TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study

Primary outcomes

1. 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.

2. 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

3. 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.

4. 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

   • Impaired
   • Normal

   Reflexes 0 Absent or Trace

   • Hyper-reflexive
   • 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.