Porous vs Non-Porous Cages for Lumbar Fusion

Overseen By Francis Farhadi, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kentucky

Must not be taking: Glucocorticoids, Immunosuppressives, Methotrexate

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: Immediate post-surgery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates two types of cages used in back surgery to fuse unstable spinal bones. The first is the CONDUIT Porous Titanium Spinal Cage, made of porous titanium with tiny holes to promote bone growth. The second is the PROTI 360 Titanium-Coated PEEK Spinal Cage, a titanium-coated plastic (PEEK) without holes. Researchers aim to determine which cage is more effective for spine fusion surgery. Suitable candidates for this trial are those needing this specific back surgery who have not improved with regular treatments for at least six months. As an unphased trial, this study provides a unique opportunity to contribute to understanding which spinal cage may benefit future patients more effectively.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on medications that interfere with bone or soft tissue healing, like glucocorticoids or immunosuppressives, you may not be eligible to participate.

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

Previous studies found the CONDUIT Porous Titanium Spinal Cage to be safe. Research showed these cages could lower the risk of implant sinking and promote bone fusion. Patients generally tolerated these cages well, with no major safety issues reported.

Studies also demonstrated the safety of the PROTI 360 Titanium-Coated PEEK Spinal Cage. The titanium coating aids bone fusion and reduces the chance of implant movement. These cages fit well with the spine, and patients usually experienced positive results with few side effects.

Both treatments aim to help the spine heal and remain stable. While the current trial won't add more safety data, past research supports the safety of these options for use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for lumbar fusion because they offer innovative approaches to stabilizing the spine. The CONDUIT Porous Titanium Spinal Cage stands out with its solid titanium structure infused with microscopic porous canals, which encourage bone growth and fusion between unstable vertebrae. This is different from the standard options that might not have such advanced features to promote bone adhesion and proliferation. On the other hand, the PROTI 360 Titanium-Coated PEEK Spinal Cage uses a medical-grade polymer with a titanium coating, aiming to stimulate bone fusion without the porous design. Each treatment offers a unique mechanism to enhance spinal stability, potentially providing better outcomes for patients with spinal instability.

What evidence suggests that these spinal cages are effective for lumbar fusion?

This trial will compare the effectiveness of two different spinal cages for lumbar fusion. Research has shown that the CONDUIT Porous Titanium Spinal Cage, one of the treatments in this trial, effectively helps spinal bones fuse, with studies finding a 90.3% success rate in some cases. This success might reduce the need for additional surgery by improving bone healing. Meanwhile, the PROTI 360 Titanium-Coated PEEK Spinal Cage, another treatment option in this trial, also shows strong performance, with an 88.4% success rate in promoting bone fusion. Both cages are designed to stabilize the spine and support bone growth, offering promising results for patients undergoing lower back fusion surgeries. ^{1 2 4 5 6}

Who Is on the Research Team?

Francis Farhadi, MD, PhD

Principal Investigator

University of Kentucky

Craig van Horne, MD, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need lumbar fusion surgery and haven't responded to non-surgical treatments for at least 6 months. They must be able to follow the study plan and give consent. Exclusions include previous lumbar fusion, substance abuse, pregnancy, ongoing litigation or compensation claims related to back pain, infections, metal sensitivity, extreme obesity (BMI >40), certain medical conditions or medications affecting bone healing.

Inclusion Criteria

I am over 18 years old.

I am mentally and physically capable of following the study's requirements.

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

Exclusion Criteria

I have had spine fusion surgery in my lower back.

Patients involved in another investigational drug or device study

I have insufficient tissue over my surgery area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo lumbar interbody fusion procedures using either porous titanium cages or non-porous titanium-coated PEEK cages

Immediate post-surgery

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple intervals

24 months

Preoperative, 3, 6, 12, and 24 month follow-ups

Interim Analysis

An interim analysis is conducted to evaluate early findings and determine if the trial should continue

Mid-trial

What Are the Treatments Tested in This Trial?

Interventions

• CONDUIT Porous Titanium Spinal Cage
• PROTI 360 Titanium-Coated PEEK Spinal Cage

Trial Overview The trial compares two types of spinal cages used in lumbar fusion surgeries: one made from porous titanium and another coated with titanium on PEEK material. Participants will be randomly assigned to receive either cage during their scheduled surgery.

How Is the Trial Designed?

Group I: CONDUIT Porous Titanium Spinal Cage Active Control 1 Intervention

Solid titanium spinal cage, infused with microscopic, porous canals to allow for adhesion and proliferation of bone graft factors contributing to spinal ossification, and ultimately, spinal fusion between vertebrae demonstrating instability.

Group II: PROTI 360 Titanium-Coated PEEK Spinal Cage Active Control 1 Intervention

Spinal cage composed primarily of a medical-grade polymer: poly-ether-ether-ketone (PEEK), with a titanium coating that is etched, but lacking porous features. These design features also attempt to stimulate spinal vertebrae fusion through bone-graft ossification and enhance vertebral stability.

CONDUIT Porous Titanium Spinal Cage is already approved in United States for the following indications:

Approved in United States as CONDUIT Porous Titanium Spinal Cage for:

• Lumbar interbody fusion procedures (TLIF)

Who Is Running the Clinical Trial?

