We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00744861
Previous Study | Return to List | Next Study

Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery (EXO-SPINE)

This study has been terminated.
(Terminated following interim analysis)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00744861
First Posted: September 1, 2008
Last Update Posted: July 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bioventus LLC
  Purpose
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 Intervention
Lumbar Degenerative Disc Disease Device: Low Intensity Pulsed Ultrasound Device: Sham

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bioventus LLC:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 310
Study Start Date: September 2008
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: Bioventus LLC
ClinicalTrials.gov Identifier: NCT00744861     History of Changes
Other Study ID Numbers: EX-SPINE0907
First Submitted: August 29, 2008
First Posted: September 1, 2008
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


To Top