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Titan Spine Endoskeleton TT/TO Study

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ClinicalTrials.gov Identifier: NCT03910309
Recruitment Status : Terminated
First Posted : April 10, 2019
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Titan Spine

Brief 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.

Condition or disease Intervention/treatment
Degenerative Disc Disease, Spondylolisthesis Device: TLIF with Titan TT/TO interbody cage

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Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : January 2015
Actual Primary Completion Date : July 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


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
Device: TLIF with Titan TT/TO interbody cage
fusion surgery




Primary Outcome Measures :
  1. Pain measured by VAS [ Time Frame: 2 years ]
    1 to 10

  2. Function measured by oswestry disability index [ Time Frame: 2 years ]
    10 question score


Secondary Outcome Measures :
  1. Success of fusion [ Time Frame: 3 months, 6 months, 12 months, 24 months ]
    Fusion will be assessed by AP/Lat Flex/Ext radiographs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  1. Be 18-75 years of age, and skeletally mature
  2. 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.
  3. 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.
  4. Psychosocially, mentally and physically able to comply with protocol, post-operative management and follow-up schedule.
  5. Subject must understand and sign the written Informed Consent.

Exclusion Criteria:

  1. Previous history of fusion surgery at the index level(s).
  2. 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.)
  3. 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)
  4. Any terminal or autoimmune disease including but not limited to HIV infection, rheumatoid arthritis or lupus.
  5. Any other concurrent medical disease that might impair normal healing process.
  6. Morbid obesity (BMI ≥ 40 kg/m2).
  7. Investigational drug or device use within 30 days.
  8. Currently a prisoner.
  9. 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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03910309


Locations
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United States, Alaska
Kenai Spine
Soldotna, Alaska, United States, 99669
United States, California
Spine Care Institute
Daly City, California, United States, 94051
Spine Clinic of Monteray bay
Soquel, California, United States, 95073
United States, Florida
Laser Spine Institute
Tampa, Florida, United States, 33607
United States, Georgia
Polaris Spine
Atlanta, Georgia, United States, 30328
Chatham Orthopedic Associates
Savannah, Georgia, United States, 31405
United States, Idaho
Spine Institute of Idaho
Meridian, Idaho, United States, 83642
United States, Oregon
Southern Oregon Orthopedics
Medford, Oregon, United States, 97504
Sponsors and Collaborators
Titan Spine
Investigators
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Principal Investigator: Reginald Davis, MD Laser Spine Institute

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Responsible Party: Titan Spine
ClinicalTrials.gov Identifier: NCT03910309     History of Changes
Other Study ID Numbers: TLIF1-150
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Keywords provided by Titan Spine:
degenerative disc disease, spondylolisthesis
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spondylolisthesis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis