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Single-centre, prospective, randomized comparative study to compare the maximum flexion and Chair Raise achievement ratios of the Scorpio PS and and the Scorpio NRG PS. Documentation of all complications.
Surveillance design: Single-centre, prospective, randomized comparative study. Objectives: To compare the maximum flexion (active and passive) and Chair Raise achievement ratios. All complications will be documented.
Number of subjects to be enrolled: All consecutive Scorpio patients are included until a group size of 88 is reached.
Clinical evaluations: Chair raise test, Stair climb test, Western Ontario McMaster Osteoarthritis Index (WOMAC) patient self evaluation, EuroQuol - 5 dimension (EQ-5D) patient questionnaire. Standard clinical, functional and pain parameters (Knee Society Score), pre-operatively and post-operatively. All per- and post-op complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scorpio PS | Active Comparator | Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio PS Total Knee Replacement. |
|
| Scorpio NRG PS | Active Comparator | Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio NRG PS Total Knee Replacement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scorpio PS (posterior stable) | Device | Implantation of total knee prosthesis |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Maximum Passive and Active Flexion. | Comparison of maximum flexion, both passive and active between Scorpio NRG PS knee prosthesis and the Scorpio PS knee prosthesis. The active flexion-tolerated range is greater/equal 70 degree. The passive flexion-tolerated range is greater/equal 80 degree. The Hyperextension tolerated range is 0 to 10 degree. Higher scores mean a better outcome. | 5 years follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Feczko, MD | Clinical Trial Center Maastricht BV | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Trial Center Maastricht BV | Maastricht | Limburg | 6229 HX | Netherlands |
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| ID | Title | Description |
|---|---|---|
| FG000 | Scorpio PS | Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio PS Total Knee Replacement. Scorpio PS (posterior stable): Implantation of total knee prosthesis |
| FG001 | Scorpio NRG PS | Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio NRG PS Total Knee Replacement. Scorpio NRG PS: Implantation of total knee prosthesis |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Scorpio PS | Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio PS Total Knee Replacement. Scorpio PS (posterior stable): Implantation of total knee prosthesis |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Comparison of Maximum Passive and Active Flexion. | Comparison of maximum flexion, both passive and active between Scorpio NRG PS knee prosthesis and the Scorpio PS knee prosthesis. The active flexion-tolerated range is greater/equal 70 degree. The passive flexion-tolerated range is greater/equal 80 degree. The Hyperextension tolerated range is 0 to 10 degree. Higher scores mean a better outcome. | At the 5 years follow-up data of 36 participants per study arm were analyzed. | Posted | Mean | Standard Deviation | degree | 5 years follow-up |
|
Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up.
Definitions do not differ.
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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 | Scorpio PS | Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio PS Total Knee Replacement. Scorpio PS (posterior stable): Implantation of total knee prosthesis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Britta von den Brincken, Clinical Study Manager | Stryker | +491638999202 | britta.vondenbrincken@stryker.com |
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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 | Jun 8, 2010 | May 6, 2019 | Prot_SAP_000.pdf |
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| Scorpio NRG PS |
| Device |
Implantation of total knee prosthesis |
|
| pre-operative, 6, 12, 26 weeks and 1, 2 and 5 years follow-up |
| Chair Raise Test | A measurement to assess functional lower extremity strength. The participant is seated on a chair. Arms are crossed at the wrists and held against the chest. The participant is instructed to arise from an adjustable chair with the knees in a 90 degree angle (measurement with Goniometer) without using arms. | pre-operative, 6, 12, 26 weeks and 1, 2 and 5 years follow-up |
| WOMAC Patient Questionnaire | The WOMAC collects information specific to osteoarthritis outcomes. The patient response questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and function. Each question is scored from 0 to 4 for each set of factors, with 0 indicating no pain, stiffness, or limited in function, and 4 indicating extreme pain stiffness, or limited in function. Total WOMAC scores range from 0 to 96 wit lower values representing better outcomes. | pre-operative, 12, 26 weeks and 1, 2 and 5 years follow-up |
| EQ-5D (Euro-Quol 5-Dimension) Patient Questionnaire | The EQ-5D is a subject-completed questionnaire designed to assess subject health state values. 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. | pre-operative, 12, 26 weeks and 1, 2 and 5 years follow-up |
| Lost to Follow-up |
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| Meet exclusion criterion |
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| Withdrawal by Subject |
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| Not study device |
|
| Scorpio NRG PS |
Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio NRG PS Total Knee Replacement. Scorpio NRG PS: Implantation of total knee prosthesis |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Scorpio NRG PS | Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio NRG PS Total Knee Replacement. Scorpio NRG PS: Implantation of total knee prosthesis |
|
|
| Secondary | 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, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome. | Because some patients missed to attend some visits as well as early termination cases, the numbers in some follow-ups differ from number analyzed | Posted | Mean | Standard Deviation | units on a scale | pre-operative, 6, 12, 26 weeks and 1, 2 and 5 years follow-up |
