Proximal Humerus Fractures Randomized Control Trial
Proximal Humerus Fracture
About this trial
This is an interventional treatment trial for Proximal Humerus Fracture
Eligibility Criteria
Inclusion Criteria:
- Displaced 2- or 3-part proximal humerus fractures by the Neer classification.
- Displaced 4-part proximal humeral fractures by the Neer classification that are deemed amenable to surgical fixation.
- > 60 years of age
- Low energy mechanism of injury
- Acute fracture (<3 weeks)
Exclusion Criteria:
- 4-part proximal humerus fractures that are not deemed amenable to surgical fixation (eg. due to osteopenic bone, thin head or tuberosity fragments); fractures that are better suited to treatment with arthroplasty
- Isolated greater tuberosity fractures
- Ipsilateral upper extremity significant injury, concomitant fracture or polytrauma
- Open fracture
- Previous ipsilateral shoulder surgery
- Patients with active worker's compensation claims (due to the expectation of lower rates of success in this patient population)
- Active joint or systemic infection
- Patients with convulsive disorders, collagen diseases, and any other conditions that might affect the mobility of the shoulder joint
- Major medical illness (life expectancy less than 2 years, unacceptably high operative risk, or not medically cleared by preoperative anesthesia consult)
- Unable to speak or read English/French
- Psychiatric illness that precludes informed consent
- Unwilling to be followed for 2 years
Sites / Locations
- The Ottawa Hospital
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
nonoperative management
locking plate surgical fixation
Treatment will consist of sling immobilization for a period of 6 weeks. Details and treatment timeline as follows: 0 - 3 weeks: immobilization with a shoulder sling, range of motion of elbow, hand and wrist 3 - 6 weeks: same as 0-3 weeks, with addition of pendulum exercises every two hours After 6 weeks: Active mobilization and removal of sling. Light activity permitted and physiotherapy for range of motion permitted as tolerated. After 6 months: no further restriction will be placed. Full home and work activity permitted.
Standardized operative management protocol as follows: Pre-operative medical clearance established via anesthesia consults if required for medically complex patients. Provision of pre-operative intravenous (IV) antibiotic prophylaxis: Administration of general anesthetic. Patient positioning and preparation: Patient is carefully placed in the beach-chair position, Deltopectoral approach Fracture reduction and fixation with confirmation with intraoperative fluoroscopy images.