Clinical and Radiographic Outcomes of TLIF w/3D Printed Cellular Implant

Launched by FARHAN KARIM · Aug 23, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a surgical procedure called transforaminal lumbar interbody fusion (TLIF) using a specially designed 3D printed titanium implant. The goal is to see how well this new implant helps patients with conditions like lower back pain due to degenerative disc disease, foraminal stenosis (narrowing of the spaces in the spine), and other related issues. Researchers want to find out how effective the surgery is in relieving pain and improving the spine's ability to heal after the procedure.

To participate in this trial, you must be an adult aged between 35 and 80 years with specific back problems that require surgery at one or two levels in your lower back. Before joining, you'll need to read and understand the study details and questionnaires. If you’re eligible, you can expect to undergo the surgery and be monitored for your recovery and spine healing over time. It's an opportunity to receive a cutting-edge treatment while contributing to valuable research in spinal health.

Gender

ALL

Eligibility 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