Twin Cities Spine Center
Minneapolis, Minnesota, 55404, United States
NCT Number: NCT05691062
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Phase 4
Minneapolis, Minnesota, 55404, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Titanium fusion device will be utilized for one-level lumbar fusion.
PEEK fusion device will be utilized for one-level lumbar fusion.
Time frame: 12 months Post-Op
Assess fusion status of 1 level Lumbar TLIF by reviewing patient CT Scan completed for study purposes.
Time frame: Up to 24 months Post-op
Monitor and Record Complications and Revision Surgeries
Time frame: Preoperative time frame up to 24 months Post-op
Data collected from patient self reported outcome tools
Twin Cities Spine Center
Other
A Prospective, Randomized Comparison of Titanium vs. PEEK Fusion Devices in 1 Level TLIF
Acronym: TLIF
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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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