Lumbar Fusion With Porous Versus Non-Porous Cages

Launched by UNIVERSITY OF KENTUCKY · Oct 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two types of cages used in spinal fusion surgery, which is a procedure to help stabilize the spine. The goal is to compare the results of surgeries that use porous titanium cages versus non-porous titanium-coated PEEK cages. Both types of cages are designed to support the spine during healing, but the researchers want to see if one type works better than the other in helping patients recover and get back to their daily activities.

To be eligible for this trial, participants need to be at least 18 years old and have not found relief from their back pain through other treatments for at least six months. They should be scheduled for specific spinal surgery and able to follow the study's requirements, like attending follow-up visits. However, there are certain conditions that may exclude someone from participating, such as previous spinal surgeries, certain medical issues, or if they are currently pregnant. Those who join the trial will have their recovery monitored closely, and they’ll help researchers learn more about which type of cage might lead to better outcomes for future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Patients will be considered for inclusion if:
• • 1. They are scheduled to undergo combined interbody and posterolateral spinal fusion surgery using either the DePuy Synthes CONDUIT™ porous titanium cage or the DePuy Synthes PROTI 360º™ non-porous titanium-coated PEEK cage in conjunction with local autograft bone, and supplementation with a pedicle screw system.
• • 2. They are over the age of 18 years old.
• • 3. They have been unresponsive to conservative care for a minimum of 6 months.
• • 4. They are in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.
• Exclusion Criteria:
• Certain comorbidities and medical statuses may render patients ineligible for surgery, or put them at an increased risk for complications or injury by participating in the study. Therefore, patients will be excluded from enrollment if:
• • 1. They have had previous lumbar arthrodesis surgery.
• • 2. They require additional bone grafting materials other than local autograft bone.
• • 3. There is inadequate tissue coverage over the operative site.
• • 4. There is an open wound local to the operative area, or rapid joint disease, bone absorption, or osteoporosis.
• • 5. Subject has a condition requiring medications that may interfere with bone or soft tissue healing(i.e., oral or parenteral glucocorticoids, immunosuppressives, methotrexate, etc.).
• • 6. Subject has an active local or systemic infection.
• • 7. Subject has a metal sensitivity/foreign body sensitivity (cages will be implanted).
• • 8. Subject is morbidly obese, defined as a body mass index (BMI) greater than 40.
• • 9. Subject has any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study.
• • 10. Subject is currently involved in another investigational drug or device study that could confound study data.
• • 11. There is a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up.
• • 12. Subjects who are pregnant or plan to become pregnant in the next 12 months or who are lactating. This restriction is due to the inherent risk radiography presents to an embryo or fetus and is considered standard of care.
• • 13. Subject is involved in or planning to engage in litigation or receiving Worker's Compensation related to neck or back pain. Participation may effect the assessments made by case workers and legal teams.
• • 14. Subject is a prisoner.