Knee Osteoarthritis
Conditions
Brief summary
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.
Interventions
DEVICETotal knee arthroplasty: mobile bearing
Total knee arthroplasty: mobile bearing
Sponsors
University of Lausanne Hospitals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients suffering from a primary unilateral knee osteoarthritis and requiring a knee replacement * Informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gait Stride Length | 5years | distance in meters of gait stride lenght measured by a data logger with five inertial sensors |
| EuroQoL Quality of Life Scale (EQ-5D) | 5years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Semi-objective Evaluation Knee Sciety Score (KSS) Clinical Outcome Measures | 5years | 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. |
| Number of Participants With Dislocation | 5years | count of numbers of dislocated implants. |
Countries
Switzerland
Participant flow
Pre-assignment details
8 patients were excluded
Participants by arm
| Arm | Count |
|---|---|
| TKA Mobile TKA mobile
Total knee arthroplasty: mobile bearing: Total knee arthroplasty: mobile bearing | 26 |
| TKA Fix TKA fix | 30 |
| Total | 56 |
Baseline characteristics
| Characteristic | TKA Mobile | TKA Fix | Total |
|---|---|---|---|
| Age, Continuous | 67.1 years STANDARD_DEVIATION 8.3 | 70.2 years STANDARD_DEVIATION 7.1 | 68.7 years STANDARD_DEVIATION 7.7 |
| Sex: Female, Male Female | 17 Participants | 12 Participants | 29 Participants |
| Sex: Female, Male Male | 9 Participants | 18 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 1 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
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.
Time frame: 5years
Population: data collected in 25 patients on each group (as this a patient reported outcome, thr data was missing in some of the cases)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Preoperative | EuroQoL Quality of Life Scale (EQ-5D) | 75.3 score on a scale | Standard Deviation 17.5 |
| 5 Years | EuroQoL Quality of Life Scale (EQ-5D) | 79.9 score on a scale | Standard Deviation 18 |
Primary
Gait Stride Length
distance in meters of gait stride lenght measured by a data logger with five inertial sensors
Time frame: 5years
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Preoperative | Gait Stride Length | 1.2 meters |
| 5 Years | Gait Stride Length | 1.2 meters |
Comparison: FB group was designated the control group. We determined a sample size based in clinical criteria. Using an α of 0.05 and β of 0.8, the required sample size was calculated to be 24 patients in each group to achieve a power of 80%. Descriptive analysis was completed on demographic information and clinical and radiological outcomes. Nonparametric tests (Wilcoxon's signed ranks or rank sum tests) were used for comparison of scores. The chi-squared test was used for dichotomous variables.p-value: 0.05Wilcoxon (Mann-Whitney)
Secondary
Number of Participants With Dislocation
count of numbers of dislocated implants.
Time frame: 5years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Preoperative | Number of Participants With Dislocation | 0 Participants |
| 5 Years | Number of Participants With Dislocation | 0 Participants |
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.
Time frame: 5years
Population: data collected in 25 patients on each group (as this a patient reported outcome, thr data was missing in some of the cases)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Preoperative | Semi-objective Evaluation Knee Sciety Score (KSS) Clinical Outcome Measures | 51.7 score on a scale | Standard Deviation 12.8 |
| 5 Years | Semi-objective Evaluation Knee Sciety Score (KSS) Clinical Outcome Measures | 49.3 score on a scale | Standard Deviation 19.4 |