TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study

• 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: Globus Medical Inc
• Information provided by (Responsible Party): Globus Medical Inc

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lumbar Degenerative Disc Disease	Device: TRIUMPH® Lumbar Artificial Disc	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

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

   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Georgia

Memorial Health University Medical Center

Savannah, Georgia, United States, 31403

Sponsors and Collaborators

Globus Medical Inc

More Information

• Responsible Party: Globus Medical Inc
• ClinicalTrials.gov Identifier: NCT01198470
• Other Study ID Numbers: G090143
• First Posted: September 10, 2010
• Results First Posted: October 2, 2018
• Last Update Posted: October 2, 2018
• Last Verified: October 2018

Keywords provided by Globus Medical Inc:

Low back pain; Leg pain; Discogenic pain; Degenerative Disc Disease (DDD); Herniated disc; Radiculopathy

Additional relevant MeSH terms:

Intervertebral Disc Degeneration; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases