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 BONE GROWTH STIMULATOR OVERVIEW


Bone growth stimulation is done when satisfactory healing is not occurring naturally or when the pace of healing is too slow. This condition is called fracture nonunion, and it occurs more frequently among adults than children, in people with severe or complex fractures, and in people who smoke.

The theory behind applying an electric current to fractures to stimulate healing is based on the fact that the concave side of the bone becomes negatively charged and the convex side is positively charged. It is believed that artificially encouraging this charging with an electric current will speed healing. In 1996, the Food and Drug Administration (FDA) also approved the application of low intensity ultrasound pulses as a treatment for fracture nonunion.


Ultrasound and electromagnetic stimulation are expensive and are used only when healing problems exist for a substantial length of time. Each method must be used for at least three to six months to be effective.


DONJOY EXTERNAL DEVICES

Fracture Healing
  (Nonunions)
CMF OL1000 Bone Growth Stimulators are portable, battery-powered medical devices indicated for use in the noninvasive treatment of an established nonunion fracture acquired secondary to trauma, excluding all vertebrae and flat bones.

 

OL 1000


Device description: 

  • Light-weight and comfortable
  • Easy-to-use & Noninvasive
  • Requires simple, one-button operation
  • Device is worn for only 30 minutes per day
  • Can be used with internal or external fixation or over a cast


 





Literature:

OLMultiCentPaper.pdf

   


Spinal Fusion

CMF SpinaLogic® is a portable, battery-powered, micro-controlled, noninvasive bone growth stimulator indicated as an adjunct electromagnetic treatment to primary lumbar spinal fusion surgery for one or two levels. 


SPINALOGIC®


Device description:
  • Light-weight and comfortable
  • Easy-to-use
  • Can be used after anterior or posterior approach in fusion surgery
  • Noninvasive
  • Requires simple, one-button operation
  • Device is worn for only 30 minutes per day

 


 





BIOMET EXTERNAL DEVICES

Fracture Healing (Nonunions)

The lightest and most convenient way to treat nonunions.

 
ORTHOPAK
®
 2                                      
                                      
                                                             
       Device description:
  • Proprietary capacitive coupling technology offers a large field of influence within area of electrodes for treating even your largest fracture site.
  • Flexible electrodes allow for easy placement even in the most difficult-to-reach nonunion fracture sites.
  • Continuous 24-hour treatment provides an optimized treatment dose.
  • Rechargeable battery system offers convenient easy treatment maximizing patient compliance.

Literature:

OrthoPak2.pdf
  
Spinal Fusion 
Stringent success criteria: combined clinical and radiographic.  Statistically significant results with and without spinal fixation. 

SpinalPak
® II

Device description:

  • Lightest weight noninvasive system
  • Still less than an ounce at the fusion site and less than 4 ounces overall
  • Unobtrusive treatment enhances patient comfort with ergonomic shape
  • LCD display indicates the patient is receiving treatment at the fusion        site
  • New rechargeable batteries (2) and battery charger included for even easier uninterrupted treatment
  • Compliance monitor available for the actual treatment time received by the patient

Literature:
SpinalPakII.pdf
 
Bone Healing 
Introduced in 1979 as a noninvasive alternative or adjunct to surgery.  Indicated for nonunion fractures, 
failed fusions and congenital pseudarthrosis.  FLX
® Flexible Treatment Coil is placed directly over fracture site.

Bone Healing System
®
                        
Device description:
  • Does not require surgery
  • Has been prescribed by over 25,000 surgeons
  • A safe and painless device worn externally over the fracture site
  • Lightweight, comfortable and easy to use
  • May be worn during normal daily routine or while sleeping
  • Cost-effective treatment
  • Device is clipped to a belt (worn like a pager)
 

 

BIOMET INTERNAL DEVICES
The OsteoGen® surgically implanted bone growth stimulator is a useful adjunct for the treatment of nonunions when surgery is already planned or when patient compliance may be a concern. Because the OsteoGen™ is totally surgically implanted, patients are assured of therapeutic treatment directly at the nonunion site 24 hours a day for at least 6 months.
 
OsteoGen® Bone Growth Stimulator

Device description:

  • Compatible with bone graft surgery in the surgical treatments (internal and external fixation)
  • Commonly used for the management of nonunions.
  • Commonly used for nonunions in the following areas: 
    • femur, tibia, fibula, humerus, clavicle, ulna, radius
  • May be used as an adjunct to internal/external fixation and autograft


OsteoGen® -M Bone Growth Stimulator
 
 Device description:
 
  • Pre-formed cathode facilitates quick and easy placement against decorticated bone
  • Increases contact between cathode and host bone to enhance application of current
  • Provides an electrified scaffold for stimulating bone growth
  • Totally implanted to assure patient compliance
  • No special surgical instrumentation required
  • Generator has 6-month minimum implant life for continuous treatment 24 hours/day
  • Made from biocompatible inert titanium and silicone so not to add to risk of infection

Literature:




 
Contact us in order to learn more about Bone Growth Stimulation.