Initial History
- Right reverse obliquity subtrochanteric femur fracture
11 Months Post-injury
- CT scan shows persistent hypertronphic nonunion
- Hardware and fracture stable
- EXOGEN prescribed
Post-Op
- Post-op locked cephalomedullary nailing
- Persistent pain/lack of healing
- Underwent nail dynamization at 9 months post-injury
3 Months of EXOGEN Use, 14 Months Post-injury
- Nonunion healed
- Symptoms resolved
- Additional surgery avoided
3 Months
- No progression of healing
- Nonunion diagnosis
- EXOGEN prescribed
- Remained in long-leg cast
7 Months
- Nonunion healed
- Additional bone healing evident
- Surgery avoided
5 Months
- Progressed to short-legged walking cast
- Significant bony healing
3 Months Post-Op
- No progression with healing, nonunion diagnosis
- Screw from prior surgery is bending
- EXOGEN prescribed
- Boot with weight bearing continued
8 Months Post-Op
- Patient returned to football
7 Months Post-Op, 17 Weeks of EXOGEN Use
- Complete union noted 17 weeks after initiating EXOGEN
- Patient asymptomatic
- Additional surgery avoided
Summary of Indications for Use
The EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of established nonunions* excluding skull and vertebra. The EXOGEN device has also been reported as effective as an adjunctive non-invasive treatment of established nonunions in patients:
- With internal or external fracture fixation hardware present. EXOGEN cannot penetrate metal and therefore should not be applied directly over hardware.
- Undergoing treatment for infection at the fracture site. EXOGEN is not intended to treat the infection.
- Believed to have diminished bone quality. EXOGEN is not intended to treat diminished bone quality.
In addition, EXOGEN is indicated for accelerating the time to a healed fracture for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or Grade I open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopedically managed by closed reduction and cast immobilization.
There are no known contraindications for the EXOGEN device. Safety and effectiveness have not been established for individuals lacking skeletal maturity, pregnant or nursing women, patients with cardiac pacemakers, on fractures due to bone cancer, or on patients with poor blood circulation or clotting problems. Some patients may be sensitive to the ultrasound gel.
*A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.
Full prescribing information can be found in product labelling, at EXOGEN.com, or by calling Customer Service at 1-800-836-4080.
