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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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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

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Proximal Humerus Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Patients are randomly assigend, masking is not possible.

Study Groups

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Standard rehabilitation protocol

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Rehabilitation protocol with CPM

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

Group Type ACTIVE_COMPARATOR

Continuous passive motion therapy

Intervention Type DEVICE

Patients will be supplied with a continuous passive motion device which will allow additional individual treatment of the affected shoulder for 6 weeks.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No