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NCT Number: NCT05366140

Thoracic-Lumbar Arthrodesis- Implanet Jazz

Establish a data repository of patients who have undergone single, two-, or three-level lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System.

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Key information

Conditions

Spondylolisthesis Back Pain Bone Diseases Degenerative Disease Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases Spinal Stenosis Spondylolysis Spondylosis

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location status: Recruiting

Location contact

H F Farhadi, MD, PhD

CONTACT

[email protected]

859-562-0247

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

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

Primary outcomes

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

    Time frame: 5- years

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

Study contacts

Contact information is provided by the study sponsor or research team.

H F Farhadi, MD, PhD

CONTACT

[email protected]

859-562-0247

Sponsors and collaborators

Lead sponsor

Francis Farhadi

Other

Collaborators

  • Implanet America, Inc.

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2028
First posted
May 9, 2022
Registry last updated
Oct 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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