Ignite Creation Date:
2024-05-06 @ 7:16 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05952622
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-07-19
First Post:
2023-04-19
Brief Title:
Outcome After Plate Osteosynthesis of Proximal Humerus Fractures Using Continous Passive Motioning Therapy
Sponsor:
Technische Universität Dresden
Organization:
Technische Universität Dresden
Study Overview
Official Title:
Comparison of Functional and Patient-reported Outcome Using Continuous Passive Motion in Rehabilitation After Plate Osteosynthesis of Proximal Humerus Fractures
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None