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Titanium vs. PEEK Fusion Devices in 1 Level TLIF — TLIF  

Spine Fusion Clinical Trial

Official title:
A Prospective, Randomized Comparison of Titanium vs. PEEK Fusion Devices in 1 Level TLIF

Clinical Trial Summary

The objective of this study is to evaluate and follow the clinical and radiographic outcomes of patients undergoing 1 level TLIF randomized to either a titanium or a PEEK spacer to 24 months after surgery.

Clinical Trial Description

Transforaminal lumbar interbody fusion (TLIF) remains a common surgical technique for the management of lumbar spondylosis requiring decompression and fusion. The choice of interbody spacer remains dependent on surgeon preference with a variety of options available for use. Two of the most commonly used interbody spacers are made of polyetheretherketone (PEEK) and titanium.1 While both spacers have produced reliable rates of fusion with good clinical outcomes, debate remains as to which interbody spacer is superior. Proponents of PEEK argue that it is radiolucent and has an elastic modulus similar to bone thus decreasing rates of subsidence. However, PEEK is a hydrophobic material that does not integrate with bone. Titanium on the other hand demonstrates osseointegration and may lead to increased rates of fusion.While there are retrospective studies available comparing the two materials, the studies are small and there is a paucity of prospective data comparing the radiographic and clinical outcomes of these spacers. Given the frequency with which these spacers are used, it is important to determine which spacer produces better clinical and radiographic outcomes for patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05691062
Study type Interventional
Source Twin Cities Spine Center
Contact John M Dawson, PhD
Phone 612-775-6200
Email jmdawson@tcspine.com
Status Not yet recruiting
Phase Phase 4
Start date June 1, 2023
Completion date January 11, 2028
View Details
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