This study examines the effect of adjunctive use of the SpinalStim bone growth stimulator on lumbar fusion rate in high risk subjects who have had lumbar fusion surgery. All participants will wear the bone growth stimulator for a minimum of 2 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 SpinalStim™ device on lumbar fusion rate in high risk subjects who have undergone lumbar fusion surgery. High risk subjects are those who are currently using nicotine, who are having a multi-level fusion, who have had a prior failed fusion at any lumbar level, who are diabetic or 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 lumbar fusion surgery and asked if they would like to participate in a study looking at the efficacy of lumbar fusion with adjunctive use of the SpinalStim bone growth simulator. The type of lumbar fusion surgery performed (lateral lumbar interbody fusion \[XLIF\], posterior lumbar interbody fusion \[PLIF\], anterior lumbar interbody fusion \[ALIF\], posterolateral fusion) is up to the Investigator; the subjects in the study must be agreeable to using the bone growth stimulator daily for 6 months post surgery.
Study Type
OBSERVATIONAL
Enrollment
206
PEMF osteogenesis stimulator
ClinTech Center for Spine Health
Johnstown, Colorado, United States
fusion rate
number of subjects with fused lumbar vertebrae, determined by X-rays and CT scans
Time frame: 12 months
Device compliance
actual minutes per day device was used compared with prescribed treatment time
Time frame: 6 months
revision rate
how many subjects had to be reoperated (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 treatment on subject quality of life
Time frame: 12 months
Oswestry Disability Index
used to examine the effect of PEMF treatment on subject disability
Time frame: 12 months
VAS pain
used to assess the effect of PEMF treatment on reduction of pain
Time frame: 12 months
EQ-5D
used to assess the effect of PEMF treatment on quality of life and economic impact
Time frame: 12 months
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