Titanium vs. PEEK Fusion Devices in 1 Level TLIF (TLIF)

January 18, 2023 updated by: Bayard Carlson, Twin Cities Spine Center

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Twin Cities Spine Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months Post-Op
Revision Surgeries
Time Frame: Up to 24 months Post-op
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
Time Frame: Preoperative time frame up to 24 months Post-op
Data collected from patient self reported outcome tools
Preoperative time frame up to 24 months Post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Twin Cities Spine Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 11, 2023

Primary Completion (Anticipated)

January 11, 2027

Study Completion (Anticipated)

January 11, 2028

Study Registration Dates

First Submitted

January 9, 2023

First Submitted That Met QC Criteria

January 18, 2023

First Posted (Actual)

January 19, 2023

Study Record Updates

Last Update Posted (Actual)

January 19, 2023

Last Update Submitted That Met QC Criteria

January 18, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1944564

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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