Back to resultsUltrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery (EXO-SPINE)
Primary Purpose
Lumbar Degenerative Disc Disease
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exospine sham
Exospine
Exogen 4000+
Exogen 4000+ sham
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Degenerative Disc Disease focused on measuring Lumbar Fusion, exospine, Exo-Spine, LIPUS, Exogen
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Sham Comparator
Active Comparator
Sham Comparator
Arm Label
Exogen 4000+
Exogen 4000+ sham
Exospine
Exospine sham
Arm Description
Low intensity pulsed ultrasound (LIPUS) delivered via Exogen 4000+ (single transducer) device for a treatment duration of 20 minutes per fusion site per day.
Non-active sham device identical to Exogen 4000+ (single transducer); treatment duration of 20 minutes per fusion site per day
Low intensity pulsed ultrasound delivered via Exospine device (dual transducers); treatment duration of 20 minutes per day
Non-active sham device identical to Exospine (dual transducers); treatment duration of 20 minutes per day
Outcomes
Primary Outcome Measures
Number of Participants With Posterolateral Fusion Success at the Treated Level
Fusion success at the treated level was defined as at least 2 of 3 independent blinded radiologists agree all 3 of the following criteria were met.
Confirmation of bridging bone based on computed tomography (CT) evidence of a continuous bony connection between the transverse processes on both posterolateral sides, assessed using a numeric grading scale.
No evidence of motion defined as <5° angulation based on flexion and extension radiographs.
No evidence of translational movement defined as <3 mm difference based on flexion and extension radiographs.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00744861
Brief Title
Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery
Acronym
EXO-SPINE
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 Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Terminated following interim analysis
Study Start Date
September 2008 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bioventus LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Adjunct therapy for increasing posterolateral fusion success following single level posterior instrumented lumbar surgery.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Degenerative Disc Disease
Keywords
Lumbar Fusion, exospine, Exo-Spine, LIPUS, Exogen
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
328 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exogen 4000+
Arm Type
Active Comparator
Arm Description
Low intensity pulsed ultrasound (LIPUS) delivered via Exogen 4000+ (single transducer) device for a treatment duration of 20 minutes per fusion site per day.
Arm Title
Exogen 4000+ sham
Arm Type
Sham Comparator
Arm Description
Non-active sham device identical to Exogen 4000+ (single transducer); treatment duration of 20 minutes per fusion site per day
Arm Title
Exospine
Arm Type
Active Comparator
Arm Description
Low intensity pulsed ultrasound delivered via Exospine device (dual transducers); treatment duration of 20 minutes per day
Arm Title
Exospine sham
Arm Type
Sham Comparator
Arm Description
Non-active sham device identical to Exospine (dual transducers); treatment duration of 20 minutes per day
Intervention Type
Device
Intervention Name(s)
Exospine sham
Intervention Description
Inactive Exospine LIPUS device (dual transducers)
Intervention Type
Device
Intervention Name(s)
Exospine
Intervention Description
Active Exospine LIPUS device (dual transducers)
Intervention Type
Device
Intervention Name(s)
Exogen 4000+
Intervention Description
Active Exogen LIPUS device (single transducer)
Intervention Type
Device
Intervention Name(s)
Exogen 4000+ sham
Intervention Description
Inactive Exogen 4000+ LIPUS device (single transducer)
Primary Outcome Measure Information:
Title
Number of Participants With Posterolateral Fusion Success at the Treated Level
Description
Fusion success at the treated level was defined as at least 2 of 3 independent blinded radiologists agree all 3 of the following criteria were met.
Confirmation of bridging bone based on computed tomography (CT) evidence of a continuous bony connection between the transverse processes on both posterolateral sides, assessed using a numeric grading scale.
No evidence of motion defined as <5° angulation based on flexion and extension radiographs.
No evidence of translational movement defined as <3 mm difference based on flexion and extension radiographs.
Time Frame
12 months post treatment start
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Fischgrund, MD
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery
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