Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Research has been discontinued - there will be no further data collection or analysis
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Establish a data repository of patients who have undergone single, two-, or three-level lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Cohort |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who have undergone lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System | 60 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients who are candidates for single, two- or three-level spinal arthrodesis surgery supplemented by the Implanet Jazz System
Not provided
| Name | Affiliation | Role |
|---|---|---|
| H. Francis Farhadi, MD, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013168 | Spondylolisthesis |
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013169 | Spondylolysis |
| D055009 | Spondylosis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| D009140 |
| Musculoskeletal Diseases |