A Phase 4 interventional study of Titanium Fusion Device and PEEK Fusion Device in Spine Fusion, Lumbar Spondylolisthesis and Lumbar Stenosis, sponsored by Twin Cities Spine Center. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-06-24.
Sponsored by Twin Cities Spine Center · Phase 4, Interventional, and Treatment
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.
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.
227 studies on the registry are indexed under Spondylolisthesis; 43 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 143 interventional studies indexed under Spondylolisthesis.
Browse Spondylolisthesis studies →Twin Cities Spine Center is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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Exclusion Criteria
Medtronic Capstone
Device: PEEK Fusion Device
Medtronic Adaptix
Device: Titanium Fusion Device
Titanium fusion device will be utilized for one-level lumbar fusion.
PEEK fusion device will be utilized for one-level lumbar fusion.
Fusion Status of 1 level Lumbar TLIF
Assess fusion status of 1 level Lumbar TLIF by reviewing patient CT Scan completed for study purposes.
Time frame: 12 months Post-Op
Revision Surgeries
Monitor and Record Complications and Revision Surgeries
Time frame: Up to 24 months Post-op
Patient Reported Outcome Measures
Data collected from patient self reported outcome tools
Time frame: Preoperative time frame up to 24 months Post-op
Plan to share: No
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Twin Cities Spine Center