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

This study has been terminated.
(Terminated following interim analysis)
Sponsor:
Information provided by (Responsible Party):
Bioventus LLC
ClinicalTrials.gov Identifier:
NCT00744861
First received: August 29, 2008
Last updated: July 23, 2013
Last verified: July 2013

August 29, 2008
July 23, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • To evaluate the effect(s) of the investigational treatment on general health status [ Time Frame: 6 month and 12 month post treatment ] [ Designated as safety issue: No ]
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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.
 
Terminated
310
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
Both
18 Years to 81 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00744861
EX-SPINE0907
No
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