Columbus, Ohio 43210


Purpose:

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


Study summary:

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.


Criteria:

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.


NCT ID:

NCT02411799


Primary Contact:

Principal Investigator
H. Francis Farhadi, M.D., PhD.
Assistant Professor

Amy J Minnema
Phone: 614-685-9827
Email: amy.minnema@osumc.edu


Backup Contact:

N/A


Location Contact:

Columbus, Ohio 43210
United States

Amy J Minnema
Phone: 614-685-9827
Email: amy.minnema@osumc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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