Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery

Bioventus LLC328 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

328

Conditions

Lumbar Degenerative Disc Disease

Interventions

Exospine shamDEVICE

Inactive Exospine LIPUS device (dual transducers)

ExospineDEVICE

Active Exospine LIPUS device (dual transducers)

Exogen 4000+DEVICE

Active Exogen LIPUS device (single transducer)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 81 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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. 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.

Time frame: 12 months post treatment start

Data from ClinicalTrials.gov

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