Trial Outcomes & Findings for Stryker NTX Registry Scorpio NRG (Re-"Energize"), Triathlon Total Knee, Triathlon Partial Knee Resurfacing (PKR) With X3 Polyethylene Insert (NCT NCT02525562)

Last Updated: 2024-02-22

Results Overview

Survivorship shown in Kaplan Meier survival curves (statistic used to estimate the survival function from lifetime data).

Recruitment status

TERMINATED

Study phase

Target enrollment

237 participants

Primary outcome timeframe

Preoperative to 1 year, 1 year, 3 years, and 5 years. Survivorship is unavailable at 10 years due to study termination.

Results posted on

2024-02-22

Participant Flow

237 participants enrolled - 14 participants censored = 223 participants followed. All participants received a Triathlon Total Knee Replacement. No participants received a Scorpio NRG Total Knee Replacement or a Triathlon Partial Knee Resurfacing Replacement.

Participant milestones

Participant milestones
Measure	Triathlon Total Knee System Patients eligible for Triathlon Total Knee System with X3 insert Triathlon Total Knee System with X3 insert: Total knee replacement Total Knee Replacement: Total Knee Replacement	Scorpio NRG Total Knee System Patients eligible for Scorpio NRG Total Knee System with X3 insert Scorpio NRG Total Knee System with X3 insert: Total knee replacement Total Knee Replacement: Total Knee Replacement	Triathlon Partial Knee Resurfacing Patients eligible for Triathlon PKR System with X3 insert Triathlon PKR System with X3 insert: Partial Knee Resurfacing Partial Knee Resurfacing: Partial Knee Resurfacing
Overall Study STARTED	223	0	0
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	223	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Triathlon Total Knee System Patients eligible for Triathlon Total Knee System with X3 insert Triathlon Total Knee System with X3 insert: Total knee replacement Total Knee Replacement: Total Knee Replacement	Scorpio NRG Total Knee System Patients eligible for Scorpio NRG Total Knee System with X3 insert Scorpio NRG Total Knee System with X3 insert: Total knee replacement Total Knee Replacement: Total Knee Replacement	Triathlon Partial Knee Resurfacing Patients eligible for Triathlon PKR System with X3 insert Triathlon PKR System with X3 insert: Partial Knee Resurfacing Partial Knee Resurfacing: Partial Knee Resurfacing
Overall Study Death	9	0	0
Overall Study Lost to Follow-up	19	0	0
Overall Study Withdrawal by Subject	37	0	0
Overall Study Revision/Removal of Study Device	4	0	0
Overall Study Study Closed by Sponsor	154	0	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Triathlon Total Knee System n=223 Participants Patients eligible for Triathlon Total Knee System with X3 insert Triathlon Total Knee System with X3 insert: Total knee replacement Total Knee Replacement: Total Knee Replacement
Age, Continuous	68.61 Years STANDARD_DEVIATION 8.08 • n=223 Participants
Sex: Female, Male Female	151 Participants n=223 Participants
Sex: Female, Male Male	72 Participants n=223 Participants
Region of Enrollment Luxembourg	30 participants n=223 Participants
Region of Enrollment United Kingdom	100 participants n=223 Participants
Region of Enrollment Germany	93 participants n=223 Participants

PRIMARY outcome

Timeframe: Preoperative to 1 year, 1 year, 3 years, and 5 years. Survivorship is unavailable at 10 years due to study termination.

Population: This primary outcome measure (10 year) was not analyzed due to termination of the study. Results display number of participants at each timepoint (i.e., preoperative to 1 year, 1 year, 3 years, and 5 years) that remain free from revision; 10 year not reported due to study termination. Overall number of participants analyzed is based upon the preoperative to 1 year population, originally 223 participants with 4 early terms (no surgery), therefore n=219.

Survivorship shown in Kaplan Meier survival curves (statistic used to estimate the survival function from lifetime data).

Outcome measures

Outcome measures
Measure	Triathlon Total Knee System n=219 Participants Patients eligible for Triathlon Total Knee System with X3 insert Triathlon Total Knee System with X3 insert: Total knee replacement Total Knee Replacement: Total Knee Replacement
Survivorship of the Device Free from Revision at Preoperative to 1 year	218 participants free from revision
Survivorship of the Device Free from Revision at 1 year	207 participants free from revision
Survivorship of the Device Free from Revision at 3 years	170 participants free from revision
Survivorship of the Device Free from Revision at 5 years	150 participants free from revision

SECONDARY outcome

Timeframe: Pre-operative, 1, 3, and 5 years. The KSS for 7 and 10 year timepoints are unavailable due to study termination.

