Evaluation of Triathlon - a New Total Knee Prosthesis System - Triathlon vs. Duracon

Evaluation of Triathlon - a New Total Knee Prosthesis System. Prospective, Comparative, Randomised, Roentgen Stereophotogrammetric Analysis (RSA) Series

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00436982

Enrollment

Registered

2007-02-19

Start date

2006-02-28

Completion date

2017-01-04

Last updated

2024-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty, Replacement, Knee

Brief summary

The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective randomized clinical trial.

Detailed description

The evaluation is carried out by a prospective randomised RSA-study with Triathlon cemented knee prosthesis versus Duracon cemented knee prosthesis.

Interventions

DEVICECemented Triathlon total knee system

Orthopaedic implant

DEVICEDuracon total knee system

Orthopaedic implant

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

1. Patients suffering exclusively from osteo arthritis (OA), Stage II-V \[Ahlbäck, 1968\] will be operated. 2. Patients requiring knee prosthesis, suitable for the use of Duracon and Triathlon knee system 3. Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographical evaluations and the prescribed rehabilitation. 4. Patients who signed the Ethics Committee approved Informed Consent Form prior to surgery.

Exclusion criteria

1. Previous major knee surgery 2. Other significant disabling problems from the muscular-skeletal system than in the knees 3. Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living (body mass index, kg/m2: BMI above 35). 4. Patients with active or suspected infection. 5. Patients with malignancy - active malignancy. 6. Patients with severe osteoporosis, Paget's disease, renal osteodystrophy. 7. Patients immunologically suppressed, or receiving steroids in excess of physiologic dose requirements. 8. The patient has a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient's ability to limit weight bearing or places an extreme load on the implant during the healing period. 9. Female patients planning a pregnancy during the course of the study. 10. Patients with systemic or metabolic disorders leading to progressive bone deterioration. 11. Patients, who as judged by the surgeon, are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule. 12. Patients with other severe concurrent joint involvements, which can affect their outcome. 13. Patients with other concurrent illnesses, which are likely to affect their outcome such as sickle cell anaemia, systemic lupus erythematosus or renal disease requiring dialysis. 14. Patients under the protection of law (e.g. guardianship).

Design outcomes

Primary

Measure	Time frame	Description
Roentgen Stereophotogrammetric Analysis (RSA)	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.

Secondary

Measure	Time frame	Description
Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)	[Time Frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years]	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.
Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	pre-operative, 3 months, 1, 2, 5, 7 and 10 years	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/
Investigation of Clinical Performance and Patient Outcome With EQ-5D Patient Questionnaire	pre-operative, 3 months, 1, 2, 5, 7 and 10 years	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.
Roentgen Stereophotogrammetric Analysis (RSA)	3 months, 1, 5, 7 and 10 years	To compare the maximum total point motion (MTPM) of the Triathlon and Duracon tibial components by means of RSA.
Duration Hospital Stay	preoperative to discharge	—
Blood Loss	intra-operative	Blood loss during surgery
Mean Operative Time	intra-operative	Skin to skin operative time

Countries

Sweden

Participant flow

Recruitment details

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.

Participants by arm

Arm	Count
Triathlon 30 patients randomized into the Triathlon arm	30
Duracon 30 patients randomized into the Duracon arm	30
Total	60

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Did not receive allocated intervention	0	1
Overall Study	no RSA data	1	2
Overall Study	Withdrawal by Subject	3	1

Baseline characteristics

Characteristic	Triathlon	Duracon	Total
Age, Continuous	69 years	66 years	68 years
Region of Enrollment Sweden	30 participants	30 participants	60 participants
Sex: Female, Male Female	22 Participants	18 Participants	40 Participants
Sex: Female, Male Male	8 Participants	12 Participants	20 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	4 / 30	5 / 30
serious Total, serious adverse events	4 / 30	3 / 30

Outcome results

Primary

Roentgen Stereophotogrammetric Analysis (RSA)

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

Time frame: 2 years

Arm	Measure	Value (MEAN)	Dispersion
Triathlon	Roentgen Stereophotogrammetric Analysis (RSA)	0.65 mm	Standard Deviation 0.66
Duracon	Roentgen Stereophotogrammetric Analysis (RSA)	0.81 mm	Standard Deviation 0.48

Secondary

Blood Loss

Blood loss during surgery

Time frame: intra-operative

Population: The protocol indicates blood loss as a secondary measure but this value was not collected. Therefore no data can be posted.

