Titan Spine Endoskeleton TT/TO Study

Titan Spine

Status: Terminated

Conditions: Degenerative Disc Disease, Spondylolisthesis

Treatments: Device: TLIF with Titan TT/TO interbody cage

Study type: Observational

Funder types: Industry

Identifiers

NCT03910309

TLIF1-150

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

75 participants in 1 patient group

1 or 2 level TLIF candidates

Description:

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

Treatment:

Device: TLIF with Titan TT/TO interbody cage