The bone4ce device is indicated for the treatment of fresh bone fractures and established non-unions excluding treatment of the skull and the vertebral column. The location and type of fracture will influence results. This non-invasive treatment can only be prescribed by a physician or other health professional.
Low-intensity pulsed ultrasound is a useful therapeutic option and an adjunct therapy to conventional treatment options like surgical intervention for bone fracture healing in selected indications and conditions and for high-risk patients. The use of low-intensity pulsed ultrasound is current medical practice. It represents “state of the art technology”. Based on clinical data, low-intensity pulsed ultrasound has been proven to be effective in certain indications and conditions.
The bone4ce device has been proven to be safe and effective in the following indications and conditions:
- Closed or grade-I open tibia fresh fracture (LIPUS used as an adjunct to conventional orthopedic management (closed reduction, immobilization by cast, reamed intramedullary nailing or external fixation))
- Distal radial fresh fractures (LIPUS used as an adjunct to conventional orthopedic management (closed reduction, immobilization by cast))
- Fresh scaphoid fractures (LIPUS used as an adjunct to immobilization for example with a splint)
- Delayed union of tibia (distal/proximal) fractures (immobilized for example with fixateur externe)
- Delayed union of osteomized fibula.
Which patients is the ultrasound therapy suitable for?
The bone4ce therapy is suitable for all fracture patients who wish to get fi t faster for their work or hobbies and for aftercare following operations, e.g. hallux valgus.
The objective for high-risk patients with bone fractures is to get the healing process started in order to ensure rapid healing. A high risk of pseudarthrosis exists, for example, in the case of fracture patients with osteoporosis, diabetes, obesity, kidney disease, those on medication such as steroids or smokers.
Plates and screws inserted in operations are not a contraindication.
Especially suitable for professional groups with high strain:
Security Forces – Functional disability after operation
Craftmen – Daily mechanical overload of joints
Armed Forces – Excessive strain after threats to safety
Therapists – Physical burdens of work
Insurance systems in Europe, Australia, USA and Canada, etc. have diff erent rules about meeting the costs. High-risk patients and high-risk fractures, private and occupational accidents, fresh fractures and osteotomies – all of these are handled differently according to the country. Please contact your sales partner or our headquarters in Germany if you require further information.