Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery

Not Applicable

Terminated

• Conditions: Lumbar Degenerative Disc Disease
• Interventions: Device: Exogen 4000+; Device: Exogen 4000+ sham; Device: Exospine; Device: Exospine sham

• Registration Number: NCT00744861
• Lead Sponsor: Bioventus LLC

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.

Study Timeline

• Study First Submitted: 2008-08-29
• Study First Submitted QC: 2008-08-29
• Study Start: 2008-09
• Study First Posted: 2008-09-01
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Results First Submitted: 2016-03-03
• Status Verified: 2021-03
• Results First Submitted QC: 2021-03-08
• Last Update Submitted: 2021-03-08
• Results First Posted: 2021-04-02
• Last Update Posted: 2021-04-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 328

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exogen 4000+	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.
Exogen 4000+ sham	Exogen 4000+ sham	Non-active sham device identical to Exogen 4000+ (single transducer); treatment duration of 20 minutes per fusion site per day
Exospine	Exospine	Low intensity pulsed ultrasound delivered via Exospine device (dual transducers); treatment duration of 20 minutes per day
Exospine sham	Exospine sham	Non-active sham device identical to Exospine (dual transducers); treatment duration of 20 minutes per day

Primary Outcome Measures

Name	Time	Method
Number of Participants With Posterolateral Fusion Success at the Treated Level	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.