Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery

Study Overview
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Brief Summary
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Adjunct therapy for increasing posterolateral fusion success following single level posterior instrumented lumbar surgery.

Detailed Description
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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.

Official Title
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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

Conditions
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Lumbar Degenerative Disc Disease

Intervention / Treatment
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* Device: Exospine sham
* Device: Exospine
* Device: Exogen 4000+
* Device: Exogen 4000+ sham


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 81 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exogen 4000+<br>Low intensity pulsed ultrasound (LIPUS) delivered via Exogen 4000+ (single transducer) device for a treatment duration of 20 minutes per fusion site per day. | Device: Exogen 4000+<br>* Active Exogen LIPUS device (single transducer)<br>|
| Sham Comparator: Exogen 4000+ sham<br>Non-active sham device identical to Exogen 4000+ (single transducer); treatment duration of 20 minutes per fusion site per day | Device: Exogen 4000+ sham<br>* Inactive Exogen 4000+ LIPUS device (single transducer)<br>|
| Active Comparator: Exospine<br>Low intensity pulsed ultrasound delivered via Exospine device (dual transducers); treatment duration of 20 minutes per day | Device: Exospine<br>* Active Exospine LIPUS device (dual transducers)<br>|
| Sham Comparator: Exospine sham<br>Non-active sham device identical to Exospine (dual transducers); treatment duration of 20 minutes per day | Device: Exospine sham<br>* Inactive Exospine LIPUS device (dual transducers)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months post treatment start | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar Fusion, exospine, Exo-Spine, LIPUS, Exogen