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Clinical Trials/NCT05691062
NCT05691062
Enrolling by Invitation
Phase 4

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

Twin Cities Spine Center1 site in 1 country80 target enrollmentSeptember 1, 2024

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Spine Fusion
Sponsor
Twin Cities Spine Center
Enrollment
80
Locations
1
Primary Endpoint
Revision Surgeries
Status
Enrolling by Invitation
Last Updated
10 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
September 1, 2024
End Date
January 11, 2028
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Twin Cities Spine Center
Responsible Party
Principal Investigator
Principal Investigator

Bayard Carlson

Staff Surgeon

Twin Cities Spine Center

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Revision Surgeries

Time Frame: Up to 24 months Post-op

Monitor and Record Complications and Revision Surgeries

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.

Secondary Outcomes

  • Patient Reported Outcome Measures(Preoperative time frame up to 24 months Post-op)

Study Sites (1)

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