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Sponsored by: |
DePuy Spine |
Information provided by: | DePuy Spine |
ClinicalTrials.gov Identifier: | NCT00215319 |
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 III |
Drug Information available for: | S 1 (Combination) |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 146 |
Study Start Date: | December 2000 |
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:
Secondary Endpoints Include:
Comparison:
Results will be compared to an historical control group treated with the Lumbar I/F Cage with VSP System.
Ages Eligible for Study: | 18 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
DePuy Spine |
Study ID Numbers: | G990313 |
First Received: | September 13, 2005 |
Last Updated: | October 4, 2006 |
ClinicalTrials.gov Identifier: | NCT00215319 |
Health Authority: | United States: Food and Drug Administration |
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