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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
103
Patients will be supplied with a continuous passive motion device which will allow additional individual treatment of the affected shoulder for 6 weeks.
University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden
Dresden, Saxony, Germany
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 frame: 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 frame: 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 frame: 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 frame: 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 frame: Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment
Influence of demographic factors upon rehabilitation process
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Evaluation of the underlying demographic factors (gender, age, BMI) and whether these affect the functional and patient-reported outcome (univariate regressional analysis)
Time frame: Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment