Degenerative Disc Disease, SpondylolisthesisNCT03910309
Titan Spine Endoskeleton TT/TO Study
An observational study of Degenerative Disc Disease, Spondylolisthesis, run by Titan Spine at 8 sites in United States.
Trial summary
This is a prospective, multi-center controlled observational clinical study. All subjects will receive Titan Endoskeleton TT/TO acid etched titanium implant for the planned procedure. Each site will have a predetermined bonegraft extender to be used in all enrolled subjects at that site. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Degenerative Disc Disease, Spondylolisthesis
- What is being tested?
- TLIF with Titan TT/TO interbody cage
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 8 sitesUnited States
- Study dates
- Jan 2015to Sep 2018
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: One hundred and fifty (150) subjects will participate in the study at a max of 15 clinical sites. All subjects will have been diagnosed with lumbar spine disease at one or two levels of the lumbar spine that requires lumbar interbody fusion procedure as per the opinion of the treating surgeon.Subjects will be offered the opportunity to participate in the trial if he/she is determined to be a candidate for TLIF fusion surgery. The population will be drawn from an existing patient population per participating site.
Who may be able to join
- Be 18-75 years of age, and skeletally mature
- Have clinical and radiological evidence of degenerative disc disease at one or two levels of the lumbar spine between L2-S1. May also have spondylosis, spinal stenosis, or spondylolisthesis at these levels.
- In the opinion of the treating surgeon, must already be a qualified candidate for lumbar fusion surgery including 6 months of conservative care prior to surgical intervention.
- Psychosocially, mentally and physically able to comply with protocol, post-operative management and follow-up schedule.
- Subject must understand and sign the written Informed Consent.
Who cannot join
- Previous history of fusion surgery at the index level(s).
- Clinical, laboratory and/or radiological evidence of back pain secondary to acute or chronic infection, malignancy, other space occupying lesions and metabolic bone demineralization diseases (e.g. osteomalacia, gout, Paget's disease etc.)
- Osteoporosis defined as a DEXA bone density measurement T score ≤ 2.5 (Necessity for DEXA scan will be determined by investigator's standard of care)
- Any terminal or autoimmune disease including but not limited to HIV infection, rheumatoid arthritis or lupus.
- Any other concurrent medical disease that might impair normal healing process.
- Morbid obesity (BMI ≥ 40 kg/m2).
Show all 10Show fewer
- Investigational drug or device use within 30 days.
- Currently a prisoner.
- Currently experiencing a major mental illness (psychosis, schizophrenia, major affective disorder) which may indicate that the symptoms are psychological rather than of physical origin.
- -
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Polaris Spine
Atlanta, Georgia, 30328
Spine Care Institute
Daly City, California, 94051
Southern Oregon Orthopedics
Medford, Oregon, 97504
Spine Institute of Idaho
Meridian, Idaho, 83642
Chatham Orthopedic Associates
Savannah, Georgia, 31405
Kenai Spine
Soldotna, Alaska, 99669
Spine Clinic of Monteray bay
Soquel, California, 95073
Laser Spine Institute
Tampa, Florida, 33607
About this study
Official title: A Prospective Investigation Comparing Bone Graft Extenders in Transforaminal Interbody Fusions (TLIF) With an Acid Etched Titanium Implant: A Clinical Outcomes and Cost Analysis
This is a prospective, multi-center controlled observational clinical study. All subjects will receive Titan Endoskeleton TT/TO acid etched titanium implant for the planned procedure. Each site will have a predetermined bonegraft extender to be used in all enrolled subjects at that site.
