Arthroplasty, Replacement, Knee
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEScorpio PS (posterior stable)
Implantation of total knee prosthesis
DEVICEScorpio NRG PS
Implantation of total knee prosthesis
Sponsors
Stryker Orthopaedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients requiring a primary total knee arthroplasty (TKA) * Male and nonpregnant female patients * Between 18 and 80 years of age at time of surgery * Patients with a diagnosis of osteoarthritis (OA), avascular necrosis (AVN), and not severe posttraumatic arthritis * No previous osteosynthesis of the involved knee during the last 12 months * Patients who understand the conditions of the study and are wiling to participate for the length of the described follow up * Patients who are capable of, and have given, informed consent for participation in the study
Exclusion criteria
* Patients requiring revision surgery of a previous implanted total knee system * Patients with a diagnosis of severe posttraumatic arthritis (TA) and rheumatoid arthritis (RA) * Patients with active infection * Patients with malignancy * Patients with an immobile hip or ankle arthrodesis * Severe obese patients (BMI \> 35) * Patients with a neurological deficit * Previous history of unicompartmental knee arthroplasty or patellar prosthesis * Patients with concurrent illnesses which are likely to affect their outcome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Maximum Passive and Active Flexion. | 5 years follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Score (KSS) | pre-operative, 6, 12, 26 weeks and 1, 2 and 5 years follow-up | 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. |
| Chair Raise Test | pre-operative, 6, 12, 26 weeks and 1, 2 and 5 years follow-up | 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. |
| WOMAC Patient Questionnaire | pre-operative, 12, 26 weeks and 1, 2 and 5 years follow-up | 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. |
| EQ-5D (Euro-Quol 5-Dimension) Patient Questionnaire | pre-operative, 12, 26 weeks and 1, 2 and 5 years follow-up | 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. |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 42 |
| 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 | 42 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 2 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Meet exclusion criterion | 0 | 1 |
| Overall Study | Not study device | 1 | 0 |
| Overall Study | Revision of study device components | 2 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Scorpio NRG PS | Total | Scorpio PS |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 27 Participants | 50 Participants | 23 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 34 Participants | 19 Participants |
| Age, Continuous | 66.22 years STANDARD_DEVIATION 8.09 | 65.83 years STANDARD_DEVIATION 8.06 | 65.44 years STANDARD_DEVIATION 8.01 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Netherlands | 42 participants | 84 participants | 42 participants |
| Sex: Female, Male Female | 19 Participants | 37 Participants | 18 Participants |
| Sex: Female, Male Male | 23 Participants | 47 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 42 | 2 / 42 |
| other Total, other adverse events | 0 / 42 | 0 / 42 |
| serious Total, serious adverse events | 10 / 42 | 13 / 42 |
Outcome results
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.
Time frame: 5 years follow-up
Population: At the 5 years follow-up data of 36 participants per study arm were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Scorpio PS | Comparison of Maximum Passive and Active Flexion. | Passive range of motion | 124.58 degree | Standard Deviation 10.04 |
| Scorpio PS | Comparison of Maximum Passive and Active Flexion. | Passive Flexion | 126.64 degree | Standard Deviation 9.22 |
| Scorpio PS | Comparison of Maximum Passive and Active Flexion. | Passive Extension | 1.81 degree | Standard Deviation 2.33 |
| Scorpio PS | Comparison of Maximum Passive and Active Flexion. | Active range of motion | 118.64 degree | Standard Deviation 10.15 |
| Scorpio PS | Comparison of Maximum Passive and Active Flexion. | Active Extension | 0.61 degree | Standard Deviation 1.08 |
| Scorpio PS | Comparison of Maximum Passive and Active Flexion. | Active Flexion | 120.11 degree | Standard Deviation 9.77 |
| Scorpio NRG PS | Comparison of Maximum Passive and Active Flexion. | Active Extension | 0.97 degree | Standard Deviation 1.5 |
| Scorpio NRG PS | Comparison of Maximum Passive and Active Flexion. | Passive range of motion | 125.14 degree | Standard Deviation 23.01 |
| Scorpio NRG PS | Comparison of Maximum Passive and Active Flexion. | Active range of motion | 125.72 degree | Standard Deviation 8.66 |
| Scorpio NRG PS | Comparison of Maximum Passive and Active Flexion. | Passive Flexion | 131.33 degree | Standard Deviation 8.49 |
| Scorpio NRG PS | Comparison of Maximum Passive and Active Flexion. | Active Flexion | 126.69 degree | Standard Deviation 8.75 |
| Scorpio NRG PS | Comparison of Maximum Passive and Active Flexion. | Passive Extension | 2.72 degree | Standard Deviation 2.48 |
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.
