Titan Spine Endoskeleton TT/TO Study

Stopped early

Conditions studied: Degenerative Disc Disease, Spondylolisthesis

In brief

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.

Key facts

Study ID

NCT03910309

Run by

Titan Spine

People needed

75

Starts

2015-01-01

Expected to finish

2018-09-01

Last updated by the study team

2019-04-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Kenai Spine — Soldotna, Alaska, United States
• Spine Care Institute — Daly City, California, United States
• Spine Clinic of Monteray bay — Soquel, California, United States
• Laser Spine Institute — Tampa, Florida, United States
• Polaris Spine — Atlanta, Georgia, United States
• Chatham Orthopedic Associates — Savannah, Georgia, United States
• Spine Institute of Idaho — Meridian, Idaho, United States
• Southern Oregon Orthopedics — Medford, Oregon, United States

Full record on ClinicalTrials.gov

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