Tibial Stress Fracture/Nonunion
EXOGEN Helps an Active Runner Return to the Race

This patient testimonial is representative of an approved indication for use of EXOGEN in Canada. This may not be representative of a USA FDA-approved indication for use of EXOGEN in the United States.

Situation:

Halifax, N.S., Canada — In September 2019, Michael Gfeller was preparing to participate in his dream race in Switzerland, the Jungfrau Marathon. He was training to run up a mountain.

A kinesiologist by profession, Michael is passionate about competitive running and coaching endurance athletes to achieve their goals. In May 2018, however, the pain in his leg “got so bad, I couldn’t make it to the end of the driveway,” he explained.

As Michael described it, that was just the beginning of his journey. A colleague recommended that he get an X-ray. Eventually, a CT scan in July revealed he had a tibia stress fracture. At the time, Michael was trying to maintain his fitness by cycling and swimming, but even that became painful.

Michael was prescribed the use of an aircast and six to eight weeks rest. After that, he was sent for more imaging. There was no improvement and Michael was referred to an orthopaedic surgeon and advised to use crutches.

“I thought I was young and invincible,” he said. “I was so itchy to exercise, I felt like I was going backwards.” By November, Michael’s latest CT scan revealed no evidence of healing. “That was pretty discouraging. I felt like I wasted a whole season of training.”
“It’s a worthwhile investment to get your life back.”

Solution:

After six months without progress, Michael’s spouse recommended that he ask his doctor about EXOGEN. As a physiotherapist, she thought the device might help, Michael explained. “She is focused on evidence-based medicine.”

Success:

Michael began using EXOGEN at the end of November and did not miss a treatment day until he got the results he was hoping for. In February 2019, Michael was healed. “I had 100% compliance,” he said. “It was straightforward and easy.”

“It is emotionally hard, knowing that you have to lean on other people. My wife cut the grass all season and I had to pay my neighbor in beer to shovel my driveway,” he joked. “It’s humbling and discouraging to have to lean on other people more than you want to.”

After the good news, Michael was back to training. It took him eight weeks to be able to run continuously without walking breaks. By June, he ran 102 kilometers in an endurance trail race. “[EXOGEN] was the push I needed,” he said. “It’s a worthwhile investment to get your life back.”

Disclaimer: Information presented in patient testimonials is representative of a specific patient experience only and does not constitute medical advice.

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.