Secondary

Duration Hospital Stay

Time frame: preoperative to discharge

Arm	Measure	Value (MEAN)	Dispersion
Triathlon	Duration Hospital Stay	4.9 days	Standard Deviation 2.58
Duracon	Duration Hospital Stay	4.76 days	Standard Deviation 0.91

Secondary

Investigation of Clinical Performance and Patient Outcome With EQ-5D Patient Questionnaire

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.

Time frame: 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

Arm	Measure	Group	Value (MEAN)	Dispersion
Triathlon	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
Triathlon	Investigation of Clinical Performance and Patient Outcome With EQ-5D Patient Questionnaire	EQ-5D 5 years	0.76 units on a scale	Standard Deviation 0.3
Triathlon	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
Triathlon	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
Duracon	Investigation of Clinical Performance and Patient Outcome With EQ-5D Patient Questionnaire	EQ-5D 10 years	0.75 units on a scale	Standard Deviation 0.26
Duracon	Investigation of Clinical Performance and Patient Outcome With EQ-5D Patient Questionnaire	EQ-5D 2 years	0.80 units on a scale	Standard Deviation 0.22
Duracon	Investigation of Clinical Performance and Patient Outcome With EQ-5D Patient Questionnaire	EQ-5D 7 years	0.73 units on a scale	Standard Deviation 0.29
Duracon	Investigation of Clinical Performance and Patient Outcome With EQ-5D Patient Questionnaire	EQ-5D 5 years	0.78 units on a scale	Standard Deviation 0.26

Secondary

Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire

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/

Time frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years

Population: Participants with data available at each time point.

