Degenerative Disc Disease, Foraminal Stenosis, Lumbar Spinal Stenosis, Lumbar Spondylolisthesis
Conditions
Keywords
transforaminal, degenerative disc disease (DDD), Lumbar Fusion, Interbody Fusion
Brief summary
This study is designed to evaluate clinical outcomes and spine fusion rates for patients undergoing transforaminal lumbar interbody fusion using the CONDUIT 3D printed titanium TLIF cage.
Detailed description
This prospective, single-center study is being conducted as a post market evaluation of the CONDUIT 3D printed titanium TLIF Cage. Patients undergoing transforaminal lumbar interbody fusions due to lumbar spinal pathology (i.e. central foraminal stenosis, degenerative disc disease, and/or lumbar spondylolisthesis) and have failed conservative care will be recruited for this study. Patients will be serially evaluated at 6 month intervals for a total of 24 months post index procedure to assess patient reported outcomes, clinical outcomes, and radiographic parameter, specifically spine fusion rates.
Interventions
DEVICECONDUIT™ Interbody Platform composed of the EIT (Emerging Implant Technologies) Cellular Titanium®
Patients undergoing 1-2 contiguous levels of interbody fixation from a transforaminal approach for spinal segments L2-S1
Sponsors
DePuy Synthes
Farhan Karim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Skeletally mature adults ages 35 - 80 years of age, inclusive * Diagnosis of lumbar degenerative disc disease with or without neurologic deficit and associated central and/or unilateral/bilateral foraminal stenosis * Subject undergoing one or two level transforaminal lumbar interbody fusion * Able to read and understand all documents used in this study , including the informed consent and patient-reported outcome questionnaires
Exclusion criteria
* Patients over 80 years of age * Patients under 35 years of age * Current smokers * BMI\>42 * Subject has spondylolisthesis \> 2 * Subjects with multilevel \>2 levels of symptomatic disease * Subjects with significant spinal deformity * Subject is pregnant, plans to become pregnant or is breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Fusion | 18 months | Fusion success measured by radiological assessment. Evidence of fusion demonstrated by bone formation through the cage on anteroposterior (AP) and Lateral radiographs, Flexion and Extension radiographs at 18 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Back and Leg Visual Analog Scale (VAS) | 6 months | Improvement in the VAS as measured by a minimum of a 20 point improvement |
| Back and Leg Visual Analog Scale | 18 months | Improvement in the VAS as measured by a minimum of a 20 point improvement |
| Oswestry Disability Index (ODI) | 6 months | Clinical Improvement will be defined by improvement in Oswestry Disability Index (ODI) \>20% |
| Adverse Events | up to 24 months | Number of procedure and device related adverse events |
| Intervention Rates | up to 24 months | Rates of reoperation and/or revision procedures at index level(s) |
Countries
United States
Contacts
Primary ContactBethany Samperi
Backup ContactMatthew Solomito, PhD
Outcome results
None listed