SpondylolisthesisNCT05366140
Thoracic-Lumbar Arthrodesis- Implanet Jazz
An observational study of Spondylolisthesis and Spinal Stenosis, run by Francis Farhadi at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Spondylolisthesis, Spinal Stenosis, Degenerative Disease
- What is being tested?
- Prospective follow-up of patients who have received instrumented lumbar arthrodesis supplemented the Implanet Jazz System(TM)
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2022to Sep 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Individuals who have not yet reached the age of 18.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40536
H F Farhadi, MD, PhD, 859-562-0247, Francis.Farhadi@uky.edu
About this study
Official title: Prospective Follow-up of Patients Undergoing Instrumented Thoracic and Lumbar Arthrodesis Supplemented by the Implanet Jazz System TM.
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.
- Conditions
- Spondylolisthesis, Spinal Stenosis, Degenerative Disease
- Being tested
- Prospective follow-up of patients who have received instrumented lumbar arthrodesis supplemented the Implanet Jazz System(TM)
- Keywords
- Thoracic-Lumbar Arthrodesis, Spinal fusion, back pain
- Medical subject headings
- Spondylolisthesis, Spinal Stenosis, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5- years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start3 Feb 2022
- Primary completionSep 2026 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondylolisthesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Francis Farhadi
- Sponsor type
- University, hospital or other
- Collaborators
- Implanet America, Inc.
- Responsible party
- Sponsor-investigator, Francis Farhadi, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366140
- Sponsor's protocol ID
- 73811
- Status last verified
- Oct 2025
- First submitted
- 4 May 2022
- Last updated
- 27 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Follow-up of Patients Undergoing Instrumented Thoracic and Lumbar Arthrodesis Supplemented by the Implanet Jazz System TM.
- ClinicalTrials.gov ID
- NCT05366140
- Acronym / sponsor ID
- 73811
- Conditions
- Spondylolisthesis, Spinal Stenosis, Degenerative Disease
- Keywords
- Thoracic-Lumbar Arthrodesis, Spinal fusion, back pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Francis FarhadiUniversity, hospital or other
- Collaborators
- Implanet America, Inc.
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Individuals who have not yet reached the age of 18.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospective 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. | Other | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spondylolisthesis and Spinal Stenosis, run by Francis Farhadi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact H F Farhadi, MD, PhD (859-562-0247, Francis.Farhadi@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical prospective review- Prospective Database study for future studies (time frame: 5- years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025; AzTrials last refreshed its copy on 30 Oct 2026.