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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
Sponsor:
Information provided by (Responsible Party):
Bioventus LLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lumbar Degenerative Disc Disease Device: Low Intensity Pulsed Ultrasound Device: Sham Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2008
Actual Primary Completion Date : May 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Low Intensity Pulsed Ultrasound
Low Intensity Pulsed Ultrasound
Device: Low Intensity Pulsed Ultrasound
Sham Comparator: Sham
Sham (inactive) low intensity pulsed ultrasound device
Device: Sham



Primary Outcome Measures :
  1. Posterolateral fusion success at the treated level [ Time Frame: 6 months and 12 months post treatment ]

Secondary Outcome Measures :
  1. To evaluate the effect(s) of the investigational treatment on pain/disability status [ Time Frame: 12 months post treatment ]
  2. To evaluate the effect(s) of the investigational treatment on general health status [ Time Frame: 6 month and 12 month post treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 81 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00744861


  Show 26 Study Locations
Sponsors and Collaborators
Bioventus LLC
Investigators
Principal Investigator: Jeffrey Fischgrund, MD William Beaumont Hospitals

Responsible Party: Bioventus LLC
ClinicalTrials.gov Identifier: NCT00744861     History of Changes
Other Study ID Numbers: EX-SPINE0907
First Posted: September 1, 2008    Key Record Dates
Last Update Posted: July 24, 2013
Last Verified: July 2013

Keywords provided by Bioventus LLC:
Lumbar Fusion
exospine
Exo-Spine

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases