Titanium vs Polymer Spinal Cages for Spinal Conditions

Overseen By Shelby Miracle

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

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

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

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

Compensation: Varies

Number of Visits: 4

Duration: Surgery and immediate recovery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of spinal implants—titanium and polymer—to determine which is more effective for individuals undergoing spinal fusion surgery. Spinal fusion connects two or more bones in the spine, and the trial will assess how well each implant aids bone healing and overall recovery. Individuals who have tried other treatments for back issues without success for at least six months may be suitable candidates for this trial.

As an unphased study, this trial provides a unique opportunity to contribute to advancements in spinal surgery.

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 prior data suggests that these spinal cages are safe for lumbar fusion procedures?

Research has shown that both the Medtronic Adaptix™ titanium implants and the Medtronic CAPSTONE® PEEK cage have safety information available.

For the Adaptix™ titanium implants, possible risks include the implant moving out of place, breaking, and the body reacting against the implant. These risks are common with many implants, but awareness is important.

PEEK cages, such as those in the CAPSTONE® system, are often used in spinal surgeries. Some studies suggest they might not fuse as quickly as titanium-coated options. However, they have been used for a long time, and many patients have experienced good results.

Both treatments have undergone safety studies, and while risks exist, many patients have had positive experiences. Always consult your doctor to determine if these options are suitable for you. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer innovative approaches to spinal fusion, a common procedure for treating spinal conditions. The Medtronic Adaptix™ titanium implants are notable for their robust strength and potential for better integration with bone due to the titanium's biocompatibility. In contrast, the Medtronic CAPSTONE® PEEK cage is made of a polymer that offers flexibility and radiolucency, allowing for easier monitoring of the bone healing process through imaging. Both treatments are used in conjunction with a mix of autograft and allograft bone, avoiding the need for additional bone harvesting from the patient's iliac crest, which can reduce patient discomfort and recovery time. These features make the treatments promising alternatives to traditional spinal fusion methods, which often rely on iliac crest autografts and metal cages.

What evidence suggests that this trial's treatments could be effective for spinal conditions?

This trial will compare Medtronic Adaptix™ titanium implants with Medtronic CAPSTONE® PEEK cages for spinal fusion surgeries. Research has shown that titanium implants, like the Adaptix, bond well with bone, potentially speeding up healing and reducing complications. Meanwhile, the CAPSTONE® PEEK cages have demonstrated effectiveness in aiding bone fusion and improving spine alignment in some patients. Specifically, a study of patients with neck spine issues found that PEEK cages helped maintain disc space and spine angle stability. Both treatments hold promise, but success can vary based on individual patient factors. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Medtronic Adaptix™ titanium implants
• Medtronic CAPSTONE® PEEK cage

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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 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 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 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]

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]

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]

Citations

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Can activated titanium interbody cages accelerate or ... These studies will evaluate the relative implant-bone integration and fusion rates achieved by either micro-etched Ti or standard PEEK interbody devices.

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05182489/adaptix-rct-evaluating-adaptixtm-versus-peek-cages

Adaptix RCT Evaluating Adaptix™ Versus PEEK Cages The randomized controlled trial will prospectively evaluate the efficacy of Medtronic Adaptix™ titanium implants supplemented with a pedicle ...

3. withpower.com withpower.com/trial/phase-intervertebral-disc-degeneration-9-2021-19b33

Titanium vs Polymer Spinal Cages for Spinal Conditions In a study of 104 patients undergoing anterior cervical diskectomy, both plain PEEK cages and titanium-coated PEEK (TiPEEK) cages showed similar fusion rates ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05182489?term=medtronic%20fusion&viewType=Table&rank=1

Adaptix RCT Evaluating Adaptix™ Versus PEEK Cages The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12106382/

Lumbar Fusion With Micro- & Nano-Textured, 3D Printed ... A novel synthetic material for spinal fusion: a prospective clinical trial of porous bioactive titanium metal for lumbar interbody fusion.

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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: ...

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Indications, Safety, and Warnings - Adaptix Interbody System POTENTIAL ADVERSE EVENTS · Implant migration. · Breakage of the device(s). · Foreign body reaction to the implants including possible tumor formation, auto immune ...

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Adaptix Interbody Fusion Device - Spine Products Discover the Adaptix interbody fusion device with Titan nanoLOCK surface technology for PLIF and TLIF procedures.