ClinicalTrials.gg
TerminatedNCT03434223Updated Sep 10, 2021

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

An observational study in Spondylolisthesis, Spinal Stenosis and Degenerative Disease, sponsored by Ohio State University. Terminated at 1 site in United States. Open to participants aged 60 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-09-10.

Sponsored by Ohio State University · Observational

Why this study was terminated
Research has been discontinued - there will be no further data collection or analysis
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3
Ages
60 Years to 99 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 102 studies in Spondylolisthesis with a site in United States — 14 open to participants now, 19 under way, none of them phase 3. Spondylolisthesis · United States.

Enrollment
35th of 38
3 · median 114
Started
2016
with 8 others
Observational
38 of 102
6 open now
Registered
58th of 102
by date
Lead sponsor
5 of 102
Ohio State University

Among the 102 studies in Spondylolisthesis with a site in United States, this one is the 35th largest by enrollment of the 38 observational ones that give a count, is one of 9 that started in 2016, is one of 38 observational ones, and was the 58th registered.

Spondylolisthesis

227 studies on the registry are indexed under Spondylolisthesis; 43 are open to participants now.

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Open to participants now

14 of the 102 studies in Spondylolisthesis with a site in United States are open now. Recruiting first, the newest first:

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All 14 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 27 Spondylolisthesis studies recruiting now, 11 (41%) set no upper age limit and 8 (30%) stop at 75 or younger; 7 take children under 18; 3 take healthy volunteers.

This study: 60 Years to 99 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Spondylolisthesis
  • Spinal Stenosis
  • Degenerative Disease
04

Who can participate

Ages eligible
60 Years to 99 Years
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients under the age of 60 years old are excluded.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3 participants (actual)
Target follow-up
60 Months
Patient registry
Yes

Groups and cohorts

  • Single Cohort
06

What researchers measure

Primary outcomes

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

    Time frame: 60 months

07

Study locations

1 site
  • The Ohio State University Wexner Medical Center
    Columbus, Ohio 43210, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2016 to primary completion in Jun 2019, 29 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 9, 2018
First posted
Feb 15, 2018
StartActual
Dec 29, 2016
Primary completionActual
Jun 6, 2019
CompletionActual
Jun 6, 2019
Last update
Sep 10, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03434223
Responsible party
H Francis Farhadi, MD, PhD (Assistant Professor, Ohio State University) — Principal investigator
First posted
Feb 15, 2018
Start date
Dec 29, 2016
Primary completion
Jun 6, 2019
Completion
Jun 6, 2019
Last update
Sep 10, 2021

Study contacts

H. Francis Farhadi, MD, PhD
principal investigator · The Ohio State University Wexner Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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