Trial Outcomes & Findings for Evaluation of Triathlon - a New Total Knee Prosthesis System - Triathlon vs. Duracon (NCT NCT00436982)
NCT ID: NCT00436982
Last Updated: 2024-02-22
Results Overview
To compare the maximum total point motion (MTPM) of the Triathlon and Duracon tibial components at two years assessed by means of RSA.
COMPLETED
NA
60 participants
2 years
2024-02-22
Participant Flow
The recruitment period was from February to November 2006. In a single centre patients were prospectively randomised to receive either a cemented Triathlon total knee system or a Duracon total knee system. Randomisation with envelopes, 30 patients in each group. Only one knee per participant was enrolled for the study.
Participant milestones
| Measure |
Cemented Triathlon Total Knee System
30 patients were randomized into the Triathlon total knee system arm. TheTriathlon total knee system is the successor of the Duracon total knee system and was observed in a prospective randomised, parallel, double-blind study.
Cemented Triathlon total knee system: Orthopaedic implant
|
Duracon Total Knee System
30 patients were randomized into the Duracon total knee system arm. The Duracon total knee system is the predecessor of the Triathlon total knee system and was observed in a prospective randomised, parallel, double-blind study.
Duracon total knee system: Orthopaedic implant
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
26
|
26
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Cemented Triathlon Total Knee System
30 patients were randomized into the Triathlon total knee system arm. TheTriathlon total knee system is the successor of the Duracon total knee system and was observed in a prospective randomised, parallel, double-blind study.
Cemented Triathlon total knee system: Orthopaedic implant
|
Duracon Total Knee System
30 patients were randomized into the Duracon total knee system arm. The Duracon total knee system is the predecessor of the Triathlon total knee system and was observed in a prospective randomised, parallel, double-blind study.
Duracon total knee system: Orthopaedic implant
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Did not receive allocated intervention
|
0
|
1
|
|
Overall Study
no RSA data
|
1
|
2
|
Baseline Characteristics
Evaluation of Triathlon - a New Total Knee Prosthesis System - Triathlon vs. Duracon
Baseline characteristics by cohort
| Measure |
Triathlon
n=30 Participants
30 patients randomized into the Triathlon arm
|
Duracon
n=30 Participants
30 patients randomized into the Duracon arm
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69 years
n=5 Participants
|
66 years
n=7 Participants
|
68 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsTo compare the maximum total point motion (MTPM) of the Triathlon and Duracon tibial components at two years assessed by means of RSA.
Outcome measures
| Measure |
Triathlon
n=26 Participants
30 patients randomized into the Triathlon arm
|
Duracon
n=26 Participants
30 patients randomized into the Duracon arm
|
|---|---|---|
|
Roentgen Stereophotogrammetric Analysis (RSA)
|
0.65 mm
Standard Deviation 0.66
|
0.81 mm
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: 3 months, 1, 5, 7 and 10 yearsPopulation: Participants with data available at each time point.
To compare the maximum total point motion (MTPM) of the Triathlon and Duracon tibial components by means of RSA.
Outcome measures
| Measure |
Triathlon
n=30 Participants
30 patients randomized into the Triathlon arm
|
Duracon
n=30 Participants
30 patients randomized into the Duracon arm
|
|---|---|---|
|
Roentgen Stereophotogrammetric Analysis (RSA)
MTPM 3 months
|
0.45 mm
Standard Deviation 0.28
|
0.44 mm
Standard Deviation 0.27
|
|
Roentgen Stereophotogrammetric Analysis (RSA)
MTPM 1 year
|
0.6 mm
Standard Deviation 0.5
|
0.64 mm
Standard Deviation 0.36
|
|
Roentgen Stereophotogrammetric Analysis (RSA)
MTPM 5 years
|
0.65 mm
Standard Deviation 0.38
|
1.1 mm
Standard Deviation 1.19
|
|
Roentgen Stereophotogrammetric Analysis (RSA)
MTPM 7 years
|
0.67 mm
Standard Deviation 0.46
|
0.65 mm
Standard Deviation 0.3
|
|
Roentgen Stereophotogrammetric Analysis (RSA)
MTPM 10 years
|
0.75 mm
Standard Deviation 0.54
|
0.6 mm
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: [Time Frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years]Population: Participants with data available 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
n=30 Participants
30 patients randomized into the Triathlon arm
|
Duracon
n=30 Participants
30 patients randomized into the Duracon arm
|
|---|---|---|
|
Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)
KSS Pain/Motion pre-operative
|
17.3 units on a scale
Standard Deviation 10.50
|
18.3 units on a scale
Standard Deviation 11.24
|
|
Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)
KSS Pain/Motion 3 months
|
86.09 units on a scale
Standard Deviation 9.61
|
86.55 units on a scale
Standard Deviation 14.57
|
|
Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)
KSS Pain/Motion 1 year
|
93.51 units on a scale
Standard Deviation 6.94
|
95.43 units on a scale
Standard Deviation 9.71
|
|
Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)
KSS Pain/Motion 2 years
|
94.96 units on a scale
Standard Deviation 7.58
|
94.79 units on a scale
Standard Deviation 7.55
|
|
Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)
KSS Pain/Motion 5 years
|
93.14 units on a scale
Standard Deviation 9.12
|
94.24 units on a scale
Standard Deviation 9.71
|
|
Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)
KSS Pain/Motion 7 years
|
90.06 units on a scale
Standard Deviation 11.29
|
95.13 units on a scale
Standard Deviation 11.21
|
|
Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)
KSS Pain/Motion 10 years
|
93.6 units on a scale
Standard Deviation 10.45
|
96.79 units on a scale
Standard Deviation 6.83
|
|
Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)
KSS Function pre-operative
|
51.17 units on a scale
Standard Deviation 12.30
|
53.67 units on a scale
Standard Deviation 6.81
|
|
Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)
KSS Function 3 months
|
70 units on a scale
Standard Deviation 10.89
|
72.76 units on a scale
Standard Deviation 14.91
|
|
Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)
KSS Function 1 year
|
80 units on a scale
Standard Deviation 18.17
|
84.42 units on a scale
Standard Deviation 15
|
|
Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)
KSS Function 2 years
|
86.67 units on a scale
Standard Deviation 14.9
|
88.57 units on a scale
Standard Deviation 15.51
|
|
Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)
KSS Function 5 years
|
81.82 units on a scale
Standard Deviation 20.68
|
81.67 units on a scale
Standard Deviation 18.66
|
|
Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)
KSS Function 7 years
|
76.11 units on a scale
Standard Deviation 27.73
|
92.5 units on a scale
Standard Deviation 15.71
|
|
Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)
KSS Function 10 years
|
78.33 units on a scale
Standard Deviation 21.10
|
84.38 units on a scale
Standard Deviation 16.82
|
SECONDARY outcome
Timeframe: pre-operative, 3 months, 1, 2, 5, 7 and 10 yearsPopulation: Participants with data available at each time point.
KOOS consists of 5 subscales; Pain, other Symptoms, Activities of Daily Living (ADL), Sport and Recreation Function (Sport/Rec) and knee-related Quality of Life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. \[taken from User Guide\] http://www.koos.nu/
Outcome measures
| Measure |
Triathlon
n=30 Participants
30 patients randomized into the Triathlon arm
|
Duracon
n=30 Participants
30 patients randomized into the Duracon arm
|
|---|---|---|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
QOL pre-operative
|
23.75 units on a scale
Standard Deviation 14.44
|
24.38 units on a scale
Standard Deviation 14.62
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
QOL 3 months
|
51.79 units on a scale
Standard Deviation 20.61
|
54.09 units on a scale
Standard Deviation 23.87
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
QOL 1 year
|
58.48 units on a scale
Standard Deviation 22.13
|
65.51 units on a scale
Standard Deviation 21.04
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
QOL 2 years
|
62.73 units on a scale
Standard Deviation 25.56
|
71.35 units on a scale
Standard Deviation 25.42
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
QOL 5 years
|
69.87 units on a scale
Standard Deviation 30.04
|
80.06 units on a scale
Standard Deviation 18.71
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
QOL 7 years
|
68.75 units on a scale
Standard Deviation 28.36
|
86.33 units on a scale
Standard Deviation 12.95
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
QOL 10 years
|
65.83 units on a scale
Standard Deviation 25.1
|
73.53 units on a scale
Standard Deviation 27.56
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
Symptoms preoperative
|
51.25 units on a scale
Standard Deviation 18.67
|
53.65 units on a scale
Standard Deviation 16.36
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
Symptoms 3 months
|
66.84 units on a scale
Standard Deviation 18.62
|
65.87 units on a scale
Standard Deviation 17.50
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
Symptoms 1 year
|
75.51 units on a scale
Standard Deviation 17.08
|
77.51 units on a scale
Standard Deviation 15.84
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
Symptoms 2 years
|
78.17 units on a scale
Standard Deviation 16.29
|
81.87 units on a scale
Standard Deviation 16.57
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
Symptoms 5 years
|
81.81 units on a scale
Standard Deviation 20.41
|
83.16 units on a scale
