Prospective Follow-up of Elderly Patients Undergoing Instrumented Lumbar Arthrodesis Supplemented by the Implanet Jazz System(TM)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Degenerative Disease
- Spinal Stenosis
- Spondylolisthesis
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 60 years and 99 years
- Gender
- Both males and females
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 participatin...
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.
Tracking Information
- NCT #
- NCT03434223
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: H. Francis Farhadi, MD, PhD The Ohio State University Wexner Medical Center