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The purpose of this study is to evaluate the fusion rate and clinical outcomes at 1 year of 20 patients with degenerative disc disease who undergo a Transforaminal Lumbar Interbody Fusion (TLIF) with the Stryker Tritanium Spinal System. This is an on-label, post-market outcomes study to build on the body of long-term evidence for the device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tritanium | Experimental | TLIF with Tritanium® PL cage and pedicle screw fixation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stryker Tritanium Spinal System | Device | open transforaminal lumbar interbody fusion (TLIF) utilizing the Stryker Tritanium cages with pedicle screw fixation according to instructions for use and package labeling for on-label indications |
| Measure | Description | Time Frame |
|---|---|---|
| Fusion Rate | Fusion status at 1 year post-operatively was graded as - fused (best outcome), progressing, or pseudoarthrosis (failed fusion) | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chambliss Harrod, MD | Bone and Joint Clinic of Baton Rouge | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tritanium | TLIF with Tritanium® PL cage and pedicle screw fixation Stryker Tritanium Spinal System: open transforaminal lumbar interbody fusion (TLIF) utilizing the Stryker Tritanium cages with pedicle screw fixation according to instructions for use and package labeling for on-label indications |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tritanium | TLIF with Tritanium® PL cage and pedicle screw fixation Stryker Tritanium Spinal System: open transforaminal lumbar interbody fusion (TLIF) utilizing the Stryker Tritanium cages with pedicle screw fixation according to instructions for use and package labeling for on-label indications |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fusion Rate | Fusion status at 1 year post-operatively was graded as - fused (best outcome), progressing, or pseudoarthrosis (failed fusion) | Posted | Count of Participants | Participants | 1 year |
|
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1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tritanium | TLIF with Tritanium® PL cage and pedicle screw fixation Stryker Tritanium Spinal System: open transforaminal lumbar interbody fusion (TLIF) utilizing the Stryker Tritanium cages with pedicle screw fixation according to instructions for use and package labeling for on-label indications |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Extension of fusion | Surgical and medical procedures | Non-systematic Assessment | 1 subject had a locked pseudoarthrosis with progressive isthmic spondylolisthesis at an adjacent level. This necessitated an extension of fusion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cage Fracture | Product Issues | Non-systematic Assessment | One incidental cage fracture in a setting of solid fusion was noted in the CT analysis. No intervention was necessary as the subject was doing well. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Projects Director | Bone and Joint Clinic of Baton Rouge | 2254218207 | aobrien@bjcbr.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 26, 2016 | Jul 19, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C535531 | Intervertebral disc disease |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| 0 |
| 20 |
| 1 |
| 20 |
| 1 |
| 20 |
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