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

The Ohio State University

Status: Terminated

Conditions: Degenerative Disease; Spondylolisthesis; Spinal Stenosis

Study type: Observational

Funder types: Other

Identifiers

NCT03434223

2016H0350

Details and patient eligibility

About

Establish a data repository of patients who have undergone single, two-, or three-level lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 60 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

3 participants in 1 patient group

Single Cohort