TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Globus Medical Inc
ClinicalTrials.gov Identifier:
NCT01198470
First received: September 8, 2010
Last updated: March 15, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Lumbar Degenerative Disc Disease
Device: TRIUMPH® Lumbar Artificial Disc
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Clinical Investigation of the TRIUMPH Lumbar Disc: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Globus Medical Inc:

Primary Outcome Measures:
  • ODI score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: September 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01198470

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

No publications provided

Responsible Party: Globus Medical Inc
ClinicalTrials.gov Identifier: NCT01198470     History of Changes
Other Study ID Numbers: G090143
Study First Received: September 8, 2010
Last Updated: March 15, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 16, 2014