Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2026-01-03 @ 11:04 PM
Study NCT ID:
NCT00744861
Status:
TERMINATED
Last Update Posted:
2021-04-02
First Post:
2008-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery
Sponsor:
Bioventus LLC
Organization:
Study Overview
Official Title:
EXO-SPINE: A Prospective, Multi-center, Double-blind, Randomized, Placebo Controlled Pivotal Study of Ultrasound as Adjunctive Therapy for Increasing Posterolateral Fusion Success Following Single Level Posterior Instrumented Lumbar Surgery
Status:
TERMINATED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated following interim analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXO-SPINE
Brief Summary:
Adjunct therapy for increasing posterolateral fusion success following single level posterior instrumented lumbar surgery.
Detailed Description:
The purpose of this study is to determine whether using active low intensity pulsed ultrasound as adjunct therapy following single level posterior instrumented lumbar surgery increases the posterolateral success rate when compared to inactive (placebo) therapy.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: