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

Adjunct therapy for increasing posterolateral fusion success following single level posterior instrumented lumbar surgery.

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.

Inclusion Criteria:

• The subject has a documented diagnosis of degenerative disc disease with up to Grade I spondylolisthesis at the target level
• Requires spinal fusion of a single level disc space (L2 to S1) with the use of local bone graft.
• Requires a posterolateral fusion procedure with or without an interbody fusion procedure using a posterior approach
• The subject has failed non-operative treatment lasting at least 6 months.

Exclusion Criteria:

• Requires spinal fusion at more than one lumbar level.
• Is pregnant, is lactating or plans to become pregnant before discontinuation of study treatment