Time frame: pre-operative, 6, 12, 26 weeks and 1, 2 and 5 years follow-up
Population: In some cases it was missed to do the Chair rise test.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Scorpio PS | Chair Raise Test | Can arise from chair at 12 weeks | 39 Participants |
| Scorpio PS | Chair Raise Test | Can arise from chair at 1 year | 37 Participants |
| Scorpio PS | Chair Raise Test | Can arise from chair at 6 weeks | 34 Participants |
| Scorpio PS | Chair Raise Test | Can arise from chair at 2 years | 39 Participants |
| Scorpio PS | Chair Raise Test | Can arise from chair at 26 weeks | 40 Participants |
| Scorpio PS | Chair Raise Test | Can arise from chair at 5 years | 34 Participants |
| Scorpio PS | Chair Raise Test | Can arise from chair pre-operative | 26 Participants |
| Scorpio NRG PS | Chair Raise Test | Can arise from chair at 5 years | 34 Participants |
| Scorpio NRG PS | Chair Raise Test | Can arise from chair pre-operative | 30 Participants |
| Scorpio NRG PS | Chair Raise Test | Can arise from chair at 6 weeks | 37 Participants |
| Scorpio NRG PS | Chair Raise Test | Can arise from chair at 12 weeks | 39 Participants |
| Scorpio NRG PS | Chair Raise Test | Can arise from chair at 26 weeks | 38 Participants |
| Scorpio NRG PS | Chair Raise Test | Can arise from chair at 1 year | 39 Participants |
| Scorpio NRG PS | Chair Raise Test | Can arise from chair at 2 years | 36 Participants |
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.
Time frame: pre-operative, 12, 26 weeks and 1, 2 and 5 years follow-up
Population: Because some patients missed to attend some visits as well as early termination cases, the numbers in some follow-ups differ from number analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Scorpio PS | EQ-5D (Euro-Quol 5-Dimension) Patient Questionnaire | Pre-operative EQ-5D | 0.60 units on a scale | Standard Deviation 0.21 |
| Scorpio PS | EQ-5D (Euro-Quol 5-Dimension) Patient Questionnaire | 12 weeks EQ-5D | 0.76 units on a scale | Standard Deviation 0.16 |
| Scorpio PS | EQ-5D (Euro-Quol 5-Dimension) Patient Questionnaire | 26 weeks EQ-5D | 0.76 units on a scale | Standard Deviation 0.2 |
| Scorpio PS | EQ-5D (Euro-Quol 5-Dimension) Patient Questionnaire | 1 year EQ-5D | 0.72 units on a scale | Standard Deviation 0.32 |
| Scorpio PS | EQ-5D (Euro-Quol 5-Dimension) Patient Questionnaire | 2 years EQ-5D | 0.76 units on a scale | Standard Deviation 0.28 |
| Scorpio PS | EQ-5D (Euro-Quol 5-Dimension) Patient Questionnaire | 5 years EQ-5D | 0.77 units on a scale | Standard Deviation 0.26 |
| Scorpio NRG PS | EQ-5D (Euro-Quol 5-Dimension) Patient Questionnaire | 2 years EQ-5D | 0.81 units on a scale | Standard Deviation 0.24 |
| Scorpio NRG PS | EQ-5D (Euro-Quol 5-Dimension) Patient Questionnaire | Pre-operative EQ-5D | 0.53 units on a scale | Standard Deviation 0.25 |
| Scorpio NRG PS | EQ-5D (Euro-Quol 5-Dimension) Patient Questionnaire | 1 year EQ-5D | 0.82 units on a scale | Standard Deviation 0.19 |
| Scorpio NRG PS | EQ-5D (Euro-Quol 5-Dimension) Patient Questionnaire | 12 weeks EQ-5D | 0.77 units on a scale | Standard Deviation 0.19 |
| Scorpio NRG PS | EQ-5D (Euro-Quol 5-Dimension) Patient Questionnaire | 5 years EQ-5D | 0.80 units on a scale | Standard Deviation 0.23 |
| Scorpio NRG PS | EQ-5D (Euro-Quol 5-Dimension) Patient Questionnaire | 26 weeks EQ-5D | 0.78 units on a scale | Standard Deviation 0.22 |
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.
