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Titanium vs. PEEK Fusion Devices in 1 Level TLIF

NCT05691062 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-06-24

No results posted yet for this study

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.

Conditions

  • Spine Fusion
  • Lumbar Spondylolisthesis
  • Lumbar Stenosis

Interventions

DEVICE

Titanium Fusion Device

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

DEVICE

PEEK Fusion Device

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

Sponsors & Collaborators

  • Twin Cities Spine Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2027-01-11
Completion
2028-01-11
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05691062 on ClinicalTrials.gov