Fresh fracture indication:
Warnings:
The safety and effectiveness of the use of this device has
not been established for the following:
•
Fracture locations other than the distal radius (end of the
large bone in the forearm) or tibial diaphysis (middle 80%
of the large bone in your lower leg).
•
Fractures with post-reduction displacement of more than
50% (i.e., fractures in which the opposing broken bone
ends are out of alignment by more than one half of the
width of the bone).
•
Fractures that are open Grade II or III (fractures with large
wounds) or that require surgical intervention or with
internal or external fixation (screws and/or plates used to
hold your broken bone in place) or that are not sufficiently
stable for the closed reduction (manipulation of the fracture
without surgery) and cast immobilization (cast treatment).
•
Individuals lacking skeletal maturity (generally below 18
years of age although one patient in the tibia study was 17
years of age) or who are pregnant/nursing women.
•
Pathological fractures due to bone pathology or malignancy
(fractures due to disease).
•
Individuals with thrombophlebitis (blood clot in a vein),
vascular insufficiency (poor blood supply), abnormal skin
sensitivity (very sensitive skin), sensory paralysis (lack of
sensation), alcoholism and/or nutritional deficiency.
•
Individuals receiving steroid, anti-coagulant, prescription
non-steroidal anti-inflammatory, calcium channel blocker
and/or diphosphonate therapy. Individuals using these
therapies were excluded from the studies because of the
possible effects of these therapies on bone metabolism.
Precautions:
•
Animal studies conducted to date do not suggest any long
term adverse effects from the use of this device. Clinical
studies conducted for the EXOGEN™ PMA with long term
patient follow up for up to 78 months do not suggest any
long term adverse side effects from the use of this device.
However, possible longer-term adverse effects in humans
are unknown.
•
The EXOGEN device will not correct or affect the post-
reduction (when your fracture is initially set and placed in a
cast) condition of your fracture such as displacement of the
bone ends at your fracture or improper alignment of your
fractured bone.
•
The age ranges of the patients in the fresh fracture PMA
study were 17–67 years of age (54% were 31 years of age
or older) in the tibia study and 20–78 (74% were 50 years
of age or older) in the Colles’ study. The effect of EXOGEN
therapy on patients outside this age range is unknown.
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