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Clinical Trial Summary

Patients suffering from a proximal humerus fracture treated with plate osteosynthesis will receive either regular aftercare (physiotherapy) or aftercare assisted with continous passive motion (physiotherapy + CPM). Change in functional and patient-reported outcome (PROM) over time will be evaluated and compared.


Clinical Trial Description

The investigators will conduct a prospective, monocentric study focusing on the rehabilitation process after surgical treatment of proximal humerus fractures. Patients treated with plate osteosynthesis and eligible to participate will be randomly assigend to either a regular rehabilitation protocol (immobilization and physiotherapy) or a rehabilitation protocol with the additional use of a continous passive motion device (immobilization, physiotherapy and CPM). After 6 and 12 weeks as well as 1 year in a follow-up examination functional (range of motion) and patient-reported outcome (Disabilities of Arm, Shoulder and Hand Score [DASH], Constant-Score, pain on visual analogue scale, subjective satisfaction) will be evaluated. Results will be compared towards possible differences and effect of CPM therapy. In addition demographic factors (age, sex, BMI, etc.) and complications will be analysed. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05952622
Study type Interventional
Source Technische Universität Dresden
Contact
Status Active, not recruiting
Phase N/A
Start date April 1, 2018
Completion date December 31, 2023

See also
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Completed NCT03646253 - Analysis of Four-fragment Fractures of the Proximal Humerus: the Interest of 2D and 3D Imagery and Inter- and Intra-observer Reproducibility
Recruiting NCT05351112 - PMCF Study on the Safety, Performance and Clinical Benefits Data of the Anatomical Shoulder 2.0 Fracture System
Not yet recruiting NCT05943574 - PMCF Study on the Safety, Performance and Clinical Benefits Data of the XtraFix® Small External Fixation System
Not yet recruiting NCT04572022 - Impact of Mobile Health Technology Application on Proximal Humerus Fracture Care Practice N/A