Standard Deviation 19.40
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
Symptoms 7 years
|
82.14 units on a scale
Standard Deviation 15.87
|
92.63 units on a scale
Standard Deviation 14.13
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
Symptoms 10 years
|
81.62 units on a scale
Standard Deviation 19.15
|
88.45 units on a scale
Standard Deviation 13.15
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
Pain preoperative
|
42.11 units on a scale
Standard Deviation 16.88
|
43.61 units on a scale
Standard Deviation 14.07
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
Pain 3 months
|
70.57 units on a scale
Standard Deviation 20.23
|
70.21 units on a scale
Standard Deviation 21.52
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
Pain 1 year
|
73.64 units on a scale
Standard Deviation 19.39
|
82.77 units on a scale
Standard Deviation 19.59
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
Pain 2 years
|
79.94 units on a scale
Standard Deviation 19.89
|
84.82 units on a scale
Standard Deviation 20.83
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
Pain 5 years
|
81.31 units on a scale
Standard Deviation 21.23
|
85.45 units on a scale
Standard Deviation 19.44
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
Pain 7 years
|
80.56 units on a scale
Standard Deviation 19.29
|
91.15 units on a scale
Standard Deviation 14.74
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
Pain 10 years
|
80.74 units on a scale
Standard Deviation 19.20
|
84.31 units on a scale
Standard Deviation 20.99
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
ADL preoperative
|
47.27 units on a scale
Standard Deviation 14.58
|
50.14 units on a scale
Standard Deviation 15.58
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
ADL 3 months
|
73.22 units on a scale
Standard Deviation 18.23
|
73.35 units on a scale
Standard Deviation 23.09
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
ADL 1 year
|
74.28 units on a scale
Standard Deviation 20.23
|
84.42 units on a scale
Standard Deviation 15.45
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
ADL 2 years
|
76.74 units on a scale
Standard Deviation 21.78
|
84.90 units on a scale
Standard Deviation 20.22
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
ADL 5 years
|
78.07 units on a scale
Standard Deviation 23.60
|
83.05 units on a scale
Standard Deviation 19.39
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
ADL 7 years
|
75.25 units on a scale
Standard Deviation 22.90
|
89.34 units on a scale
Standard Deviation 13.18
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
ADL 10 years
|
73.21 units on a scale
Standard Deviation 24.42
|
80.02 units on a scale
Standard Deviation 24.98
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
Sport/Rec preOP
|
6.5 units on a scale
Standard Deviation 8.22
|
10 units on a scale
Standard Deviation 14.20
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
Sport/Rec 3 months
|
20.19 units on a scale
Standard Deviation 18.58
|
29.55 units on a scale
Standard Deviation 21.50
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
Sport/Rec 1 year
|
30.46 units on a scale
Standard Deviation 23.80
|
38.65 units on a scale
Standard Deviation 28.52
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
Sport/Rec 2 years
|
28.65 units on a scale
Standard Deviation 21.66
|
46.17 units on a scale
Standard Deviation 32.47
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
Sport/Rec 5 years
|
36.14 units on a scale
Standard Deviation 26.50
|
38.33 units on a scale
Standard Deviation 30.51
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
Sport/Rec 7 years
|
22.5 units on a scale
Standard Deviation 25.34
|
44.06 units on a scale
Standard Deviation 33.08
|
|
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire
Sport/Rec 10 years
|
25.33 units on a scale
Standard Deviation 19.68
|
50.15 units on a scale
Standard Deviation 30.29
|
SECONDARY outcome
Timeframe: pre-operative, 3 months, 1, 2, 5, 7 and 10 yearsPopulation: Participants with data available at each time point. Overall number of participants and units analyzed is based upon the 2 year population
The EQ-5D is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas; the EQ visual analogue scale (EQ VAS) and EQ-5D descriptive system. The EQ VAS collects health state values using a 20 cm visual analogue scale with the endpoints labeled best imaginable health state at the top and worst imaginable health state at the bottom, having numeric values of 100 to 0 respectively. The EQ-5D Time Trade-off (TTO) descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/comfort and anxiety/depression. Each dimension has three levels: no problems, some problems and extreme problems, where an overall score of 1 represents full health. NOTE: While the protocol includes pre-operative, 3 months, and 1 year, this data was not collected.
