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