Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery
Status: | Terminated |
---|---|
Conditions: | Orthopedic |
Therapuetic Areas: | Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 18 - 81 |
Updated: | 10/14/2017 |
Start Date: | September 2008 |
End Date: | June 2012 |
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
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.
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
We found this trial at
26
sites
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