Thoracic-Lumbar Arthrodesis- Implanet Jazz

Spinal Stenosis Clinical Trial

Official title:

Prospective Follow-up of Patients Undergoing Instrumented Thoracic and Lumbar Arthrodesis Supplemented by the Implanet Jazz System TM.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05366140
• Other study ID #: 73811
• Status: Recruiting
• Start date: February 3, 2022
• Est. completion date: September 2032

Study information

• Verified date: October 2023
• Source: University of Kentucky
• Contact: H F Farhadi, MD, PhD
• Phone: 859-562-0247
• Email: Francis.Farhadi[@]uky.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 2032
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Degenerative Disease
• Spinal Stenosis
• Spondylolisthesis

Intervention

Other:
• Prospective follow-up of patients who have received instrumented lumbar arthrodesis supplemented the Implanet Jazz System(TM)
To assess the clinical outcomes of patients receiving standard of care Implanet Jazz System(TM) at the time of their instrumented lumbar arthrodesis.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
H. Francis Farhadi	Implanet America, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical prospective review- Prospective Database study for future studies	Collecting clinical measurements. Examples of these clinical measurements are the VAS Pain Scale, SF-36, NDI, and ODI.	5- years