ClinicalTrials.gg
RecruitingNCT05366140Updated Nov 3, 2026

Thoracic-Lumbar Arthrodesis- Implanet Jazz

An observational study in Spondylolisthesis, Spinal Stenosis and Degenerative Disease, sponsored by Francis Farhadi. Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Francis Farhadi · Observational

From the registry’s dates

  • Started Feb 2022; still recruiting 4 years 9 months later.
Updated Nov 3, 2026Primary completion movedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 100 Years
Sex
All
01

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' patients 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.

02

Conditions studied

  • Spondylolisthesis
  • Spinal Stenosis
  • Degenerative Disease

Keywords

  • Thoracic-Lumbar Arthrodesis
  • Spinal fusion
  • back pain
03

In context

Spondylolisthesis

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

This study's planned enrollment of 300 is above the median of 108 across 79 observational studies indexed under Spondylolisthesis.

Browse Spondylolisthesis studies →

Lead sponsor

Francis Farhadi is the lead sponsor of 9 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult men and women of any/all ethnic groups who are appropriate candidates for hybrid thoracolumbar fixation and will receive the Implanet Jazz System (TM) during their arthrodesis surgery.

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

  • Male and female patients, 18 years of age and older
  • Qualified candidate for hybrid thoracolumbar fixation with the Implanet Jazz System TM during arthrodesis surgery.

Exclusion criteria

Exclusion Criteria:

  • Individuals who have not yet reached the age of 18.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Interventions

  • OtherProspective follow-up of patients who have received instrumented lumbar arthrodesis supplemented the Implanet Jazz System(TM)

    To assess the clinical outcomes of patients receiving standard of care Implanet Jazz System(TM) at the time of their instrumented lumbar arthrodesis.

06

What researchers measure

Primary outcomes

  1. clinical prospective review- Prospective Database study for future studies

    Collecting clinical measurements. Examples of these clinical measurements are the VAS Pain Scale, SF-36, NDI, and ODI.

    Time frame: 5- years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Sep 2026→Jun 2028
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    Primary completion Sep 2026→Jun 2028
    + 2 other changes: verification date and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05366140
Lead sponsor
Francis Farhadi
Collaborators
Implanet America, Inc.
Responsible party
Francis Farhadi (Associate Professor, University of Kentucky) — Sponsor-investigator
First posted
May 9, 2022
Start date
Feb 3, 2022
Primary completion
Jun 2028 (estimated)
Completion
Sep 2028 (estimated)
Last update
Nov 3, 2026

Study contacts

H F Farhadi, MD, PhD
Contact
Francis.Farhadi@uky.edu
859-562-0247

Oversight

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

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