Titanium vs. PEEK Fusion Devices in 1 Level TLIF

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Spine Fusion, Lumbar Spondylolisthesis, Lumbar Stenosis

Intervention / Treatment
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* Device: Titanium Fusion Device
* Device: PEEK Fusion Device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized clinical trial with two cohorts.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEEK<br>Medtronic Capstone | Device: PEEK Fusion Device<br>* PEEK fusion device will be utilized for one-level lumbar fusion.<br>|
| Experimental: Titanium<br>Medtronic Adaptix | Device: Titanium Fusion Device<br>* Titanium fusion device will be utilized for one-level lumbar fusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion Status of 1 level Lumbar TLIF | Assess fusion status of 1 level Lumbar TLIF by reviewing patient CT Scan completed for study purposes. | 12 months Post-Op | 
| Revision Surgeries | Monitor and Record Complications and Revision Surgeries | Up to 24 months Post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Outcome Measures | Data collected from patient self reported outcome tools | Preoperative time frame up to 24 months Post-op |