Titanium vs Polymer Spinal Cages for Spinal Conditions

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Ohio State University

Must not be taking: Glucocorticoids, Immunosuppressives, Methotrexate, others

Disqualifiers: Previous lumbar surgery, Osteoporosis, Infection, Obesity, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing two different types of spinal implants in patients needing back surgery to see which one works better. The implants help stabilize the spine and promote bone growth to fuse the vertebrae together.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on medications that interfere with bone or soft tissue healing, like certain steroids or immunosuppressives.

What data supports the effectiveness of the treatment Medtronic Adaptix™ titanium implants and Medtronic CAPSTONE® PEEK cage for spinal conditions?

Research suggests that titanium cages may have better fusion rates compared to PEEK cages, which could imply that titanium implants like Medtronic Adaptix™ might be more effective in promoting bone healing in spinal surgeries. ^{1 2 3 4 5}

Is it safe to use titanium or PEEK spinal cages in humans?

Research shows that both titanium and PEEK spinal cages are generally safe for use in humans, but PEEK cages may have higher nonunion rates (where bones don't heal together as expected) compared to titanium cages. More long-term studies are needed to fully understand their safety. ^{1 2 5 6 7}

How is the treatment with Medtronic Adaptix™ titanium implants and Medtronic CAPSTONE® PEEK cage different from other treatments for spinal conditions?

This treatment is unique because it compares the use of titanium implants, known for their strength and osseointegration (ability to bond with bone), with PEEK cages, which are favored for their radiologic visibility and compatibility with MRI scans. The study aims to evaluate the fusion behavior and bacterial adhesion characteristics of these materials, which are important factors in spinal surgeries. ^{1 2 5 8 9}

Research Team

Eligibility Criteria

Adults over 18 needing lumbar fusion surgery for conditions like spondylolisthesis or degenerative disc disease, who've had no relief from 6 months of conservative care. Excludes those with prior lumbar surgery, certain medical conditions, obesity (BMI >45), infections, metal sensitivities, substance abuse history, pregnancy/lactation plans within a year, and involvement in litigation or other studies.

Inclusion Criteria

I am scheduled for a specific spinal fusion surgery using Medtronic cages and GRAFTON™ mix.

My condition hasn't improved after 6 months of standard treatment.

I am over 18 years old.

Exclusion Criteria

I take medication that could affect bone or tissue healing.

I currently have an infection.

Subject has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo lumbar fusion surgery using either Medtronic Adaptix™ titanium implants or CAPSTONE® PEEK cages, supplemented with a pedicle screw system and a 50:50 mixture of autograft: allograft.

Surgery and immediate recovery

Follow-up

Participants are monitored for clinical and radiographic outcomes, with assessments at 3, 6, 12, and 24 months post-surgery.

24 months

4 visits (in-person) at 3, 6, 12, and 24 months

Treatment Details

Interventions

• Medtronic Adaptix™ titanium implants (Implant)
• Medtronic CAPSTONE® PEEK cage (Implant)

Trial Overview The trial compares two types of spinal fusion implants: Medtronic Adaptix™ titanium cage and CAPSTONE® PEEK cage. It aims to see which implant works better when used with local bone graft mix and pedicle screw systems in spine surgeries.

Participant Groups

Group I: Medtronic Adaptix™ titanium implants Experimental Treatment 1 Intervention

This arm will use Medtronic Adaptix™ titanium implants supplemented with a pedicle screw system. Both cages will be used in conjunction with a 50:50 mixture of autograft: allograft using milled local autograft bone and GRAFTON™ DBM DBF (no iliac crest autograft will be utilized).

Group II: Medtronic CAPSTONE® PEEK cage Active Control 1 Intervention

This arm will use Medtronic CAPSTONE® PEEK cage supplemented with a pedicle screw system. Both cages will be used in conjunction with a 50:50 mixture of autograft: allograft using milled local autograft bone and GRAFTON™ DBM DBF (no iliac crest autograft will be utilized).

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Dr. John J. Warner

Ohio State University

Chief Executive Officer since 2023

MD, MBA

Dr. Peter Mohler

Ohio State University

Chief Medical Officer since 2023

PhD in Molecular Biology

Findings from Research

In a study of 104 patients undergoing anterior cervical diskectomy, both plain PEEK cages and titanium-coated PEEK (TiPEEK) cages showed similar fusion rates after two years, with 86% fusion in the PEEK group and 82% in the TiPEEK group, indicating no significant advantage of TiPEEK (p=0.59).

Clinical evaluations revealed no differences in neurological outcomes or pain scores between the two groups, suggesting that the type of cage used does not impact patient recovery or pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PEEK Cages versus Titanium-Coated PEEK Cages in Single-Level Anterior Cervical Fusion: A Randomized Controlled Study. Schröder, J., Kampulz, T., Bajaj, SK., et al.[2023]

The study evaluated the effectiveness of a composite titanium/PEEK cage for anterior cervical discectomy and fusion (ACDF) in 195 patients, showing a high overall fusion rate of 94.1% and significant improvement in clinical outcomes without any implant-related complications.

Allograft demonstrated a significantly higher fusion rate (97.7%) compared to the synthetic bone graft substitute β-tricalcium phosphate (77.6%), although both graft types similarly improved clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integral fixation titanium/polyetheretherketone cages for cervical arthrodesis: Two-year clinical outcomes and fusion rates using β-tricalcium phosphate or supercritical carbon dioxide treated allograft. Mobbs, RJ., Amin, T., Ho, D., et al.[2022]

In a study of 37 patients with cervical degenerative disease, both curved and wedge-shaped PEEK cages improved disc height and segmental angle after surgery, indicating effective clinical outcomes.

