Evaluating outcomes of a 3D printed implant for spinal fusion

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.