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Stryker NTX Registry Scorpio NRG (Re-Energize), Triathlon Total Knee, Triathlon Partial Knee Resurfacing (PKR) With X3 Polyethylene Insert

Stryker NTX Registry Scorpio NRG Triathlon Total Knee, Triathlon PKR With X3 Insert International Multicentre Outcomes Register

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02525562
Acronym
NTX
Enrollment
237
Registered
2015-08-17
Start date
2012-06-28
Completion date
2020-05-28
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

Provide outcomes information with regard to surgical and implant performance and patient clinical outcomes of the patients who are eligible for either a Total Knee Arthroplasty (TKA) replacement surgery or Partial Knee Resurfacing (unicompartmental knee arthroplasty, UKA)

Detailed description

The objective of this registry is to provide outcomes information with regard to surgical and implant performance and patient clinical outcomes of the patients who are eligible for a either a Total Knee Arthroplasty (TKA) replacement surgery involving the Scorpio NRG or Triathlon Total Knee System or Triathlon PKR Partial Knee Resurfacing (unicompartmental knee arthroplasty, UKA), all of which with X3 inlay. The register will follow the standard clinical procedures used by the institutions for patient selection for knee arthroplasty surgery, patient surgery and patient follow-up. Therefore there will be, with regard to this register, no additional assessment, examination, procedure or follow-up visits compared to those usually performed in the institution (routine standard normal procedures).

Interventions

DEVICETriathlon Total Knee System with X3 insert

Total knee replacement

DEVICEScorpio NRG Total Knee System with X3 insert

Total knee replacement

DEVICETriathlon PKR System with X3 insert

Partial Knee Resurfacing

PROCEDURETotal Knee Replacement

Total Knee Replacement

PROCEDUREPartial Knee Resurfacing

Partial Knee Resurfacing

Sponsors

Stryker Orthopaedics
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. Patients requiring primary TKA, suitable for the use of the Scorpio NRG with X3 insert or Triathlon Total Knee System with X3 insert, or, patients requiring partial knee resurfacing (unicompartmental knee) suitable for the use of the Triathlon PKR (Partial Knee Resurfacing) System with X3 insert 2. Patients who understand the conditions of the outcomes registry and are willing and able to comply with the standard post-operative evaluations and the prescribed rehabilitation. 3. Patients who signed the Informed Consent Form (approved by Ethics Committee if required) prior to surgery.

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Survivorship of the DevicePreoperative to 1 year, 1 year, 3 years, and 5 years. Survivorship is unavailable at 10 years due to study termination.Survivorship shown in Kaplan Meier survival curves (statistic used to estimate the survival function from lifetime data).

Secondary

MeasureTime frameDescription
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)Pre-operative, 1, 3, and 5 years. The KSS for 7 and 10 year timepoints are unavailable due to study termination.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.
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.Pre-operative, 1, 3, and 5 years. The KOOS for 7 and 10 year timepoints are unavailable due to study termination.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.
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D) Patient Questionnaire.Pre-operative, 1, 3, and 5 years. The EQ-5D for 7 and 10 year timepoints is unavailable due to study termination.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).

Countries

Germany, Luxembourg, United Kingdom

Participant flow

Pre-assignment details

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.

Participants by arm

ArmCount
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
223
Total223

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyDeath900
Overall StudyLost to Follow-up1900
Overall StudyRevision/Removal of Study Device400
Overall StudyStudy Closed by Sponsor15400
Overall StudyWithdrawal by Subject3700

Baseline characteristics

CharacteristicTriathlon Total Knee System
Age, Continuous68.61 Years
STANDARD_DEVIATION 8.08
Race and Ethnicity Not Collected— Participants
Region of Enrollment
Germany
93 participants
Region of Enrollment
Luxembourg
30 participants
Region of Enrollment
United Kingdom
100 participants
Sex: Female, Male
Female
151 Participants
Sex: Female, Male
Male
72 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2239 / 223
other
Total, other adverse events
0 / 22352 / 223
serious
Total, serious adverse events
18 / 22355 / 223

Outcome results

Primary

Survivorship of the Device

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

Time frame: 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.

ArmMeasureGroupValue (NUMBER)
Triathlon Total Knee SystemSurvivorship of the DeviceFree from Revision at Preoperative to 1 year218 participants free from revision
Triathlon Total Knee SystemSurvivorship of the DeviceFree from Revision at 1 year207 participants free from revision
Triathlon Total Knee SystemSurvivorship of the DeviceFree from Revision at 3 years170 participants free from revision
Triathlon Total Knee SystemSurvivorship of the DeviceFree from Revision at 5 years150 participants free from revision
Secondary

Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D) Patient Questionnaire.

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).

