Proximal Humerus Fracture
Conditions
Keywords
proximal humerus fracture, plate osteosynthesis, rehabilitation, continuous passive motion
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.
Interventions
DEVICEContinuous 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.
Sponsors
Technische Universität Dresden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Patients are randomly assigend, masking is not possible.
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
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Range of Motion (ROM) after 6 weeks, 12 weeks and 1 year | Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment | 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° |
| Change of Disabilities of Arm, Shoulder and Hand Score (DASH) after 6 weeks, 12 weeks and 1 year | Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment | Evaluation of the subjective function (patient reported outcome) using the DASH-Score, 0-100, best: 0, worst: 100 |
| Change of Constant-Score (CSS) after 6 weeks, 12 weeks and 1 year | Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment | Evaluation of the subjective function (patient reported outcome) using the Constant-Score, 0-100, best: 100, worst: 0 |
| Change of Pain on visual analogue scale (VAS) after 6 weeks, 12 weeks and 1 year | Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment | Evaluation of the subjective pain using a visual analogue scale, 0-10, best:0, worst: 10 |
| Change of Subjective satisfaction with surgical treatment (SSV) after 6 weeks, 12 weeks and 1 year | Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment | Evaluation of the subjective satisfaction using the subjective shoulder value, 0-100, best:100, worst: 0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Influence of demographic factors upon rehabilitation process | Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment | Evaluation of the underlying demographic factors (gender, age, BMI) and whether these affect the functional and patient-reported outcome (univariate regressional analysis) |
Countries
Germany
Outcome results
None listed