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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)
Information provided by (Responsible Party):
Bioventus LLC Identifier:
First received: August 29, 2008
Last updated: July 23, 2013
Last verified: July 2013
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


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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00744861

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

Responsible Party: Bioventus LLC Identifier: NCT00744861     History of Changes
Other Study ID Numbers: EX-SPINE0907
Study First Received: August 29, 2008
Last Updated: July 23, 2013

Keywords provided by Bioventus LLC:
Lumbar Fusion

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases processed this record on September 21, 2017