- Being tested
- TLIF with Titan TT/TO interbody cage
- Keywords
- degenerative disc disease, spondylolisthesis
- Medical subject headings
- Intervertebral Disc Degeneration, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLIF with Titan TT/TO interbody cageDevice
fusion surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 or 2 level TLIF candidates | Any subject determined to ALREADY be a candidate for 1 or 2 level transforaminal interbody fusion surgery Receives: Device: TLIF with Titan TT/TO interbody cage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measured by VAS
1 to 10
Measured: 2 years
Function measured by oswestry disability index
10 question score
Measured: 2 years
Secondary outcomes (1)
Success of fusion
Fusion will be assessed by AP/Lat Flex/Ext radiographs
Measured: 3 months, 6 months, 12 months, 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 Apr 2019
- Study startJan 2015
- Primary completionJul 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc Disease, SpondylolisthesisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Titan Spine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Reginald Davis, MD, Principal investigator, Laser Spine Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910309
- Sponsor's protocol ID
- TLIF1-150
- Status last verified
- Apr 2019
- First submitted
- 15 Aug 2016
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Investigation Comparing Bone Graft Extenders in Transforaminal Interbody Fusions (TLIF) With an Acid Etched Titanium Implant: A Clinical Outcomes and Cost Analysis
- ClinicalTrials.gov ID
- NCT03910309
- Acronym / sponsor ID
- TLIF1-150
- Keywords
- degenerative disc disease, spondylolisthesis
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Titan SpineIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jul 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 10 Apr 2019 (actual)
- 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.
This is a prospective, multi-center controlled observational clinical study. All subjects will receive Titan Endoskeleton TT/TO acid etched titanium implant for the planned procedure. Each site will have a predetermined bonegraft extender to be used in all enrolled subjects at that site.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 or 2 level TLIF candidates | – | Device: TLIF with Titan TT/TO interbody cageAny subject determined to ALREADY be a candidate for 1 or 2 level transforaminal interbody fusion surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- One hundred and fifty (150) subjects will participate in the study at a max of 15 clinical sites. All subjects will have been diagnosed with lumbar spine disease at one or two levels of the lumbar spine that requires lumbar interbody fusion procedure as per the opinion of the treating surgeon.Subjects will be offered the opportunity to participate in the trial if he/she is determined to be a candidate for TLIF fusion surgery. The population will be drawn from an existing patient population per participating site.
Key inclusion criteria (5 listed)
- Be 18-75 years of age, and skeletally mature
- Have clinical and radiological evidence of degenerative disc disease at one or two levels of the lumbar spine between L2-S1. May also have spondylosis, spinal stenosis, or spondylolisthesis at these levels.
- In the opinion of the treating surgeon, must already be a qualified candidate for lumbar fusion surgery including 6 months of conservative care prior to surgical intervention.
- Psychosocially, mentally and physically able to comply with protocol, post-operative management and follow-up schedule.
- Subject must understand and sign the written Informed Consent.
Key exclusion criteria (10 listed)
- Previous history of fusion surgery at the index level(s).
- Clinical, laboratory and/or radiological evidence of back pain secondary to acute or chronic infection, malignancy, other space occupying lesions and metabolic bone demineralization diseases (e.g. osteomalacia, gout, Paget's disease etc.)
- Osteoporosis defined as a DEXA bone density measurement T score ≤ 2.5 (Necessity for DEXA scan will be determined by investigator's standard of care)
- Any terminal or autoimmune disease including but not limited to HIV infection, rheumatoid arthritis or lupus.
- Any other concurrent medical disease that might impair normal healing process.
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 |
|---|---|---|
| TLIF with Titan TT/TO interbody cagefusion surgery | Device | 1 or 2 level TLIF candidates |
Primary outcome
Pain measured by VAS
Time frame: 2 years
1 to 10
Function measured by oswestry disability index
Time frame: 2 years
10 question score
1 secondary outcome
Success of fusion
Time frame: 3 months, 6 months, 12 months, 24 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
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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.
Reginald Davis, MD principal investigator
Laser Spine Institute
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease, Spondylolisthesis, run by Titan Spine at 8 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 10 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: stopped early, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Pain measured by VAS (time frame: 2 years). The study lists 2 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 10 Apr 2019.