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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)
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scorpio NRG Total Knee System | Other | Patients eligible for Scorpio NRG Total Knee System with X3 insert |
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| Triathlon Total Knee System | Other | Patients eligible for Triathlon Total Knee System with X3 insert |
|
| Triathlon Partial Knee Resurfacing | Other | Patients eligible for Triathlon PKR System with X3 insert |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triathlon Total Knee System with X3 insert | Device | Total knee replacement |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Survivorship of the Device | Survivorship shown in Kaplan Meier survival curves (statistic used to estimate the survival function from lifetime data). | Preoperative to 1 year, 1 year, 3 years, and 5 years. Survivorship is unavailable at 10 years due to study termination. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Romain Seil, MD | Centre Hospitalier du Luxembourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kliniken Dr. Erler gGmbH | Nuremberg | Bavaria | 90429 | Germany | ||
| Centre Hospitalier de Luxembourg |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Scorpio NRG Total Knee System |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 25, 2011 |
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| Scorpio NRG Total Knee System with X3 insert |
| Device |
Total knee replacement |
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| Triathlon PKR System with X3 insert | Device | Partial Knee Resurfacing |
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| Total Knee Replacement | Procedure | Total Knee Replacement |
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| Partial Knee Resurfacing | Procedure | Partial Knee Resurfacing |
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| Pre-operative, 1, 3, and 5 years. The KSS for 7 and 10 year timepoints are unavailable due to study termination. |
| 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. | Pre-operative, 1, 3, and 5 years. The KOOS for 7 and 10 year timepoints are unavailable due to study termination. |
| 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). | Pre-operative, 1, 3, and 5 years. The EQ-5D for 7 and 10 year timepoints is unavailable due to study termination. |
| Luxembourg |
| L-1210 |
| Luxembourg |
| Worcestersire Acute Hospital NHS Trust, Alexandra Hospital | Redditch | Worcestersire | B98 7UB | United Kingdom |
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 |
| FG002 | 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 |
| COMPLETED |
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| NOT COMPLETED |
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Includes participants who received the Triathlon Total Knee System and were not censored from analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Survivorship of the Device | Survivorship shown in Kaplan Meier survival curves (statistic used to estimate the survival function from lifetime data). | 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. | Posted | Number | participants free from revision | Preoperative to 1 year, 1 year, 3 years, and 5 years. Survivorship is unavailable at 10 years due to study termination. |
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| 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. | 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). | Posted | Mean | Standard Deviation | units on a scale | Pre-operative, 1, 3, and 5 years. The KSS for 7 and 10 year timepoints are unavailable due to study termination. |
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| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Pre-operative, 1, 3, and 5 years. The KOOS for 7 and 10 year timepoints are unavailable due to study termination. |
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| 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | Pre-operative, 1, 3, and 5 years. The EQ-5D for 7 and 10 year timepoints is unavailable due to study termination. |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Operative Adverse Events | Triathlon Total Knee System with X3 insert, reported by participant. | 0 | 223 | 18 | 223 | 0 | 223 |
| EG001 | Non-operative Adverse Events | Triathlon Total Knee System with X3 insert, reported by participant. | 9 | 223 | 55 | 223 | 52 | 223 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-operative | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Non-Operative | Eye disorders | MedDRA | Non-systematic Assessment |
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| Non-Operative | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Operative | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Non-Operative | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Operative | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Operative | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Non-Operative | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Non-Operative | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
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| Non-Operative | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Non-Operative | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
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| Non-Operative | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
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| Operative | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Non-Operative | Vascular disorders | MedDRA | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elective Procedures | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Non-Operative | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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The study was terminated at the 5-year timepoint, therefore the primary outcome measure of survivorship of the device at 10-years was not analyzed.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stryker JR Clinical Research | Stryker Orthopaedics | 201-831-5000 | StrykerJRClinical@stryker.com |
| Dec 21, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
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| Germany |
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| Free from Revision at 3 years |
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| Free from Revision at 5 years |
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