Prospective Follow-up of Elderly Patients Undergoing Instrumented Lumbar Arthrodesis Supplemented by the Implanet Jazz System(TM)
Status: | Recruiting |
---|---|
Conditions: | Orthopedic, Orthopedic |
Therapuetic Areas: | Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 60 - 99 |
Updated: | 8/24/2018 |
Start Date: | December 29, 2016 |
End Date: | December 1, 2021 |
Contact: | Amy J Minnema, BS |
Email: | amy.minnema@osumc.edu |
Phone: | (614)685-9827 |
Establish a data repository of patients who have undergone single, two-, or three-level
lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System.
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' elderly patients (aged ≥ 60 years) 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.
Site Investigators' elderly patients (aged ≥ 60 years) 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.
Inclusion Criteria:
- Patients who are candidates for single, two- or three-level spinal arthrodesis surgery
supplemented by the Implanet Jazz System
- Patients at least 60 years of age.
Exclusion Criteria:
- Patients under the age of 60 years old are excluded.
We found this trial at
1
site
410 W 10th Ave
Columbus, Ohio 43210
Columbus, Ohio 43210
(614) 293-8652
Principal Investigator: H. Francis Farhadi, MD, PhD
Phone: 614-685-9827
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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