Lumbar Fusion With Porous Versus Non-Porous Cages (NCT05583864) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Lumbar Fusion With Porous Versus Non-Porous Cages
United States108 participantsStarted 2022-11-01
Plain-language summary
The objective of this single site, randomized controlled trial is to assess and compare radiographic and clinical outcomes in patients who are to undergo lumbar interbody fusion procedures (TLIF), supplemented with pedicle screw instrumentation, using one of the following interventions:
1. Porous titanium cages
2. Non-porous titanium-coated poly-ether-ether-ketone (PEEK) cages.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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.
✓. They are over the age of 18 years old.
✓. They have been unresponsive to conservative care for a minimum of 6 months.
✓. 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
✕. They have had previous lumbar arthrodesis surgery.
✕. They require additional bone grafting materials other than local autograft bone.
✕. There is inadequate tissue coverage over the operative site.
✕. There is an open wound local to the operative area, or rapid joint disease, bone absorption, or osteoporosis.
✕. Subject has a condition requiring medications that may interfere with bone or soft tissue healing(i.e., oral or parenteral glucocorticoids, immunosuppressives, methotrexate, etc.).
✕. Subject has an active local or systemic infection.