Thoracic-Lumbar Arthrodesis- Implanet Jazz

Recruiting

• Conditions: Spondylolisthesis; Spinal Stenosis; Degenerative Disease

• Registration Number: NCT05366140
• Lead Sponsor: Francis Farhadi

Brief 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.

Study Timeline

• Study Start: 2022-02-03
• Study First Submitted: 2022-05-04
• Study First Submitted QC: 2022-05-04
• Study First Posted: 2022-05-09
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-09
• Primary Completion: 2025-09
• Study Completion: 2032-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
clinical prospective review- Prospective Database study for future studies	5- years	Collecting clinical measurements. Examples of these clinical measurements are the VAS Pain Scale, SF-36, NDI, and ODI.

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States