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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two devices, titanium and PEEK (a type of plastic), used in spinal fusion surgery to determine which works better for patients with lumbar stenosis (narrowing of the spinal canal) and spondylolisthesis (a slipped vertebra). Researchers will evaluate how well each device supports the spine and aids recovery over two years. Individuals who have undergone single-level spinal fusion surgery after at least six weeks of non-surgical treatments are suitable candidates for this trial. As a Phase 4 trial, this research involves FDA-approved devices and aims to understand their benefits for more patients, offering participants a chance to contribute to broader medical knowledge.

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 is the safety track record for these fusion devices?

Studies have shown that both PEEK and titanium devices are generally safe for spinal fusion surgeries. Research indicates that PEEK devices, such as the CAPSTONE® system, have a high success rate in facilitating bone fusion. A review of several studies found that about 95.6% of patients with PEEK devices experienced successful fusion without major issues.

For titanium devices, research also shows good results. Specifically, the Adaptix system from Medtronic demonstrated promising outcomes in lower back fusions. While some reports mention side effects, these are uncommon, and the device is considered safe overall.

Both PEEK and titanium devices are widely used in surgeries, suggesting they are well-tolerated by most patients. However, as with any medical treatment, there is always a small risk of side effects or complications. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the use of Titanium and PEEK devices for spinal fusion because they offer unique advantages over traditional options. Titanium devices, like Medtronic Adaptix, are known for their exceptional strength and biocompatibility, which can promote better integration with bone. On the other hand, PEEK devices, such as Medtronic Capstone, are praised for being more flexible and having a modulus of elasticity closer to natural bone, potentially reducing stress on adjacent vertebrae. These differences could lead to improved long-term outcomes for patients undergoing spinal fusion surgery.

What evidence suggests that this trial's devices could be effective for spinal fusion?

This trial will compare the effectiveness of PEEK and Titanium devices for spinal fusion. Research has shown that PEEK devices yield promising results in spinal fusion surgeries. In one study, 51.2% of patients achieved the best level of bone fusion, and overall fusion rates were good, indicating that PEEK devices facilitate effective bone joining after surgery.

For participants in the Titanium arm of this trial, studies suggest even better fusion success. Specifically, one study found that titanium devices had a higher success rate at 6 months compared to PEEK. Both devices perform well, but titanium might offer a slight advantage in promoting bone fusion. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

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.

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

Pregnant patients

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9747220/

Clinical and Cost-Effectiveness of Lumbar Interbody Fusion ... The Tritanium cohort showed better ODI scores, higher fusion rates, lower subsidence, and lower indirect costs associated with surgical management, when ...

2. e-neurospine.org e-neurospine.org/m/journal/view.php?number=1288

Comparison Between 3-Dimensional-Printed Titanium ... The PEEK fusion grades were grade I: 51.2% (22 patients), grade II: 41.9% (18 patients), and grade III: 7.0% (3 patients). For overall fusion ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12300856/

Clinical Outcomes of 3D-Printed Titanium Patient-Specific ... The mean QoL index scores improved significantly (p < 0.01) from a pre-operative 0.257 (0.332 SD) to 0.815 (0.208 SD) at 24 months. Conclusions: ...

4. ijssurgery.com ijssurgery.com/content/early/2024/06/13/8615

Cost-Effectiveness and Clinical Outcomes of Lateral ... All radiographic results (lumbar lordosis, foraminal height, and disc height) were improved at 2 years of follow-up in both groups (P < 0.001); ...

5. thespinemarketgroup.com thespinemarketgroup.com/wp-content/uploads/2020/07/Capstone-Peek-SGT.Medtronic.pdf

CAPSTONE® PEEK Spinal System The safety and effectiveness of this device for any other conditions are unknown. The implants are not prostheses. In the absence of fusion, the instrumentation ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf13/K133645.pdf

IV. V. a. PERIMETER® C Spinal System (PEEK) The CAPSTONE® Spinal System consists of PEEK cages with tantalum markers of various widths and heights, which can be inserted between two lumbar ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12133797/

Titanium-Coated Polyetheretherketone Cages Versus ... The results from this study suggest that TiPEEK cages may demonstrate earlier fusion as compared to PEEK cages, particularly at 6 months.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6159719/

Polyetheretherketone (PEEK) Rods for Lumbar Fusion Meta-analysis of interbody fusion success rate in PEEK rod patients yields the estimate of 95.6% (confidence interval: 91.6% to 98.4%).