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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 or 2 level TLIF candidates | Any subject determined to ALREADY be a candidate for 1 or 2 level transforaminal interbody fusion surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TLIF with Titan TT/TO interbody cage | Device | fusion surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain measured by VAS | 1 to 10 | 2 years |
| Function measured by oswestry disability index | 10 question score | 2 years |
| 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 |
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Inclusion Criteria:
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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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.
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| Name | Affiliation | Role |
|---|---|---|
| Reginald Davis, MD | Laser Spine Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kenai Spine | Soldotna | Alaska | 99669 | United States | ||
| Spine Care Institute |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D013168 | Spondylolisthesis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
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| Daly City |
| California |
| 94051 |
| United States |
| Spine Clinic of Monteray bay | Soquel | California | 95073 | United States |
| Laser Spine Institute | Tampa | Florida | 33607 | United States |
| Polaris Spine | Atlanta | Georgia | 30328 | United States |
| Chatham Orthopedic Associates | Savannah | Georgia | 31405 | United States |
| Spine Institute of Idaho | Meridian | Idaho | 83642 | United States |
| Southern Oregon Orthopedics | Medford | Oregon | 97504 | United States |
| D055009 |
| Spondylosis |