CompletedPhase 3

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

United States139 participantsStarted 2000-12

Plain-language 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.

Who can participate

Age range18 Years – 79 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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,

What they're measuring

Radiographic Fusion

Oswestry Disability Index

Motor Function

Adverse Events

Secondary Surgical Interventions

Trial details

NCT IDNCT00215319

SponsorDePuy Spine

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-11

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