Population: Participants with available data through 5 years. Overall number of participants analyzed is based upon the pre-operative population that completed a KSS evaluation. One participant did not have data KSS data available at the preoperative timepoint (n=222).

The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability (Pain/Motion KSS subscale is 0 to 100, with 100 representing a better outcome), and one for functional parameters (Function KSS subscale is 0 to 100, with 100 representing a better outcome). Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points, and Combined KSS is the summed average of the Pain/Motion and Function sub-scores, leading to a Combined KSS total ranging from 0 to 200 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 Total Knee System n=222 Participants Patients eligible for Triathlon Total Knee System with X3 insert Triathlon Total Knee System with X3 insert: Total knee replacement Total Knee Replacement: Total Knee Replacement
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) Combined KSS Mean Preoperative Score (0-200 points)	101.1 units on a scale Standard Deviation 26.53
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) Combined KSS Mean 1 Year Score (0-200 points)	155.32 units on a scale Standard Deviation 29.82
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) Combined KSS Mean 3 Year Score (0-200 points)	161.4 units on a scale Standard Deviation 30.03
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) Combined KSS Mean 5 Year Score (0-200 points)	158.03 units on a scale Standard Deviation 29.32

SECONDARY outcome

Timeframe: Pre-operative, 1, 3, and 5 years. The KOOS for 7 and 10 year timepoints are unavailable due to study termination.

Population: Participants with available data through 5 years. Overall number of participants analyzed is based upon the pre-operative population. The Function in Sport and Recreation, Number of Analyzed Participants at 3-years and 5-years is lower than other subscales due to participants not selecting a box on the Likert scale at these timepoints.

KOOS consists of 5 subscales: Symptoms, Pain, 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 for each subscale (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score is calculated for each subscale, with a minimum of 0 indicating extreme symptoms and a maximum of 100 indicating no symptoms. Only subscale scores are reported.

Outcome measures

Outcome measures
Measure	Triathlon Total Knee System n=223 Participants Patients eligible for Triathlon Total Knee System with X3 insert Triathlon Total Knee System with X3 insert: Total knee replacement Total Knee Replacement: Total Knee Replacement
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. Quality of Life: KOOS Mean Preoperative Score	23.12 units on a scale Standard Deviation 17.22
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. Symptoms: KOOS Mean Preoperative Score	45.95 units on a scale Standard Deviation 19.96
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. Symptoms: KOOS Mean 1 Year Score	78.96 units on a scale Standard Deviation 16.42
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. Symptoms: KOOS Mean 3 Year Score	81.05 units on a scale Standard Deviation 17.23
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. Symptoms: KOOS Mean 5 Year Score	81.43 units on a scale Standard Deviation 16.7
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. Pain: KOOS Mean Preoperative Score	40.02 units on a scale Standard Deviation 17.51
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. Pain: KOOS Mean 1 Year Score	81.2 units on a scale Standard Deviation 17.59
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. Pain: KOOS Mean 3 Year Score	82.28 units on a scale Standard Deviation 19.93
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. Pain: KOOS Mean 5 Year Score	82.02 units on a scale Standard Deviation 19.98
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. Function, Daily Living: KOOS Mean Preoperative Score	43.05 units on a scale Standard Deviation 19.27
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. Function, Daily Living: KOOS Mean 1 Year Score	79.28 units on a scale Standard Deviation 18.68
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. Function, Daily Living: KOOS Mean 3 Year Score	80.33 units on a scale Standard Deviation 20.68
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. Function, Daily Living: KOOS Mean 5 Year Score	78.86 units on a scale Standard Deviation 21.38
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. Function, Sports and Recreational: KOOS Mean Preoperative Score	14.46 units on a scale Standard Deviation 19.93
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. Function, Sports and Recreational: KOOS Mean 1 Year Score	47.24 units on a scale Standard Deviation 29.27
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. Function, Sports and Recreational: KOOS Mean 3 Year Score	52.11 units on a scale Standard Deviation 30.86
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. Function, Sports and Recreational: KOOS Mean 5 Year Score	50.42 units on a scale Standard Deviation 30.65
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. Quality of Life: KOOS Mean 1 Year Score	67.11 units on a scale Standard Deviation 25.33
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. Quality of Life: KOOS Mean 3 Year Score	67.02 units on a scale Standard Deviation 27.19
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. Quality of Life: KOOS Mean 5 Year Score	69.77 units on a scale Standard Deviation 26.17

SECONDARY outcome

Timeframe: Pre-operative, 1, 3, and 5 years. The EQ-5D for 7 and 10 year timepoints is unavailable due to study termination.

