Trial Outcomes & Findings for Evaluation of Triathlon - A New Total Knee Prosthesis System - Roentgen Stereophotogrammetric Analysis (RSA) Triathlon CR vs. PS (NCT NCT02522728)

Last Updated: 2024-02-22

Results Overview

Roentgen Stereophotogrammetric Analysis (RSA) is a technique to measure migration of prosthesis components relative to the bone which allows conclusions regarding the fixation of an implant. This study assesses the fixation and stability of the Triathlon total knee prosthesis at 2 years by RSA as a predictor of late mechanical loosening.

Recruitment status

COMPLETED

Study phase

Target enrollment

58 participants

Primary outcome timeframe

2 years follow-up

Results posted on

2024-02-22

Participant Flow

Participant milestones

Participant milestones
Measure	Triathlon CR Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome. Triathlon CR: Implantation of Knee Prosthesis	Triathlon PS Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome. Triathlon PS: Implantation of Knee Prosthesis
Overall Study STARTED	28	30
Overall Study COMPLETED	16	19
Overall Study NOT COMPLETED	12	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Triathlon CR Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome. Triathlon CR: Implantation of Knee Prosthesis	Triathlon PS Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome. Triathlon PS: Implantation of Knee Prosthesis
Overall Study Withdrawal by Subject	6	6
Overall Study Death	4	3
Overall Study Adverse Event	2	1
Overall Study Did not receive randomized study device	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Triathlon CR n=28 Participants Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome. Triathlon CR: Implantation of Knee Prosthesis	Triathlon PS n=30 Participants Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome. Triathlon PS: Implantation of Knee Prosthesis	Total n=58 Participants Total of all reporting groups
Age, Continuous	68.07 years STANDARD_DEVIATION 8.11 • n=28 Participants	67.47 years STANDARD_DEVIATION 7.64 • n=30 Participants	67.77 years STANDARD_DEVIATION 7.88 • n=58 Participants
Sex: Female, Male Female	19 Participants n=28 Participants	16 Participants n=30 Participants	35 Participants n=58 Participants
Sex: Female, Male Male	9 Participants n=28 Participants	14 Participants n=30 Participants	23 Participants n=58 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Sweden	28 participants n=28 Participants	30 participants n=30 Participants	58 participants n=58 Participants
Ahlbäck Classification Grade 1	0 Participants n=28 Participants	0 Participants n=30 Participants	0 Participants n=58 Participants
Ahlbäck Classification Grade 2	8 Participants n=28 Participants	18 Participants n=30 Participants	26 Participants n=58 Participants
Ahlbäck Classification Grade 3	20 Participants n=28 Participants	12 Participants n=30 Participants	32 Participants n=58 Participants
Ahlbäck Classification Grade 4	0 Participants n=28 Participants	0 Participants n=30 Participants	0 Participants n=58 Participants
Ahlbäck Classification Grade 5	0 Participants n=28 Participants	0 Participants n=30 Participants	0 Participants n=58 Participants

PRIMARY outcome

Timeframe: 2 years follow-up

Population: The number included in the analysis differs from the overall number analysed because that data were not collected.

Outcome measures

Outcome measures
Measure	Triathlon CR n=22 Participants Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome. Triathlon CR: Implantation of Knee Prosthesis	Triathlon PS n=27 Participants Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome. Triathlon PS: Implantation of Knee Prosthesis
Assessment of Fixation and Stability of the Triathlon Total Knee Prosthesis by Roentgen Stereophotogrammetric Analysis (RSA)	0.68 mm Standard Deviation 0.41	0.79 mm Standard Deviation 0.53

SECONDARY outcome

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

Population: The number included in the analysis in one or more rows differs from the overall number analysed because that data were not collected.

The Knee Society Clinical Rating System is comprised of two distinct sub-scores: 1. assessment score for pain, range of motion (ROM) and joint stability, 2. score 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 CR n=28 Participants Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome. Triathlon CR: Implantation of Knee Prosthesis	Triathlon PS n=30 Participants Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome. Triathlon PS: Implantation of Knee Prosthesis
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) pre-op assessment score	20.43 units on a scale Standard Deviation 8.37	25.5 units on a scale Standard Deviation 7.41
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) 3 months assessment score	91.88 units on a scale Standard Deviation 9.94	91.57 units on a scale Standard Deviation 12.65
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) 1 year assessment score	95.00 units on a scale Standard Deviation 7.61	94.70 units on a scale Standard Deviation 8.32
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) 2 years assessment score	97.00 units on a scale Standard Deviation 5.41	97.39 units on a scale Standard Deviation 4.60
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) 5 years assessment score	95.47 units on a scale Standard Deviation 9.64	98.33 units on a scale Standard Deviation 3.42
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) 7 years assessment score	94.12 units on a scale Standard Deviation 11.88	98.10 units on a scale Standard Deviation 4.58
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) 10 years assessment score	95.06 units on a scale Standard Deviation 12.57	97.78 units on a scale Standard Deviation 6.99
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) pre-op function score	49.11 units on a scale Standard Deviation 11.71	50.67 units on a scale Standard Deviation 12.71
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) 3 months function score	79.80 units on a scale Standard Deviation 15.10	72.17 units on a scale Standard Deviation 17.78
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) 1 year function score	88.54 units on a scale Standard Deviation 17.41	85.00 units on a scale Standard Deviation 16.76
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) 2 years function score	94.32 units on a scale Standard Deviation 8.49	89.46 units on a scale Standard Deviation 15.89
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) 5 years function score	87.89 units on a scale Standard Deviation 17.27	89.79 units on a scale Standard Deviation 17.84
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) 7 years function score	89.41 units on a scale Standard Deviation 15.70	88.00 units on a scale Standard Deviation 16.42
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) 10 years function score	93.43 units on a scale Standard Deviation 13.26	91.39 units on a scale Standard Deviation 13.48

