Titan Spine Endoskeleton TT/TO Study

Terminated

• Conditions: Degenerative Disc Disease, Spondylolisthesis
• Interventions: Device: TLIF with Titan TT/TO interbody cage

• Registration Number: NCT03910309
• Lead Sponsor: Titan Spine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-08-15
• Primary Completion: 2018-07
• Study Completion: 2018-09
• Status Verified: 2019-04
• Study First Submitted QC: 2019-04-08
• Last Update Submitted: 2019-04-08
• Study First Posted: 2019-04-10
• Last Update Posted: 2019-04-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1 or 2 level TLIF candidates	TLIF with Titan TT/TO interbody cage	Any subject determined to ALREADY be a candidate for 1 or 2 level transforaminal interbody fusion surgery

Primary Outcome Measures

Name	Time	Method
Function measured by oswestry disability index	2 years	10 question score
Pain measured by VAS	2 years	1 to 10

Secondary Outcome Measures

Name	Time	Method
Success of fusion	3 months, 6 months, 12 months, 24 months	Fusion will be assessed by AP/Lat Flex/Ext radiographs

Trial Locations

Locations (8)

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