Population: Participants with available data through 5 years. Overall number of participants analyzed is based upon the pre-operative population with EQ-5D data available. Number of Analyzed Participants at the Preoperative timepoint for this assessment (EQ-5D) is fewer than overall due to two participants not completing the preoperative questionnaire, therefore n=221.

The EuroQol-5 Dimension (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 visual analogue scale (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 Total Knee System n=221 Participants Patients eligible for Triathlon Total Knee System with X3 insert Triathlon Total Knee System with X3 insert: Total knee replacement Total Knee Replacement: Total Knee Replacement
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D) Patient Questionnaire. Descriptive EQ-5D: Mean Preoperative Score	0.42 units on a scale Standard Deviation 0.33
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D) Patient Questionnaire. Descriptive EQ-5D: Mean 1 Year Score	0.76 units on a scale Standard Deviation 0.26
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D) Patient Questionnaire. Descriptive EQ-5D: Mean 3 Year Score	0.77 units on a scale Standard Deviation 0.26
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D) Patient Questionnaire. Descriptive EQ-5D: Mean 5 Year Score	0.76 units on a scale Standard Deviation 0.27
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D) Patient Questionnaire. EQ-5D VAS: Mean Preoperative Score	62 units on a scale Standard Deviation 21.9
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D) Patient Questionnaire. EQ-5D VAS: Mean 1 Year Score	74.7 units on a scale Standard Deviation 19.1
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D) Patient Questionnaire. EQ-5D VAS: Mean 3 Year Score	73.6 units on a scale Standard Deviation 19.8
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D) Patient Questionnaire. EQ-5D VAS: Mean 5 Year Score	71.5 units on a scale Standard Deviation 19.5

Adverse Events

Operative Adverse Events

Serious events: 18 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-operative Adverse Events