The curved PEEK cage showed a lower subsidence rate (6%) compared to the wedge cage (20%), suggesting that the design of the cage can influence stability and reduce the risk of complications post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Study between a Curved and a Wedge PEEK Cage for Single-level Anterior Cervical Discectomy and Interbody Fusion. Kim, HS., Song, JS., Heo, W., et al.[2020]

In a study involving 127 patients undergoing posterior lumbar interbody fusion (PLIF), nanocoated PEEK cages (titanium and calcium phosphate) showed significantly higher fusion rates (93.9% and 88.0%, respectively) compared to uncoated PEEK cages (65.6%) after one year, indicating better osseointegration.

Despite similar clinical outcomes across all groups in terms of pain and disability scores, the enhanced fusion rates of nanocoated cages suggest they may offer improved long-term benefits, particularly in patients at risk for incomplete fusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of Posterior Lumbar Interbody Fusion With Ti- and CaP-Nanocoated Polyetheretherketone Cages: Comparative Study of the 1-Year Radiological and Clinical Outcome. Willems, K., Lauweryns, P., Verleye, G., et al.[2022]

In a study comparing the adhesion characteristics of bacteria on different spinal cage materials, polished titanium cages showed significantly lower bacterial adherence for MRSA compared to PEEK and TiMe cages after 56 hours, indicating a potential safety advantage for titanium in preventing infections.

PEEK cages exhibited higher bacterial counts for S.epidermidis and MSSA compared to titanium cages, suggesting that while PEEK may be beneficial for E.coli, it generally has poorer adhesion characteristics for other harmful bacteria, which could impact their efficacy in spinal surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bacterial adhesion characteristics on implant materials for intervertebral cages: titanium or PEEK for spinal infections? Krätzig, T., Mende, KC., Mohme, M., 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]

The new porous PEEK biomaterial, with approximately 50% porosity and a mean pore size of 100 microns, demonstrated strong mechanical properties suitable for implant applications, including a tensile strength of 14.5 MPa and flexural strength of 21.6 MPa.

In vitro studies showed that marrow stromal cells cultured on porous PEEK exhibited early signs of differentiation and mineralization, indicating good cytocompatibility and potential for enhanced tissue integration in implant devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical and in vitro investigation of a porous PEEK foam for medical device implants. Landy, BC., Vangordon, SB., McFetridge, PS., et al.[2021]

A systematic review of 37 studies involving 2363 patients found that both PEEK and titanium interbody cages showed similar surgical and radiographic outcomes, including fusion rates and complications, after anterior cervical discectomy and fusion.

In contrast, poly-methyl-methacrylate (PMMA) cages demonstrated a significantly lower fusion rate (56%) compared to PEEK (94%) and titanium (95%) cages, indicating that PMMA may not be as effective when used alone without graft material.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Outcomes Between Cage Materials Used for Patients Undergoing Anterior Cervical Discectomy and Fusion with Standalone Cages: A Systematic Review and Meta-Analysis. Onyedimma, C., Jallow, O., Yolcu, YU., et al.[2022]

In a study comparing 3D printed titanium (3DPT) cages and polyetheretherketone (PEEK) cages in spinal fusion surgeries, both types achieved excellent clinical outcomes, but the 3DPT cage showed significantly lower subsidence rates at 3 and 6 months post-surgery.

The 3DPT cage also demonstrated superior bone-cage interface contact compared to the PEEK cage, indicating better integration with the surrounding bone, which may enhance the overall effectiveness of spinal fusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between Three-Dimensional Printed Titanium and PEEK Cages for Cervical and Lumbar Interbody Fusion: A Prospective Controlled Trial. Deng, Z., Zou, Q., Wang, L., et al.[2023]

References

1. Germany pubmed.ncbi.nlm.nih.gov

PEEK Cages versus Titanium-Coated PEEK Cages in Single-Level Anterior Cervical Fusion: A Randomized Controlled Study. [2023]

2. India pubmed.ncbi.nlm.nih.gov

Integral fixation titanium/polyetheretherketone cages for cervical arthrodesis: Two-year clinical outcomes and fusion rates using β-tricalcium phosphate or supercritical carbon dioxide treated allograft. [2022]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Comparative Study between a Curved and a Wedge PEEK Cage for Single-level Anterior Cervical Discectomy and Interbody Fusion. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of Posterior Lumbar Interbody Fusion With Ti- and CaP-Nanocoated Polyetheretherketone Cages: Comparative Study of the 1-Year Radiological and Clinical Outcome. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Bacterial adhesion characteristics on implant materials for intervertebral cages: titanium or PEEK for spinal infections? [2021]

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

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

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

Mechanical and in vitro investigation of a porous PEEK foam for medical device implants. [2021]

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

Comparison of Outcomes Between Cage Materials Used for Patients Undergoing Anterior Cervical Discectomy and Fusion with Standalone Cages: A Systematic Review and Meta-Analysis. [2022]

9. Australia pubmed.ncbi.nlm.nih.gov

Comparison between Three-Dimensional Printed Titanium and PEEK Cages for Cervical and Lumbar Interbody Fusion: A Prospective Controlled Trial. [2023]