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

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

Study Overview

• Status: Terminated
• Conditions: Spinal Stenosis; Spondylolisthesis; Degenerative Disease

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.

• Study Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who are candidates for single, two- or three-level spinal arthrodesis surgery supplemented by the Implanet Jazz System

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Single Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients who have undergone lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System	60 months

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: H. Francis Farhadi, MD, PhD, The Ohio State University Wexner Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2016
• Primary Completion (Actual): June 6, 2019
• Study Completion (Actual): June 6, 2019

Study Registration Dates

• First Submitted: February 9, 2018
• First Submitted That Met QC Criteria: February 9, 2018
• First Posted (Actual): February 15, 2018

Study Record Updates

• Last Update Posted (Actual): September 10, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Spinal Stenosis; Spondylolisthesis
• Other Study ID Numbers: 2016H0350

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No