NCT03910309TerminatedNot Applicable
A Prospective Investigation Comparing Bone Graft Extenders in Transforaminal Interbody Fusions (TLIF) With an Acid Etched Titanium Implant: A Clinical Outcomes and Cost Analysis
Titan Spine8 sites in 1 country75 target enrollmentStarted: January 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 75
- Locations
- 8
- Primary Endpoint
- Function measured by oswestry disability index
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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-S
- •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.
Outcomes
Primary Outcomes
Function measured by oswestry disability index
Time Frame: 2 years
10 question score
Pain measured by VAS
Time Frame: 2 years
1 to 10
Secondary Outcomes
- Success of fusion(3 months, 6 months, 12 months, 24 months)
Investigators
Study Sites (8)
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