- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03910309
Titan Spine Endoskeleton TT/TO Study
April 8, 2019 updated by: Titan Spine
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
75
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Alaska
-
Soldotna, Alaska, United States, 99669
- Kenai Spine
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California
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Daly City, California, United States, 94051
- Spine Care Institute
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Soquel, California, United States, 95073
- Spine Clinic of Monteray bay
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Florida
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Tampa, Florida, United States, 33607
- Laser Spine Institute
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Georgia
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Atlanta, Georgia, United States, 30328
- Polaris Spine
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Savannah, Georgia, United States, 31405
- Chatham Orthopedic Associates
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Idaho
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Meridian, Idaho, United States, 83642
- Spine Institute of Idaho
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Oregon
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Medford, Oregon, United States, 97504
- Southern Oregon Orthopedics
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- 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.
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1 or 2 level TLIF candidates
Any subject determined to ALREADY be a candidate for 1 or 2 level transforaminal interbody fusion surgery
|
fusion surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain measured by VAS
Time Frame: 2 years
|
1 to 10
|
2 years
|
Function measured by oswestry disability index
Time Frame: 2 years
|
10 question score
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success of fusion
Time Frame: 3 months, 6 months, 12 months, 24 months
|
Fusion will be assessed by AP/Lat Flex/Ext radiographs
|
3 months, 6 months, 12 months, 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Reginald Davis, MD, Laser Spine Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
July 1, 2018
Study Completion (Actual)
September 1, 2018
Study Registration Dates
First Submitted
August 15, 2016
First Submitted That Met QC Criteria
April 8, 2019
First Posted (Actual)
April 10, 2019
Study Record Updates
Last Update Posted (Actual)
April 10, 2019
Last Update Submitted That Met QC Criteria
April 8, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TLIF1-150
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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