Titan Spine Endoskeleton TT/TO Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-09-30

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.

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Detailed Description

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Conditions

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Degenerative Disc Disease, Spondylolisthesis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1 or 2 level TLIF candidates

Any subject determined to ALREADY be a candidate for 1 or 2 level transforaminal interbody fusion surgery

TLIF with Titan TT/TO interbody cage

Intervention Type DEVICE

fusion surgery

Interventions

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TLIF with Titan TT/TO interbody cage

fusion surgery

Intervention Type DEVICE

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No