Data collection for patients undergoing lumbar spinal fusion with Implanet Jazz System
Prospective Follow-up of Patients Undergoing Instrumented Thoracic and Lumbar Arthrodesis Supplemented by the Implanet Jazz System TM.
University of Kentucky · NCT05366140
This study is collecting information from patients who have had back surgery using the Implanet Jazz System to see how well the device works over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Kentucky (other) |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT05366140 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish a comprehensive data repository for patients who have undergone single, two-, or three-level lumbar instrumented arthrodesis procedures using the Implanet Jazz System. The study will collect clinical data at multiple time points post-surgery, including 6 weeks, 3, 6, 12, 24, 36, 48, and 60 months, to evaluate the outcomes and effectiveness of the device. The Implanet Jazz System is designed to provide temporary stabilization during the fusion process, enhancing the surgical approach for conditions like spondylolisthesis and spinal stenosis.
Who should consider this trial
Good fit: Ideal candidates for this study are male and female patients aged 18 and older who are qualified for hybrid thoracolumbar fixation with the Implanet Jazz System.
Not a fit: Patients under the age of 18 will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and recovery for patients undergoing lumbar spinal fusion.
How similar studies have performed: Other studies have shown promising results with similar spinal fusion approaches, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Lexington, Kentucky
- University of Kentucky — Lexington, Kentucky, United States (RECRUITING)
Study contacts
- Study coordinator: H F Farhadi, MD, PhD
- Email: Francis.Farhadi@uky.edu
- Phone: 859-562-0247
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spondylolisthesis, Spinal Stenosis, Degenerative Disease, Thoracic-Lumbar Arthrodesis, Spinal fusion, back pain