NCT03434223

Prospective Follow-up of Elderly Patients Undergoing Instrumented Lumbar Arthrodesis Supplemented by the Implanet Jazz System(TM)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 3 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 60 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spondylolisthesis
• Spinal Stenosis
• Degenerative Disease

Timeline

• Start date: 2016-12-29
• Primary completion: 2019-06-06
• Completion: 2019-06-06
• First posted: 2018-02-15
• Last updated: 2021-09-10

Locations

1 site across 1 country: United States