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NCT03434223 Clinical Trial

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

Spinal Stenosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03434223
Other study ID # 2016H0350
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date December 29, 2016
Est. completion date June 6, 2019

Study information
Verified date September 2021
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 3
Est. completion date June 6, 2019
Est. primary completion date June 6, 2019
Accepts healthy volunteers No
Gender All
Age group 60 Years to 99 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States The Ohio State University Wexner Medical Center Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients who have undergone lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System 60 months
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