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| Name | Class |
|---|---|
| DePuy Synthes | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1-2 contiguous levels of interbody fixation from a transforaminal approach for spinal segments L2-S1 | One to two contiguous levels of interbody fixation from a transforaminal approach for spinal segments L2-S1 whose condition requires the use of interbody fusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CONDUIT™ Interbody Platform composed of the EIT (Emerging Implant Technologies) Cellular Titanium® | Device | Patients undergoing 1-2 contiguous levels of interbody fixation from a transforaminal approach for spinal segments L2-S1 |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Fusion | 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 | 18 months |
| Radiographic Fusion | 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 24 months | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Back and Leg Visual Analog Scale (VAS) | Improvement in the VAS as measured by a minimum of a 20 point improvement | 6 months |
| Back and Leg Visual Analog Scale (VAS) | Improvement in the VAS as measured by a minimum of a 20 point improvement |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be skeletally mature adults ages 35-80 years of age undergoing one or two level transforaminal lumbar interbody fusion. These patients will have a diagnosis of lumbar degenerative disc disease with or without neurologic deficit and associated central and/or unilateral /bilateral foraminal stenosis.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bethany Samperi | Contact | 860-972-5978 | bethany.samperi@hhchealth.org | |
| Matthew Solomito, PhD | Contact | 203-525-7659 | matthew.solomito@hhchealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Farhan Karim, DO | Hartford Hospital; Hartford Healthcare Bone & Joint Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Healthcare Bone and Joint Institute | Recruiting | Hartford | Connecticut | 06106 | United States |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D013168 | Spondylolisthesis |
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
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| 12 months |
| Back and Leg Visual Analog Scale | Improvement in the VAS as measured by a minimum of a 20 point improvement | 18 months |
| Oswestry Disability Index (ODI) | Clinical Improvement will be defined by improvement in Oswestry Disability Index (ODI) >20% | 6 months |
| Oswestry Disability Index (ODI) | Clinical Improvement will be defined by improvement in Oswestry Disability Index (ODI) >20% | 12 months |
| Oswestry Disability Index (ODI) | Clinical Improvement will be defined by improvement in Oswestry Disability Index (ODI) >20% | 18 months |
| Adverse Events | Number of procedure and device related adverse events | up to 24 months |
| Intervention Rates | Rates of reoperation and/or revision procedures at index level(s) | up to 24 months |
| D055009 |
| Spondylosis |