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OpenTrials
Enrolling by Invitation

NCT Number: NCT05691062

Titanium vs. PEEK Fusion Devices in 1 Level TLIF

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.

Enrolling by Invitation

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Twin Cities Spine Center

Minneapolis, Minnesota, 55404, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing 1 level TLIF for the treatment of lumbar stenosis and spondylolisthesis who have failed at least 6 weeks of non-operative treatment.
  • Patients between 18-70 years of age at the time of surgery.

Exclusion criteria

  • Patients under 18 or over 70 years of age at the time of surgery.
  • Patients undergoing more than 1 level of surgery.
  • Patients who have had prior lumbar fusion.
  • Patients requiring surgery for the management of infection, tumor, or trauma.
  • Patients who are pregnant.

Treatment and study plan

Titanium Fusion Device

Device

Titanium fusion device will be utilized for one-level lumbar fusion.

PEEK Fusion Device

Device

PEEK fusion device will be utilized for one-level lumbar fusion.

Primary outcomes

  1. Fusion Status of 1 level Lumbar TLIF

    Time frame: 12 months Post-Op

    Assess fusion status of 1 level Lumbar TLIF by reviewing patient CT Scan completed for study purposes.

  2. Revision Surgeries

    Time frame: Up to 24 months Post-op

    Monitor and Record Complications and Revision Surgeries

Secondary outcomes

  1. Patient Reported Outcome Measures

    Time frame: Preoperative time frame up to 24 months Post-op

    Data collected from patient self reported outcome tools

Sponsors and collaborators

Lead sponsor

Twin Cities Spine Center

Other

Registry information

Official study title

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

Acronym: TLIF

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jan 19, 2023
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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