Serious events: 55 serious events

Other events: 52 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Operative Adverse Events n=223 participants at risk Triathlon Total Knee System with X3 insert, reported by participant.	Non-operative Adverse Events n=223 participants at risk Triathlon Total Knee System with X3 insert, reported by participant.
Cardiac disorders Non-operative	— 0/0 • All operative site and general medical adverse events, as well as elective surgery involving other joints, over the course of the 5-year surveillance period (original 10 years surveillance, however, study terminated early). Censored were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard Adverse Event (AE) and Serious Adverse Event) SAE terms were used in this study.	4.9% 11/223 • Number of events 11 • All operative site and general medical adverse events, as well as elective surgery involving other joints, over the course of the 5-year surveillance period (original 10 years surveillance, however, study terminated early). Censored were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard Adverse Event (AE) and Serious Adverse Event) SAE terms were used in this study.
Eye disorders Non-Operative	— 0/0 • All operative site and general medical adverse events, as well as elective surgery involving other joints, over the course of the 5-year surveillance period (original 10 years surveillance, however, study terminated early). Censored were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard Adverse Event (AE) and Serious Adverse Event) SAE terms were used in this study.	0.45% 1/223 • Number of events 1 • All operative site and general medical adverse events, as well as elective surgery involving other joints, over the course of the 5-year surveillance period (original 10 years surveillance, however, study terminated early). Censored were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard Adverse Event (AE) and Serious Adverse Event) SAE terms were used in this study.
Gastrointestinal disorders Non-Operative	— 0/0 • All operative site and general medical adverse events, as well as elective surgery involving other joints, over the course of the 5-year surveillance period (original 10 years surveillance, however, study terminated early). Censored were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard Adverse Event (AE) and Serious Adverse Event) SAE terms were used in this study.	2.7% 6/223 • Number of events 6 • All operative site and general medical adverse events, as well as elective surgery involving other joints, over the course of the 5-year surveillance period (original 10 years surveillance, however, study terminated early). Censored were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard Adverse Event (AE) and Serious Adverse Event) SAE terms were used in this study.
Infections and infestations Operative	0.45% 1/223 • Number of events 1 • All operative site and general medical adverse events, as well as elective surgery involving other joints, over the course of the 5-year surveillance period (original 10 years surveillance, however, study terminated early). Censored were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard Adverse Event (AE) and Serious Adverse Event) SAE terms were used in this study.	— 0/0 • All operative site and general medical adverse events, as well as elective surgery involving other joints, over the course of the 5-year surveillance period (original 10 years surveillance, however, study terminated early). Censored were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard Adverse Event (AE) and Serious Adverse Event) SAE terms were used in this study.
Infections and infestations Non-Operative	— 0/0 • All operative site and general medical adverse events, as well as elective surgery involving other joints, over the course of the 5-year surveillance period (original 10 years surveillance, however, study terminated early). Censored were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard Adverse Event (AE) and Serious Adverse Event) SAE terms were used in this study.	0.45% 1/223 • Number of events 1 • All operative site and general medical adverse events, as well as elective surgery involving other joints, over the course of the 5-year surveillance period (original 10 years surveillance, however, study terminated early). Censored were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard Adverse Event (AE) and Serious Adverse Event) SAE terms were used in this study.
Injury, poisoning and procedural complications Operative	0.90% 2/223 • Number of events 2 • All operative site and general medical adverse events, as well as elective surgery involving other joints, over the course of the 5-year surveillance period (original 10 years surveillance, however, study terminated early). Censored were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard Adverse Event (AE) and Serious Adverse Event) SAE terms were used in this study.	— 0/0 • All operative site and general medical adverse events, as well as elective surgery involving other joints, over the course of the 5-year surveillance period (original 10 years surveillance, however, study terminated early). Censored were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard Adverse Event (AE) and Serious Adverse Event) SAE terms were used in this study.
Musculoskeletal and connective tissue disorders Operative	5.8% 13/223 • Number of events 13 • All operative site and general medical adverse events, as well as elective surgery involving other joints, over the course of the 5-year surveillance period (original 10 years surveillance, however, study terminated early). Censored were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard Adverse Event (AE) and Serious Adverse Event) SAE terms were used in this study.	— 0/0 • All operative site and general medical adverse events, as well as elective surgery involving other joints, over the course of the 5-year surveillance period (original 10 years surveillance, however, study terminated early). Censored were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard Adverse Event (AE) and Serious Adverse Event) SAE terms were used in this study.
Musculoskeletal and connective tissue disorders Non-Operative	— 0/0 • All operative site and general medical adverse events, as well as elective surgery involving other joints, over the course of the 5-year surveillance period (original 10 years surveillance, however, study terminated early). Censored were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard Adverse Event (AE) and Serious Adverse Event) SAE terms were used in this study.	7.2% 16/223 • Number of events 18 • All operative site and general medical adverse events, as well as elective surgery involving other joints, over the course of the 5-year surveillance period (original 10 years surveillance, however, study terminated early). Censored were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard Adverse Event (AE) and Serious Adverse Event) SAE terms were used in this study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Operative	— 0/0 • All operative site and general medical adverse events, as well as elective surgery involving other joints, over the course of the 5-year surveillance period (original 10 years surveillance, however, study terminated early). Censored were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard Adverse Event (AE) and Serious Adverse Event) SAE terms were used in this study.	4.0% 9/223 • Number of events 9 • All operative site and general medical adverse events, as well as elective surgery involving other joints, over the course of the 5-year surveillance period (original 10 years surveillance, however, study terminated early). Censored were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard Adverse Event (AE) and Serious Adverse Event) SAE terms were used in this study.
Nervous system disorders Non-Operative	— 0/0 • All operative site and general medical adverse events, as well as elective surgery involving other joints, over the course of the 5-year surveillance period (original 10 years surveillance, however, study terminated early). Censored were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard Adverse Event (AE) and Serious Adverse Event) SAE terms were used in this study.	0.45% 1/223 • Number of events 1 • All operative site and general medical adverse events, as well as elective surgery involving other joints, over the course of the 5-year surveillance period (original 10 years surveillance, however, study terminated early). Censored were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard Adverse Event (AE) and Serious Adverse Event) SAE terms were used in this study.
Renal and urinary disorders Non-Operative	— 0/0 • All operative site and general medical adverse events, as well as elective surgery involving other joints, over the course of the 5-year surveillance period (original 10 years surveillance, however, study terminated early). Censored were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard Adverse Event (AE) and Serious Adverse Event) SAE terms were used in this study.	1.8% 4/223 • Number of events 5 • All operative site and general medical adverse events, as well as elective surgery involving other joints, over the course of the 5-year surveillance period (original 10 years surveillance, however, study terminated early). Censored were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard Adverse Event (AE) and Serious Adverse Event) SAE terms were used in this study.
Reproductive system and breast disorders Non-Operative	— 0/0 • All operative site and general medical adverse events, as well as elective surgery involving other joints, over the course of the 5-year surveillance period (original 10 years surveillance, however, study terminated early). Censored were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard Adverse Event (AE) and Serious Adverse Event) SAE terms were used in this study.	0.45% 1/223 • Number of events 1 • All operative site and general medical adverse events, as well as elective surgery involving other joints, over the course of the 5-year surveillance period (original 10 years surveillance, however, study terminated early). Censored were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard Adverse Event (AE) and Serious Adverse Event) SAE terms were used in this study.
Skin and subcutaneous tissue disorders Operative	0.90% 2/223 • Number of events 2 • All operative site and general medical adverse events, as well as elective surgery involving other joints, over the course of the 5-year surveillance period (original 10 years surveillance, however, study terminated early). Censored were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard Adverse Event (AE) and Serious Adverse Event) SAE terms were used in this study.	— 0/0 • All operative site and general medical adverse events, as well as elective surgery involving other joints, over the course of the 5-year surveillance period (original 10 years surveillance, however, study terminated early). Censored were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard Adverse Event (AE) and Serious Adverse Event) SAE terms were used in this study.
Vascular disorders Non-Operative	— 0/0 • All operative site and general medical adverse events, as well as elective surgery involving other joints, over the course of the 5-year surveillance period (original 10 years surveillance, however, study terminated early). Censored were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard Adverse Event (AE) and Serious Adverse Event) SAE terms were used in this study.	2.2% 5/223 • Number of events 5 • All operative site and general medical adverse events, as well as elective surgery involving other joints, over the course of the 5-year surveillance period (original 10 years surveillance, however, study terminated early). Censored were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard Adverse Event (AE) and Serious Adverse Event) SAE terms were used in this study.

