Recruitment

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