Titanium vs. PEEK Fusion Devices in 1 Level TLIF

Phase 4

Not yet recruiting

• Conditions: Spine Fusion; Lumbar Spondylolisthesis; Lumbar Stenosis
• Interventions: Device: Titanium Fusion Device; Device: PEEK Fusion Device

• Registration Number: NCT05691062
• Lead Sponsor: Twin Cities Spine Center

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.

Study Timeline

• Study First Submitted: 2023-01-09
• Study First Submitted QC: 2023-01-18
• Study First Posted: 2023-01-19
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-12
• Study Start: 2023-06-01
• Primary Completion: 2027-01-11
• Study Completion: 2028-01-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Titanium	Titanium Fusion Device	Medtronic Adaptix
PEEK	PEEK Fusion Device	Medtronic Capstone

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Patient Reported Outcome Measures	Preoperative time frame up to 24 months Post-op	Data collected from patient self reported outcome tools

Trial Locations

Locations (1)

Twin Cities Spine Center; 🇺🇸 Minneapolis, Minnesota, United States