- PJ Cundy, FRACS, DC Paterson, MD, FRCS, FRACS.
A Ten-Year Review of Treatment of Delayed Union and Nonunion with an
Implanted Bone Growth Stimulator. Clin Orthop Relat Res. 1990 Oct;
(259): 216-22.
*MRI safety information has not yet been established for OsteoGen
Implantable Bone Growth Stimulators. The FDA approved device trade
name is the EBI OsteoGen Implantable Growth Stimulator.
INDICATIONS AND USAGE
The Stimulator is indicated in the treatment of long bone nonunions.
A nonunion is considered to be established when the fracture site
shows no visibly progressive signs of healing. The original 1980 PMA
included two clinical studies; neither was designed for long-term
follow-up. In the first study (N=30) the patients were followed for a
minimum of ten (10) years, with an overall follow-up rate of 48.2%.
The long-term success rate was 66.7%. This calculation excludes the
initial treatment successes not followed for ten (10) years (N=11).
The second study (N=107) followed the patients for a minimum of four
(4) years with overall follow-up rate of 25.6%. The long-term success
rate was 38.8%. This calculation excludes the initial treatment
successes not followed for four (4) years (N=58). In both studies,
patients had difficult nonunion fractures: 0.7 and 1.5 number of
average prior surgeries, average 28.4 and 24.3 months (median 24 and
16) disability since original injury, and 43.3% and 24.3% infected
prior to treatment, respectively.
CONTRAINDICATIONS
There are no known contraindications to the use of this device,
however, due to insufficient clinical experience, it is not
recommended that it be used in the following conditions: pathological
fractures due to malignant tumors or in the presence of active osteomyelitis.
