|
52.93 units on a scale
Standard Deviation 9.28
|
|
Short Form Health Survey 12 (SF-12)_Mental Component Summary (MCS)
SF12 MCS 2 years
|
52.78 units on a scale
Standard Deviation 9.27
|
|
Short Form Health Survey 12 (SF-12)_Mental Component Summary (MCS)
SF12 MCS 5 years
|
52.95 units on a scale
Standard Deviation 10.39
|
SECONDARY outcome
Timeframe: Pre-operative to 5 years Post-OperativePopulation: Participants with available data. Participants=knees.
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 minimum score of 0 to a maximum 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 |
ShapeMatch Cutting Guides With Triathlon
n=100 Participants
Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
|
|---|---|
|
Knee Society Clinical Rating System (KSS) Pain Scores
KSS Pain Preop
|
32.95 units on a scale
Standard Deviation 14.06
|
|
Knee Society Clinical Rating System (KSS) Pain Scores
KSS Pain 3 months
|
69.05 units on a scale
Standard Deviation 18.46
|
|
Knee Society Clinical Rating System (KSS) Pain Scores
KSS Pain 6 months
|
71.36 units on a scale
Standard Deviation 15.21
|
|
Knee Society Clinical Rating System (KSS) Pain Scores
KSS Pain 1 year
|
76.75 units on a scale
Standard Deviation 16.53
|
|
Knee Society Clinical Rating System (KSS) Pain Scores
KSS Pain 2 years
|
78.04 units on a scale
Standard Deviation 16.32
|
|
Knee Society Clinical Rating System (KSS) Pain Scores
KSS Pain 5 years
|
75.60 units on a scale
Standard Deviation 13.96
|
SECONDARY outcome
Timeframe: Pre-operative to 5 years Post-OperativePopulation: Participants with available data. Participants=knees.
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 minimum score of 0 to a maximum 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 |
ShapeMatch Cutting Guides With Triathlon
n=100 Participants
Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
|
|---|---|
|
Knee Society Clinical Rating System (KSS) Functional Scores
KSS functional Preop
|
43.45 units on a scale
Standard Deviation 19.25
|
|
Knee Society Clinical Rating System (KSS) Functional Scores
KSS functional 3 months
|
66.82 units on a scale
Standard Deviation 20.07
|
|
Knee Society Clinical Rating System (KSS) Functional Scores
KSS functional 6 months
|
75.45 units on a scale
Standard Deviation 20.28
|
|
Knee Society Clinical Rating System (KSS) Functional Scores
KSS functional 1 year
|
76.99 units on a scale
Standard Deviation 19.79
|
|
Knee Society Clinical Rating System (KSS) Functional Scores
KSS functional 2 years
|
74.82 units on a scale
Standard Deviation 23.62
|
|
Knee Society Clinical Rating System (KSS) Functional Scores
KSS functional 5 years
|
71.44 units on a scale
Standard Deviation 25.47
|
SECONDARY outcome
Timeframe: Pre-operative to 5 years Post-OperativePopulation: Participants with available data. Participants=knees.
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 minimum score of 0 to a maximum 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 |
ShapeMatch Cutting Guides With Triathlon
n=100 Participants
Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
|
|---|---|
|
Knee Society Clinical Rating System (KSS) Range of Motion Scores
KSS ROM Preop
|
108.59 units on a scale
Standard Deviation 16.74
|
|
Knee Society Clinical Rating System (KSS) Range of Motion Scores
KSS ROM 3 months
|
110.40 units on a scale
Standard Deviation 14.38
|
|
Knee Society Clinical Rating System (KSS) Range of Motion Scores
KSS ROM 6 months
|
112.71 units on a scale
Standard Deviation 12.71
|
|
Knee Society Clinical Rating System (KSS) Range of Motion Scores
KSS ROM 1 year
|
115.30 units on a scale
Standard Deviation 12.36
|
|
Knee Society Clinical Rating System (KSS) Range of Motion Scores
KSS ROM 2 years
|
115.09 units on a scale
Standard Deviation 12.40
|
|
Knee Society Clinical Rating System (KSS) Range of Motion Scores
KSS ROM 5 years
|
119.11 units on a scale
Standard Deviation 13.06
|
SECONDARY outcome
Timeframe: 1 to 5 years Post-OperativePopulation: Participants with available data. Participants=knees.
