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Instrumented Thoracic and Lumbar Arthrodesis Supplemented by the Implanet Jazz SystemTMd

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ClinicalTrials.gov Identifier: NCT02411799
Recruitment Status : Recruiting
First Posted : April 8, 2015
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
H Francis Farhadi, Ohio State University

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

Condition or disease
Spondylolisthesis Spinal Stenosis Proximal Joint Kyphosis (PJK)

Detailed Description:

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.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 60 Months
Official Title: Prospective Multi-Center Follow-up of Patients Undergoing Instrumented Thoracic and Lumbar Arthrodesis Supplemented by the Implanet Jazz SystemTM
Study Start Date : April 2015
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2025



Primary Outcome Measures :
  1. Number of patients who have undergone thoracic and/or lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System. [ Time Frame: 60 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are candidates for hybrid thoracolumbar fixation with the Implanet Jazz System during arthrodesis surgery.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02411799


Contacts
Contact: Amy J Minnema 614-685-9827 amy.minnema@osumc.edu

Locations
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Amy J Minnema    614-685-9827    amy.minnema@osumc.edu   
Principal Investigator: H. Francis Farhadi, MD, PhD         
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: H. Francis Farhadi, M.D., PhD. Assistant Professor

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: H Francis Farhadi, Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT02411799     History of Changes
Other Study ID Numbers: 2014H0433
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Spinal Stenosis
Spondylolisthesis
Kyphosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis
Spinal Curvatures