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

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

    • Alaska
      • Soldotna, Alaska, United States, 99669
        • Kenai Spine
    • California
      • Daly City, California, United States, 94051
        • Spine Care Institute
      • Soquel, California, United States, 95073
        • Spine Clinic of Monteray bay
    • Florida
      • Tampa, Florida, United States, 33607
        • Laser Spine Institute
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Polaris Spine
      • Savannah, Georgia, United States, 31405
        • Chatham Orthopedic Associates
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Spine Institute of Idaho
    • Oregon
      • Medford, Oregon, United States, 97504
        • Southern Oregon Orthopedics

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:

  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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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

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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