The device transmits a low intensity ultrasound signal to the fracture site through coupling gel. Due to the very low intensity of the ultrasound, little or no sensation is felt by the patient during the treatment. A design feature alerts the patient in case of improper application or performance of the device. The snap-on cap has a spring attached to its inner side which keeps a light pressure force on the transducer, thereby ensuring contact of the transducer surface with the skin.
Coupling gel must be applied to the transducer surface at the start of each treatment period in order to permit transmission of the ultrasound signal from the transducer surface to the skin over the fracture site.
Both containers of coupling gel are completely full. While the accelerated healing potential and non-union treatment capabilities of the system continue to provide the same non-invasive alternative to surgery, the design upgrades make it easier to operate further optimizing patient care," said Ken Reali, vice president and general manager, Orthopedic Clinical Therapies.
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Use it, try it, not happy? Returns are simple, even if you have worn the product, we've got you covered. Your doctor may also recommend that you increase your daily intake of increase your daily intake of vitamin D , vitamin C , and calcium during the treatment process. This can encourage the bones to produce new, healthy cells to assist in the healing process. Bone stimulators are often used to treat nonunions, which are broken bones that fail to heal.
Infections are also a cause of nonunions, particularly after surgery. A bone stimulator delivers ultrasonic or pulsed electromagnetic waves to the nonunion site to stimulate healing. The effectiveness of bone stimulators for bone fracture healing remains unclear. Researchers have had mixed results in determining whether these devices can affect the bone microstructure and help heal fractures.
A review of studies found that patients treated with electrical stimulation experienced less pain and lower rates of persistent nonunions. However, a review of randomized controlled trials showed that pain was only reduced in 1 of the 4 trials studied, and the electrical stimulation had no significant effect on the bone healing.
Since electrical stimulation treatment has no side effects, researchers agree that more research on its use and effectiveness is warranted. If you do not have insurance, ask your doctor how much this treatment will cost. In one study , patients who received bone stimulators after surgical procedures incurred higher costs, on average. However, recent research showed that electrical bone growth stimulation is linked to lower healthcare costs when compared to low-intensity pulsed ultrasound stimulation or other non-stimulation treatment options.
To date, bone growth stimulators are not known to induce any adverse side effects in people. However, Podiatry Today cautions that bone stimulators should not be used in the following cases:.
If nonsurgical methods, such as bone stimulation, are not working, a bone graft might be necessary. Bone grafts provide fresh bone cells to the nonunion and encourage healing.
If authorization for a rental unit is requested beyond the approved 3 months, new x-rays or radiology reports must be submitted. All authorization requests for treatment of nonunion must include serial x-rays which demonstrate that no progressive signs of healing have occurred.
For non-healing spinal fusions, at least two x-rays over the course of three months are required. For non-healing fractures, at least two x-rays 30 days or more apart are required. All authorization requests must document that the device is requested for an FDA-approved indication, that coverage criteria listed above are met, and that no contraindications are present.
FDA-approved Devices not an exhaustive list.
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