NCT05366140

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
28mo left

Started Feb 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Feb 2022Sep 2028

Study Start

First participant enrolled

February 3, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 9, 2022

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

October 27, 2025

Status Verified

October 1, 2025

Enrollment Period

4.6 years

First QC Date

May 4, 2022

Last Update Submit

October 23, 2025

Conditions

SpondylolisthesisSpinal StenosisDegenerative Disease

Keywords

Thoracic-Lumbar ArthrodesisSpinal fusionback pain

Outcome Measures

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.

    5- years

Interventions

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.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

RECRUITING

MeSH Terms

Conditions

SpondylolisthesisSpinal StenosisBack Pain

Condition Hierarchy (Ancestors)

SpondylolysisSpondylosisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

H F Farhadi, MD, PhD

CONTACT

859-562-0247Francis.Farhadi@uky.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 4, 2022

First Posted

May 9, 2022

Study Start

February 3, 2022

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2028

Last Updated

October 27, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)