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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Arthroplasty, Replacement, Hip
- Sponsor
- Aesculap AG
- Locations
- 2
- Primary Endpoint
- Osteoarthritis Outcome Score
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
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
Investigators
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
Outcomes
Primary Outcomes
Osteoarthritis Outcome Score
Time Frame: 12 weeks after surgery
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.
Secondary Outcomes
- Course of Active Range of Motion(repeatedly from pre-op consultation until final follow-up approx. 7 months after surgery)
- Patient User Experience(at final follow-up approx. 7 months after surgery)
- Economical [time and costs](12 weeks after surgery)
- Patient satisfaction(12 weeks after surgery)
- Patient compliance(at final follow-up approx. 7 months after surgery)
- Development of Pain(repeatedly through study completion, an average of 7 months postoperatively.)
- Fatigue(at pre-operative consultation, post-operative consultation (12 weeks) and 6 months after surgery)
- Radiographic Analysis(through study completion, an average of 7 months postoperatively)
- Number of (Serious) Adverse Events(through study completion, an average of 7 months postoperatively)