Degenerative Disc Disease, Spondylolisthesis Clinical Trial
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
| NCT number | NCT03910309 |
| Other study ID # | TLIF1-150 |
| Secondary ID | |
| Status | Terminated |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2015 |
| Est. completion date | September 2018 |
| Verified date | April 2019 |
| Source | Titan Spine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Terminated |
| Enrollment | 75 |
| Est. completion date | September 2018 |
| Est. primary completion date | July 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Polaris Spine | Atlanta | Georgia |
| United States | Spine Care Institute | Daly City | California |
| United States | Southern Oregon Orthopedics | Medford | Oregon |
| United States | Spine Institute of Idaho | Meridian | Idaho |
| United States | Chatham Orthopedic Associates | Savannah | Georgia |
| United States | Kenai Spine | Soldotna | Alaska |
| United States | Spine Clinic of Monteray bay | Soquel | California |
| United States | Laser Spine Institute | Tampa | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Titan Spine |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pain measured by VAS | 1 to 10 | 2 years | |
| Primary | Function measured by oswestry disability index | 10 question score | 2 years | |
| Secondary | Success of fusion | Fusion will be assessed by AP/Lat Flex/Ext radiographs | 3 months, 6 months, 12 months, 24 months |