Arthroplasty, Replacement, Knee
Conditions
Brief summary
The purpose of this study is to collect basic function, radiographic and patient satisfaction data for observation and analysis.
Detailed description
Evaluation of the effect of the component design on functional performance by comparing postoperative Knee Society Scores (KSS) with preoperative. Evaluate post-operative radiographic findings. Evaluate the effect of component design on patient activity by comparing postoperative Lower Extremity Activity Scale (LEAS) with preoperative. Evaluate patient satisfaction using Short-Form-36 Health Survey (SF-36). Evaluate quality of life using Knee Injury and Osteoarthritis Outcome Score (KOOS) and EuroQuol-5 dimension patient questionaire (EQ-5D).
Interventions
DEVICEPrimary total knee replacement (Scorpio NRG CR Total Knee System)
Scorpio NRG CR Total Knee System
Sponsors
Stryker Orthopaedics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patient is able to understand the meaning of the study and is willing to sign the Ethic Commission approved, study specific Informed Patient Consent Form. 2. The subject is a male or non-pregnant female between 40 and 75 years of age. 3. The subject requires a primary total knee replacement. 4. Patients with osteoarthritis or posttraumatic arthritis (no rheumatoid arthritis) 5. The subject has intact collateral ligaments. 6. The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation. 7. The subject is capable of understanding the patient scores in the national language.
Exclusion criteria
1. The subject is morbidly obese, defined as Body Mass Index (BMI) of \> 40. 2. The subject has a history of total or unicompartmental reconstruction of the affected joint. 3. The subject will be operated bilaterally. 4. Patients who had a Total Hip Arthroplasty (THA) on contralateral and/or ipsilateral side within the last year that is considered to have an unsatisfactory outcome (Patients with contralateral and/or ipsilateral THA \> 1 year ago with good outcome can be included in the study). 5. Patients who had a Total Knee Arthroplasty (TKA) on contralateral side within the last 6 months that is considered to have an unsatisfactory outcome. (Patients with contralateral TKA \> 6 months ago with good outcome can be included in the study). 6. Patients who will need lower limb joint replacement for another joint within one year. 7. The subject has had a high tibial osteotomy or femoral osteotomy. 8. The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. 9. The subject has a systemic or metabolic disorder leading to progressive bone deterioration. 10. The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements. 11. The subject's bone stock in compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis. 12. The subject has had a knee fusion to the affected joint. 13. The subject has an active or suspected latent infection in or about the knee joint. 14. Proven or suspected hypersensitivity to one or more than one of the device materials (see Appendix 10 table of chemical composition). 15. Female patients planning a pregnancy during the course of the study. 16. The subject is a prisoner. 17. severe deformities: varus/valgus deformity \>10° (mech. axis), bowed femur \> 20 degree, flexion contracture \>10°
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival Rate | 7 year follow-up | Assess survival (absence of revision) at 7 year follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Pre-operative, 3 months, 1, 3, 5 and optional 7 years | 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. |
| Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire | Pre-operative, 3 months,1, 3, 5 and optional 7 years | The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level. |
| Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Pre-operative, 3 months,1, 3, 5 and optional 7 years | The SF-36 is a 36-item patient completed questionnaire to measure general health and well-being. It includes physical and mental status component sub scores (physical function, physical role functioning, body pain, general health, vitality, social functioning, emotional role, mental health); each ranging from 0-100. Low values represent a poor health state and high values represent a good health state. |
| Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. | Pre-operative,1, 5 and optional 7 years | KOOS consists of 5 subscales: Pain, other symptoms, 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 (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms). |
| Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). | Pre-operative, 3 months,1, 3, 5 and optional 7 years | 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
Austria, Germany, Netherlands, United Kingdom
Participant flow
Recruitment details
205 participants who agreed to participate in the study following completion of the informed consent process were enrolled into the study
Participants by arm
| Arm | Count |
|---|---|
| Scorpio NRG CR Total Knee System Primary total knee replacement
Primary total knee replacement (Scorpio NRG CR Total Knee System): Scorpio NRG CR Total Knee System | 205 |
| Total | 205 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 8 |
| Overall Study | Death | 10 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Subjects received Scorpio NRG PS (Posterior Stabilizing) | 4 |
| Overall Study | Withdrawal by Subject | 18 |
Baseline characteristics
| Characteristic | Scorpio NRG CR Total Knee System | — |
|---|---|---|
| Age, Continuous | 65.53 years STANDARD_DEVIATION 6.5 | — |
| Indication Osteoarthritis | 200 participants | — |
| Indication Post-traumatic Arthritis | 4 participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Europe | 205 participants | — |
| Sex: Female, Male Female | 132 Participants | — |
| Sex: Female, Male Male | 72 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 10 / 205 |
| other Total, other adverse events | 15 / 205 |
| serious Total, serious adverse events | 88 / 205 |
Outcome results
Primary
Survival Rate
Assess survival (absence of revision) at 7 year follow-up
Time frame: 7 year follow-up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Scorpio NRG CR Total Knee System | Survival Rate | Tibial Tray Revision | 1 Participants |
| Scorpio NRG CR Total Knee System | Survival Rate | Total Knee Arthroplasty Revision | 4 Participants |
| Scorpio NRG CR Total Knee System | Survival Rate | Femoral Component Revision | 2 Participants |
| Scorpio NRG CR Total Knee System | Survival Rate | Inlay Revision | 1 Participants |
| Scorpio NRG CR Total Knee System | Survival Rate | No Revision | 189 Participants |
Secondary
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).
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, 3 months,1, 3, 5 and optional 7 years
Population: Numbers analyzed represent evaluable cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). | Pre-operative visual analogue scale (VAS) | 70.97 units on a scale | Standard Deviation 16.75 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). | VAS at 3 months | 76.96 units on a scale | Standard Deviation 13.92 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). | VAS at 1 year | 77.41 units on a scale | Standard Deviation 14.4 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). | VAS at 3 years | 75.09 units on a scale | Standard Deviation 14.11 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). | VAS at 5 years | 76.84 units on a scale | Standard Deviation 13.23 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). | VAS at 7 years | 77.03 units on a scale | Standard Deviation 14.77 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). | Pre-operative descriptive EQ-5D | 0.55 units on a scale | Standard Deviation 0.26 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). | Descriptive EQ-5D at 3 months | 0.77 units on a scale | Standard Deviation 0.17 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). | Descriptive EQ-5D at 1 year | 0.84 units on a scale | Standard Deviation 0.17 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). | Descriptive EQ-5D at 3 years | 0.83 units on a scale | Standard Deviation 0.19 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). | Descriptive EQ-5D at 5 years | 0.82 units on a scale | Standard Deviation 0.2 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). | Descriptive EQ-5D at 7 years | 0.83 units on a scale | Standard Deviation 0.19 |
Secondary
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.
KOOS consists of 5 subscales: Pain, other symptoms, 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 (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms).
