Orthofix Cervical-Stim 2505CE, Инструкция по эксплуатации

Страница: 6 / 137

4
symptomatic radiculopathy. The purpose of the study was to evaluate the
safety and effectiveness of the PEMF Cervical-Stim device as an adjunct for
high-risk patients who undergo cervical fusion. All subjects underwent
anterior cervical discectomy and fusion using the Smith-Robinson technique
with the Atlantis Plate. Subjects were randomly assigned to either the control
group (standard treatment, n=160) or the treatment group (standard treatment
plus the Cervical-Stim, n=163). Standard treatment was at the physician's
discretion but typically included the standard hospital stay, use of a soft cervical
collar, appropriate medications and physical therapy.
Subjects who met the following inclusion and exclusion criteria were eligible
for participation in the study:
Inclusion Criteria
Adult male or female, 18-75 years old with radiographic evidence of
compressed cervical nerve root(s), symptomatic radiculopathy, pain of 5 or
greater on the Visual Analog Scale (VAS) and/or any muscle weakness and
primary cervical spinal fusion performed using the Smith-Robinson technique
with allograft bone and an anterior cervical plate. The fusion procedure must
have been either multi-level (>1 fusion level) or the subject was a smoker
(one pack/day or more) or both; and signed informed consent.
Exclusion Criteria
Traumatic cervical injury, posterior approach or revision fusion, autograft
or bone substitute materials for graft source, history of vascular migraine
headache or prone to uncontrolled seizures or epilepsy (controlled or
uncontrolled) or any neurological diseases or injury; depressed immune
system, regional conditions (Spondylitis, Paget’s disease, rheumatoid arthritis),
infection (systemic or local) within 2 weeks prior to surgery, systemic
conditions (cancer, cardiac arrhythmia, thyroid disease, uncontrolled diabetes
mellitus, renal disease/dysfunction, chronic steroid use or other conditions that
may have affected bone metabolism), cardiac pacemakers, defibrillators, dorsal
column stimulators, hearing aids, cochlear prostheses and cranial stimulators,
subjects who were pregnant, nursing or had planned to become pregnant
within 12 months, subjects that had participated in other clinical studies within
the last 12 months, or had mental or physical conditions which may have
precluded compliance with physician instructions.
Evaluation and Follow-Up
Follow-up visits were to have been performed at months 1, 2, 3, 6 and 12
and annually thereafter until the last subject enrolled reached 12 months.
Device Usage
Subjects assigned to the treatment group (Cervical-Stim) were instructed
to wear the device for four hours per day for a minimum of three months
postoperative. Surgeons could, at their discretion, extend the Cervical-Stim
treatment up to six months postoperative.
E
n
gli
sh