Arm	Measure	Group	Value (MEAN)	Dispersion
Triathlon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	QOL 2 years	62.73 units on a scale	Standard Deviation 25.56
Triathlon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Pain 2 years	79.94 units on a scale	Standard Deviation 19.89
Triathlon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Symptoms 3 months	66.84 units on a scale	Standard Deviation 18.62
Triathlon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Pain 5 years	81.31 units on a scale	Standard Deviation 21.23
Triathlon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	QOL 3 months	51.79 units on a scale	Standard Deviation 20.61
Triathlon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Pain 7 years	80.56 units on a scale	Standard Deviation 19.29
Triathlon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Symptoms 1 year	75.51 units on a scale	Standard Deviation 17.08
Triathlon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Pain 10 years	80.74 units on a scale	Standard Deviation 19.2
Triathlon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	QOL 5 years	69.87 units on a scale	Standard Deviation 30.04
Triathlon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	ADL preoperative	47.27 units on a scale	Standard Deviation 14.58
Triathlon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Symptoms 2 years	78.17 units on a scale	Standard Deviation 16.29
Triathlon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	ADL 3 months	73.22 units on a scale	Standard Deviation 18.23
Triathlon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	QOL pre-operative	23.75 units on a scale	Standard Deviation 14.44
Triathlon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	ADL 1 year	74.28 units on a scale	Standard Deviation 20.23
Triathlon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Symptoms 5 years	81.81 units on a scale	Standard Deviation 20.41
Triathlon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	ADL 5 years	78.07 units on a scale	Standard Deviation 23.6
Triathlon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	QOL 7 years	68.75 units on a scale	Standard Deviation 28.36
Triathlon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	ADL 7 years	75.25 units on a scale	Standard Deviation 22.9
Triathlon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Symptoms 7 years	82.14 units on a scale	Standard Deviation 15.87
Triathlon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	ADL 10 years	73.21 units on a scale	Standard Deviation 24.42
Triathlon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	QOL 1 year	58.48 units on a scale	Standard Deviation 22.13
Triathlon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Sport/Rec preOP	6.5 units on a scale	Standard Deviation 8.22
Triathlon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Symptoms 10 years	81.62 units on a scale	Standard Deviation 19.15
Triathlon	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
Triathlon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	QOL 10 years	65.83 units on a scale	Standard Deviation 25.1
Triathlon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Sport/Rec 1 year	30.46 units on a scale	Standard Deviation 23.8
Triathlon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Pain preoperative	42.11 units on a scale	Standard Deviation 16.88
Triathlon	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
Triathlon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	ADL 2 years	76.74 units on a scale	Standard Deviation 21.78
Triathlon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Sport/Rec 5 years	36.14 units on a scale	Standard Deviation 26.5
Triathlon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Pain 3 months	70.57 units on a scale	Standard Deviation 20.23
Triathlon	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
Triathlon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Symptoms preoperative	51.25 units on a scale	Standard Deviation 18.67
Triathlon	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
Triathlon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Pain 1 year	73.64 units on a scale	Standard Deviation 19.39
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Sport/Rec 10 years	50.15 units on a scale	Standard Deviation 30.29
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	QOL pre-operative	24.38 units on a scale	Standard Deviation 14.62
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	QOL 3 months	54.09 units on a scale	Standard Deviation 23.87
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	QOL 1 year	65.51 units on a scale	Standard Deviation 21.04
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	QOL 2 years	71.35 units on a scale	Standard Deviation 25.42
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	QOL 5 years	80.06 units on a scale	Standard Deviation 18.71
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	QOL 7 years	86.33 units on a scale	Standard Deviation 12.95
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	QOL 10 years	73.53 units on a scale	Standard Deviation 27.56
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Symptoms preoperative	53.65 units on a scale	Standard Deviation 16.36
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Symptoms 3 months	65.87 units on a scale	Standard Deviation 17.5
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Symptoms 1 year	77.51 units on a scale	Standard Deviation 15.84
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Symptoms 2 years	81.87 units on a scale	Standard Deviation 16.57
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Symptoms 5 years	83.16 units on a scale	Standard Deviation 19.4
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Symptoms 7 years	92.63 units on a scale	Standard Deviation 14.13
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Symptoms 10 years	88.45 units on a scale	Standard Deviation 13.15
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Pain preoperative	43.61 units on a scale	Standard Deviation 14.07
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Pain 3 months	70.21 units on a scale	Standard Deviation 21.52
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Pain 1 year	82.77 units on a scale	Standard Deviation 19.59
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Pain 2 years	84.82 units on a scale	Standard Deviation 20.83
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Pain 5 years	85.45 units on a scale	Standard Deviation 19.44
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Pain 7 years	91.15 units on a scale	Standard Deviation 14.74
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Pain 10 years	84.31 units on a scale	Standard Deviation 20.99
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	ADL preoperative	50.14 units on a scale	Standard Deviation 15.58
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	ADL 3 months	73.35 units on a scale	Standard Deviation 23.09
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	ADL 2 years	84.90 units on a scale	Standard Deviation 20.22
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	ADL 5 years	83.05 units on a scale	Standard Deviation 19.39
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	ADL 7 years	89.34 units on a scale	Standard Deviation 13.18
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	ADL 10 years	80.02 units on a scale	Standard Deviation 24.98
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Sport/Rec preOP	10 units on a scale	Standard Deviation 14.2
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Sport/Rec 3 months	29.55 units on a scale	Standard Deviation 21.5
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Sport/Rec 1 year	38.65 units on a scale	Standard Deviation 28.52
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Sport/Rec 2 years	46.17 units on a scale	Standard Deviation 32.47
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Sport/Rec 5 years	38.33 units on a scale	Standard Deviation 30.51
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	Sport/Rec 7 years	44.06 units on a scale	Standard Deviation 33.08
Duracon	Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire	ADL 1 year	84.42 units on a scale	Standard Deviation 15.45

Secondary

Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)

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.

Time frame: [Time Frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years]

Population: Participants with data available at each time point.

