Table 3. Adverse Events and Crossoversa.
| Description | No. of patients | |
|---|---|---|
| Surgery (n = 38) | Bracing (n = 44) | |
| Serious adverse event | ||
| Cardiovascular b | 1 | 1 |
| Minor adverse event | ||
| Fracture nonunionc | 0 | 11 |
| Refractured | 0 | 1 |
| Secondary temporary radial nerve palsye | 3 | 1 |
| Superficial wound infectionf | 2 | 1 |
| Wound seroma | 1 | 0 |
| Shoulder adhesive capsulitis | 1 | 1 |
| Loss of reductiong | 0 | 1 |
| Sensory disturbance in the forearmh | 0 | 1 |
| Reason for crossover to surgery | ||
| Nonunion (time range, 3-7.5 mo) | 8 | |
| Loss of reduction (at 6 wk) | 1 | |
| Refracture (at 8 mo) | 1 | |
| Intolerable pain in the fracture site (at 1 wk) | 1 | |
| Not tolerating the bracing (at 1 and 6 wk) | 2 | |
The 13 patients in the bracing group who had surgery are included in the bracing group.
One person in the surgery group had a cardiac arrhythmia warranting cardioversion in the recovery room after the operation. The patient has a history of cardiac arrhythmias. One person in the bracing group had a pulmonary embolism 4 weeks after the initial trauma and the reason for embolism was evaluated to be decreased mobility and staying mainly in bed because of the humeral fracture.
Eight patients underwent surgery at 12 months. The definition for nonunion and indication for an operation promoting union was no bridging fracture callus in 3 of the 4 cortices in x-ray (anteroposterior and lateral view) and clinically tested mobility in the fracture site at 12 weeks or later after the fracture. The proportion of patients with a fracture union observed in each group is presented in eTable 12 in Supplement 2.
One patient with 35° varus malunion underwent surgery due to a refracture of the humerus when doing bench press in the gym 8 months after the initial trauma. The fracture healed uneventfully.
All secondary radial nerve palsies resolved completely within 12 months. One patient in the bracing group had the secondary palsy after operation due to nonunion of the fracture.
All superficial wound infections healed with oral antibiotics without surgical intervention. One patient in the bracing group developed a superficial infection after surgical treatment due to loss of reduction.
The patient underwent surgery at 6 weeks after the initial trauma. The proximal side of the fracture was threatening the skin integrity.
The patient had a minor sensory disturbance of lateral antebrachial cutaneous nerve after the operation, which was done due to intolerable pain at the fracture site at one week after the initial trauma. The sensory disturbance was permanent.