SECONDARY outcome

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

Population: The number included in the analysis in one or more rows differs from the overall number analysed because that data were not collected.

KOOS consists of 5 subscales: Pain, other symptoms, function in daily living , function in sport and recreation 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 problems or a better outcome and 0 indicating extreme problems or a worse outcome).

Outcome measures

Outcome measures
Measure	Triathlon CR n=28 Participants Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome. Triathlon CR: Implantation of Knee Prosthesis	Triathlon PS n=30 Participants Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome. Triathlon PS: Implantation of Knee Prosthesis
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire pre-op symptom	47.37 units on a scale Standard Deviation 18.19	54.66 units on a scale Standard Deviation 20.05
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire 3 months symptom	65.67 units on a scale Standard Deviation 17.13	66.11 units on a scale Standard Deviation 14.47
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire 1 year symptom	75.96 units on a scale Standard Deviation 18.72	76.19 units on a scale Standard Deviation 14.99
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire 2 years symptom	91.49 units on a scale Standard Deviation 18.46	82.78 units on a scale Standard Deviation 15.49
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire 5 years symptom	86.47 units on a scale Standard Deviation 19.94	87.80 units on a scale Standard Deviation 12.19
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire 7 years symptom	82.98 units on a scale Standard Deviation 18.58	87.86 units on a scale Standard Deviation 11.73
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire 10 years symptom	84.29 units on a scale Standard Deviation 18.30	84.82 units on a scale Standard Deviation 14.42
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire pre-op pain	38.79 units on a scale Standard Deviation 18.56	43.80 units on a scale Standard Deviation 18.57
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire 3 months pain	70.11 units on a scale Standard Deviation 15.51	71.62 units on a scale Standard Deviation 20.20
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire 1 year pain	83.77 units on a scale Standard Deviation 14.17	79.81 units on a scale Standard Deviation 18.92
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire 2 years pain	88.01 units on a scale Standard Deviation 17.32	87.98 units on a scale Standard Deviation 13.75
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire 5 years pain	85.53 units on a scale Standard Deviation 23.86	90.74 units on a scale Standard Deviation 13.84
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire 7 years pain	86.37 units on a scale Standard Deviation 24.03	88.19 units on a scale Standard Deviation 15.61
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire 10 years pain	90.88 units on a scale Standard Deviation 17.16	88.49 units on a scale Standard Deviation 14.47
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire pre-op ADL	44.16 units on a scale Standard Deviation 16.16	45.07 units on a scale Standard Deviation 14.86
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire 3 months ADL	72.28 units on a scale Standard Deviation 14.82	73.68 units on a scale Standard Deviation 18.70
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire 1 year ADL	83.64 units on a scale Standard Deviation 17.07	78.73 units on a scale Standard Deviation 19.86
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire 2 years ADL	86.61 units on a scale Standard Deviation 14.21	83.85 units on a scale Standard Deviation 15.62
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire 5 years ADL	84.06 units on a scale Standard Deviation 20.82	87.32 units on a scale Standard Deviation 16.98
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire 7 years ADL	84.26 units on a scale Standard Deviation 20.08	84.20 units on a scale Standard Deviation 19.31
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire 10 years ADL	88.53 units on a scale Standard Deviation 18.61	82.82 units on a scale Standard Deviation 18.05
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire pre-op Sport Rec	18.15 units on a scale Standard Deviation 25.39	11.72 units on a scale Standard Deviation 12.77
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire 3 months Sport Rec	27.80 units on a scale Standard Deviation 19.16	30.70 units on a scale Standard Deviation 24.00
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire 1 year Sport Rec	38.91 units on a scale Standard Deviation 21.84	37.81 units on a scale Standard Deviation 23.65
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire 2 years Sport Rec	41.88 units on a scale Standard Deviation 27.45	45.53 units on a scale Standard Deviation 22.21
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire 5 years Sport Rec	41.32 units on a scale Standard Deviation 31.26	56.46 units on a scale Standard Deviation 29.40
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire 7 years Sport Rec	45.88 units on a scale Standard Deviation 30.68	44.00 units on a scale Standard Deviation 24.58
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire 10 years Sport Rec	52.67 units on a scale Standard Deviation 27.77	43.75 units on a scale Standard Deviation 28.37
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire Pre-op QOL	21.76 units on a scale Standard Deviation 11.55	24.57 units on a scale Standard Deviation 14.46
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire 3 months QOL	52.25 units on a scale Standard Deviation 17.29	56.47 units on a scale Standard Deviation 22.72
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire 1 year QOL	68.84 units on a scale Standard Deviation 18.05	67.63 units on a scale Standard Deviation 24.59
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire 2 years QOL	77.84 units on a scale Standard Deviation 22.14	79.02 units on a scale Standard Deviation 19.70
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire 5 years QOL	80.59 units on a scale Standard Deviation 24.99	82.55 units on a scale Standard Deviation 18.97
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire 7 years QOL	75.54 units on a scale Standard Deviation 25.66	81.25 units on a scale Standard Deviation 17.33
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire 10 years QOL	64.43 units on a scale Standard Deviation 18.79	63.75 units on a scale Standard Deviation 11.93

