TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01198470
Recruitment Status : Completed
First Posted : September 10, 2010
Last Update Posted : March 20, 2017
Information provided by (Responsible Party):
Globus Medical Inc

Brief 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.

Condition or disease Intervention/treatment Phase
Lumbar Degenerative Disc Disease Device: TRIUMPH® Lumbar Artificial Disc Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Clinical Investigation of the TRIUMPH Lumbar Disc: A Pilot Study
Study Start Date : September 2010
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Iodine

Arm Intervention/treatment
Experimental: TRIUMPH® Artificial Disc
Treatment of degenerative disc disease with the TRIUMPH Lumbar Artificial Disc. This is a non-randomized pilot study with only one arm (no control).
Device: TRIUMPH® Lumbar Artificial Disc
The TRIUMPH® Lumbar Artificial Disc is an articulating artificial disc inserted using a posterolateral approach to the lumbar spine.

Primary Outcome Measures :
  1. ODI score [ Time Frame: 24 months ]
    Improvement of at least 15 points in pain/disability using the Oswestry Disability Index (ODI) score at 24 months compared with the score at baseline.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01198470

United States, Georgia
Memorial Health University Medical Center
Savannah, Georgia, United States, 31403
Sponsors and Collaborators
Globus Medical Inc

Responsible Party: Globus Medical Inc Identifier: NCT01198470     History of Changes
Other Study ID Numbers: G090143
First Posted: September 10, 2010    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: March 2017

Keywords provided by Globus Medical Inc:
Low back pain
Leg pain
Discogenic pain
Degenerative Disc Disease (DDD)
Herniated disc

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Growth Substances
Physiological Effects of Drugs