NCT05952622

Outcome After Plate Osteosynthesis of Proximal Humerus Fractures Using Continous Passive Motioning Therapy

Comparison of Functional and Patient-reported Outcome Using Continuous Passive Motion in Rehabilitation After Plate Osteosynthesis of Proximal Humerus Fractures

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Technische Universität Dresden · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Proximal Humerus Fracture

Interventions

Type	Name	Description
DEVICE	Continuous passive motion therapy	Patients will be supplied with a continuous passive motion device which will allow additional individual treatment of the affected shoulder for 6 weeks.

Timeline

• Start date: 2018-04-01
• Primary completion: 2022-02-28
• Completion: 2023-12-31
• First posted: 2023-07-19
• Last updated: 2023-07-19

Locations

1 site across 1 country: Germany