This study examines the effect of adjunctive use of the CervicalStim bone growth stimulator on cervical fusion rate in high risk subjects who have undergone cervical fusion surgery. All participants will wear the bone growth stimulator every day for 4 hours/day for 6 months.
The purpose of this post market prospective study is to examine the effect of the adjunctive use of the Orthofix CervicalStim device on cervical fusion rate in high risk subjects who have undergone cervical fusion surgery. High risk subjects are those who are having a multi-level (2 or more) cervical fusion, who are smokers, who are diabetic or those who are osteoporotic. Because this is a post market prospective study, subjects who are enrolled in this study will be identified by the Investigator as needing cervical fusion surgery and asked to participate in a study looking at the efficacy of cervical fusion with adjunctive use of the CervicalStim bone growth simulator. The type of cervical fusion surgery performed is up to the Investigator; the subjects in the study must be agreeable to using the bone growth stimulator for 6 months post-surgery. The subjects will be followed for 12 months.
Study Type
OBSERVATIONAL
Enrollment
211
Orthofix CervicalStim bone growth stimulator
ClinTech Center for Spine Health
Johnstown, Colorado, United States
cervical fusion rate
fusion rate assessed via radiographic confirmation (Xray and CT)
Time frame: 12 months
Device Compliance
actual minutes per day device was used compared with prescribed use
Time frame: 6 months
revision rate
how many subjects had to be revised at the same level(s) during the course of the study
Time frame: 12 months
SF-36
used to assess the effect of PEMF therapy on the subject's quality of life
Time frame: 12 months
Neck Disability Index (NDI)
used to assess the effect of PEMF therapy on the reduction of neck pain
Time frame: 12 months
EQ-5D
used to assess the effect of PEMF therapy on quality of life as well as economic impact
Time frame: 12 months
VAS pain
used to assess the effect of PEMF therapy on reduction of pain
Time frame: 12 months
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