The Forgotten Joint Score is a newly-developed twelve-item, self-reported assessment of how aware recipients of hip and knee joint replacement are of their joint in everyday life. The total score for the FJS is summed, averaged then multiplied by 25 (never = 0 points; almost never = 1 point; seldom = 2 points; sometimes = 3 points; mostly = 4 points). Total score range of 0 to 100.
Outcome measures
| Measure |
ShapeMatch Cutting Guides With Triathlon
n=100 Participants
Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
|
|---|---|
|
Forgotten Joint Score (FJS)
FJS 1 year
|
54.48 units on a scale
Standard Deviation 30.58
|
|
Forgotten Joint Score (FJS)
FJS 2 years
|
40.28 units on a scale
Standard Deviation 30.08
|
|
Forgotten Joint Score (FJS)
FJS 5 years
|
68.82 units on a scale
Standard Deviation 31.17
|
Adverse Events
ShapeMatch Cutting Guides With Triathlon
Serious adverse events
| Measure |
ShapeMatch Cutting Guides With Triathlon
n=96 participants at risk
Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
|
|---|---|
|
Blood and lymphatic system disorders
Non-Operative site
|
2.1%
2/96 • Number of events 15 • 5 years
|
|
Cardiac disorders
Non-operative site
|
5.2%
5/96 • Number of events 6 • 5 years
|
|
Ear and labyrinth disorders
Non-operative site
|
2.1%
2/96 • Number of events 2 • 5 years
|
|
Eye disorders
Non-operative site
|
5.2%
5/96 • Number of events 5 • 5 years
|
|
Gastrointestinal disorders
Non-operative site
|
2.1%
2/96 • Number of events 2 • 5 years
|
|
General disorders
Non-operative site
|
3.1%
3/96 • Number of events 3 • 5 years
|
|
Hepatobiliary disorders
Non-operative site
|
1.0%
1/96 • Number of events 1 • 5 years
|
|
Infections and infestations
Non-operative site
|
1.0%
1/96 • Number of events 1 • 5 years
|
|
Infections and infestations
Operative site
|
2.1%
2/96 • Number of events 4 • 5 years
|
|
Injury, poisoning and procedural complications
Non-Operative site
|
2.1%
2/96 • Number of events 2 • 5 years
|
|
Injury, poisoning and procedural complications
Operative Site
|
4.2%
4/96 • Number of events 4 • 5 years
|
|
Metabolism and nutrition disorders
Non-operative site
|
1.0%
1/96 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Non-operative site
|
29.2%
28/96 • Number of events 38 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Operative site
|
8.3%
8/96 • Number of events 8 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-operative site
|
5.2%
5/96 • Number of events 11 • 5 years
|
|
Psychiatric disorders
Non-operative site
|
1.0%
1/96 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Non-operative site
|
5.2%
5/96 • Number of events 5 • 5 years
|
|
Reproductive system and breast disorders
Non-operative site
|
2.1%
2/96 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Non-operative site
|
7.3%
7/96 • Number of events 9 • 5 years
|
|
Skin and subcutaneous tissue disorders
Non-operative site
|
3.1%
3/96 • Number of events 3 • 5 years
|
|
Skin and subcutaneous tissue disorders
Operative site
|
1.0%
1/96 • Number of events 1 • 5 years
|
|
Surgical and medical procedures
Non-operative site
|
22.9%
22/96 • Number of events 38 • 5 years
|
|
Surgical and medical procedures
Operative site
|
6.2%
6/96 • Number of events 6 • 5 years
|
|
Vascular disorders
Non-operative side
|
4.2%
4/96 • Number of events 4 • 5 years
|
Other adverse events
| Measure |
ShapeMatch Cutting Guides With Triathlon
n=96 participants at risk
Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
|
|---|---|
|
General disorders
Non-operative site
|
8.3%
8/96 • Number of events 10 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Non-operative site
|
21.9%
21/96 • Number of events 32 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Operative site
|
5.2%
5/96 • Number of events 9 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Non-operative site
|
8.3%
8/96 • Number of events 10 • 5 years
|
|
Skin and subcutaneous tissue disorders
Non-operative site
|
5.2%
5/96 • Number of events 6 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Discloser must give at least 40 days notice to Sponsor including a copy of the proposed publication. The Sponsor can then provide comments (which Discloser is not bound to follow), request delay of publication by no more than 120 days to allow for Sponsor to protect its intellectual property, or request that the Discloser remove certain proprietary or confidential information from the study (other than the results of the study).
- Publication restrictions are in place
Restriction type: OTHER