Arm	Measure	Group	Value (MEAN)	Dispersion
Triathlon	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
Triathlon	Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)	KSS Function pre-operative	51.17 units on a scale	Standard Deviation 12.3
Triathlon	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 10.5
Triathlon	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
Triathlon	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
Triathlon	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
Triathlon	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
Triathlon	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
Triathlon	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
Triathlon	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
Triathlon	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
Triathlon	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
Triathlon	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
Triathlon	Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)	KSS Function 10 years	78.33 units on a scale	Standard Deviation 21.1
Duracon	Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)	KSS Function 10 years	84.38 units on a scale	Standard Deviation 16.82
Duracon	Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)	KSS Pain/Motion pre-operative	18.3 units on a scale	Standard Deviation 11.24
Duracon	Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)	KSS Pain/Motion 3 months	86.55 units on a scale	Standard Deviation 14.57
Duracon	Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)	KSS Pain/Motion 1 year	95.43 units on a scale	Standard Deviation 9.71
Duracon	Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)	KSS Pain/Motion 2 years	94.79 units on a scale	Standard Deviation 7.55
Duracon	Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)	KSS Pain/Motion 5 years	94.24 units on a scale	Standard Deviation 9.71
Duracon	Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)	KSS Pain/Motion 7 years	95.13 units on a scale	Standard Deviation 11.21
Duracon	Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)	KSS Pain/Motion 10 years	96.79 units on a scale	Standard Deviation 6.83
Duracon	Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)	KSS Function pre-operative	53.67 units on a scale	Standard Deviation 6.81
Duracon	Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)	KSS Function 3 months	72.76 units on a scale	Standard Deviation 14.91
Duracon	Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)	KSS Function 1 year	84.42 units on a scale	Standard Deviation 15
Duracon	Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)	KSS Function 2 years	88.57 units on a scale	Standard Deviation 15.51
Duracon	Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)	KSS Function 5 years	81.67 units on a scale	Standard Deviation 18.66
Duracon	Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)	KSS Function 7 years	92.5 units on a scale	Standard Deviation 15.71

Secondary

Mean Operative Time

Skin to skin operative time

Time frame: intra-operative

Arm	Measure	Value (MEAN)	Dispersion
Triathlon	Mean Operative Time	66.47 minutes	Standard Deviation 9.62
Duracon	Mean Operative Time	63.7 minutes	Standard Deviation 12.21

Secondary

Roentgen Stereophotogrammetric Analysis (RSA)

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

Time frame: 3 months, 1, 5, 7 and 10 years

Population: Participants with data available at each time point.

Arm	Measure	Group	Value (MEAN)	Dispersion
Triathlon	Roentgen Stereophotogrammetric Analysis (RSA)	MTPM 10 years	0.75 mm	Standard Deviation 0.54
Triathlon	Roentgen Stereophotogrammetric Analysis (RSA)	MTPM 3 months	0.45 mm	Standard Deviation 0.28
Triathlon	Roentgen Stereophotogrammetric Analysis (RSA)	MTPM 1 year	0.6 mm	Standard Deviation 0.5
Triathlon	Roentgen Stereophotogrammetric Analysis (RSA)	MTPM 5 years	0.65 mm	Standard Deviation 0.38
Triathlon	Roentgen Stereophotogrammetric Analysis (RSA)	MTPM 7 years	0.67 mm	Standard Deviation 0.46
Duracon	Roentgen Stereophotogrammetric Analysis (RSA)	MTPM 7 years	0.65 mm	Standard Deviation 0.3
Duracon	Roentgen Stereophotogrammetric Analysis (RSA)	MTPM 5 years	1.1 mm	Standard Deviation 1.19
Duracon	Roentgen Stereophotogrammetric Analysis (RSA)	MTPM 3 months	0.44 mm	Standard Deviation 0.27
Duracon	Roentgen Stereophotogrammetric Analysis (RSA)	MTPM 10 years	0.6 mm	Standard Deviation 0.28
Duracon	Roentgen Stereophotogrammetric Analysis (RSA)	MTPM 1 year	0.64 mm	Standard Deviation 0.36

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026

Evaluation of Triathlon - a New Total Knee Prosthesis System - Triathlon vs. Duracon

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Roentgen Stereophotogrammetric Analysis (RSA)

Blood Loss

Duration Hospital Stay

Investigation of Clinical Performance and Patient Outcome With EQ-5D Patient Questionnaire

Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire

Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)

Mean Operative Time

Roentgen Stereophotogrammetric Analysis (RSA)