Outcome measures
| Measure |
Triathlon
n=28 Participants
30 patients randomized into the Triathlon arm
|
Duracon
n=26 Participants
30 patients randomized into the Duracon arm
|
|---|---|---|
|
Investigation of Clinical Performance and Patient Outcome With EQ-5D Patient Questionnaire
EQ-5D 2 years
|
0.79 units on a scale
Standard Deviation 0.24
|
0.80 units on a scale
Standard Deviation 0.22
|
|
Investigation of Clinical Performance and Patient Outcome With EQ-5D Patient Questionnaire
EQ-5D 5 years
|
0.76 units on a scale
Standard Deviation 0.30
|
0.78 units on a scale
Standard Deviation 0.26
|
|
Investigation of Clinical Performance and Patient Outcome With EQ-5D Patient Questionnaire
EQ-5D 7 years
|
0.86 units on a scale
Standard Deviation 0.24
|
0.73 units on a scale
Standard Deviation 0.29
|
|
Investigation of Clinical Performance and Patient Outcome With EQ-5D Patient Questionnaire
EQ-5D 10 years
|
0.78 units on a scale
Standard Deviation 0.24
|
0.75 units on a scale
Standard Deviation 0.26
|
SECONDARY outcome
Timeframe: intra-operativeSkin to skin operative time
Outcome measures
| Measure |
Triathlon
n=30 Participants
30 patients randomized into the Triathlon arm
|
Duracon
n=30 Participants
30 patients randomized into the Duracon arm
|
|---|---|---|
|
Mean Operative Time
|
66.47 minutes
Standard Deviation 9.62
|
63.7 minutes
Standard Deviation 12.21
|
SECONDARY outcome
Timeframe: preoperative to dischargeOutcome measures
| Measure |
Triathlon
n=30 Participants
30 patients randomized into the Triathlon arm
|
Duracon
n=30 Participants
30 patients randomized into the Duracon arm
|
|---|---|---|
|
Duration Hospital Stay
|
4.9 days
Standard Deviation 2.58
|
4.76 days
Standard Deviation 0.91
|
SECONDARY outcome
Timeframe: intra-operativePopulation: The protocol indicates blood loss as a secondary measure but this value was not collected. Therefore no data can be posted.
Blood loss during surgery
Outcome measures
Outcome data not reported
Adverse Events
Triathlon
Duracon
Serious adverse events
| Measure |
Triathlon
n=30 participants at risk
30 patients randomized into the Triathlon arm
|
Duracon
n=30 participants at risk
30 patients randomized into the Duracon arm
|
|---|---|---|
|
Vascular disorders
Stroke
|
0.00%
0/30 • During entire 10 years follow-up of all patients
All serious adverse events and operative site events occuring in this study were reported.
|
3.3%
1/30 • Number of events 1 • During entire 10 years follow-up of all patients
All serious adverse events and operative site events occuring in this study were reported.
|
|
Musculoskeletal and connective tissue disorders
Fracture proximal tibia
|
3.3%
1/30 • Number of events 1 • During entire 10 years follow-up of all patients
All serious adverse events and operative site events occuring in this study were reported.
|
0.00%
0/30 • During entire 10 years follow-up of all patients
All serious adverse events and operative site events occuring in this study were reported.
|
|
Musculoskeletal and connective tissue disorders
Hip fracture
|
0.00%
0/30 • During entire 10 years follow-up of all patients
All serious adverse events and operative site events occuring in this study were reported.
|
3.3%
1/30 • Number of events 1 • During entire 10 years follow-up of all patients
All serious adverse events and operative site events occuring in this study were reported.
|
|
Musculoskeletal and connective tissue disorders
Supercondylar humerus fracture
|
3.3%
1/30 • Number of events 1 • During entire 10 years follow-up of all patients
All serious adverse events and operative site events occuring in this study were reported.
|
0.00%
0/30 • During entire 10 years follow-up of all patients
All serious adverse events and operative site events occuring in this study were reported.
|
|
Psychiatric disorders
Depression
|
3.3%
1/30 • Number of events 1 • During entire 10 years follow-up of all patients
All serious adverse events and operative site events occuring in this study were reported.
|
0.00%
0/30 • During entire 10 years follow-up of all patients
All serious adverse events and operative site events occuring in this study were reported.
|
|
Cardiac disorders
Atrioventricular block
|
3.3%
1/30 • Number of events 1 • During entire 10 years follow-up of all patients
All serious adverse events and operative site events occuring in this study were reported.
|
0.00%
0/30 • During entire 10 years follow-up of all patients
All serious adverse events and operative site events occuring in this study were reported.
|
|
Cardiac disorders
Cardiac Arrhythmia
|
0.00%
0/30 • During entire 10 years follow-up of all patients
All serious adverse events and operative site events occuring in this study were reported.
|
3.3%
1/30 • Number of events 1 • During entire 10 years follow-up of all patients
All serious adverse events and operative site events occuring in this study were reported.
|
Other adverse events
| Measure |
Triathlon
n=30 participants at risk
30 patients randomized into the Triathlon arm
|
Duracon
n=30 participants at risk
30 patients randomized into the Duracon arm
|
|---|---|---|
|
Vascular disorders
Deep Vein Thrombosis
|
13.3%
4/30 • Number of events 4 • During entire 10 years follow-up of all patients
All serious adverse events and operative site events occuring in this study were reported.
|
16.7%
5/30 • Number of events 5 • During entire 10 years follow-up of all patients
All serious adverse events and operative site events occuring in this study were reported.
|
Additional Information
Eric Garling, PhD, Snr. Director Medical & Scientific Affairs Europe
Stryker EU Operations B.V. Herikerbergweg 110 1101 CM Amsterdam The Netherlands
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60