CompletedNot Applicable

TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study

United States20 participantsStarted 2010-09

Plain-language summary

The purpose of this investigation is to evaluate the safety and effectiveness of the TRIUMPH® Lumbar Artificial Disc for the treatment of patients who are suffering from Degenerative Disc Disease (DDD) at one level from L1 to S1.

Who can participate

Age range

18 Years – 65 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: * Degenerative Disc Disease in one vertebral level between L1 and S1 * Able to understand and sign informed consent * Had at least 6 months of conservative treatment * Oswestry Disability Index Score of at least 30 (one a 100 point scale) * Other inclusion criteria as specified in approved IDE protocol Exclusion Criteria: * Bilateral leg pain * Back or leg pain of unknown etiology * Prior fusion surgery or another spinal device implanted at any other lumbar level * Osteoporosis or osteopenia * Other exclusion criteria as specified in approved IDE protocol

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

Number of Participants With a Change of at Least 15 Points in Pain/Disability Using the Oswestry Disability Index (ODI) Score at 24 Months Compared With the Score at Baseline

Timeframe: 24 months

Number of Participants With No Device Failures

Timeframe: 24 months

Number of Participants With Major Complications Defined as Major Vessel Injury or Neurological Damage

Timeframe: 24 months

Number of Participants Determined to Have a Normal Neurological Status

Timeframe: 24 months

Trial details

NCT IDNCT01198470

SponsorGlobus Medical Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-12

Results submitted2018-08-20

View on ClinicalTrials.gov More Lumbar Degenerative Disc Disease trials

Who can participate

Age range

18 Years – 65 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.

What they're measuring

Number of Participants With a Change of at Least 15 Points in Pain/Disability Using the Oswestry Disability Index (ODI) Score at 24 Months Compared With the Score at Baseline

Timeframe: 24 months

Number of Participants With No Device Failures

Timeframe: 24 months

Number of Participants With Major Complications Defined as Major Vessel Injury or Neurological Damage

Timeframe: 24 months

Number of Participants Determined to Have a Normal Neurological Status

Timeframe: 24 months