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

Sponsor
Ohio State University (Other)
Overall Status
Terminated
CT.gov ID
NCT03434223
Collaborator
(none)
3
Enrollment
1
Location
29.2
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    3 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Follow-up of Elderly Patients Undergoing Instrumented Lumbar Arthrodesis Supplemented by the Implanet Jazz System(TM)
    Actual Study Start Date :
    Dec 29, 2016
    Actual Primary Completion Date :
    Jun 6, 2019
    Actual Study Completion Date :
    Jun 6, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Single Cohort

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients who have undergone lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System [60 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Ohio State University Wexner Medical Center Columbus Ohio United States 43210

    Sponsors and Collaborators

    • Ohio State University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    H Francis Farhadi, MD, PhD, Assistant Professor, Ohio State University
    ClinicalTrials.gov Identifier:
    NCT03434223
    Other Study ID Numbers:
    • 2016H0350
    First Posted:
    Feb 15, 2018
    Last Update Posted:
    Sep 10, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Spinal Stenosis
    Spondylolisthesis

    Study Results

    No Results Posted as of Sep 10, 2021