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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DePuy Spine
ClinicalTrials.gov Identifier:
NCT00215319
First received: September 13, 2005
Last updated: May 22, 2014
Last verified: May 2014

September 13, 2005
May 22, 2014
December 2000
November 2006   (final data collection date for primary outcome measure)
  • Radiographic Fusion [ Designated as safety issue: No ]
  • Oswestry Disability Index [ Designated as safety issue: No ]
  • Motor Function [ Designated as safety issue: Yes ]
  • Adverse Events [ Designated as safety issue: Yes ]
  • Secondary Surgical Interventions [ Designated as safety issue: Yes ]
  • Radiographic Fusion
  • Oswestry Disability Index
  • Motor Function
  • Adverse Events
  • Secondary Surgical Interventions
Complete list of historical versions of study NCT00215319 on ClinicalTrials.gov Archive Site
  • SF-36 [ Designated as safety issue: No ]
  • Graft site pain [ Designated as safety issue: No ]
  • Back pain [ Designated as safety issue: No ]
  • Leg pain [ Designated as safety issue: No ]
  • Disc space height [ Designated as safety issue: No ]
  • SF-36
  • Graft site pain
  • Back pain
  • Leg pain
  • Disc space height
Not Provided
Not Provided
 
Titanium Surgical Mesh and MOSS-Miami Screws for Lumbar Fusion.
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

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.

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.

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Degenerative Disc Disease
Device: Lumbar I/F with cage and pedicle screws
Surgical Titanium Mesh™ with MOSS-Miami™ Pedicle Screws
Experimental: TSM Cage
Lumbar I/F with cage and pedicle screws
Intervention: Device: Lumbar I/F with cage and pedicle screws
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
139
November 2006
November 2006   (final data collection date for primary outcome measure)

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,
Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00215319
G990313
No
DePuy Spine
DePuy Spine
Not Provided
Not Provided
DePuy Spine
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP