Degenerative Disc DiseasePhase 3XL TDRNCT00927238
XL TDR® eXtreme Lateral Total Disc Replacement for the Treatment of Lumbar Degenerative Disc Disease (DDD)
A Phase 3 study testing XL TDR and Lumbar fusion surgery in people with Degenerative Disc Disease, run by NuVasive at 17 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of XL TDR in patients with single-level degenerative disc disease compared to other devices approved by the FDA for the same or similar indications. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- XL TDR and Lumbar fusion surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 17 sitesUnited States
- Study dates
- Jul 2009to Jul 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years of age (inclusive and skeletally mature) at the time of surgery
- Diagnosis of image-confirmed symptomatic DDD at one of the following levels: L1/L2, L2/L3, L3/L4, or L4/L5
- DDD diagnosed using patient history and image-confirmation such as (but not limited to), MRI, CT, or CT Myelogram with one or more of the following factors: contained herniated nucleus pulposus, facet joint degeneration/changes, decreased disc height >2mm, and/or scarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule
- Preoperative ODI ≥ 30 points
- Unresponsive to conservative treatment for ≥ 6 months
Who cannot join
- Symptomatic multilevel lumbar degeneration
- Chronic back or leg pain of unknown etiology
- Non-contained or extruded herniated nucleus pulpous
- Previous or other lumbar surgery at any level except prior discectomy, laminotomy, or nucleolysis at the same level
- Involved vertebral endplates dimensionally smaller than 45mm in the medial-lateral and/or 20mm in the anterior/posterior directions
- Idiopathic scoliosis
Show all 30Show fewer
- Defect in the pars interarticularis
- Radiographic signs of significant instability at operative level
- Lytic spondylolisthesis or degenerative spondylolisthesis > than grade 1
- Bony lumbar spinal stenosis
- Radiographic confirmation of significant facet joint disease or degeneration
- Another lumbar device implanted
- Clinically compromised vertebral bodies at the affected level due to trauma
- Presence of metastases or active spinal tumor malignancy
- Osteopenia, osteoporosis, or metabolic bone disease
- Active local or systemic infection, including AIDS and hepatitis
- Rheumatoid arthritis or other autoimmune disease
- Taking any medications or supplements which potentially interfere with bone/soft tissue healing
- Progressive neuromuscular disease
- Allergy to device materials, specifically: cobalt-chromium-molybdenum alloy, titanium, and hydroxyapatite
- BMI >40
- Pregnant, or may become pregnant within follow-up period of study
- Enrolled in another investigational study within the last 90 days
- Waddell signs of inorganic behavior ≥3
- History of substance abuse
- Involved in active spinal litigation
- Receiving workman's compensation for spinal condition
- Mentally incompetent
- Incarcerated
- Unwilling or unable to comply with all protocol visits/assessments
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
West Augusta Spine Specialists
Augusta, Georgia, 30909
Central Texas Spine Institute
Austin, Texas, 78731
Silicon Valley Spine Institute
Campbell, California, 95008
Spine Colorado / Durango Orthopedic Associates
Durango, Colorado, 81301
Spine Midwest
Jefferson City, Missouri, 65101
Western Regional Spine Center for Brain and Spine Surgery
Las Vegas, Nevada, 89109
Buffalo Spine Surgery
Lockport, New York, 14094
Southern Oregon Orthopedics
Medford, Oregon, 97504
South Florida Spine Institute
Miami Beach, Florida, 33140
Southeastern Spine Institute
Mt. Pleasant, South Carolina, 29464
Christiana Spine Center
Newark, Delaware, 19713
Southeastern Spine Center & Research Institute
Sarasota, Florida, 34342
Spine Institute of Louisiana
Shreveport, Louisiana, 71101
Northwest Orthopaedic Specialists
Spokane, Washington, 99208
University of South Florida
Tampa, Florida, 33606
Conejo Orthopaedic and Spine Institute
Thousand Oaks, California, 91360
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
Official title: A Pivotal, Multi-Center, Clinical Trial Evaluating The Safety And Effectiveness of The Lumbar TDR Device In Patients With Single-Level Lumbar Degenerative Disc Disease
The purpose of this study is to evaluate the safety and effectiveness of XL TDR in patients with single-level degenerative disc disease compared to other devices approved by the FDA for the same or similar indications.
Read the detailed description
The XL TDR® eXtreme Lateral Total Disc Replacement consists of two endplates that are provided in a number of sizes to accommodate a variety of patient anatomies and pathologies. The XL TDR device is made up of a ball and socket articulation and the joint is made of CoCrMo alloy.
The XL TDR is intended to be used to reconstruct the spine following the removal of part or all of the intervertebral disc on one level of the lumbar spine.
The XL TDR is indicated for reconstruction of the disc following discectomy in skeletally mature subjects with symptomatic degenerative disc disease (DDD) of the lumbar spine at one level from L1-L5. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history radiographic studies.
- Conditions
- Degenerative Disc Disease
- Being tested
- XL TDR, Lumbar fusion surgery
- Keywords
- Single Level, Lumbar Disc Disease, DDD
- Medical subject headings
- Intervertebral Disc Degeneration, Intervertebral disc disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XL TDRDevice
Also called Total disc replacement
This will be a lateral approach discectomy and reconstruction with the insertion of the XL TDR device.
Lumbar fusion surgeryOther
Lumbar fusion surgery
| Study group | Role | What they receive |
|---|---|---|
| XL TDR | Experimental | The XL TDR is indicated for reconstruction of the disc following discectomy in skeletally mature subjects with symptomatic degenerative disc disease (DDD) of the lumbar spine at one level from L1-L5. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history radiographic studies. Receives: Device: XL TDR; Other: Lumbar fusion surgery |
| Outcomes from lumbar fusion study | Other | Not described Receives: Other: Lumbar fusion surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in ODI
Measured: December 2012
Secondary outcomes (1)
Disc Height
Measured: December 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuVasive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William D Smith, MD, Principal investigator, Western Regional Center for Brain and Spine Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927238
- Sponsor's protocol ID
- NUVA-LTDR-0701
- Acronym
- XL TDR
- Status last verified
- Jul 2015
- First submitted
- 22 Jun 2009
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal, Multi-Center, Clinical Trial Evaluating The Safety And Effectiveness of The Lumbar TDR Device In Patients With Single-Level Lumbar Degenerative Disc Disease
- ClinicalTrials.gov ID
- NCT00927238
- Acronym / sponsor ID
- XL TDR / NUVA-LTDR-0701
- Conditions
- Degenerative Disc Disease
- Keywords
- Single Level, Lumbar Disc Disease, DDD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- NuVasiveIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 24 Jun 2009 (estimated)
- Results
- Not posted in the source record
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 study is to evaluate the safety and effectiveness of XL TDR in patients with single-level degenerative disc disease compared to other devices approved by the FDA for the same or similar indications.
Detailed description
The XL TDR® eXtreme Lateral Total Disc Replacement consists of two endplates that are provided in a number of sizes to accommodate a variety of patient anatomies and pathologies. The XL TDR device is made up of a ball and socket articulation and the joint is made of CoCrMo alloy.
The XL TDR is intended to be used to reconstruct the spine following the removal of part or all of the intervertebral disc on one level of the lumbar spine.
The XL TDR is indicated for reconstruction of the disc following discectomy in skeletally mature subjects with symptomatic degenerative disc disease (DDD) of the lumbar spine at one level from L1-L5. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history radiographic studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XL TDR | Experimental | Device: XL TDR, Other: Lumbar fusion surgeryThe XL TDR is indicated for reconstruction of the disc following discectomy in skeletally mature subjects with symptomatic degenerative disc disease (DDD) of the lumbar spine at one level from L1-L5. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history radiographic studies. |
| Outcomes from lumbar fusion study | Other | Other: Lumbar fusion surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-70 years of age (inclusive and skeletally mature) at the time of surgery
- Diagnosis of image-confirmed symptomatic DDD at one of the following levels: L1/L2, L2/L3, L3/L4, or L4/L5
- DDD diagnosed using patient history and image-confirmation such as (but not limited to), MRI, CT, or CT Myelogram with one or more of the following factors: contained herniated nucleus pulposus, facet joint degeneration/changes, decreased disc height >2mm, and/or scarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule
- Preoperative ODI ≥ 30 points
- Unresponsive to conservative treatment for ≥ 6 months
Key exclusion criteria (30 listed)
- Symptomatic multilevel lumbar degeneration
- Chronic back or leg pain of unknown etiology
- Non-contained or extruded herniated nucleus pulpous
- Previous or other lumbar surgery at any level except prior discectomy, laminotomy, or nucleolysis at the same level
- Involved vertebral endplates dimensionally smaller than 45mm in the medial-lateral and/or 20mm in the anterior/posterior directions
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 |
|---|---|---|
| XL TDRAlso: Total disc replacementThis will be a lateral approach discectomy and reconstruction with the insertion of the XL TDR device. | Device | XL TDR |
| Lumbar fusion surgeryLumbar fusion surgery | Other | Outcomes from lumbar fusion study, XL TDR |
Primary outcome
Improvement in ODI
Time frame: December 2012
1 secondary outcome
Disc Height
Time frame: December 2012
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
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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.
William D Smith, MD principal investigator
Western Regional Center for Brain and Spine Surgery
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing XL TDR and Lumbar fusion surgery in people with Degenerative Disc Disease, run by NuVasive at 17 sites 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 30 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 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement in ODI (time frame: December 2012). 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 30 Jul 2015.