Titanium vs. PEEK Devices for Spinal Fusion

(TLIF Trial)

Overseen By Berit A Swanberg, BA

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Twin Cities Spine Center

Disqualifiers: Age under 18, Over 70, Prior lumbar fusion, Infection, Tumor, Trauma, Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the PEEK and Titanium Fusion Devices for spinal fusion treatment?

Research shows that PEEK devices have advantages like being more similar to bone and causing fewer imaging issues, while titanium-coated PEEK devices may lead to better early fusion rates and pain reduction. Both materials have been used successfully in spinal surgeries with low rejection rates. ^{1 2 3 4 5}

Is it safe to use Titanium and PEEK devices for spinal fusion in humans?

Titanium and PEEK implants have been used in spinal surgery with low rejection rates, indicating they are generally safe for human use. ^{1 2 3 4 6}

How do PEEK and Titanium devices for spinal fusion differ from other treatments?

PEEK devices are unique because they have a density similar to bone, are radiolucent (allowing X-rays to pass through), and do not cause artifacts in CT and MRI scans, unlike titanium. Titanium devices, while strong, can be too stiff, potentially leading to stress shielding, whereas PEEK offers a more flexible alternative that may reduce this risk. ^{1 2 7 8 9}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults aged 18-70 who need a single-level spinal fusion (TLIF) to treat lumbar stenosis and spondylolisthesis, after not improving with at least 6 weeks of non-surgical care. It's not open to those who've had previous lumbar fusions, are pregnant, or need surgery due to infection, tumors, or trauma.

Inclusion Criteria

I have lower back issues not improved after 6 weeks of non-surgery treatments.

Exclusion Criteria

I am having surgery that involves more than one part of my body.

Pregnant patients

I need surgery for an infection, cancer, or injury.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Recovery

Participants undergo 1 level TLIF surgery with either a titanium or PEEK spacer

Immediate post-op period

Follow-up

Participants are monitored for safety and effectiveness, including fusion status and complications

24 months

Regular follow-up visits, including CT scans and patient-reported outcomes

Treatment Details

Interventions

• PEEK Fusion Device
• Titanium Fusion Device

Trial Overview The study compares two types of spacers used in spinal fusion surgery: one made of titanium and the other made from PEEK material. Patients will be randomly assigned to receive either device and monitored for clinical and radiographic outcomes up to 24 months post-surgery.

Participant Groups

Group I: Titanium Experimental Treatment 1 Intervention

Medtronic Adaptix

Group II: PEEK Experimental Treatment 1 Intervention

Medtronic Capstone

Who Is Running the Clinical Trial?

Twin Cities Spine Center

Lead Sponsor

Trials

4

Recruited

1,300+

Findings from Research

In a matched cohort study of 462 patients (154 with PEEK rods and 308 with titanium rods) undergoing lumbar spine fusion, there was no significant difference in the risk of adjacent segment disease (ASD) between the two rod systems, suggesting that PEEK rods do not reduce ASD risk as previously theorized.

Patients who received PEEK rods had a significantly lower likelihood of readmission compared to those with titanium rods, with no nonunions or complications observed in the PEEK group, indicating a potential safety advantage for PEEK rods in lumbar spine fusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do PEEK Rods for Posterior Instrumented Fusion in the Lumbar Spine Reduce the Risk of Adjacent Segment Disease? Hirt, D., Prentice, HA., Harris, JE., et al.[2021]

In a study of 82 patients undergoing minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF), the use of titanium-coated PEEK (TiPEEK) cages resulted in significantly higher spinal fusion rates at 6 months compared to standard PEEK cages (91.8% vs. 76%).

Despite the higher fusion rates with TiPEEK at 6 months, patient-reported outcomes such as pain scores and disability indices showed minimal differences between the TiPEEK and PEEK groups, indicating that both cage types provide similar patient satisfaction and functional improvement post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of Polyetheretherketone and Titanium-Coated Polyetheretherketone in Minimally Invasive Transforaminal Lumbar Interbody Fusion: A Randomized Clinical Trial. Singhatanadgige, W., Tangchitcharoen, N., Kerr, SJ., et al.[2022]

In a study involving 26 patients undergoing lumbar interbody fusion, the titanium-coated PEEK cage showed significantly greater bone growth (vertebral cancellous condensation) compared to the uncoated PEEK cage, indicating better osteoconductivity.

The titanium-coated PEEK cage achieved an 88% fusion rate at 3 months post-surgery without any observed cage subsidence, suggesting it may enhance clinical outcomes in spinal fusion procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison in the same intervertebral space between titanium-coated and uncoated PEEK cages in lumbar interbody fusion surgery. Kashii, M., Kitaguchi, K., Makino, T., et al.[2021]

In a study using cadaveric spines, it was found that PEEK constructs provided adequate stability in the sagittal and coronal planes but significantly compromised stability during axial rotation, suggesting limitations in their use for spinal reconstruction.

The research indicated that hybrid constructs combining PEEK cages with titanium rods offered improved stability, particularly in extension and lateral bending, making them a preferable option for anterior thoracolumbar reconstructions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomechanical rigidity of an all-polyetheretherketone anterior thoracolumbar spinal reconstruction construct: an in vitro corpectomy model. Moon, SM., Ingalhalikar, A., Highsmith, JM., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Titanium versus polyetheretherketone implants for vertebral body replacement in the treatment of 77 thoracolumbar spinal fractures. [2020]

2. Greece pubmed.ncbi.nlm.nih.gov

Titanium‑coated polyetheretherketone cages vs. polyetheretherketone cages in lumbar interbody fusion: A systematic review and meta‑analysis. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Do PEEK Rods for Posterior Instrumented Fusion in the Lumbar Spine Reduce the Risk of Adjacent Segment Disease? [2021]

4. United States pubmed.ncbi.nlm.nih.gov

A Comparison of Polyetheretherketone and Titanium-Coated Polyetheretherketone in Minimally Invasive Transforaminal Lumbar Interbody Fusion: A Randomized Clinical Trial. [2022]

5. Pakistan pubmed.ncbi.nlm.nih.gov

Radiological and clinical outcomes in patients undergoing anterior cervical discectomy and fusion: Comparing titanium and PEEK (polyetheretherketone) cages. [2022]

6. Japan pubmed.ncbi.nlm.nih.gov

Comparison in the same intervertebral space between titanium-coated and uncoated PEEK cages in lumbar interbody fusion surgery. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of PEEK rods versus titanium alloy rods in cervical fusion in a new sheep model. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Biomechanical rigidity of an all-polyetheretherketone anterior thoracolumbar spinal reconstruction construct: an in vitro corpectomy model. [2022]

9. Austria pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of PEEK rods versus titanium alloy rods in lumbar fusion: a preliminary report. [2022]