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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
  Purpose

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.


Condition Intervention Phase
Degenerative Disc Disease
 Device: Surgical Titanium Mesh™ with MOSS-Miami™ Pedicle Screws
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by DePuy Spine:

Primary Outcome Measures:
  • Radiographic Fusion
  • Oswestry Disability Index
  • Motor Function
  • Adverse Events
  • Secondary Surgical Interventions

Secondary Outcome Measures:
  • SF-36
  • Graft site pain
  • Back pain
  • Leg pain
  • Disc space height

Estimated Enrollment: 146
Study Start Date: December 2000
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.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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,
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00215319

Locations
United States, Alabama
TSM Investigational Site A
Dothan, Alabama, United States, 36301
United States, Indiana
TSM Investigational Site B
Fort Wayne, Indiana, United States, 46825
Sponsors and Collaborators
DePuy Spine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00215319     History of Changes
Other Study ID Numbers: G990313
Study First Received: September 13, 2005
Last Updated: October 4, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by DePuy Spine:
Degenerative disc disease at up to 2 levels (L2-S1)

Additional relevant MeSH terms:
Intervertebral Disk Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on June 13, 2013