Clinical trial NCT05182320: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Arthroplasty, Replacement, Hip
Arthroplasty, Replacement, Knee
Clinical Outcome
Patient Satisfaction
Treatment Cost
Keywords: randomized comparative study
clinical outcome
App based sensor
Home Exercise
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2022-01-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing primary unilateral Total Knee and Hip Arthroplasty

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


Eligibility criteria: 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

Primary outcomes:
measure: Osteoarthritis Outcome Score
timeFrame: 12 weeks after surgery
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 12 weeks after surgery
measure: Patient User Experience
timeFrame: at final follow-up approx. 7 months after surgery
measure: Patient compliance
timeFrame: at final follow-up approx. 7 months after surgery
measure: Economical [time and costs]
timeFrame: 12 weeks after surgery
measure: Course of Active Range of Motion
timeFrame: repeatedly from pre-op consultation until final follow-up approx. 7 months after surgery
measure: Development of Pain
timeFrame: repeatedly through study completion, an average of 7 months postoperatively.
measure: Fatigue
timeFrame: at pre-operative consultation, post-operative consultation (12 weeks) and 6 months after surgery
measure: Radiographic Analysis
timeFrame: through study completion, an average of 7 months postoperatively
measure: Number of (Serious) Adverse Events
timeFrame: through study completion, an average of 7 months postoperatively
Other outcomes:
Locations:
city: Ravensburg
country: Germany
facility: Sportklinik Ravensburg GmbH & Co. KG
state: Baden-Württemberg
city: Bad Neustadt An Der Saale
country: Germany
facility: RHÖN-KLINIKUM Campus Bad Neustadt
Study officials:
References: