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NCT02411799 Clinical Trial

Instrumented Thoracic and Lumbar Arthrodesis Supplemented by the Implanet Jazz SystemTMd

Spinal Stenosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02411799
Other study ID # 2014H0433
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date April 2015
Est. completion date June 30, 2021

Study information
Verified date September 2021
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 154
Est. completion date June 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States The Ohio State University Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients who have undergone thoracic and/or lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System. 60 months
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