Arthroplasty, Replacement, Knee
Conditions
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
Total knee replacement
Total knee replacement
Partial Knee Resurfacing
Total Knee Replacement
Partial Knee Resurfacing
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Survivorship of the Device | Preoperative 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Arm | Count |
|---|---|
| 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 |
| Total | 223 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 9 | 0 | 0 |
| Overall Study | Lost to Follow-up | 19 | 0 | 0 |
| Overall Study | Revision/Removal of Study Device | 4 | 0 | 0 |
| Overall Study | Study Closed by Sponsor | 154 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 37 | 0 | 0 |
Baseline characteristics
| Characteristic | Triathlon Total Knee System | — |
|---|---|---|
| Age, Continuous | 68.61 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 type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 223 | 9 / 223 |
| other Total, other adverse events | 0 / 223 | 52 / 223 |
| serious Total, serious adverse events | 18 / 223 | 55 / 223 |
Outcome results
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Triathlon Total Knee System | Survivorship of the Device | Free from Revision at Preoperative to 1 year | 218 participants free from revision |
| Triathlon Total Knee System | Survivorship of the Device | Free from Revision at 1 year | 207 participants free from revision |
| Triathlon Total Knee System | Survivorship of the Device | Free from Revision at 3 years | 170 participants free from revision |
| Triathlon Total Knee System | Survivorship of the Device | Free from Revision at 5 years | 150 participants free from revision |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triathlon Total Knee System | 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 |
| Triathlon Total Knee System | 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 |
| Triathlon Total Knee System | 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 |
| Triathlon Total Knee System | 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 |
| Triathlon Total Knee System | 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 |
| Triathlon Total Knee System | 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 |
| Triathlon Total Knee System | 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 |
| Triathlon Total Knee System | 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 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triathlon Total Knee System | 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 |
| Triathlon Total Knee System | 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 |
| Triathlon Total Knee System | 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 |
| Triathlon Total Knee System | 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 |
| Triathlon Total Knee System | 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 |
| Triathlon Total Knee System | 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 |
| Triathlon Total Knee System | 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 |
| Triathlon Total Knee System | 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 |
| Triathlon Total Knee System | 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 |
| Triathlon Total Knee System | 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 |
| Triathlon Total Knee System | 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 |
| Triathlon Total Knee System | 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 |
| Triathlon Total Knee System | 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 |
| Triathlon Total Knee System | 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 |
| Triathlon Total Knee System | 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 |
| Triathlon Total Knee System | 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 |
| Triathlon Total Knee System | 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 |
| Triathlon Total Knee System | 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 |
| Triathlon Total Knee System | 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 |
| Triathlon Total Knee System | 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 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triathlon Total Knee System | 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 |
| Triathlon Total Knee System | 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 |
| Triathlon Total Knee System | 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 |
| Triathlon Total Knee System | 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 |