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

Technische Universität Dresden

Status: Active, not recruiting

Conditions: Proximal Humerus Fracture

Treatments: Device: Continuous passive motion therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05952622

CPM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 103 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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103 participants in 2 patient groups

Standard rehabilitation protocol

No Intervention group

Description:

Standard rehabilitation after surgical treatment consisting of initial immobilization followed by physiotherapy.

Rehabilitation protocol with CPM

Active Comparator group

Description:

Additional treatment of patients with continuous passive motion after initial immobilization for 6 weeks.

Treatment:

Device: Continuous passive motion therapy