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Triathlon Total Knee SystemInvestigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D) Patient Questionnaire.Descriptive EQ-5D: Mean 5 Year Score0.76 units on a scaleStandard Deviation 0.27
Triathlon Total Knee SystemInvestigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D) Patient Questionnaire.EQ-5D VAS: Mean Preoperative Score62 units on a scaleStandard Deviation 21.9
Triathlon Total Knee SystemInvestigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D) Patient Questionnaire.EQ-5D VAS: Mean 1 Year Score74.7 units on a scaleStandard Deviation 19.1
Triathlon Total Knee SystemInvestigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D) Patient Questionnaire.EQ-5D VAS: Mean 3 Year Score73.6 units on a scaleStandard Deviation 19.8
Triathlon Total Knee SystemInvestigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D) Patient Questionnaire.Descriptive EQ-5D: Mean Preoperative Score0.42 units on a scaleStandard Deviation 0.33
Triathlon Total Knee SystemInvestigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D) Patient Questionnaire.Descriptive EQ-5D: Mean 1 Year Score0.76 units on a scaleStandard Deviation 0.26
Triathlon Total Knee SystemInvestigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D) Patient Questionnaire.Descriptive EQ-5D: Mean 3 Year Score0.77 units on a scaleStandard Deviation 0.26
Triathlon Total Knee SystemInvestigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D) Patient Questionnaire.EQ-5D VAS: Mean 5 Year Score71.5 units on a scaleStandard Deviation 19.5
Secondary

Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.

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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Triathlon Total Knee SystemInvestigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.Symptoms: KOOS Mean Preoperative Score45.95 units on a scaleStandard Deviation 19.96
Triathlon Total Knee SystemInvestigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.Symptoms: KOOS Mean 1 Year Score78.96 units on a scaleStandard Deviation 16.42
Triathlon Total Knee SystemInvestigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.Symptoms: KOOS Mean 3 Year Score81.05 units on a scaleStandard Deviation 17.23
Triathlon Total Knee SystemInvestigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.Pain: KOOS Mean 1 Year Score81.2 units on a scaleStandard Deviation 17.59
Triathlon Total Knee SystemInvestigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.Function, Daily Living: KOOS Mean Preoperative Score43.05 units on a scaleStandard Deviation 19.27
Triathlon Total Knee SystemInvestigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.Function, Daily Living: KOOS Mean 1 Year Score79.28 units on a scaleStandard Deviation 18.68
Triathlon Total Knee SystemInvestigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.Function, Daily Living: KOOS Mean 3 Year Score80.33 units on a scaleStandard Deviation 20.68
Triathlon Total Knee SystemInvestigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.Function, Daily Living: KOOS Mean 5 Year Score78.86 units on a scaleStandard Deviation 21.38
Triathlon Total Knee SystemInvestigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.Function, Sports and Recreational: KOOS Mean Preoperative Score14.46 units on a scaleStandard Deviation 19.93
Triathlon Total Knee SystemInvestigation 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 Score47.24 units on a scaleStandard Deviation 29.27
Triathlon Total Knee SystemInvestigation 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 Score52.11 units on a scaleStandard Deviation 30.86
Triathlon Total Knee SystemInvestigation 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 Score50.42 units on a scaleStandard Deviation 30.65
Triathlon Total Knee SystemInvestigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.Quality of Life: KOOS Mean 1 Year Score67.11 units on a scaleStandard Deviation 25.33
Triathlon Total Knee SystemInvestigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.Quality of Life: KOOS Mean 3 Year Score67.02 units on a scaleStandard Deviation 27.19
Triathlon Total Knee SystemInvestigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.Quality of Life: KOOS Mean 5 Year Score69.77 units on a scaleStandard Deviation 26.17
Triathlon Total Knee SystemInvestigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.Symptoms: KOOS Mean 5 Year Score81.43 units on a scaleStandard Deviation 16.7
Triathlon Total Knee SystemInvestigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.Pain: KOOS Mean Preoperative Score40.02 units on a scaleStandard Deviation 17.51
Triathlon Total Knee SystemInvestigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.Pain: KOOS Mean 3 Year Score82.28 units on a scaleStandard Deviation 19.93
Triathlon Total Knee SystemInvestigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.Pain: KOOS Mean 5 Year Score82.02 units on a scaleStandard Deviation 19.98
Triathlon Total Knee SystemInvestigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.Quality of Life: KOOS Mean Preoperative Score23.12 units on a scaleStandard Deviation 17.22
Secondary

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

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.

Time frame: 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).

ArmMeasureGroupValue (MEAN)Dispersion
Triathlon Total Knee SystemInvestigation 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 scaleStandard Deviation 26.53
Triathlon Total Knee SystemInvestigation 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 scaleStandard Deviation 29.82
Triathlon Total Knee SystemInvestigation 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 scaleStandard Deviation 30.03
Triathlon Total Knee SystemInvestigation 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 scaleStandard Deviation 29.32

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026