Thoracic-Lumbar Arthrodesis- Implanet Jazz
Purpose
Establish a data repository of patients who have undergone single, two-, or three-level lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System.
Conditions
- Spondylolisthesis
- Spinal Stenosis
- Degenerative Disease
Eligibility
- Eligible Ages
- Between 18 Years and 100 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Recruiting Locations
UK Center for Clinical and Translational Science and nearby locations
Lexington, Kentucky 40536
More Details
- NCT ID
- NCT05366140
- Status
- Recruiting
- Sponsor
- H. Francis Farhadi
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.