Thoracic-Lumbar Arthrodesis- Implanet Jazz
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prospective follow-up of patients who have received instrumented lumbar arthrodesis supplemented the Implanet Jazz System(TM).
- Who it may be relevant to
- Registry conditions: Spondylolisthesis, Spinal Stenosis, Degenerative Disease. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Follow-up of Patients Undergoing Instrumented Thoracic and Lumbar Arthrodesis Supplemented by the Implanet Jazz System TM.
Overview
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.
Interventions
- 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.
Primary outcome measures
- clinical prospective review- Prospective Database study for future studies [Time frame: 5- years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Kentucky — Lexington
Identifiers
NCT: NCT05366140 · 73811