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The purpose of this study is to collect basic function, radiographic and patient satisfaction data for observation and analysis.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scorpio NRG CR Total Knee System | Other | Primary total knee replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary total knee replacement (Scorpio NRG CR Total Knee System) | Device | Scorpio NRG CR Total Knee System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival Rate | Assess survival (absence of revision) at 7 year follow-up | 7 year follow-up |
| 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, 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 |
|---|---|---|
| Martin Krismer, Prof. | Medical University Innsbruck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Hospital Innsbruck | Innsbruck | Tyrol | A-6020 | Austria | ||
| Knappschaftskrankenhaus Dortmund |
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205 participants who agreed to participate in the study following completion of the informed consent process were enrolled into the study
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Survival Rate | Assess survival (absence of revision) at 7 year follow-up | Posted | Count of Participants | Participants | 7 year follow-up |
|
|
Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
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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 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Quadriceps tendon rupture | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Knee pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Britta von den Brincken, Sr. 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 | Jan 9, 2019 | Mar 3, 2021 | Prot_SAP_000.pdf |
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| Pre-operative, 3 months, 1, 3, 5 and optional 7 years |
| 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. | Pre-operative, 3 months,1, 3, 5 and optional 7 years |
| 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. | Pre-operative, 3 months,1, 3, 5 and optional 7 years |
| 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). | Pre-operative,1, 5 and optional 7 years |
| 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). | Pre-operative, 3 months,1, 3, 5 and optional 7 years |
| Dortmund |
| North Rhine-Westphalia |
| 44309 |
| Germany |
| Orthopaedische Maatschap Leeuwarden | Leeuwarden | Provincie Friesland | 8934 AD | Netherlands |
| St. Antonius Ziekenhuis | Nieuwegein | Utrecht | 3435 CM | Netherlands |
| Royal Devon and Exeter NHS Foundation Trust | Exeter | Devon | EX2 5DW | United Kingdom |
| Adverse Event |
|
| Protocol Violation |
|
| Subjects received Scorpio NRG PS (Posterior Stabilizing) |
|
| years |
|
| Sex: Female, Male | Gender information permanently missing in one case. | 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 |
|
| Indication | Indication information permanently missing in one case. | Number | participants |
|
|
| 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. | Numbers analyzed represent evaluable cases | Posted | Mean | Standard Deviation | units on a scale | Pre-operative, 3 months, 1, 3, 5 and optional 7 years |
|
|
|
| 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. | Numbers analyzed represent evaluable cases. | Posted | Mean | Standard Deviation | units on a scale | Pre-operative, 3 months,1, 3, 5 and optional 7 years |
|
|
|
| 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. | Numbers analyzed represent evaluable cases. | Posted | Mean | Standard Deviation | units on a scale | Pre-operative, 3 months,1, 3, 5 and optional 7 years |
|
|
|
| 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). | Numbers analyzed represent evaluable cases. The KOOS was collected pre-operatively and at 1, 5 and 7 years only. | Posted | Mean | Standard Deviation | units on a scale | Pre-operative,1, 5 and optional 7 years |
|
|
|
| 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). | Numbers analyzed represent evaluable cases. | Posted | Mean | Standard Deviation | units on a scale | Pre-operative, 3 months,1, 3, 5 and optional 7 years |
|
|
|
| 10 |
| 205 |
| 88 |
| 205 |
| 15 |
| 205 |
| Inlay wear | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Instability | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Aseptic loosening | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Post cruciate ligament rupture | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Great toe surgery | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Retropatellar arthritis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Arthrofibrosis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Shoulder tendon rupture | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Carpal tunnel syndrome | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Elbow fracture | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Per-trochanteric fracture | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Knee pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Ankle arthrosis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Patella subluxation | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Adhesion | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
|
| Myocard infarction | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
|
| Heart valve disease | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
|
| Cardiovascular collapse | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
|
| Cehst pain | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
|
| Heart failure and dyspnea | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
|
| Diverticulitis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Suicide | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| General health issues | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hepatitis E | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
|
| Polyarteritis nodosa | Immune system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Pneumonia infections | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Deep joint infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| pre-patellar bursitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| head/spinal cord trauma | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| Wound dehiscence/hematoma | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| Death unknown cause | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Fraxiparine allergy | Product Issues | MedDRA (19.0) | Systematic Assessment |
|
| Kidney stone | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
|
