Thoracic-Lumbar Arthrodesis- Implanet Jazz

Status Recruiting

Clinical Trial Summary

Establish a data repository of patients who have undergone single, two-, or three-level lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System.

Clinical Trial Description

To collect and organize data into a repository from the Principal Investigator's and other Site Investigators' patients 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05366140
Study type	Observational [Patient Registry]
Source	University of Kentucky
Contact	H F Farhadi, MD, PhD
Phone	859-562-0247
Email	Francis.Farhadi@uky.edu
Status	Recruiting
Phase
Start date	February 3, 2022
Completion date	September 2032

View Details

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