Spine FusionPhase 4TLIFNCT05691062
Titanium vs. PEEK Fusion Devices in 1 Level TLIF
A Phase 4 study testing Titanium Fusion Device and PEEK Fusion Device in people with Spine Fusion and Lumbar Spondylolisthesis, run by Twin Cities Spine Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spine Fusion, Lumbar Spondylolisthesis, Lumbar Stenosis
- What is being tested?
- Titanium Fusion Device and PEEK Fusion Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to 11 Jan 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Twin Cities Spine Center
Minneapolis, Minnesota, 55404
About this study
Official title: 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.
Read the 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.
- Conditions
- Spine Fusion, Lumbar Spondylolisthesis, Lumbar Stenosis
- Being tested
- Titanium Fusion Device, PEEK Fusion Device
- Medical subject headings
- Spondylolisthesis, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titanium Fusion DeviceDevice
Titanium fusion device will be utilized for one-level lumbar fusion.
PEEK Fusion DeviceDevice
PEEK fusion device will be utilized for one-level lumbar fusion.
| Study group | Role | What they receive |
|---|---|---|
| PEEK | Experimental | Medtronic Capstone Receives: Device: PEEK Fusion Device |
| Titanium | Experimental | Medtronic Adaptix Receives: Device: Titanium Fusion Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion Status of 1 level Lumbar TLIF
Assess fusion status of 1 level Lumbar TLIF by reviewing patient CT Scan completed for study purposes.
Measured: 12 months Post-Op
Revision Surgeries
Monitor and Record Complications and Revision Surgeries
Measured: Up to 24 months Post-op
Secondary outcomes (1)
Patient Reported Outcome Measures
Data collected from patient self reported outcome tools
Measured: Preoperative time frame up to 24 months Post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start1 Sep 2024
- Primary completion11 Jan 2027 (estimated)
- Study completion11 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Spine FusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized clinical trial with two cohorts.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Twin Cities Spine Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bayard Carlson, Twin Cities Spine Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691062
- Sponsor's protocol ID
- 1944564
- Acronym
- TLIF
- Status last verified
- Jun 2025
- First submitted
- 9 Jan 2023
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28963159Hasegawa 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.
PubMed 32675599Villavicencio 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.
PubMed 34116214Seaman 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.
PubMed 28736113Cuzzocrea 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.
PubMed 30536223Nemoto 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.
PubMed 25015180
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Comparison of Titanium vs. PEEK Fusion Devices in 1 Level TLIF
- ClinicalTrials.gov ID
- NCT05691062
- Acronym / sponsor ID
- TLIF / 1944564
- Conditions
- Spine Fusion, Lumbar Spondylolisthesis, Lumbar Stenosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Twin Cities Spine CenterUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 11 Jan 2027 (estimated)
- Study completion
- 11 Jan 2028 (estimated)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective randomized clinical trial with two cohorts.
| Arm | Type | Receives |
|---|---|---|
| PEEK | Experimental | Device: PEEK Fusion DeviceMedtronic Capstone |
| Titanium | Experimental | Device: Titanium Fusion DeviceMedtronic Adaptix |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Titanium Fusion DeviceTitanium fusion device will be utilized for one-level lumbar fusion. | Device | Titanium |
| PEEK Fusion DevicePEEK fusion device will be utilized for one-level lumbar fusion. | Device | PEEK |
Primary outcome
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.
Revision Surgeries
Time frame: Up to 24 months Post-op
Monitor and Record Complications and Revision Surgeries
1 secondary outcome
Patient Reported Outcome Measures
Time frame: Preoperative time frame up to 24 months Post-op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Background: PubMed 28963159Rickert 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.
- Background: PubMed 32675599Hasegawa 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.
- Background: PubMed 34116214Villavicencio 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.
- Background: PubMed 28736113Seaman 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.
- Background: PubMed 30536223Cuzzocrea 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.
- Background: PubMed 25015180Nemoto 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Titanium Fusion Device and PEEK Fusion Device in people with Spine Fusion and Lumbar Spondylolisthesis, run by Twin Cities Spine Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fusion Status of 1 level Lumbar TLIF (time frame: 12 months Post-Op). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05691062, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.