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

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ClinicalTrials.gov Identifier: NCT03434223
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
H Francis Farhadi, MD, PhD, Ohio State University

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
Spondylolisthesis Spinal Stenosis 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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 60 Months
Official Title: Prospective Follow-up of Elderly Patients Undergoing Instrumented Lumbar Arthrodesis Supplemented by the Implanet Jazz System(TM)
Actual Study Start Date : December 29, 2016
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Group/Cohort
Single Cohort



Primary Outcome Measures :
  1. Number of patients who have undergone lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System [ Time Frame: 60 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434223


Contacts
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Contact: Amy J Minnema, BS (614)685-9827 amy.minnema@osumc.edu

Locations
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United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Amy J Minnema, BS    614-685-9827    amy.minnema@osumc.edu   
Principal Investigator: H. Francis Farhadi, MD, PhD         
Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: H. Francis Farhadi, MD, PhD The Ohio State University Wexner Medical Center

Additional Information:

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Responsible Party: H Francis Farhadi, MD, PhD, Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT03434223     History of Changes
Other Study ID Numbers: 2016H0350
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Stenosis
Spondylolisthesis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis