TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study

Not Applicable

Completed

• Conditions: Lumbar Degenerative Disc Disease
• Interventions: Device: TRIUMPH® Lumbar Artificial Disc

• Registration Number: NCT01198470
• Lead Sponsor: Globus Medical Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-08
• Study First Submitted QC: 2010-09-08
• Study First Posted: 2010-09-10
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Results First Submitted: 2018-08-20
• Status Verified: 2018-10
• Results First Submitted QC: 2018-10-01
• Last Update Submitted: 2018-10-01
• Results First Posted: 2018-10-02
• Last Update Posted: 2018-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TRIUMPH® Artificial Disc	TRIUMPH® Lumbar 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).

Primary Outcome Measures

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

Trial Locations

Locations (1)

Memorial Health University Medical Center; 🇺🇸 Savannah, Georgia, United States