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

Withdrawn

• Conditions: Arthroplasty, Replacement, Hip; Patient Satisfaction; Clinical Outcome; Arthroplasty, Replacement, Knee; Treatment Cost
• Interventions: Device: Control; Device: OrthoPath

• Registration Number: NCT05182320
• Lead Sponsor: Aesculap AG

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-01
• Study First Submitted QC: 2021-12-20
• Study First Posted: 2022-01-10
• Study Start: 2023-06-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-24
• Last Update Posted: 2023-08-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Control	-
OrthoPath	OrthoPath	-

Primary Outcome Measures

Name	Time	Method
Osteoarthritis Outcome Score	12 weeks after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Course of Active Range of Motion	repeatedly from pre-op consultation until final follow-up approx. 7 months after surgery	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)
Economical [time and costs]	12 weeks after surgery	Comparing conventional rehabilitation methods and tele-rehabilitation under cost aspects enlarged by quality aspects such as acceptance and satisfaction degree of the patient
Patient User Experience	at final follow-up approx. 7 months after surgery	A measurement just for the patients of the study group. The user feedback is collected at the endpoint
Patient satisfaction	12 weeks after surgery	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".
Patient compliance	at final follow-up approx. 7 months after surgery	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
Development of Pain	repeatedly through study completion, an average of 7 months postoperatively.	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.
Fatigue	at pre-operative consultation, post-operative consultation (12 weeks) and 6 months after surgery	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.
Radiographic Analysis	through study completion, an average of 7 months postoperatively	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
Number of (Serious) Adverse Events	through study completion, an average of 7 months postoperatively	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

Trial Locations

Locations (2)

Sportklinik Ravensburg GmbH & Co. KG; 🇩🇪 Ravensburg, Baden-Württemberg, Germany

RHÖN-KLINIKUM Campus Bad Neustadt; 🇩🇪 Bad Neustadt An Der Saale, Germany