Status:
WITHDRAWN
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
Lead Sponsor:
Aesculap AG
Conditions:
Arthroplasty, Replacement, Hip
Arthroplasty, Replacement, Knee
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05182320
Start Date
June 1 2023
End Date
June 1 2023
Last Update
August 25 2023
Active Locations (2)
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1
Sportklinik Ravensburg GmbH & Co. KG
Ravensburg, Baden-Wurttemberg, Germany, 88214
2
RHÖN-KLINIKUM Campus Bad Neustadt
Bad Neustadt an der Saale, Germany, 97616