NCT03176303

Study Using the SpinalStim Device Following Lumbar Fusion Surgery

A Multi-Center, Open-Label, Prospective Study of SpinalStim™ (MOP-SS) as Adjunctive Care Following Lumbar Fusion Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 206 (actual)
• Sponsor: Orthofix Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lumbar Spine Degeneration

Interventions

Type	Name	Description
DEVICE	SpinalStim	PEMF osteogenesis stimulator

Timeline

• Start date: 2017-06-28
• Primary completion: 2021-07-12
• Completion: 2021-07-12
• First posted: 2017-06-05
• Last updated: 2022-09-16

Locations

1 site across 1 country: United States