The Effect of the Timing of Postoperative Mobilisation After Locking Plate Osteosynthesis of Fractures of the Surgical Neck of the Humerus
- Conditions
- Humeral Fracture
- Interventions
- Procedure: Immediate mobilisation after locking-plate osteosynthesisProcedure: Standard mobilisation after locking plate osteosynthesisDevice: Osteosynthesis with a locking plate (Philos)
- Registration Number
- NCT01524965
- Lead Sponsor
- University of Helsinki
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 94
- Age 18 years or older
- Surgery can be performed within 10 days of injury
- A dislocated (>1cm or 35 degrees) AO 11-A2, -A3, -B1 or -B2 fracture of the surgical neck of the proximal humerus with a possible fracture of the Tuberculum Majus
- Glenohumeral dislocation
- Fracture of the Tuberculum Minus
- Open fracture
- Additional fractures in the shoulder region
- Other injuries requiring surgical treatment
- Clinically significant injury of the brachial plexus or vasculature
- Pathological fracture associated with cancer
- History of a fracture of the clavicle, scapula or humerus, or history of a very significant disease or trauma of the shoulder region (hemiparesis, tumour, osteomyelitis, grave arthrosis etc)
- Rheumatoid Arthritis in the shoulder requiring active treatment
- Reduced co-operation or incapability for independent living (dementia, mental illness, drug- or alcohol abuse etc)
- Unwillingness to accept some of the treatment options.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Immediate mobilisation Osteosynthesis with a locking plate (Philos) - Immediate mobilisation Immediate mobilisation after locking-plate osteosynthesis - Standard mobilisation Standard mobilisation after locking plate osteosynthesis - Standard mobilisation Osteosynthesis with a locking plate (Philos) -
- Primary Outcome Measures
Name Time Method Disablities of Arm, Hand and Shoulder 2 years Validated patient-reported upper extremity function scale
- Secondary Outcome Measures
Name Time Method Constant Score 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years subjective and objective shoulder score
Simple Shoulder Test (SST) 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years another shoulder score
Pain in rest and motion (2 different values) 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years Numeric rating scale 0-10
Subjective satisfaction 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years Patient reported, Numeric Rating Scale 0-10
Quality of Life 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years Using the 15D instrument
Complications 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years Complications of surgery and postoperative phase
Trial Locations
- Locations (1)
Töölö Hospital, Helsinki University Central Hospital
🇫🇮Helsinki, Finland