Pilot Study: Development of an Outcome Score for Patients With Knee Osteoarthritis and/or Knee Joint Endoprosthesis Using an App Developed at the Clinic for Orthopedics
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Design: Single-center, prospective pilot study. The app collects patient-authorized movement data already stored on smartphones as well as future data. Participants choose which data to share. In addition, they are prompted to complete gait tests and knee function tests. PROMs (KOOS, SF-36, satisfaction) are administered at regular intervals.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• aged 18 years or older
• german speaking
• signed informed consent
• using own smartphone
Locations
Other Locations
Germany
Department of Orthopaedics and Sports Orthopaedics TUM University Hospital Rechts der Isar
RECRUITING
Munich
Contact Information
Primary
Christina Valle, Dr. med
christina.valle@tum.de
+498941406508
Backup
Florian Hinterwimmer, Dr. rer. nat.
florian.hinterwimmer@tum.de
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 1250
Treatments
Experimental: App-Group
Group which is using the app before and after TKA
No_intervention: Non-App Group
In this arm, patients with osteoarthritis or those who have undergone TKA/THA surgery are included without using the app. These patients receive the same questionnaires as the app group by post, with a request to complete and return them. The patients do not need to play any further active role in the study.
Active_comparator: Healthy controls
In this arm, healthy participants with no lower limb conditions are given the app. This group receives the same questionnaires as all other groups and completes the gait tests in the same way as the app group comprising patients with the condition. The overall procedure is identical to that of the app group comprising patients with the condition.
Related Therapeutic Areas
Sponsors
Leads: Technical University of Munich