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Thoracic-Lumbar Arthrodesis- Implanet Jazz

Prospective Follow-up of Patients Undergoing Instrumented Thoracic and Lumbar Arthrodesis Supplemented by the Implanet Jazz System TM.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05366140
Enrollment
300
Registered
2022-05-09
Start date
2022-02-03
Completion date
2028-09-30
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Disease, Spinal Stenosis, Spondylolisthesis

Keywords

Thoracic-Lumbar Arthrodesis, Spinal fusion, back pain

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.

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.

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.

Sponsors

Implanet America, Inc.
CollaboratorUNKNOWN
Francis Farhadi
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

* Individuals who have not yet reached the age of 18.

Design outcomes

Primary

MeasureTime frameDescription
clinical prospective review- Prospective Database study for future studies5- yearsCollecting clinical measurements. Examples of these clinical measurements are the VAS Pain Scale, SF-36, NDI, and ODI.

Countries

United States

Contacts

Primary ContactH F Farhadi, MD, PhD
Francis.Farhadi@uky.edu859-562-0247

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026