Lumbar Degenerative Disc DiseaseNCT01198470
TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study
A study testing TRIUMPH® Lumbar Artificial Disc in people with Lumbar Degenerative Disc Disease, run by Globus Medical Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Degenerative Disc Disease
- What is being tested?
- TRIUMPH® Lumbar Artificial Disc
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Health University Medical Center
Savannah, Georgia, 31403
About this study
Official title: 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.
- Conditions
- Lumbar Degenerative Disc Disease
- Being tested
- TRIUMPH® Lumbar Artificial Disc
- Keywords
- Low back pain, Leg pain, Discogenic pain, Degenerative Disc Disease (DDD), Herniated disc, Radiculopathy
- Medical subject headings
- Intervertebral Disc Degeneration, Low Back Pain, Intervertebral Disc Displacement, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRIUMPH® Lumbar Artificial DiscDevice
The TRIUMPH® Lumbar Artificial Disc is an articulating artificial disc inserted using a posterolateral approach to the lumbar spine.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: TRIUMPH® Lumbar Artificial Disc |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lumbar Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Globus Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198470
- Sponsor's protocol ID
- G090143
- Status last verified
- Oct 2018
- First submitted
- 8 Sep 2010
- Last updated
- 2 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Investigation of the TRIUMPH Lumbar Disc: A Pilot Study
- ClinicalTrials.gov ID
- NCT01198470
- Acronym / sponsor ID
- G090143
- Conditions
- Lumbar Degenerative Disc Disease
- Keywords
- Low back pain, Leg pain, Discogenic pain, Degenerative Disc Disease (DDD), Herniated disc, Radiculopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Globus Medical IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Sep 2010 (estimated)
- Results
- Posted 2 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TRIUMPH® Artificial Disc | Experimental | Device: TRIUMPH® Lumbar Artificial DiscTreatment of degenerative disc disease with the TRIUMPH Lumbar Artificial Disc. This is a non-randomized pilot study with only one arm (no control). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRIUMPH® Lumbar Artificial DiscThe TRIUMPH® Lumbar Artificial Disc is an articulating artificial disc inserted using a posterolateral approach to the lumbar spine. | Device | TRIUMPH® Artificial Disc |
Primary outcome
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.
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
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRIUMPH® Lumbar Artificial Disc in people with Lumbar Degenerative Disc Disease, run by Globus Medical Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2018; AzTrials last refreshed its copy on 26 Oct 2026.