| COPD | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Necrotic wound | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | not operative site related |
|
| Posterior intervaginal plasty | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
|
| Pulmonary embolism | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
| Stroke | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
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|
| Pain motion score at 1 year |
|
|
| Pain motion score at 3 years |
|
|
| Pain motion score at 5 years |
|
|
| Pain motion score at 7 years |
|
|
| Pre-operative function score |
|
|
| Function score at 3 months |
|
|
| Function score at 1 year |
|
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| Function score at 3 years |
|
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| Function score at 5 years |
|
|
| Function score at 7 years |
|
|
|
| Activity level at 1 year |
|
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| Activity level at 3 years |
|
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| Activity level at 5 years |
|
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| Activity level at 7 years |
|
|
|
| Physical function at 1 year |
|
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| Physical function at 3 years |
|
|
| Physical function at 5 years |
|
|
| Physical function at 7 years |
|
|
| Pre-operative physical role functioning |
|
|
| Physical role functioning at 3 months |
|
|
| Physical role functioning at 1 year |
|
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| Physical role functioning at 3 years |
|
|
| Physical role functioning at 5 years |
|
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| Physical role functioning at 7 years |
|
|
| Pre-operative body pain |
|
|
| Body pain at 3 months |
|
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| Body pain at 1 year |
|
|
| Body pain at 3 years |
|
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| Body pain at 5 years |
|
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| Body pain at 7 years |
|
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| Pre-operative general health |
|
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| General health at 3 months |
|
|
| General health at 1 year |
|
|
| General health at 3 years |
|
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| General health at 5 years |
|
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| General health at 7 years |
|
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| Pre-operative vitality |
|
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| Vitality at 3 months |
|
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| Vitality at 1 year |
|
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| Vitality at 3 years |
|
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| Vitality at 5 years |
|
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| Vitality at 7 years |
|
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| Pre-operative social functioning |
|
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| Social functioning at 3 months |
|
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| Social functioning at 1 year |
|
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| Social functioning at 3 years |
|
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| Social functioning at 5 years |
|
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| Social functioning at 7 years |
|
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| Pre-operative emotional role |
|
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| Emotional role at 3 months |
|
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| Emotional role at 1 year |
|
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| Emotional role at 3 years |
|
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| Emotional role at 5 years |
|
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| Emotional role at 7 years |
|
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| Pre-operative mental health |
|
|
| Mental health at 3 months |
|
|
| Mental health at 1 year |
|
|
| Mental health at 3 years |
|
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| Mental health at 5 years |
|
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| Mental health at 7 years |
|
|
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| Symptoms at 5 years |
|
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| Symptoms at 7 years |
|
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| Pain pre-operative |
|
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| Pain at 1 year |
|
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| Pain at 5 years |
|
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| Pain at 7 years |
|
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| Function, sports and recreation activities pre-operative |
|
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| Function, sports and recreation activities at 1 year |
|
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| Function, sports and recreation activities at 5 years |
|
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| Function, sports and recreation activities at 7 years |
|
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| Quality of life (QoL) pre-operative |
|
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| QoL at 1 year |
|
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| QoL at 5 years |
|
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| QoL at 7 years |
|
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| Function, daily living pre-operative |
|
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| Function, daily living at 1 year |
|
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| Function, daily living at 5 years |
|
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| Function, daily living at 7 years |
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| VAS at 1 year |
|
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| VAS at 3 years |
|
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| VAS at 5 years |
|
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| VAS at 7 years |
|
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| Pre-operative descriptive EQ-5D |
|
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| Descriptive EQ-5D at 3 months |
|
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| Descriptive EQ-5D at 1 year |
|
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| Descriptive EQ-5D at 3 years |
|
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| Descriptive EQ-5D at 5 years |
|
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| Descriptive EQ-5D at 7 years |
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