Clinical trial NCT05952622: Outcome After Plate Osteosynthesis of Proximal Humerus Fractures Using Continous Passive Motioning Therapy
Official title: Comparison of Functional and Patient-reported Outcome Using Continuous Passive Motion in Rehabilitation After Plate Osteosynthesis of Proximal Humerus Fractures
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Proximal Humerus Fracture
Keywords: proximal humerus fracture
plate osteosynthesis
rehabilitation
continuous passive motion
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 103
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are assigned to one of two rehabilitation protocols consisting of either A: initial immobilization followed by physiotherapy or B: initial immobilization followed by physiotherapy and additional continuous passive motion therapy
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* patients with proximal humeral fracture treated with plate osteosynthesis during the enrollment period
* understanding of German language (written and oral)
* written informed consent of the patient or the legal guardian

Exclusion Criteria:

* patients not meeting the aforementioned criteria
* patients with the need of / or an already existing endoprosthesis
* patients with ipsilateral fracture of the distal radius
* patients with cerebral damage (contusio or commotio cerebri)
* patients with affection of the brachial plexus or nerve palsy
* non-compliance

Primary outcomes:
measure: Change in Range of Motion (ROM) after 6 weeks, 12 weeks and 1 year
timeFrame: Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment
measure: Change of Disabilities of Arm, Shoulder and Hand Score (DASH) after 6 weeks, 12 weeks and 1 year
timeFrame: Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment
measure: Change of Constant-Score (CSS) after 6 weeks, 12 weeks and 1 year
timeFrame: Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment
measure: Change of Pain on visual analogue scale (VAS) after 6 weeks, 12 weeks and 1 year
timeFrame: Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment
measure: Change of Subjective satisfaction with surgical treatment (SSV) after 6 weeks, 12 weeks and 1 year
timeFrame: Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment
Secondary outcomes:
measure: Influence of demographic factors upon rehabilitation process
timeFrame: Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden
state: Saxonia
Study officials:
References: