Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery - Full Text View

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:

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: Amy E Miefert, M.A., M.Ed, CCRA	901-399-6069	amy.miefert@smithnephew.com

Locations


United States, Michigan
		Recruiting
	Southfield, Michigan, United States
	Contact CWestbrook@beaumont.edu

Sponsors and Collaborators

Smith & Nephew, Inc.

More Information

Responsible Party:	Smith & Nephew, Inc. ( Amy Miefert, Sr. Clinical Project Manager )
Study ID Numbers:	EX-SPINE0907
First Received:	August 29, 2008
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00744861
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

ClinicalTrials.gov processed this record on October 24, 2008

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