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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lumbar Degenerative Disc Disease
Intervention Device: TRIUMPH® Lumbar Artificial Disc
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TRIUMPH® Artificial Disc
Hide Arm/Group Description

Treatment of degenerative disc disease with the TRIUMPH Lumbar Artificial Disc. This is a non-randomized pilot study with only one arm (no control).

TRIUMPH® Lumbar Artificial Disc: The TRIUMPH® Lumbar Artificial Disc is an articulating artificial disc inserted using a posterolateral approach to the lumbar spine.

Period Title: Overall Study
Started 20
Completed 18
Not Completed 2
Reason Not Completed
Adverse Event             2
Arm/Group Title TRIUMPH® Artificial Disc
Hide Arm/Group Description

Treatment of degenerative disc disease with the TRIUMPH Lumbar Artificial Disc. This is a non-randomized pilot study with only one arm (no control).

TRIUMPH® Lumbar Artificial Disc: The TRIUMPH® Lumbar Artificial Disc is an articulating artificial disc inserted using a posterolateral approach to the lumbar spine.

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
37.9  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
14
  70.0%
Male
6
  30.0%
Height  
Mean (Standard Deviation)
Unit of measure:  Inches
Number Analyzed 20 participants
67.2  (3.0)
Weight  
Mean (Standard Deviation)
Unit of measure:  Pounds
Number Analyzed 20 participants
178.1  (26.1)
1.Primary Outcome
Title 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
Hide Description 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.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TRIUMPH® Artificial Disc
Hide Arm/Group Description:

Treatment of degenerative disc disease with the TRIUMPH Lumbar Artificial Disc. This is a non-randomized pilot study with only one arm (no control).

TRIUMPH® Lumbar Artificial Disc: The TRIUMPH® Lumbar Artificial Disc is an articulating artificial disc inserted using a posterolateral approach to the lumbar spine.

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
16
  88.9%
2.Primary Outcome
Title Number of Participants With No Device Failures
Hide Description Any device requiring surgical revision, reoperation, removal or supplemental fixation will be considered a device failure
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TRIUMPH® Artificial Disc
Hide Arm/Group Description:

Treatment of degenerative disc disease with the TRIUMPH Lumbar Artificial Disc. This is a non-randomized pilot study with only one arm (no control).

TRIUMPH® Lumbar Artificial Disc: The TRIUMPH® Lumbar Artificial Disc is an articulating artificial disc inserted using a posterolateral approach to the lumbar spine.

Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
17
  85.0%
3.Primary Outcome
Title Number of Participants With Major Complications Defined as Major Vessel Injury or Neurological Damage
Hide Description 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.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TRIUMPH® Artificial Disc
Hide Arm/Group Description:

Treatment of degenerative disc disease with the TRIUMPH Lumbar Artificial Disc. This is a non-randomized pilot study with only one arm (no control).

TRIUMPH® Lumbar Artificial Disc: The TRIUMPH® Lumbar Artificial Disc is an articulating artificial disc inserted using a posterolateral approach to the lumbar spine.

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
4.Primary Outcome
Title Number of Participants Determined to Have a Normal Neurological Status
Hide Description

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.

Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TRIUMPH® Artificial Disc
Hide Arm/Group Description:

Treatment of degenerative disc disease with the TRIUMPH Lumbar Artificial Disc. This is a non-randomized pilot study with only one arm (no control).

TRIUMPH® Lumbar Artificial Disc: The TRIUMPH® Lumbar Artificial Disc is an articulating artificial disc inserted using a posterolateral approach to the lumbar spine.

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
15
  83.3%
Time Frame 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TRIUMPH® Artificial Disc
Hide Arm/Group Description

Treatment of degenerative disc disease with the TRIUMPH Lumbar Artificial Disc. This is a non-randomized pilot study with only one arm (no control).

TRIUMPH® Lumbar Artificial Disc: The TRIUMPH® Lumbar Artificial Disc is an articulating artificial disc inserted using a posterolateral approach to the lumbar spine.

All-Cause Mortality
TRIUMPH® Artificial Disc
Affected / at Risk (%)
Total   0/20 (0.00%)    
Hide Serious Adverse Events
TRIUMPH® Artificial Disc
Affected / at Risk (%) # Events
Total   6/20 (30.00%)    
Gastrointestinal disorders   
Gastric bypass to convert Lap Band  1/20 (5.00%)  1
General disorders   
Headache and fatigue  1/20 (5.00%)  1
Trauma *  1/20 (5.00%)  2
Device migration *  1/20 (5.00%)  1
Dural tear *  1/20 (5.00%)  1
Dysesthesia - lower extremities *  1/20 (5.00%)  1
Other *  1/20 (5.00%)  1
Pain - back *  1/20 (5.00%)  1
Weakness in bilateral legs *  1/20 (5.00%)  1
Renal and urinary disorders   
Intrauterine Growth Restriction  1/20 (5.00%)  1
Surgical and medical procedures   
Surgery - Index Level  3/20 (15.00%)  3
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TRIUMPH® Artificial Disc
Affected / at Risk (%) # Events
Total   17/20 (85.00%)    
Cardiac disorders   
Hypertension *  1/20 (5.00%)  1
General disorders   
Trauma *  6/20 (30.00%)  10
Dural tear *  1/20 (5.00%)  1
Headache * 1  4/20 (20.00%)  4
Pain - back *  4/20 (20.00%)  5
Pain - back and hip *  2/20 (10.00%)  2
Pain - back and lower extremities *  1/20 (5.00%)  1
Pain - hip *  1/20 (5.00%)  1
Pain - lower extremities *  3/20 (15.00%)  5
Pain - lower extremities with dysesthesia *  1/20 (5.00%)  2
Pain - neck and/or upper extremities *  3/20 (15.00%)  3
Wound issue *  1/20 (5.00%)  1
Seizure type incidents *  1/20 (5.00%)  1
Other *  6/20 (30.00%)  6
Dysesthesia - lower extremities *  1/20 (5.00%)  1
Paresthesia - lower extremities *  2/20 (10.00%)  2
Weakness *  1/20 (5.00%)  1
Musculoskeletal and connective tissue disorders   
Muscle spasms *  1/20 (5.00%)  1
Renal and urinary disorders   
Urogenital *  1/20 (5.00%)  1
1
Term from vocabulary, 2
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
To prevent premature disclosure of trade secrets or other confidential information, PI agrees not to present, publish, or disclose study results or information about the investigational device without the express written consent of the sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jacqueline Myer
Organization: Globus Medical
Phone: 610-930-1800 ext 1669
EMail: jmyer@globusmedical.com
Layout table for additonal information
Responsible Party: Globus Medical Inc
ClinicalTrials.gov Identifier: NCT01198470    
Other Study ID Numbers: G090143
First Submitted: September 8, 2010
First Posted: September 10, 2010
Results First Submitted: August 20, 2018
Results First Posted: October 2, 2018
Last Update Posted: October 2, 2018