Titanium vs. PEEK Fusion Devices in 1 Level TLIF

Phase 4Enrolling By InvitationNCT05691062

Twin Cities Spine Center80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Spine Fusion Lumbar Spondylolisthesis Lumbar Stenosis

Interventions

Titanium Fusion DeviceDEVICE

Titanium fusion device will be utilized for one-level lumbar fusion.

PEEK Fusion DeviceDEVICE

PEEK fusion device will be utilized for one-level lumbar fusion.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria 1. Patients undergoing 1 level TLIF for the treatment of lumbar stenosis and spondylolisthesis who have failed at least 6 weeks of non-operative treatment. 2. Patients between 18-70 years of age at the time of surgery. Exclusion Criteria 1. Patients under 18 or over 70 years of age at the time of surgery. 2. Patients undergoing more than 1 level of surgery. 3. Patients who have had prior lumbar fusion. 4. Patients requiring surgery for the management of infection, tumor, or trauma. 5. Patients who are pregnant.

Locations (1)

Twin Cities Spine Center

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

Patient Reported Outcome Measures

Data collected from patient self reported outcome tools

Time frame: Preoperative time frame up to 24 months Post-op

Data from ClinicalTrials.gov

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