Study Using the SpinalStim Device Following Lumbar Fusion Surgery
NCT03176303 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 206
Last updated 2022-09-16
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.
Conditions
- Lumbar Spine Degeneration
Interventions
- DEVICE
-
SpinalStim
PEMF osteogenesis stimulator
Sponsors & Collaborators
-
Orthofix Inc.
lead INDUSTRY
Principal Investigators
-
James T Ryaby, Ph.D. · Orthofix Inc.
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-06-28
- Primary Completion
- 2021-07-12
- Completion
- 2021-07-12
Countries
- United States
Study Locations
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