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

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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.


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
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The Woodlands, TX
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Boston, MA
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Boynton Beach, FL
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2016
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Bristol, TN
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Charlotte, North Carolina 28207
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Charlotte, NC
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Chicago, IL
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Clearwater, FL
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Egg Harbor Township, New Jersey 08234
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Egg Harbor Township, NJ
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Greenville, North Carolina 27834
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Greenville, NC
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1357
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Houston, TX
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Indianapolis, IN
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Kalamazoo, MI
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1339
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Kansas City, KS
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99
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La Jolla, CA
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Madison, WI
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Merriam, KS
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New York, NY
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Newark, NJ
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350
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Oakland, CA
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1164
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Oklahoma City, OK
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Peoria, IL
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Philadelphia, PA
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Salt Lake City, UT
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355
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San Francisco, CA
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Savannah, GA
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1958
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Southfield, MI
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