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Trial record 1 of 1 for:    NCT00744861
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Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery (EXO-SPINE)

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ClinicalTrials.gov Identifier: NCT00744861
Recruitment Status : Terminated (Terminated following interim analysis)
First Posted : September 1, 2008
Last Update Posted : July 24, 2013
Information provided by (Responsible Party):

August 29, 2008
September 1, 2008
July 24, 2013
September 2008
May 2012   (Final data collection date for primary outcome measure)
Posterolateral fusion success at the treated level [ Time Frame: 6 months and 12 months post treatment ]
Same as current
Complete list of historical versions of study NCT00744861 on ClinicalTrials.gov Archive Site
  • To evaluate the effect(s) of the investigational treatment on pain/disability status [ Time Frame: 12 months post treatment ]
  • To evaluate the effect(s) of the investigational treatment on general health status [ Time Frame: 6 month and 12 month post treatment ]
Same as current
Not Provided
Not Provided
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
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.
Not Provided
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Lumbar Degenerative Disc Disease
  • Device: Low Intensity Pulsed Ultrasound
  • Device: Sham
  • Active Comparator: Low Intensity Pulsed Ultrasound
    Low Intensity Pulsed Ultrasound
    Intervention: Device: Low Intensity Pulsed Ultrasound
  • Sham Comparator: Sham
    Sham (inactive) low intensity pulsed ultrasound device
    Intervention: Device: Sham
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
June 2012
May 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 81 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Bioventus LLC
Bioventus LLC
Not Provided
Principal Investigator: Jeffrey Fischgrund, MD William Beaumont Hospitals
Bioventus LLC
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP