Intervertebral Disc DiseaseNCT03018392
Clinical and Radiological Evaluation of Patients With DDD Following TLIF With 3-D Printed Titanium Cage
A study testing Stryker Tritanium Spinal System in people with Intervertebral Disc Disease, run by Bone and Joint Clinic of Baton Rouge.
Trial summary
The purpose of this study is to evaluate the fusion rate and clinical outcomes at 1 year of 20 patients with degenerative disc disease who undergo a Transforaminal Lumbar Interbody Fusion (TLIF) with the Stryker Tritanium Spinal System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intervertebral Disc Disease
- What is being tested?
- Stryker Tritanium Spinal System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to 28 Jan 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has one or more of the following diagnoses: degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1, and may also include up to Grade I spondylolisthesis at the involved level(s); degenerative scoliosis for which the Tritanium PL cage will be used as an adjunct to fusion
- Skeletally mature and ≥ 18 years old at time of enrollment
- Completed at least 6 months of non-operative therapy prior to surgery
- Willing and able to sign a study specific consent and comply with the requirements of the protocol including follow up visits and imaging.
Who cannot join
- 2 levels requiring surgical intervention
- Non-degenerative pathology including tumor, trauma, post-laminectomy kyphosis
- Psudeoarthrosis at the index level
- Previous fusion at the levels to be treated or at adjacent level
- Any abnormality present which affects the normal process of bone remodeling including, but not limited to, severe osteoporosis involving the spine, bone absorption, osteopenia, primary or metastatic tumors involving the spine, active infection at the site or certain metabolic disorders affecting osteogenesis.
- History of osteoporotic fracture
Show all 25Show fewer
- History of an endocrine or metabolic disorder known to affect bone and mineral metabolism
- Inadequate tissue coverage over the operative site or taking medications that may interfere with bony/soft tissue healing including chronic steroid use
- Known allergy to titanium or cobalt chrome or may be sensitive to materials
- Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C or fibromyalgia
- Lumbar kyphosis- lumbar lordosis < 20°
- Degenerative scoliosis >20° OR any other pathology scoliosis (idiopathic, congenital, posttraumatic, iatrogenic)
- Active systemic infection or infection at the operative site
- Marked local inflammation
- Any open wounds
- Pregnant, or intends to become pregnant during the study
- Current smokers
- Subject is class 3 obese (BMI >40) or overweight and can produce loads on the spinal system which can lead to failure of the fixation of the device or to failure of the device itself
- Any mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care
- Any neuromuscular deficit which places an unsafe load level on the device during the healing period
- Any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors, congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood cell count (WBC), or marked left shift in the WBC differential count.
- Any condition of senility, mental illness, or substance abuse.
- Involved in current spinal litigation that may interfere or influence patient self-assessment of function and pain
- Physical or mental condition that may interfere or influence patient self-assessment of function and pain.
- Incarcerated at the time of study enrollment
About this study
Official title: Fusion Rate and Clinical Outcomes Following 1 or 2 Level Open Transforaminal Lumbar Interbody Fusion for Degenerative Disc Disease With Novel 3-D Printed Titanium Cages With Pedicle Screw Fixation
The purpose of this study is to evaluate the fusion rate and clinical outcomes at 1 year of 20 patients with degenerative disc disease who undergo a Transforaminal Lumbar Interbody Fusion (TLIF) with the Stryker Tritanium Spinal System. This is an on-label, post-market outcomes study to build on the body of long-term evidence for the device.
- Conditions
- Intervertebral Disc Disease
- Being tested
- Stryker Tritanium Spinal System
- Medical subject headings
- Intervertebral disc disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stryker Tritanium Spinal SystemDevice
open transforaminal lumbar interbody fusion (TLIF) utilizing the Stryker Tritanium cages with pedicle screw fixation according to instructions for use and package labeling for on-label indications
| Study group | Role | What they receive |
|---|---|---|
| Tritanium | Experimental | TLIF with Tritanium® PL cage and pedicle screw fixation Receives: Device: Stryker Tritanium Spinal System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion Rate
Fusion status at 1 year post-operatively was graded as - fused (best outcome), progressing, or pseudoarthrosis (failed fusion)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startJan 2017
- Primary completion28 Jan 2020
- Study completion28 Jan 2020
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 Intervertebral 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
- Bone and Joint Clinic of Baton Rouge
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chambliss Harrod, MD, Principal investigator, Bone and Joint Clinic of Baton Rouge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018392
- Sponsor's protocol ID
- TRITANIUM
- Status last verified
- Aug 2022
- First submitted
- 10 Jan 2017
- Last updated
- 7 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fusion Rate and Clinical Outcomes Following 1 or 2 Level Open Transforaminal Lumbar Interbody Fusion for Degenerative Disc Disease With Novel 3-D Printed Titanium Cages With Pedicle Screw Fixation
- ClinicalTrials.gov ID
- NCT03018392
- Acronym / sponsor ID
- TRITANIUM
- Conditions
- Intervertebral Disc Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bone and Joint Clinic of Baton RougeUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 28 Jan 2020 (actual)
- Study completion
- 28 Jan 2020 (actual)
- First posted
- 12 Jan 2017 (estimated)
- Results
- Posted 7 Sep 2022
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 fusion rate and clinical outcomes at 1 year of 20 patients with degenerative disc disease who undergo a Transforaminal Lumbar Interbody Fusion (TLIF) with the Stryker Tritanium Spinal System. This is an on-label, post-market outcomes study to build on the body of long-term evidence for the device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tritanium | Experimental | Device: Stryker Tritanium Spinal SystemTLIF with Tritanium® PL cage and pedicle screw fixation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject has one or more of the following diagnoses: degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1, and may also include up to Grade I spondylolisthesis at the involved level(s); degenerative scoliosis for which the Tritanium PL cage will be used as an adjunct to fusion
- Skeletally mature and ≥ 18 years old at time of enrollment
- Completed at least 6 months of non-operative therapy prior to surgery
- Willing and able to sign a study specific consent and comply with the requirements of the protocol including follow up visits and imaging.
Key exclusion criteria (25 listed)
- 2 levels requiring surgical intervention
- Non-degenerative pathology including tumor, trauma, post-laminectomy kyphosis
- Psudeoarthrosis at the index level
- Previous fusion at the levels to be treated or at adjacent level
- Any abnormality present which affects the normal process of bone remodeling including, but not limited to, severe osteoporosis involving the spine, bone absorption, osteopenia, primary or metastatic tumors involving the spine, active infection at the site or certain metabolic disorders affecting osteogenesis.
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 |
|---|---|---|
| Stryker Tritanium Spinal Systemopen transforaminal lumbar interbody fusion (TLIF) utilizing the Stryker Tritanium cages with pedicle screw fixation according to instructions for use and package labeling for on-label indications | Device | Tritanium |
Primary outcome
Fusion Rate
Time frame: 1 year
Fusion status at 1 year post-operatively was graded as - fused (best outcome), progressing, or pseudoarthrosis (failed fusion)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Intervertebral Disc Disease
Not yet recruiting
CANLINK: Evaluation of the Intralink Intradiscal Device for Low Back Pain Due to Degenerative Disc Disease
Degenerative Disc Disease(DDD)
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
Not yet recruiting
Cortical Surface Functional Changes After Lever Positioning Manipulation for Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Effects of Spinal Mobilization With and Without Clinical Pilates in Patients With Lumbar Disc Herniationc Herniation
Disc Herniation
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.
Chambliss Harrod, MD principal investigator
Bone and Joint Clinic of Baton Rouge
Questions about this trial
What is this clinical trial studying?
A study testing Stryker Tritanium Spinal System in people with Intervertebral Disc Disease, run by Bone and Joint Clinic of Baton Rouge.
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 4 inclusion and 25 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 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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 7 Sep 2022). 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?
Fusion Rate (time frame: 1 year). 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 7 Sep 2022.