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

DePuy Synthes

Status and phase: Completed; Phase 3

Conditions: Degenerative Disc Disease

Treatments: Device: Lumbar I/F with cage and pedicle screws

Study type: Interventional

Funder types: Industry

Identifiers

NCT00215319

G990313

Details and patient eligibility

About

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.

Full 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.

Enrollment: 139 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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139 participants in 1 patient group

TSM Cage

Experimental group

Description:

Lumbar I/F with cage and pedicle screws

Treatment:

Device: Lumbar I/F with cage and pedicle screws