NCT03177473

Study Using the CervicalStim Device Following Cervical Fusion

A Multi-Center, Open-Label, Prospective Study of CervicalStim Device™ as Adjunctive Care Following Cervical Fusion

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 211 (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 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.

Detailed description

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.

Conditions

• Vertebral Cervical Fusion Syndrome
• Degenerative Disc Disease

Interventions

Type	Name	Description
DEVICE	CervicalStim bone growth stimulator	Orthofix CervicalStim bone growth stimulator

Timeline

• Start date: 2017-06-28
• Primary completion: 2021-08-03
• Completion: 2021-08-03
• First posted: 2017-06-06
• Last updated: 2022-09-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study