Open reduction and locking plate osteosynthesis is a commonly used and well-accepted treatment for displaced fractures of the proximal humerus. The shoulders tend to end stiff despite intensive rehabilitation, limiting the function of the upper extremity and decreasing the quality of life. The accepted postoperative mobilisation protocol includes passive exercises until six weeks postoperatively and active range of motion exercises after that. There is good evidence that conservatively treated fractures of the same site heal better and faster if mobilised immediately. The study compares "standard mobilisation" versus "immmediate mobilisation" in a prospective, randomized, controlled trial in order to find the optimal time-frame for physiotherapy to produce best possible results. Outcome measures are assessed at specific time points after the operation and comparisons between groups are made to follow the rate of recovery and end results.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
94
Immediate passive range of motion exercises are begun postoperatively, after 3 weeks, active unloaded mobilisation begins after three weeks and active, loaded use is allowed 6 weeks postoperatively. Surgical procedure is open reduction of the fracture and internal fixation of the fracture using a locking plate using standard deltopectoral approach and AO principles in fracture management.
Immediately postoperatively the arm is held in a sling, active mobilisation of healthy joints and pendel exercises are befun. Passive range of motion exercises of the shoulder are begun 3 weeks postoperatively. Active mobilisation begins after six weeks. Surgical procedure is open reduction of the fracture and internal fixation of the fracture using a locking plate using standard deltopectoral approach and AO principles in fracture management.
Standard open reduction and internal fixation using a deltopectoral approach. Fracture fixation is done using a locking plate (Philos, Synthes) following the AO principles of fracture management.
Töölö Hospital, Helsinki University Central Hospital
Helsinki, Finland
Disablities of Arm, Hand and Shoulder
Validated patient-reported upper extremity function scale
Time frame: 3 weeks
Disablities of Arm, Hand and Shoulder
Validated patient-reported upper extremity function scale
Time frame: 6 weeks
Disablities of Arm, Hand and Shoulder
Validated patient-reported upper extremity function scale
Time frame: 3 months
Disablities of Arm, Hand and Shoulder
Validated patient-reported upper extremity function scale
Time frame: 6 months
Disablities of Arm, Hand and Shoulder
Validated patient-reported upper extremity function scale
Time frame: 1 year
Disablities of Arm, Hand and Shoulder
Validated patient-reported upper extremity function scale
Time frame: 2 years
Constant Score
subjective and objective shoulder score
Time frame: 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Simple Shoulder Test (SST)
another shoulder score
Time frame: 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Pain in rest and motion (2 different values)
Numeric rating scale 0-10
Time frame: 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Subjective satisfaction
Patient reported, Numeric Rating Scale 0-10
Time frame: 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Quality of Life
Using the 15D instrument
Time frame: 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
Complications
Complications of surgery and postoperative phase
Time frame: 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
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