TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Clinical Investigation of the TRIUMPH Lumbar Disc: A Pilot Study

Conditions
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Lumbar Degenerative Disc Disease

Intervention / Treatment
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* Device: TRIUMPH® Lumbar Artificial Disc


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRIUMPH® Artificial Disc<br>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<br>* The TRIUMPH® Lumbar Artificial Disc is an articulating artificial disc inserted using a posterolateral approach to the lumbar spine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 24 months | 
| Number of Participants With No Device Failures | Any device requiring surgical revision, reoperation, removal or supplemental fixation will be considered a device failure | 24 months | 
| Number of Participants With Major Complications Defined as Major Vessel Injury or Neurological Damage | 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. | 24 months | 
| Number of Participants Determined to Have a Normal Neurological Status | 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. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low back pain, Leg pain, Discogenic pain, Degenerative Disc Disease (DDD), Herniated disc, Radiculopathy