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NCT05366140Recruiting

Thoracic-Lumbar Arthrodesis- Implanet Jazz

Francis Farhadi

Start Date

2/3/2022

Completion Date

9/1/2028

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.

Detailed 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.

Eligibility Criteria

Age Range: 18 years to 100 years

Inclusion Criteria: * Male and female patients, 18 years of age and older * Qualified candidate for hybrid thoracolumbar fixation with the Implanet Jazz System TM during arthrodesis surgery. Exclusion Criteria: * Individuals who have not yet reached the age of 18.

Interventions

OTHER

Prospective follow-up of patients who have received instrumented lumbar arthrodesis supplemented the Implanet Jazz System(TM)

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Conditions

SpondylolisthesisSpinal StenosisDegenerative Disease

Locations

University of Kentucky

Lexington, Kentucky 40536

United States