Evaluating outcomes of a 3D printed implant for spinal fusion
Clinical and Radiographic Outcomes of Transforaminal Lumbar Interbody Fusion (TLIF) With a Novel 3D Printed Cellular Titanium Implant
This study is testing a new 3D printed titanium implant for spinal fusion in patients with lumbar spine issues who haven't found relief from other treatments to see how well it works.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 35 Years to 80 Years |
| Sex | All |
| Sponsor | Hartford Hospital Academic / other |
| Locations | 1 site (Hartford, Connecticut) |
| Trial ID | NCT05023733 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the clinical outcomes and spine fusion rates in patients undergoing transforaminal lumbar interbody fusion (TLIF) using a 3D printed titanium implant. It will recruit patients with lumbar spinal conditions who have not responded to conservative treatments. Participants will be monitored at six-month intervals for two years to evaluate patient-reported outcomes, clinical results, and radiographic parameters, particularly focusing on fusion rates. The study is a post-market evaluation of the CONDUIT 3D printed titanium TLIF cage.
Who should consider this trial
Good fit: Ideal candidates are adults aged 35 to 80 with degenerative disc disease and foraminal stenosis who require lumbar fusion surgery.
Not a fit: Patients over 80 years old, current smokers, or those with significant spinal deformities will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and recovery for patients with lumbar spinal conditions.
How similar studies have performed: Other studies have shown promising results with similar 3D printed implants, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Skeletally mature adults ages 35 - 80 years of age, inclusive * Diagnosis of lumbar degenerative disc disease with or without neurologic deficit and associated central and/or unilateral/bilateral foraminal stenosis * Subject undergoing one or two level transforaminal lumbar interbody fusion * Able to read and understand all documents used in this study , including the informed consent and patient-reported outcome questionnaires Exclusion Criteria: * Patients over 80 years of age * Patients under 35 years of age * Current smokers * BMI\>42 * Subject has spondylolisthesis \> 2 * Subjects with multilevel \>2 levels of symptomatic disease * Subjects with significant spinal deformity * Subject is pregnant, plans to become pregnant or is breast feeding
Where this trial is running
Hartford, Connecticut
- Hartford Healthcare Bone and Joint Institute — Hartford, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Farhan Karim, DO — Hartford Hospital; Hartford Healthcare Bone & Joint Institute
- Study coordinator: Bethany Samperi
- Email: bethany.samperi@hhchealth.org
- Phone: 860-972-5978
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.