Clinical trial NCT00215319: Titanium Surgical Mesh and MOSS-Miami Screws for Lumbar Fusion.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Degenerative Disc Disease
Keywords: Degenerative disc disease at up to 2 levels (L2-S1)
Lead sponsor: DePuy Spine
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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,

Primary outcomes:
measure: Radiographic Fusion
measure: Oswestry Disability Index
measure: Motor Function
measure: Adverse Events
measure: Secondary Surgical Interventions
Secondary outcomes:
measure: SF-36
measure: Graft site pain
measure: Back pain
measure: Leg pain
measure: Disc space height
Other outcomes:
Locations:
city: Dothan
country: United States
facility: TSM Investigational Site A
state: Alabama
city: Fort Wayne
country: United States
facility: TSM Investigational Site B
state: Indiana
Study officials:
References: