TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study

NCT01198470 | Completed Results

• 1 other identifier: G090143
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Degenerative Disc Disease

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 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.

  24 months

Study Arms (1)

TRIUMPH® Artificial Disc

EXPERIMENTAL

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

Interventions

TRIUMPH® Lumbar Artificial Disc DEVICE

The TRIUMPH® Lumbar Artificial Disc is an articulating artificial disc inserted using a posterolateral approach to the lumbar spine.

TRIUMPH® Artificial Disc

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Globus Medical Inc: lead

Study Sites (1)

Memorial Health University Medical Center

Savannah, Georgia, 31403, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Low Back Pain; Intervertebral Disc Displacement; Radiculopathy

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hernia; Pathological Conditions, Anatomical; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Jacqueline Myer
• Organization: Globus Medical

jmyer@globusmedical.com

610-930-1800

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2010
• First Posted: September 10, 2010
• Study Start: September 1, 2010
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 2, 2018
• Results First Posted: October 2, 2018

Record last verified: 2018-10

Locations

US (1)