Outcome After Plate Osteosynthesis of Proximal Humerus Fractures Using Continous Passive Motioning Therapy
- Conditions
- Proximal Humerus Fracture
- Interventions
- Device: Continuous passive motion therapy
- Registration Number
- NCT05952622
- Lead Sponsor
- Technische Universität Dresden
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 103
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rehabilitation protocol with CPM Continuous passive motion therapy Additional treatment of patients with continuous passive motion after initial immobilization for 6 weeks.
- Primary Outcome Measures
Name Time Method 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 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
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 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 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°
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (1)
University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden
🇩🇪Dresden, Saxonia, Germany