Time frame: Pre-operative,1, 5 and optional 7 years
Population: Numbers analyzed represent evaluable cases. The KOOS was collected pre-operatively and at 1, 5 and 7 years only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. | QoL at 7 years | 65.54 units on a scale | Standard Deviation 21.81 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. | Symptoms pre-operative | 49.91 units on a scale | Standard Deviation 18.55 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. | Symptoms at 1 year | 79.58 units on a scale | Standard Deviation 15.73 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. | Symptoms at 5 years | 83.38 units on a scale | Standard Deviation 16.1 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. | Symptoms at 7 years | 85.83 units on a scale | Standard Deviation 15.46 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. | Pain pre-operative | 41.28 units on a scale | Standard Deviation 17.82 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. | Pain at 1 year | 82.9 units on a scale | Standard Deviation 19.14 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. | Pain at 5 years | 84.36 units on a scale | Standard Deviation 19.38 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. | Pain at 7 years | 86.99 units on a scale | Standard Deviation 17.74 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. | Function, sports and recreation activities pre-operative | 14.15 units on a scale | Standard Deviation 16.26 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. | Function, sports and recreation activities at 1 year | 47.89 units on a scale | Standard Deviation 29.08 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. | Function, sports and recreation activities at 5 years | 48.71 units on a scale | Standard Deviation 31.05 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. | Function, sports and recreation activities at 7 years | 52.79 units on a scale | Standard Deviation 33.45 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. | Quality of life (QoL) pre-operative | 24.36 units on a scale | Standard Deviation 14.86 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. | QoL at 1 year | 66.19 units on a scale | Standard Deviation 24.11 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. | QoL at 5 years | 66.78 units on a scale | Standard Deviation 23.41 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. | Function, daily living pre-operative | 46.59 units on a scale | Standard Deviation 18.2 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. | Function, daily living at 1 year | 82.7 units on a scale | Standard Deviation 17.35 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. | Function, daily living at 5 years | 83.47 units on a scale | Standard Deviation 18.46 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. | Function, daily living at 7 years | 84.24 units on a scale | Standard Deviation 19.23 |
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, 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, 3 months, 1, 3, 5 and optional 7 years
Population: Numbers analyzed represent evaluable cases
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Pre-operative pain motion score | 57.84 units on a scale | Standard Deviation 13.34 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Pain motion score at 3 months | 78.71 units on a scale | Standard Deviation 12.36 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Pain motion score at 1 year | 83.27 units on a scale | Standard Deviation 10.15 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Pain motion score at 3 years | 83.85 units on a scale | Standard Deviation 11.42 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Pain motion score at 5 years | 84.73 units on a scale | Standard Deviation 11.57 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Pain motion score at 7 years | 84.20 units on a scale | Standard Deviation 10.33 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Pre-operative function score | 61.54 units on a scale | Standard Deviation 17.78 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Function score at 3 months | 78.05 units on a scale | Standard Deviation 16.95 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Function score at 1 year | 87.99 units on a scale | Standard Deviation 15.68 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Function score at 3 years | 85.00 units on a scale | Standard Deviation 19.34 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Function score at 5 years | 83.75 units on a scale | Standard Deviation 19.75 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Function score at 7 years | 83.51 units on a scale | Standard Deviation 21.43 |
Secondary
Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire
The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.
Time frame: Pre-operative, 3 months,1, 3, 5 and optional 7 years
Population: Numbers analyzed represent evaluable cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire | pre-operative activity level | 8.61 units on a scale | Standard Deviation 2.51 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire | Activity level at 3 months | 9.43 units on a scale | Standard Deviation 2.81 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire | Activity level at 1 year | 11.11 units on a scale | Standard Deviation 3.06 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire | Activity level at 3 years | 10.68 units on a scale | Standard Deviation 3 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire | Activity level at 5 years | 10.38 units on a scale | Standard Deviation 3.09 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire | Activity level at 7 years | 10.75 units on a scale | Standard Deviation 3.2 |
Secondary
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
The SF-36 is a 36-item patient completed questionnaire to measure general health and well-being. It includes physical and mental status component sub scores (physical function, physical role functioning, body pain, general health, vitality, social functioning, emotional role, mental health); each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.
