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

Study Overview
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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.

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.

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

Conditions
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Proximal Humerus Fracture

Intervention / Treatment
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* Device: Continuous passive motion therapy


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard rehabilitation protocol<br>Standard rehabilitation after surgical treatment consisting of initial immobilization followed by physiotherapy. | |
| Active Comparator: Rehabilitation protocol with CPM<br>Additional treatment of patients with continuous passive motion after initial immobilization for 6 weeks. | Device: Continuous passive motion therapy<br>* Patients will be supplied with a continuous passive motion device which will allow additional individual treatment of the affected shoulder for 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Range of Motion (ROM) after 6 weeks, 12 weeks and 1 year | Objetive functional clinical result. Evaluation ot Motion of the shoulder in ° measured via goniometer. Physiological Abduction/Adduction: 180/0/40°, Anteversion/Retroversion 160/0/40°, external/internal rotation: 70/0/60° | Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment | 
| Change of Disabilities of Arm, Shoulder and Hand Score (DASH) after 6 weeks, 12 weeks and 1 year | Evaluation of the subjective function (patient reported outcome) using the DASH-Score, 0-100, best: 0, worst: 100 | Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment | 
| Change of Constant-Score (CSS) after 6 weeks, 12 weeks and 1 year | Evaluation of the subjective function (patient reported outcome) using the Constant-Score, 0-100, best: 100, worst: 0 | Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment | 
| Change of Pain on visual analogue scale (VAS) after 6 weeks, 12 weeks and 1 year | Evaluation of the subjective pain using a visual analogue scale, 0-10, best:0, worst: 10 | Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment | 
| Change of Subjective satisfaction with surgical treatment (SSV) after 6 weeks, 12 weeks and 1 year | Evaluation of the subjective satisfaction using the subjective shoulder value, 0-100, best:100, worst: 0 | Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of demographic factors upon rehabilitation process | Evaluation of the underlying demographic factors (gender, age, BMI) and whether these affect the functional and patient-reported outcome (univariate regressional analysis) | Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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proximal humerus fracture, plate osteosynthesis, rehabilitation, continuous passive motion