totale knie vervangende operatie kneeprosthesis total knee replacement
Conditions
Interventions
- Answer questionnaires
- perform ADL, while wearing multiple sensors on the body.
- wear an activity monitor (Fitbit) and the optional mobile phone with
application at home.
Sponsors
Imec Nederland
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - patient with knee osteoarthritis undergoing primary total knee replacement of one knee within 3 months. - age > 18 years - informed consent - willing to travel to hospital for 3 additional visits
Exclusion criteria
Exclusion criteria: a) Subjects with an artificial joint/limb in the lower body. b) Subjects diagnosed with and/or taking medication for any musculoskeletal, neurological disorder or inflammatory arthritis. c) Subjects who are pregnant or likely to become pregnant d) Subject with known allergy to adhesive Ag/AgCl electrodes e) Subjects using medication with phototoxic side effects: Tetracylines, Doxycycline, Phenothiazines, Dacarbazine, Ketoprofen, Lomefloxacin. In order to exclude possible local skin irritation from prolonged irradiation by LED-light (from activity monitor). f) Patients that do not want to be informed in case of incidental findings.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to determine which wearable motion sensors are suitable to measure change in physical function of TKR patients after surgery. Following this objective, we will explore if the changes in physical function, as measured with wearable sensors, is related to the PROMs. Physical function is specified as a selection of functional parameters (e.g. walking speed, step length, symmetry). All of these functional parameters can be determined using wearable motion sensors, with methods we have developed in our previous study on healthy subjects. However, each motion sensor-based calculation has a certain accuracy. Therefore, we will determine the change of each functional parameter using reference devices/software (pressure insoles, Xsens kinematics software, ECG patches). If the change of the functional parameter in TKR patients is bigger than the accuracy of the motion sensor-based calculation, the motion sensor is suitable to measure change of physical function. General function PROM is defined as score on the KOOS-PS, with a difference bigger than 2.2 within a subject as minimal clinical improvement threshold. Specific function PROM is defined as score on the PKIP, with sub scores on: stability, confidence, satisfaction and modification of activities. Both the sensor-based features and the PROMs are measured at multiple points in time (5x). To account for individual progress over time on both measures, the difference between baseline (pre-operative) and each follow-up measurement will be calculated. The relation between each functional parameter and the score on the PROMs will be explored. For an extensive description of the analysis and the endpoints, see protocol section 10. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Relation between pre-operative expectation (of multiple ADL) of the subject and the surgeon, and the PROMs. * Relation between patient specific parameters (biometrics, lifestyle, comorbidities, mental fitness), and the PROMs. * Correlation between subject reported acute pain/confidence (from VAS) and sensor based features (physiological and movement) during ADL. * Correlation between the activity level at home of the wrist worn device (fitbit) and the smartphone based (Sentiance application). For an extensive description of the analysis and the endpoints, see protocol section 10. | — |
Countries
Netherlands
Outcome results
None listed