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 range

18 Years – 79 Years

Sex

ALL

See this in plain English?

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,

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Degenerative Disc Disease trials