Time frame: Pre-operative, 3 months,1, 3, 5 and optional 7 years
Population: Numbers analyzed represent evaluable cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Pre-operative physical function | 30.62 units on a scale | Standard Deviation 7.91 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Physical function at 3 months | 40.2 units on a scale | Standard Deviation 8.86 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Physical function at 1 year | 44.67 units on a scale | Standard Deviation 8.6 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Physical function at 3 years | 43.97 units on a scale | Standard Deviation 9.8 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Physical function at 5 years | 42.41 units on a scale | Standard Deviation 10.8 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Physical function at 7 years | 43.07 units on a scale | Standard Deviation 10.71 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Pre-operative physical role functioning | 34.48 units on a scale | Standard Deviation 9.19 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Physical role functioning at 3 months | 39.04 units on a scale | Standard Deviation 9.34 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Physical role functioning at 1 year | 45.11 units on a scale | Standard Deviation 9.77 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Physical role functioning at 3 years | 44.0 units on a scale | Standard Deviation 9.77 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Physical role functioning at 5 years | 43.26 units on a scale | Standard Deviation 10.75 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Physical role functioning at 7 years | 43.65 units on a scale | Standard Deviation 10.56 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Pre-operative body pain | 42.24 units on a scale | Standard Deviation 3.23 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Body pain at 3 months | 40.69 units on a scale | Standard Deviation 3.52 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Body pain at 1 year | 39.72 units on a scale | Standard Deviation 3.28 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Body pain at 3 years | 39.47 units on a scale | Standard Deviation 3.17 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Body pain at 5 years | 39.48 units on a scale | Standard Deviation 3.74 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Body pain at 7 years | 39.35 units on a scale | Standard Deviation 3.3 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Pre-operative general health | 49.2 units on a scale | Standard Deviation 8.15 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | General health at 3 months | 51.48 units on a scale | Standard Deviation 7.57 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | General health at 1 year | 51.6 units on a scale | Standard Deviation 8.28 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | General health at 3 years | 49.9 units on a scale | Standard Deviation 8.38 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | General health at 5 years | 48.95 units on a scale | Standard Deviation 9.02 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | General health at 7 years | 48.11 units on a scale | Standard Deviation 8.82 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Pre-operative vitality | 49.94 units on a scale | Standard Deviation 8.61 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Vitality at 3 months | 52.73 units on a scale | Standard Deviation 8.93 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Vitality at 1 year | 55.71 units on a scale | Standard Deviation 9.4 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Vitality at 3 years | 54.61 units on a scale | Standard Deviation 9.46 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Vitality at 5 years | 54.42 units on a scale | Standard Deviation 8.56 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Vitality at 7 years | 54.52 units on a scale | Standard Deviation 9.38 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Pre-operative social functioning | 44.67 units on a scale | Standard Deviation 10.12 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Social functioning at 3 months | 49.17 units on a scale | Standard Deviation 8.91 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Social functioning at 1 year | 51.16 units on a scale | Standard Deviation 8.54 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Social functioning at 3 years | 51.27 units on a scale | Standard Deviation 8.26 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Social functioning at 5 years | 50.83 units on a scale | Standard Deviation 7.96 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Social functioning at 7 years | 49.97 units on a scale | Standard Deviation 8.98 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Pre-operative emotional role | 43.41 units on a scale | Standard Deviation 12.92 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Emotional role at 3 months | 46.65 units on a scale | Standard Deviation 11.65 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Emotional role at 1 year | 47.81 units on a scale | Standard Deviation 11.1 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Emotional role at 3 years | 46.83 units on a scale | Standard Deviation 10.81 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Emotional role at 5 years | 47.47 units on a scale | Standard Deviation 11.4 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Emotional role at 7 years | 46.0 units on a scale | Standard Deviation 11.78 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Pre-operative mental health | 50.23 units on a scale | Standard Deviation 9.4 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Mental health at 3 months | 52.6 units on a scale | Standard Deviation 9.86 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Mental health at 1 year | 53.39 units on a scale | Standard Deviation 9.96 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Mental health at 3 years | 53.06 units on a scale | Standard Deviation 8.8 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Mental health at 5 years | 53.52 units on a scale | Standard Deviation 8.63 |
| Scorpio NRG CR Total Knee System | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | Mental health at 7 years | 52.5 units on a scale | Standard Deviation 9.36 |