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The goal of this study is to provide gait parameters as a new objective method to assess total knee arthroplasty outcome between patients with fixed- and mobile-bearing, using an ambulatory device with minimal sensor configuration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TKA mobile | Active Comparator | TKA mobile |
|
| TKA | No Intervention | TKA fix |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total knee arthroplasty: mobile bearing | Device | Total knee arthroplasty: mobile bearing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gait Stride Length | distance in meters of gait stride lenght measured by a data logger with five inertial sensors | 5years |
| EuroQoL Quality of Life Scale (EQ-5D) | The EQ-5D is a measure of self-reported health outcomes that is applicable to a wide range of health conditions and treatments. It consists of two parts: a descriptive system (Part I) and a visual analogue scale (VAS) (Part II). Part I of the scale consists of 5 single-item dimensions including: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has a 3 point response scale designed to indicate the level of the problem. Part II uses a vertical graduated VAS (thermometer) to measure health status, ranging from worst imaginable health state to best imaginable health state. T. Descriptive data from the 5 dimensions of Part I can be used to generate a health-related quality of life profile for the subject. Part II is scored from 0 (worst health state imaginable) to 100 (best health state imaginable). The score from Part II can be used to track changes in health, on an individual or group level, over time. | 5years |
| Measure | Description | Time Frame |
|---|---|---|
| Semi-objective Evaluation Knee Sciety Score (KSS) Clinical Outcome Measures | Scoring system to clinically rate the knee abefore and after TK, scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions. | 5years |
| Number of Participants With Dislocation |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| B Jolles, MD MSc | HOSR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HOSR | Lausanne | Switzerland |
8 patients were excluded
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| ID | Title | Description |
|---|---|---|
| FG000 | TKA Mobile | TKA mobile Total knee arthroplasty with mobile bearing implant. |
| FG001 | TKA Fix | Total knee arthroplasty with fixed bearing implant. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TKA Mobile | TKA mobile Total knee arthroplasty: mobile bearing: Total knee arthroplasty: mobile bearing |
| BG001 | TKA Fix | TKA fix |
| 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 | Gait Stride Length | distance in meters of gait stride lenght measured by a data logger with five inertial sensors | Posted | Mean | Inter-Quartile Range | meters | 5years |
|
|
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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 | TKA Mobile | TKA mobile Total knee arthroplasty: mobile bearing: Total knee arthroplasty: mobile bearing |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| postoperative varus knee laxity due to a deficiency in the fibular collateral ligament | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Brigitte Jolles | University Hospital of Lausanne | 0213149629 | brigitte.jolles@chuv.ch |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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count of numbers of dislocated implants. |
| 5years |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Primary | EuroQoL Quality of Life Scale (EQ-5D) | The EQ-5D is a measure of self-reported health outcomes that is applicable to a wide range of health conditions and treatments. It consists of two parts: a descriptive system (Part I) and a visual analogue scale (VAS) (Part II). Part I of the scale consists of 5 single-item dimensions including: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has a 3 point response scale designed to indicate the level of the problem. Part II uses a vertical graduated VAS (thermometer) to measure health status, ranging from worst imaginable health state to best imaginable health state. T. Descriptive data from the 5 dimensions of Part I can be used to generate a health-related quality of life profile for the subject. Part II is scored from 0 (worst health state imaginable) to 100 (best health state imaginable). The score from Part II can be used to track changes in health, on an individual or group level, over time. | data collected in 25 patients on each group (as this a patient reported outcome, thr data was missing in some of the cases) | Posted | Mean | Standard Deviation | score on a scale | 5years |
|
|
|
| Secondary | Semi-objective Evaluation Knee Sciety Score (KSS) Clinical Outcome Measures | Scoring system to clinically rate the knee abefore and after TK, scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions. | data collected in 25 patients on each group (as this a patient reported outcome, thr data was missing in some of the cases) | Posted | Mean | Standard Deviation | score on a scale | 5years |
|
|
|
| Secondary | Number of Participants With Dislocation | count of numbers of dislocated implants. | Posted | Count of Participants | Participants | 5years |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | TKA Fix | TKA fix | 0 | 25 | 1 | 25 |
|
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| D012216 |
| Rheumatic Diseases |