Other adverse events

Other adverse events
Measure	Operative Adverse Events n=223 participants at risk Triathlon Total Knee System with X3 insert, reported by participant.	Non-operative Adverse Events n=223 participants at risk Triathlon Total Knee System with X3 insert, reported by participant.
Musculoskeletal and connective tissue disorders Non-Operative	— 0/0 • All operative site and general medical adverse events, as well as elective surgery involving other joints, over the course of the 5-year surveillance period (original 10 years surveillance, however, study terminated early). Censored were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard Adverse Event (AE) and Serious Adverse Event) SAE terms were used in this study.	4.9% 11/223 • Number of events 11 • All operative site and general medical adverse events, as well as elective surgery involving other joints, over the course of the 5-year surveillance period (original 10 years surveillance, however, study terminated early). Censored were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard Adverse Event (AE) and Serious Adverse Event) SAE terms were used in this study.
Musculoskeletal and connective tissue disorders Elective Procedures	— 0/0 • All operative site and general medical adverse events, as well as elective surgery involving other joints, over the course of the 5-year surveillance period (original 10 years surveillance, however, study terminated early). Censored were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard Adverse Event (AE) and Serious Adverse Event) SAE terms were used in this study.	18.4% 41/223 • Number of events 47 • All operative site and general medical adverse events, as well as elective surgery involving other joints, over the course of the 5-year surveillance period (original 10 years surveillance, however, study terminated early). Censored were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard Adverse Event (AE) and Serious Adverse Event) SAE terms were used in this study.

Additional Information

Stryker JR Clinical Research

Stryker Orthopaedics

Phone: 201-831-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee There is an agreement between Principal Investigators and the Sponsor (or its agents) that requires Investigators to allow Sponsor at least 30 days to review material intended for publications in order to redact any Confidential Information or Inventions therefrom.
Publication restrictions are in place

Restriction type: OTHER