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 range18 Years – 65 Years

SexALL

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

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