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| Name | Class |
|---|---|
| Implanet America, Inc. | UNKNOWN |
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Establish a data repository of patients who have undergone single, two-, or three-level lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System.
To collect and organize data into a repository from the Principal Investigator's and other Site Investigators' patients who are undergoing single, two-level, or three-level lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz SystemTM at participating centers. This device is designed to provide a stable interface between spinal constructs and the rods; it can be secured around vertebral structures (such as the lamina, transverse or spinous processes) from T1 to L5 and is intended to provide temporary stabilization as a bone anchor during the development of a solid body fusion. Of note, these patients will receive the supplemental support of the Implanet Jazz Sublaminar Band as their clinical standard of care deems necessary and separately from study participation.
Clinical data will be collected as indicated at 6 weeks, as well as 3, 6, 12, 24, 36, 48, and 60 months post-operatively in the database.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prospective follow-up of patients who have received instrumented lumbar arthrodesis supplemented the Implanet Jazz System(TM) | Other | To assess the clinical outcomes of patients receiving standard of care Implanet Jazz System(TM) at the time of their instrumented lumbar arthrodesis. |
| Measure | Description | Time Frame |
|---|---|---|
| clinical prospective review- Prospective Database study for future studies | Collecting clinical measurements. Examples of these clinical measurements are the VAS Pain Scale, SF-36, NDI, and ODI. | 5- years |
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Inclusion Criteria:
Exclusion Criteria:
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Adult men and women of any/all ethnic groups who are appropriate candidates for hybrid thoracolumbar fixation and will receive the Implanet Jazz System (TM) during their arthrodesis surgery.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| H F Farhadi, MD, PhD | Contact | 859-562-0247 | Francis.Farhadi@uky.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Recruiting | Lexington | Kentucky | 40536 | United States |
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| ID | Term |
|---|---|
| D013168 | Spondylolisthesis |
| D013130 | Spinal Stenosis |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D013169 | Spondylolysis |
| D055009 | Spondylosis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
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| D009140 |
| Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |