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 (ORTHOPATH)

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

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

Study Overview

• Status: Withdrawn
• Conditions: Arthroplasty, Replacement, Knee; Patient Satisfaction; Arthroplasty, Replacement, Hip; Clinical Outcome; Treatment Cost
• Intervention / Treatment: Device: OrthoPath; Device: Control

• Study Type: Observational

Contacts and Locations

Study Locations

• Germany
  • Bad Neustadt An Der Saale, Germany, 97616
    • Rhön-Klinikum Campus Bad Neustadt
  • Baden-Württemberg
    • Ravensburg, Baden-Württemberg, Germany, 88214
      • Sportklinik Ravensburg GmbH & Co. KG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients undergoing primary unilateral Total Knee and Hip Arthroplasty

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control	Device: Control; unilateral TKA and THA patients not using the BPMpathway rehabilitation sensor system
OrthoPath	Device: OrthoPath; unilateral TKA and THA patients using the BPMpathway rehabilitation sensor system

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aesculap AG

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (Actual): January 10, 2022

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: clinical outcome; randomized comparative study; App based sensor; Home Exercise
• Other Study ID Numbers: AAG-O-H-2108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No