Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

328 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-05-31

Brief Summary

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

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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.

Conditions

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Lumbar Degenerative Disc Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Exogen 4000+

Intervention Type DEVICE

Active Exogen LIPUS device (single transducer)

Exogen 4000+ sham

Non-active sham device identical to Exogen 4000+ (single transducer); treatment duration of 20 minutes per fusion site per day

Group Type SHAM_COMPARATOR

Exogen 4000+ sham

Intervention Type DEVICE

Inactive Exogen 4000+ LIPUS device (single transducer)

Exospine

Low intensity pulsed ultrasound delivered via Exospine device (dual transducers); treatment duration of 20 minutes per day

Group Type ACTIVE_COMPARATOR

Exospine

Intervention Type DEVICE

Active Exospine LIPUS device (dual transducers)

Exospine sham

Non-active sham device identical to Exospine (dual transducers); treatment duration of 20 minutes per day

Group Type SHAM_COMPARATOR

Exospine sham

Intervention Type DEVICE

Inactive Exospine LIPUS device (dual transducers)

Interventions

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Exospine sham

Inactive Exospine LIPUS device (dual transducers)

Intervention Type DEVICE

Exospine

Active Exospine LIPUS device (dual transducers)

Intervention Type DEVICE

Exogen 4000+

Active Exogen LIPUS device (single transducer)

Intervention Type DEVICE

Exogen 4000+ sham

Inactive Exogen 4000+ LIPUS device (single transducer)

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

81 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No