NCT00744861

Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 328 (actual)
• Sponsor: Bioventus LLC · Industry
• Sex: All
• Age: 18 Years – 81 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lumbar Degenerative Disc Disease

Interventions

Type	Name	Description
DEVICE	Exospine sham	Inactive Exospine LIPUS device (dual transducers)
DEVICE	Exospine	Active Exospine LIPUS device (dual transducers)
DEVICE	Exogen 4000+	Active Exogen LIPUS device (single transducer)
DEVICE	Exogen 4000+ sham	Inactive Exogen 4000+ LIPUS device (single transducer)

Timeline

• Start date: 2008-09-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2008-09-01
• Last updated: 2021-04-02
• Results posted: 2021-04-02