NCT05691062

Titanium vs. PEEK Fusion Devices in 1 Level TLIF

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

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Twin Cities Spine Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Spine Fusion
• Lumbar Spondylolisthesis
• Lumbar Stenosis

Interventions

Type	Name	Description
DEVICE	Titanium Fusion Device	Titanium fusion device will be utilized for one-level lumbar fusion.
DEVICE	PEEK Fusion Device	PEEK fusion device will be utilized for one-level lumbar fusion.

Timeline

• Start date: 2024-09-01
• Primary completion: 2027-01-11
• Completion: 2028-01-11
• First posted: 2023-01-19
• Last updated: 2025-06-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study