|
|
|
| Secondary | Chair Raise Test | A measurement to assess functional lower extremity strength. The participant is seated on a chair. Arms are crossed at the wrists and held against the chest. The participant is instructed to arise from an adjustable chair with the knees in a 90 degree angle (measurement with Goniometer) without using arms. | In some cases it was missed to do the Chair rise test. | Posted | Count of Participants | Participants | pre-operative, 6, 12, 26 weeks and 1, 2 and 5 years follow-up |
|
|
|
| Secondary | WOMAC Patient Questionnaire | The WOMAC collects information specific to osteoarthritis outcomes. The patient response questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and function. Each question is scored from 0 to 4 for each set of factors, with 0 indicating no pain, stiffness, or limited in function, and 4 indicating extreme pain stiffness, or limited in function. Total WOMAC scores range from 0 to 96 wit lower values representing better outcomes. | Because some patients missed to attend some visits as well as early termination cases, the numbers in some follow-ups differ from number analyzed. | Posted | Mean | Standard Deviation | units on a scale | pre-operative, 12, 26 weeks and 1, 2 and 5 years follow-up |
|
|
|
| Secondary | EQ-5D (Euro-Quol 5-Dimension) Patient Questionnaire | The EQ-5D is a subject-completed questionnaire designed to assess subject health state values. 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. | Because some patients missed to attend some visits as well as early termination cases, the numbers in some follow-ups differ from number analyzed. | Posted | Mean | Standard Deviation | units on a scale | pre-operative, 12, 26 weeks and 1, 2 and 5 years follow-up |
|
|
|
| 1 |
| 42 |
| 10 |
| 42 |
| 0 |
| 42 |
| EG001 | Scorpio NRG PS | Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio NRG PS Total Knee Replacement. Scorpio NRG PS: Implantation of total knee prosthesis | 2 | 42 | 13 | 42 | 0 | 42 |
| Hypopharinx Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Squamous Cell Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Cardiac Complaints | Cardiac disorders | Non-systematic Assessment |
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| Cardiac Collapse | Cardiac disorders | Non-systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Non-systematic Assessment |
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| Wound Leakage | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Arthroscopic Nettoyage of Knee | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Removal of fibrous tissue & blood |
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| Tooth Implant Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Abdominal Corpus Alienum | Injury, poisoning and procedural complications | Non-systematic Assessment | Corpus alienum in abdomen removed via laparoscopy |
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| Knee pain insert revision | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Hip Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Tibial Component Revision | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Flexion Contracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Peri Articular Ossification of Hip | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Prostate Resection | Reproductive system and breast disorders | Non-systematic Assessment |
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| Aneurism | Vascular disorders | Non-systematic Assessment |
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| Cerebral Infarction | Vascular disorders | Non-systematic Assessment |
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| Pulmonary Embolism | Vascular disorders | Non-systematic Assessment |
|
| Placement of patella prosthesis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Patella resurfacing | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| Pain motion Score 6 weeks |
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| Pain motion Score 12 weeks |
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| Pain motion Score 26 weeks |
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| Pain motion Score 1 year |
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| Pain motion Score 2 years |
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| Pain motion Score 5 years |
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| Function Score pre-op |
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| Function Score 6 weeks |
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| Function Score 12 weeks |
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| Function Score 26 weeks |
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| Function Score 1 year |
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| Function Score 2 years |
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| Function Score 5 years |
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| Can arise from chair at 6 weeks |
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| Can arise from chair at 12 weeks |
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| Can arise from chair at 26 weeks |
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| Can arise from chair at 1 year |
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| Can arise from chair at 2 years |
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| Can arise from chair at 5 years |
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| Total score 12 weeks |
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| Total score 26 weeks |
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| Total score 1 year |
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| Total score 2 years |
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| Total score 5 years |
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| 12 weeks EQ-5D |
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| 26 weeks EQ-5D |
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| 1 year EQ-5D |
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| 2 years EQ-5D |
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| 5 years EQ-5D |
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