Titanium Surgical Mesh and MOSS-Miami Screws for Lumbar Fusion.

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2006 by DePuy Spine.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

DePuy Spine

ClinicalTrials.gov Identifier:

NCT00215319

First received: September 13, 2005

Last updated: October 4, 2006

Last verified: October 2006

History of Changes

Tracking Information
First Received Date ^ICMJE	September 13, 2005
Last Updated Date	October 4, 2006
Start Date ^ICMJE	December 2000
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: September 14, 2005)	Radiographic Fusion Oswestry Disability Index Motor Function Adverse Events Secondary Surgical Interventions
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00215319 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 14, 2005)	SF-36 Graft site pain Back pain Leg pain Disc space height
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Titanium Surgical Mesh and MOSS-Miami Screws for Lumbar Fusion.
Official Title ^ICMJE	A Multi-Center Study to Evaluate the Safety and Efficacy of DePuy AcroMed Titanium Surgical Mesh and MOSS-Miami Spinal Fixation System Pedicle Screws for Intradiscal Fusion in the Lumbar Spine
Brief Summary	The purpose of this study is to determine the clinical success of DePuy Spine Titanium Surgical Mesh with MOSS Miami Spinal Fixation System Pedicle Screws in the treatment of one or two levels of degenerative disc disease of the lumbar spine. The observed success rate at 24 months will be compared to an historical control group treated with the Lumbar I/F Cage with VSP System.
Detailed Description	This is a single arm multi-center study to determine the clinical success of the DePuy Spine Titanium Surgical Mesh with MOSS Miami Spinal Fixation System Pedicle Screws in the treatment of one or two adjacent levels of degenerative disc disease of the lumbar spine (L2 - S1). Study Success is as a compound endpoint requiring: Radiographic Fusion, Improvement in Pain/Function, Maintenance/Improvement in Neurologic Status, and Freedom from Secondary Surgical Intervention. The rate of Adverse Events must be no worse than in the control group as well. Secondary Endpoints Include: Adverse Events SF-36 Health Related Quality of Life Disc Space Height Work Status Comparison: Results will be compared to an historical control group treated with the Lumbar I/F Cage with VSP System.
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Degenerative Disc Disease
Intervention ^ICMJE	Device: Surgical Titanium Mesh™ with MOSS-Miami™ Pedicle Screws
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	146
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Persistent back and/or leg pain refractory to 6 months of non-surgical therapy Radiographic evidence of significant disc degeneration at one or two of the adjacent lumbar levels L2-S1. Exclusion Criteria: Abnormality at more than two levels, Prior fusion surgery of the lumbar spine; prior discectomies or IDET allowed, Infection in the disc or spine, past or present, Active infection at time of surgery, Tumor in the spine, Significant osteoporosis or metabolic bone disease, Greater than Grade I spondylolisthesis or significant bony defect in the lumbar spine, Pregnant or lactating, or wishes to become pregnant within duration of study,
Gender	Both
Ages	18 Years to 79 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00215319
Other Study ID Numbers ^ICMJE	G990313
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	DePuy Spine
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	DePuy Spine
Verification Date	October 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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