Time frame: pre-operative, 6, 12, 26 weeks and 1, 2 and 5 years follow-up
Population: Because some patients missed to attend some visits as well as early termination cases, the numbers in some follow-ups differ from number analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Scorpio PS | Knee Society Score (KSS) | Pain motion Score 5 years | 69.42 units on a scale | Standard Deviation 11.94 |
| Scorpio PS | Knee Society Score (KSS) | Function Score pre-op | 61.55 units on a scale | Standard Deviation 12.12 |
| Scorpio PS | Knee Society Score (KSS) | Function Score 6 weeks | 56.63 units on a scale | Standard Deviation 15.83 |
| Scorpio PS | Knee Society Score (KSS) | Pain motion Score 26 weeks | 71.58 units on a scale | Standard Deviation 14.61 |
| Scorpio PS | Knee Society Score (KSS) | Function Score 12 weeks | 73.29 units on a scale | Standard Deviation 19.09 |
| Scorpio PS | Knee Society Score (KSS) | Pain motion Score 6 weeks | 61.65 units on a scale | Standard Deviation 16.45 |
| Scorpio PS | Knee Society Score (KSS) | Function Score 26 weeks | 87.93 units on a scale | Standard Deviation 15.49 |
| Scorpio PS | Knee Society Score (KSS) | Pain motion Score 1 year | 70.27 units on a scale | Standard Deviation 12.39 |
| Scorpio PS | Knee Society Score (KSS) | Function Score 1 year | 88.46 units on a scale | Standard Deviation 14.38 |
| Scorpio PS | Knee Society Score (KSS) | Pain motion Score pre-op | 47.65 units on a scale | Standard Deviation 11.18 |
| Scorpio PS | Knee Society Score (KSS) | Function Score 2 years | 86.79 units on a scale | Standard Deviation 22.52 |
| Scorpio PS | Knee Society Score (KSS) | Pain motion Score 2 years | 71.29 units on a scale | Standard Deviation 13.96 |
| Scorpio PS | Knee Society Score (KSS) | Function Score 5 years | 87.92 units on a scale | Standard Deviation 22.05 |
| Scorpio PS | Knee Society Score (KSS) | Pain motion Score 12 weeks | 67.66 units on a scale | Standard Deviation 13 |
| Scorpio NRG PS | Knee Society Score (KSS) | Function Score 5 years | 95.14 units on a scale | Standard Deviation 10.45 |
| Scorpio NRG PS | Knee Society Score (KSS) | Pain motion Score pre-op | 49.85 units on a scale | Standard Deviation 15.31 |
| Scorpio NRG PS | Knee Society Score (KSS) | Pain motion Score 6 weeks | 69.63 units on a scale | Standard Deviation 17.22 |
| Scorpio NRG PS | Knee Society Score (KSS) | Pain motion Score 12 weeks | 75.38 units on a scale | Standard Deviation 13.34 |
| Scorpio NRG PS | Knee Society Score (KSS) | Pain motion Score 26 weeks | 74.70 units on a scale | Standard Deviation 14.01 |
| Scorpio NRG PS | Knee Society Score (KSS) | Pain motion Score 1 year | 73.83 units on a scale | Standard Deviation 13.98 |
| Scorpio NRG PS | Knee Society Score (KSS) | Pain motion Score 2 years | 74.79 units on a scale | Standard Deviation 12.11 |
| Scorpio NRG PS | Knee Society Score (KSS) | Function Score pre-op | 60.12 units on a scale | Standard Deviation 15.36 |
| Scorpio NRG PS | Knee Society Score (KSS) | Function Score 6 weeks | 60.83 units on a scale | Standard Deviation 19.16 |
| Scorpio NRG PS | Knee Society Score (KSS) | Function Score 12 weeks | 82.80 units on a scale | Standard Deviation 14.88 |
| Scorpio NRG PS | Knee Society Score (KSS) | Function Score 26 weeks | 90.25 units on a scale | Standard Deviation 17.76 |
| Scorpio NRG PS | Knee Society Score (KSS) | Function Score 1 year | 94.88 units on a scale | Standard Deviation 12.67 |
| Scorpio NRG PS | Knee Society Score (KSS) | Function Score 2 years | 95.24 units on a scale | Standard Deviation 10 |
| Scorpio NRG PS | Knee Society Score (KSS) | Pain motion Score 5 years | 74.85 units on a scale | Standard Deviation 11.39 |
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.
Time frame: pre-operative, 12, 26 weeks and 1, 2 and 5 years follow-up
Population: Because some patients missed to attend some visits as well as early termination cases, the numbers in some follow-ups differ from number analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Scorpio PS | WOMAC Patient Questionnaire | Total score pre-operative | 49.33 units on a scale | Standard Deviation 14.37 |
| Scorpio PS | WOMAC Patient Questionnaire | Total score 12 weeks | 26.56 units on a scale | Standard Deviation 15.53 |
| Scorpio PS | WOMAC Patient Questionnaire | Total score 26 weeks | 19.95 units on a scale | Standard Deviation 16.66 |
| Scorpio PS | WOMAC Patient Questionnaire | Total score 1 year | 19.74 units on a scale | Standard Deviation 16.68 |
| Scorpio PS | WOMAC Patient Questionnaire | Total score 2 years | 18.56 units on a scale | Standard Deviation 20.93 |
| Scorpio PS | WOMAC Patient Questionnaire | Total score 5 years | 14.44 units on a scale | Standard Deviation 15.92 |
| Scorpio NRG PS | WOMAC Patient Questionnaire | Total score 2 years | 13.60 units on a scale | Standard Deviation 17.32 |
| Scorpio NRG PS | WOMAC Patient Questionnaire | Total score pre-operative | 47.63 units on a scale | Standard Deviation 15.84 |
| Scorpio NRG PS | WOMAC Patient Questionnaire | Total score 1 year | 12.98 units on a scale | Standard Deviation 13.78 |
| Scorpio NRG PS | WOMAC Patient Questionnaire | Total score 12 weeks | 18.69 units on a scale | Standard Deviation 15.22 |
| Scorpio NRG PS | WOMAC Patient Questionnaire | Total score 5 years | 12.24 units on a scale | Standard Deviation 16.52 |
| Scorpio NRG PS | WOMAC Patient Questionnaire | Total score 26 weeks | 20.21 units on a scale | Standard Deviation 19.24 |