SECONDARY outcome

Timeframe: 1, 2, 5, 7 and 10 years

Population: The number included in the analysis in one or more rows differs from the overall number analysed because that data were not collected.

The EQ-5D is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas; EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises the following five dimensions: mobility self care, usual activities, pain/comfort and anxiety/depression. Each dimension has 3 levels indicating no problems, some problems or extreme problems. The index values on a scale between -1 (low) and 1 (high) are showing the average health status according to the 5 dimensions: A low score shows worse health and a high score shows better health. With the EQ VAS the respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).

Outcome measures

Outcome measures
Measure	Triathlon CR n=28 Participants Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome. Triathlon CR: Implantation of Knee Prosthesis	Triathlon PS n=30 Participants Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome. Triathlon PS: Implantation of Knee Prosthesis
Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire Descriptive EQ-5D 1 year	0.88 units on a scale Standard Deviation 0.15	0.80 units on a scale Standard Deviation 0.12
Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire Descriptive EQ-5D 2 years	0.88 units on a scale Standard Deviation 0.15	0.89 units on a scale Standard Deviation 0.12
Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire Descriptive EQ-5D 5 years	0.85 units on a scale Standard Deviation 0.28	0.87 units on a scale Standard Deviation 0.15
Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire Descriptive EQ-5D 7 years	0.82 units on a scale Standard Deviation 0.16	0.75 units on a scale Standard Deviation 0.35
Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire Descriptive EQ-5D 10 years	0.91 units on a scale Standard Deviation 0.16	0.90 units on a scale Standard Deviation 0.14
Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire EQ-5D VAS 1 year	84 units on a scale Standard Deviation 14	83 units on a scale Standard Deviation 13
Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire EQ-5D VAS 2 year	82 units on a scale Standard Deviation 18	84 units on a scale Standard Deviation 16
Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire EQ-5D VAS 5 year	74 units on a scale Standard Deviation 14	85 units on a scale Standard Deviation 15
Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire EQ-5D VAS 7 year	78 units on a scale Standard Deviation 15	83 units on a scale Standard Deviation 23
Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire EQ-5D VAS 10 year	79 units on a scale Standard Deviation 21	83 units on a scale Standard Deviation 15

SECONDARY outcome

Timeframe: 3 months, 1, 2, 5, 7 and 10 years

Population: Plain radiographs were used for disease classification. Additional radiographs were not collected for the assessment of device fixation as the RSA analysis was used as an exact measurement of prosthesis components migration and implant fixation.

Plain radiographs will be obtained for assessment of fixation of the device.

Outcome measures

Outcome data not reported

Adverse Events

Triathlon CR

Serious events: 3 serious events

Other events: 0 other events

Deaths: 4 deaths

Triathlon PS

Serious events: 2 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Triathlon CR n=28 participants at risk Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome. Triathlon CR: Implantation of Knee Prosthesis	Triathlon PS n=30 participants at risk Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome. Triathlon PS: Implantation of Knee Prosthesis
Musculoskeletal and connective tissue disorders Total knee replacement	3.6% 1/28 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleomorphic Adenoma of Salivary Glands	0.00% 0/28 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Cancer	0.00% 0/28 • 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.
Nervous system disorders Epileptic fit	3.6% 1/28 • 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.
Vascular disorders Pressure Stroke	3.6% 1/28 • 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.

Other adverse events

Adverse event data not reported

Additional Information

Eric Garling, PhD Snr. Director Medical & Scientific Affairs Europe

Stryker Orthopaedics

Phone: +31 6 467 135 18

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60