Study Measuring the Effects of Patient Data for Total Hip and Total Knee Arthroplasty Patients Using an APP Based Sensor for Home Exercise Performance Before and After Operation

Study Overview
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Brief Summary
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Multicenter, Prospective, Randomized, Comparative Study Measuring the Effects on Clinical Outcomes, Patient Satisfaction, Costs and Benefits of Combined Pre-, Intra- and Postoperative Patient Data for THA and TKA Patients Using an APP Based Sensor for Home Exercise Performance Before and After Operation

Official Title
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Multicenter, Prospective, Randomized, Comparative Study Measuring the Effects on Clinical Outcomes, Patient Satisfaction, Costs and Benefits of Combined Pre-, Intra- and Postoperative Patient Data for THA and TKA Patients Using an APP Based Sensor for Exercise Performance Before and After Operation

Conditions
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Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Clinical Outcome, Patient Satisfaction, Treatment Cost

Intervention / Treatment
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* Device: OrthoPath
* Device: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary, unilateral total knee and hip replacement patients Participant is min. 18 years of age Participant is able and willing to provide written informed consent Participant with ability to work with smart devices Participant having its own device (Apple iPhone or iPad with latest iOS version or Android tablet or smart phone min. Android version 6) and are able to handle the app and/or sensor Exclusion Criteria: Pregnancy Participant has mental in capabilities - unable to give informed consent Participants who are unwilling or mentally and/or physically unable to adhere to study procedures Participant is having orthopaedic co-morbidities such as: previous HTO at indexed joint or prior UKA Flexion contracture > 15° Varus/valgus deformity > 10° Participant is having dementia or other cognitive impairment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OrthoPath<br> | Device: OrthoPath<br>* unilateral TKA and THA patients using the BPMpathway rehabilitation sensor system<br>|
| Control<br> | Device: Control<br>* unilateral TKA and THA patients not using the BPMpathway rehabilitation sensor system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Osteoarthritis Outcome Score | The Patient self-assessed Injury and Osteoarthritis Outcome Scores for Knee (KOOS) and hip (HOOS) are joint-specific instruments: The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). The HOOS evaluates both short-term and long-term consequences of hip injury. It holds 5 separate patient-relevant dimensions: Pain (P), Symptoms (S), Activity limitations daily living (ADL), Function in sport and recreation (SP) and hip related quality of life (QOL). Both scores are percentage scores from 0 to 100, 0 representing extreme problems and 100 representing no problems. | 12 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Based on a single question patients are asked to grade their level of satisfaction with the methodology and rehabilitation procedure. Patients can choose between very dissatisfied, dissatisfied, satisfied or very satisfied. The grades may be summarized as satisfied vs. dissatisfied. | 12 weeks after surgery | 
| Patient User Experience | A measurement just for the patients of the study group. The user feedback is collected at the endpoint | at final follow-up approx. 7 months after surgery | 
| Patient compliance | A measurement just for the patients of the study group. Data collection (Counting) how often patients use BPMpathway before and after operation to determine compliance with specification of using BPMpathway three times per day every day through data analytics | at final follow-up approx. 7 months after surgery | 
| Economical [time and costs] | Comparing conventional rehabilitation methods and tele-rehabilitation under cost aspects enlarged by quality aspects such as acceptance and satisfaction degree of the patient | 12 weeks after surgery | 
| Course of Active Range of Motion | Study Group: Measured with BPMpathway sensor and app 3 times per day for the entire duration and measures with manual goniometer during all clinical visits (in 5° steps) Control Group: Measured with manual goniometer during all clinical visits (in 5°steps) | repeatedly from pre-op consultation until final follow-up approx. 7 months after surgery | 
| Development of Pain | Study Group: Pain measured within BPMpathway app 3 times per day for the entire duration by Wong Baker Pain Score until post-operative follow-up meeting and during all clinical visits Control Group: Pain measured with Wong Baker Pain Scale during all clinical visits The Wong-Baker proves to be an inexpensive, yet easy to use, pain scale. The scale consists of six faces that range from no pain at all to the worst pain imaginable. The emotional faces range from smiling to grimacing. | repeatedly through study completion, an average of 7 months postoperatively. | 
| Fatigue | Study Group and Control Group: Measures with Fatigue Severity Scale. The Fatigue Severity Scale is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. It was originally devised for people with Multiple Sclerosis or systemic lupus erythematosus. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree; the minimum score is 9 and the maximum score is 63. The higher the score the greater the fatigue severity. | at pre-operative consultation, post-operative consultation (12 weeks) and 6 months after surgery | 
| Radiographic Analysis | Unless limited by patient or equipment constraints, all follow-up imaging exams will be obtained. Imaging will be used to evaluate the implant status as well as device condition and potential presence of device-related Adverse Events including fracture, wear, loosening or radiolucencies. X-rays are taken according to the radiographic protocol of the hospital and the set routine | through study completion, an average of 7 months postoperatively | 
| Number of (Serious) Adverse Events | During the course of the study, any upcoming intra- or postoperative (serious) adverse device events or effects related or not related to the product under investigation, will be documented in the dedicated Case Report Forms. The total number of AEs will be summarized and further evaluated by the sponsor and reported according to local legislation and necessity. Recorded complications will be categorized and analyzed in order to assess the safety of the investigational product | through study completion, an average of 7 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomized comparative study, clinical outcome, App based sensor, Home Exercise