TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study

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

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Degenerative Disc Disease
• Intervention / Treatment: Device: TRIUMPH® Lumbar Artificial Disc

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Savannah, Georgia, United States, 31403
      • Memorial Health University Medical Center

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Globus Medical Inc

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: September 8, 2010
• First Submitted That Met QC Criteria: September 8, 2010
• First Posted (Estimate): September 10, 2010

Study Record Updates

• Last Update Posted (Actual): October 2, 2018
• Last Update Submitted That Met QC Criteria: October 1, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Low back pain; Leg pain; Radiculopathy; Herniated disc; Discogenic pain; Degenerative Disc Disease (DDD)
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: G090143