Titan Spine Endoskeleton TT/TO Study

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Investigation Comparing Bone Graft Extenders in Transforaminal Interbody Fusions (TLIF) With an Acid Etched Titanium Implant: A Clinical Outcomes and Cost Analysis

Conditions
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Degenerative Disc Disease, Spondylolisthesis

Intervention / Treatment
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* Device: TLIF with Titan TT/TO interbody cage


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1 or 2 level TLIF candidates<br>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<br>* fusion surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain measured by VAS | 1 to 10 | 2 years | 
| Function measured by oswestry disability index | 10 question score | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of fusion | Fusion will be assessed by AP/Lat Flex/Ext radiographs | 3 months, 6 months, 12 months, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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degenerative disc disease, spondylolisthesis