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

March 8, 2021 updated by: Bioventus LLC

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

Adjunct therapy for increasing posterolateral fusion success following single level posterior instrumented lumbar surgery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

328

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Posterolateral Fusion Success at the Treated Level
Time Frame: 12 months post treatment start

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.

  1. 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.
  2. No evidence of motion defined as <5° angulation based on flexion and extension radiographs.
  3. No evidence of translational movement defined as <3 mm difference based on flexion and extension radiographs.
12 months post treatment start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bioventus LLC

Investigators

  • Principal Investigator: Jeffrey Fischgrund, MD, William Beaumont Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

August 29, 2008

First Submitted That Met QC Criteria

August 29, 2008

First Posted (Estimate)

September 1, 2008

Study Record Updates

Last Update Posted (Actual)

April 2, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EX-SPINE0907

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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