TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study
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|ClinicalTrials.gov Identifier: NCT01198470|
Recruitment Status : Completed
First Posted : September 10, 2010
Results First Posted : October 2, 2018
Last Update Posted : October 2, 2018
|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)|
|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|
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.
- 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
- Palpable or Visible Contraction
- Active Movement, Gravity Eliminated
- Active Movement, Against Gravity
- Active Movement, Against Some Resistance
- Active Movement, Against Full Resistance
Sensory 0 Absent
Reflexes 0 Absent or Trace
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01198470
|United States, Georgia|
|Memorial Health University Medical Center|
|Savannah, Georgia, United States, 31403|