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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

2 years

Results posted on

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

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

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

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 years

To compare the maximum total point motion (MTPM) of the Triathlon and Duracon tibial components at two years assessed by means of RSA.

Outcome measures

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 years

Population: 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

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

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 years

Population: 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

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 years

Population: 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

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-operative

Skin to skin operative time

Outcome measures

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 discharge

Outcome measures

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
Duration Hospital Stay
4.9 days
Standard Deviation 2.58
4.76 days
Standard Deviation 0.91

SECONDARY outcome

Timeframe: intra-operative

Population: 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

Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths

Duracon

Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths

Serious adverse events

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

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

Phone: +31 20 219 2660

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60