Degenerative Disease, Spinal Stenosis, Spondylolisthesis
Conditions
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' elderly patients (aged ≥ 60 years) 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
None listed
Sponsors
Ohio State University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients who are candidates for single, two- or three-level spinal arthrodesis surgery supplemented by the Implanet Jazz System * Patients at least 60 years of age.
Exclusion criteria
* Patients under the age of 60 years old are excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients who have undergone lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System | 60 months |
Countries
United States
Outcome results
None listed