University of Kentucky

Lead Sponsor

Trials

198

Recruited

224,000+

Published Research Related to This Trial

In a study of 60 patients undergoing posterior lumbar interbody fusion (PLIF), both titanium-coated and uncoated PEEK cages showed similar clinical outcomes and fusion rates after 24 months, indicating that both types of cages are effective for this surgery.

Significant improvements in pain and disability scores were observed in both groups post-surgery, with no differences in fusion rates or complications, suggesting that the choice between titanium-coated and uncoated PEEK cages may not impact patient recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PLIF surgery with titanium-coated PEEK or uncoated PEEK cages: a prospective randomised clinical and radiological study. Schnake, KJ., Fleiter, N., Hoffmann, C., et al.[2021]

In a study of 21 patients who underwent lumbar interbody fusion with titanium-coated PEEK cages, 88.4% achieved successful bone fusion after one year, indicating good efficacy of this surgical intervention.

Despite some instances of cage subsidence and screw loosening, all cases of subsidence still resulted in bone fusion, suggesting that the titanium coating may not negatively impact the overall success of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiological Outcomes of Posterior Lumbar Interbody Fusion Using a Titanium-coated PEEK Cage. Manabe, H., Sakai, T., Morimoto, M., et al.[2021]

In a study of 66 patients undergoing posterior lumbar interbody fusion (PLIF), the 3D printed porous titanium alloy cage (3D Cage) showed a significantly lower rate of intervertebral height loss compared to the poly-ether-ether-ketone cage (PEEK Cage) at 3 months and 1 year post-operation.

Both cages demonstrated similar outcomes in terms of operation time, intraoperative blood loss, and overall complications, indicating that while the 3D Cage may enhance stability and fusion rates, it does not compromise safety or recovery compared to the PEEK Cage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Application of three-dimensional printed porous titanium alloy cage and poly-ether-ether-ketone cage in posterior lumbar interbody fusion]. Wang, Y., Zhou, Y., Chai, X., et al.[2022]

The study developed a porous Ti-6Al-4V cage with a Young's modulus similar to natural bone, which promotes faster bone ingrowth compared to traditional PEEK cages in a preclinical sheep model.

The porous Ti cage demonstrated significantly better osseointegration and mechanical stability than the PEEK cage, indicating its potential for improved clinical outcomes in spinal fusion procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Porous titanium-6 aluminum-4 vanadium cage has better osseointegration and less micromotion than a poly-ether-ether-ketone cage in sheep vertebral fusion. Wu, SH., Li, Y., Zhang, YQ., 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 clinical trial involving 5 patients with unstable lumbar spine disease, a spinal fusion device made from porous bioactive titanium metal achieved successful bony union in all cases within 6 months, eliminating the need for additional bone grafting.

All clinical parameters improved significantly post-surgery, and no adverse effects were reported during the follow-up period, suggesting that this material is both effective and safe for spinal fusion applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel synthetic material for spinal fusion: a prospective clinical trial of porous bioactive titanium metal for lumbar interbody fusion. Fujibayashi, S., Takemoto, M., Neo, M., 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]

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]

A systematic review of seven clinical studies on Ti/PEEK combined cages in spinal fusion surgeries shows promising results, with fusion rates ranging from 91.7% to 100%, indicating that these implants are safe and effective.

While Ti/PEEK implants demonstrated similar fusion rates compared to standard PEEK implants, the differences in outcomes were not statistically significant, suggesting that more extensive clinical trials are needed to confirm their efficacy and establish their role in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiological and clinical outcomes of novel Ti/PEEK combined spinal fusion cages: a systematic review and preclinical evaluation. Assem, Y., Mobbs, RJ., Pelletier, MH., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05583864

Lumbar Fusion With Porous Versus Non-Porous Cages This study will capture clinical and radiographic outcomes on patients up to 2 years post-operatively. Both cages will be used in conjunction with milled local ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12387997/

Evaluating the Efficacy of a Novel Titanium Cage System in ... Results: A total of 78 levels (62 LLIF and 16 ALIF) were analyzed. Fusion rates were 90.3% (56/62) for LLIF levels and 81.3% (13/16) for ALIF ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12089121/

Do Three-Dimensional Printed Porous Titanium Relative to ... Conclusions. Use of 3D printed porous Ti cages relative to non-porous PEEK cages may mitigate pseudoarthrosis related reoperation after TLIF.

4. mdpi.com mdpi.com/2673-4095/6/3/52

High Fusion Rates with Structured Titanium TLIF Cages Conclusions: Structured titanium cages demonstrated excellent 1-year fusion rates and supported significant clinical improvement after TLIF. The addition of ...

5. withpower.com withpower.com/trial/phase-arthrodesis-9-2022-70acc

Porous vs Non-Porous Cages for Lumbar Fusion Research shows that titanium-coated PEEK cages used in lumbar fusion surgeries have a high rate of bone fusion, with 88.4% success in one study, suggesting they ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2666548425002343

Section on Innovative Spine Research and Novel ... The results suggested that the porous lattice titanium cage with microporous endplates may reduce subsidence risk and promote fusion, as it was ...