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

NCT ID: NCT05182320

Last Updated: 2023-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2023-06-01

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

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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OrthoPath

OrthoPath

Intervention Type DEVICE

unilateral TKA and THA patients using the BPMpathway rehabilitation sensor system

Control

Control

Intervention Type DEVICE

unilateral TKA and THA patients not using the BPMpathway rehabilitation sensor system

Interventions

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OrthoPath

unilateral TKA and THA patients using the BPMpathway rehabilitation sensor system

Intervention Type DEVICE

Control

unilateral TKA and THA patients not using the BPMpathway rehabilitation sensor system

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aesculap AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sportklinik Ravensburg GmbH & Co. KG

Ravensburg, Baden-Wurttemberg, Germany

Site Status

RHÖN-KLINIKUM Campus Bad Neustadt

Bad Neustadt an der Saale, , Germany

Site Status

Countries

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Germany

Other Identifiers

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AAG-O-H-2108

Identifier Type: -

Identifier Source: org_study_id

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