search
Back to results

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

Primary Purpose

Spine Fusion, Lumbar Spondylolisthesis, Lumbar Stenosis

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Titanium Fusion Device
PEEK Fusion Device
Sponsored by
Twin Cities Spine Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spine Fusion

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Twin Cities Spine Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PEEK

Titanium

Arm Description

Medtronic Capstone

Medtronic Adaptix

Outcomes

Primary Outcome Measures

Fusion Status of 1 level Lumbar TLIF
Assess fusion status of 1 level Lumbar TLIF by reviewing patient CT Scan completed for study purposes.
Revision Surgeries
Monitor and Record Complications and Revision Surgeries

Secondary Outcome Measures

Patient Reported Outcome Measures
Data collected from patient self reported outcome tools

Full Information

First Posted
January 9, 2023
Last Updated
April 10, 2023
Sponsor
Twin Cities Spine Center
search

1. Study Identification

Unique Protocol Identification Number
NCT05691062
Brief Title
Titanium vs. PEEK Fusion Devices in 1 Level TLIF
Acronym
TLIF
Official Title
A Prospective, Randomized Comparison of Titanium vs. PEEK Fusion Devices in 1 Level TLIF
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
January 11, 2027 (Anticipated)
Study Completion Date
January 11, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Twin Cities Spine Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spine Fusion, Lumbar Spondylolisthesis, Lumbar Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized clinical trial with two cohorts.
Masking
Participant
Masking Description
Subjects will be blinded to fusion device.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PEEK
Arm Type
Experimental
Arm Description
Medtronic Capstone
Arm Title
Titanium
Arm Type
Experimental
Arm Description
Medtronic Adaptix
Intervention Type
Device
Intervention Name(s)
Titanium Fusion Device
Intervention Description
Titanium fusion device will be utilized for one-level lumbar fusion.
Intervention Type
Device
Intervention Name(s)
PEEK Fusion Device
Intervention Description
PEEK fusion device will be utilized for one-level lumbar fusion.
Primary Outcome Measure Information:
Title
Fusion Status of 1 level Lumbar TLIF
Description
Assess fusion status of 1 level Lumbar TLIF by reviewing patient CT Scan completed for study purposes.
Time Frame
12 months Post-Op
Title
Revision Surgeries
Description
Monitor and Record Complications and Revision Surgeries
Time Frame
Up to 24 months Post-op
Secondary Outcome Measure Information:
Title
Patient Reported Outcome Measures
Description
Data collected from patient self reported outcome tools
Time Frame
Preoperative time frame up to 24 months Post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John M Dawson, PhD
Phone
612-775-6200
Email
jmdawson@tcspine.com
First Name & Middle Initial & Last Name or Official Title & Degree
Berit A Swanberg, BA
Phone
612-775-6200
Ext
6182
Email
baswanberg@tcspine.com
Facility Information:
Facility Name
Twin Cities Spine Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28963159
Citation
Rickert M, Fleege C, Tarhan T, Schreiner S, Makowski MR, Rauschmann M, Arabmotlagh M. Transforaminal lumbar interbody fusion using polyetheretherketone oblique cages with and without a titanium coating: a randomised clinical pilot study. Bone Joint J. 2017 Oct;99-B(10):1366-1372. doi: 10.1302/0301-620X.99B10.BJJ-2016-1292.R2.
Results Reference
background
PubMed Identifier
32675599
Citation
Hasegawa T, Ushirozako H, Shigeto E, Ohba T, Oba H, Mukaiyama K, Shimizu S, Yamato Y, Ide K, Shibata Y, Ojima T, Takahashi J, Haro H, Matsuyama Y. The Titanium-coated PEEK Cage Maintains Better Bone Fusion With the Endplate Than the PEEK Cage 6 Months After PLIF Surgery: A Multicenter, Prospective, Randomized Study. Spine (Phila Pa 1976). 2020 Aug 1;45(15):E892-E902. doi: 10.1097/BRS.0000000000003464.
Results Reference
background
PubMed Identifier
34116214
Citation
Villavicencio AT, Nelson EL, Rajpal S, Beasley K, Burneikiene S. Prospective, randomized, double-blinded clinical trial comparing PEEK and allograft spacers in patients undergoing transforaminal lumbar interbody fusion surgeries. Spine J. 2022 Jan;22(1):84-94. doi: 10.1016/j.spinee.2021.06.005. Epub 2021 Jun 8.
Results Reference
background
PubMed Identifier
28736113
Citation
Seaman S, Kerezoudis P, Bydon M, Torner JC, Hitchon PW. Titanium vs. polyetheretherketone (PEEK) interbody fusion: Meta-analysis and review of the literature. J Clin Neurosci. 2017 Oct;44:23-29. doi: 10.1016/j.jocn.2017.06.062. Epub 2017 Jul 21.
Results Reference
background
PubMed Identifier
30536223
Citation
Cuzzocrea F, Ivone A, Jannelli E, Fioruzzi A, Ferranti E, Vanelli R, Benazzo F. PEEK versus metal cages in posterior lumbar interbody fusion: a clinical and radiological comparative study. Musculoskelet Surg. 2019 Dec;103(3):237-241. doi: 10.1007/s12306-018-0580-6. Epub 2018 Dec 10.
Results Reference
background
PubMed Identifier
25015180
Citation
Nemoto O, Asazuma T, Yato Y, Imabayashi H, Yasuoka H, Fujikawa A. Comparison of fusion rates following transforaminal lumbar interbody fusion using polyetheretherketone cages or titanium cages with transpedicular instrumentation. Eur Spine J. 2014 Oct;23(10):2150-5. doi: 10.1007/s00586-014-3466-9. Epub 2014 Jul 12.
Results Reference
background

Learn more about this trial

Titanium vs. PEEK Fusion Devices in 1 Level TLIF

We'll reach out to this number within 24 hrs