Titanium vs. PEEK Fusion Devices in 1 Level TLIF

NCT05691062 | Enrolling By Invitation Phase 4 FDA Device

• 1 other identifier: 1944564
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Spine Fusion; Lumbar Spondylolisthesis; Lumbar Stenosis

Outcome Measures

Primary Outcomes (2)

• Fusion Status of 1 level Lumbar TLIF

  Assess fusion status of 1 level Lumbar TLIF by reviewing patient CT Scan completed for study purposes.

  12 months Post-Op

• Revision Surgeries

  Monitor and Record Complications and Revision Surgeries

  Up to 24 months Post-op

Secondary Outcomes (1)

• Patient Reported Outcome Measures

  Preoperative time frame up to 24 months Post-op

Study Arms (2)

PEEK

EXPERIMENTAL

Medtronic Capstone

Device: PEEK Fusion Device

Titanium

EXPERIMENTAL

Medtronic Adaptix

Device: Titanium Fusion Device

Interventions

Titanium Fusion Device DEVICE

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

Titanium

PEEK Fusion Device DEVICE

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

PEEK

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Twin Cities Spine Center: lead

Study Sites (1)

Twin Cities Spine Center

Minneapolis, Minnesota, 55404, United States

Location

Related Publications (6)

• 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.

  PMID: 28963159 BACKGROUND

• 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.

  PMID: 32675599 BACKGROUND

• 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.

  PMID: 34116214 BACKGROUND

• 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.

  PMID: 28736113 BACKGROUND

• 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.

  PMID: 30536223 BACKGROUND

• 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.

  PMID: 25015180 BACKGROUND

MeSH Terms

Conditions

Spondylolisthesis; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will be blinded to fusion device.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Surgeon

Model Details: Prospective randomized clinical trial with two cohorts.

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 19, 2023
• Study Start: September 1, 2024
• Primary Completion (Estimated): January 11, 2027
• Study Completion (Estimated): January 11, 2028
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)