Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery

Lumbar Degenerative Disc Disease Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00744861
• Other study ID #: EX-SPINE0907
• Status: Terminated
• Phase: N/A
• Start date: September 2008
• Est. completion date: May 2012

Study information

• Verified date: March 2021
• Source: Bioventus LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 328
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 81 Years

Eligibility

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

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Lumbar Degenerative Disc Disease

Intervention

Device:
• Exospine sham
Inactive Exospine LIPUS device (dual transducers)
• Exospine
Active Exospine LIPUS device (dual transducers)
• Exogen 4000+
Active Exogen LIPUS device (single transducer)
• Exogen 4000+ sham
Inactive Exogen 4000+ LIPUS device (single transducer)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bioventus LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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