Instrumented Thoracic and Lumbar Arthrodesis Supplemented by the Implanet Jazz SystemTMd



Status:Recruiting
Conditions:Orthopedic, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:3/15/2019
Start Date:April 2015
End Date:April 2025
Contact:Amy J Minnema
Email:amy.minnema@osumc.edu
Phone:614-685-9827

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Prospective Multi-Center Follow-up of Patients Undergoing Instrumented Thoracic and Lumbar Arthrodesis Supplemented by the Implanet Jazz SystemTM

Establish a data repository of patients who have undergone thoracic and/or lumbar
instrumented arthrodesis procedure supplemented by the Implanet Jazz System.

The purpose of this study is to create a data repository of patients who have undergone
spinal arthrodesis procedures supplemented with the Implanet Jazz System. 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 bony fusion.

Patients who are candidates for hybrid thoracolumbar fixation with the Implanet Jazz System
during arthrodesis surgery will be asked to participate in this protocol. Clinical data will
be collected as indicated at 6 weeks, as well as 3, 6, 12, 24, 36 48, and 60 months post
surgery in the database. Data collected will include demographic and surgical information,
physiological data, neurological assessments and patient reported outcomes. This
comprehensive database will allow for gathering of relevant information for potential future
research use.

Inclusion Criteria:

- Patients who are candidates for spinal arthrodesis surgery (thoracic and/or lumbar)
supplemented by the Implanet Jazz System are eligible to participate in this study.

Exclusion Criteria:

- Patients under the age of 18 are excluded because the investigators do not routinely
perform spinal arthrodesis surgery on these patients.
We found this trial at
1
site
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: H. Francis Farhadi, MD, PhD
Phone: 614-685-9827
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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