Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery

This study is currently recruiting participants.

Verified by Smith & Nephew, Inc., October 2008

First Received: August 29, 2008 Last Updated: April 22, 2009 History of Changes

Sponsored by:	Smith & Nephew, Inc.
Information provided by:	Smith & Nephew, Inc.
ClinicalTrials.gov Identifier:	NCT00744861

Purpose

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.

Condition	Intervention	Phase
Lumbar Degenerative Disc Disease	Device: Exogen Bone Healing System	Phase III

MedlinePlus related topics: Surgery Ultrasound

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Smith & Nephew, Inc.:

Primary Outcome Measures:

Posterolateral fusion success at the treated level [ Time Frame: 6 months and 12 months post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the effect(s) of the investigational treatment on pain/disability status [ Time Frame: 12 months post treatment ] [ Designated as safety issue: No ]
To evaluate the effect(s) of the investigational treatment on general health status [ Time Frame: 6 month and 12 month post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	September 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Device: Exogen Bone Healing System Active Ultrasound Therapy
2: Sham Comparator	Device: Exogen Bone Healing System Inactive

Eligibility

Ages Eligible for Study:	18 Years to 81 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744861

Contacts

Contact: Brett J Gordon

919-474-6747

brett.gordon@smith-nephew.com

Locations

United States, Indiana
	Recruiting
Indianapolis, Indiana, United States
United States, Massachusetts
	Recruiting
Boston, Massachusetts, United States
United States, Michigan
	Recruiting
Southfield, Michigan, United States
United States, New Jersey
	Recruiting
Egg Harbor Township, New Jersey, United States
United States, New York
	Recruiting
Endwell, New York, United States
United States, North Carolina
	Recruiting
Charlotte, North Carolina, United States
United States, Ohio
	Recruiting
Norwood, Ohio, United States
United States, Texas
	Recruiting
San Antonio, Texas, United States

Sponsors and Collaborators

Smith & Nephew, Inc.

More Information

No publications provided

Responsible Party:	Smith & Nephew, Inc. ( Brett Gordon, Sr. Clinical Project Manager )
Study ID Numbers:	EX-SPINE0907
Study First Received:	August 29, 2008
Last Updated:	April 22, 2009
ClinicalTrials.gov Identifier:	NCT00744861 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Smith & Nephew, Inc.:

Lumbar Fusion

Study placed in the following topic categories:

Spinal Diseases
Musculoskeletal Diseases
Bone Diseases

Additional relevant MeSH terms:

Spinal Diseases
Musculoskeletal Diseases
Bone Diseases

ClinicalTrials.gov processed this record on May 07, 2009