Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT01198470
Recruitment Status : Completed
First Posted : September 10, 2010
Results First Posted : October 2, 2018
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Globus Medical Inc

Tracking Information
First Submitted Date  ICMJE September 8, 2010
First Posted Date  ICMJE September 10, 2010
Results First Submitted Date  ICMJE August 20, 2018
Results First Posted Date  ICMJE October 2, 2018
Last Update Posted Date October 2, 2018
Study Start Date  ICMJE September 2010
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2018)
  • 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 [ Time Frame: 24 months ]
    The Oswestry Disability Index (ODI) is a commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
  • Number of Participants With No Device Failures [ Time Frame: 24 months ]
    Any device requiring surgical revision, reoperation, removal or supplemental fixation will be considered a device failure
  • Number of Participants With Major Complications Defined as Major Vessel Injury or Neurological Damage [ Time Frame: 24 months ]
    Major vessel injury is defined as injury of the aorta or vena cava or other major vessels (e.g. iliac arteries, superior rectal artery, iliac veins, and their branches), caused by the surgery or device, resulting in significant blood loss or requiring additional surgery to correct. Neurological damage is defined as damage to the spinal cord or a nerve root caused by the surgery or device, resulting in neurologic deficit that persists for more than 3 months and is without improvement, is progressive, or involves motor loss. Major complications are reported on adverse event case report forms.
  • Number of Participants Determined to Have a Normal Neurological Status [ Time Frame: 24 months ]
    Neurological status was assessed using a neurological status scale, which is based on four types of measurement parameters: motor, sensory, reflexes, and straight leg raise. The method for summarizing neurological status is described below. Each parameter (i.e. motor, sensory, reflexes, straight leg raise) is coded as follows: Motor 0 Total Paralysis
    1. Palpable or Visible Contraction
    2. Active Movement, Gravity Eliminated
    3. Active Movement, Against Gravity
    4. Active Movement, Against Some Resistance
    5. Active Movement, Against Full Resistance
    Sensory 0 Absent
    1. Impaired
    2. Normal
    Reflexes 0 Absent or Trace
    1. Hyper-reflexive
    2. Normal or hypo-reflexive
    Straight Leg Raise 0 0° - 70° (Abnormal) 1 > 70°-90° (Normal) If all evaluations for the parameter are determined to be normal, then the parameter is given a normal status. If any evaluations for the parameter are abnormal, then the parameter is given an abnormal status.
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2010)
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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study
Official Title  ICMJE A Prospective Clinical Investigation of the TRIUMPH Lumbar Disc: A Pilot Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lumbar Degenerative Disc Disease
Intervention  ICMJE Device: TRIUMPH® Lumbar Artificial Disc
The TRIUMPH® Lumbar Artificial Disc is an articulating artificial disc inserted using a posterolateral approach to the lumbar spine.
Study Arms  ICMJE 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).
Intervention: Device: TRIUMPH® Lumbar Artificial Disc
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2017)
20
Original Estimated Enrollment  ICMJE
 (submitted: September 8, 2010)
50
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01198470
Other Study ID Numbers  ICMJE G090143
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Globus Medical Inc
Study Sponsor  ICMJE Globus Medical Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Globus Medical Inc
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP