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

108 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares two types of cages used in back surgery for patients needing spinal fusion. One cage is made of porous titanium, and the other is titanium-coated PEEK. The cages help bones in the spine grow together and stabilize.

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 data supports the effectiveness of this treatment 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 may be effective in promoting bone growth and stability in the spine. ^{1 2 3 4 5}

Is the use of porous and non-porous cages for lumbar fusion safe?

Studies on titanium-coated PEEK cages and porous titanium metal for spinal fusion show promising safety results, with successful bone fusion and no adverse effects reported in the short term. However, more long-term research is needed to confirm these findings. ^{2 4 5 6 7}

What makes the CONDUIT Porous Titanium Spinal Cage and PROTI 360 Titanium-Coated PEEK Spinal Cage treatment unique for lumbar fusion?

The CONDUIT Porous Titanium Spinal Cage and PROTI 360 Titanium-Coated PEEK Spinal Cage are unique because they combine the benefits of titanium's bone integration with the flexibility of PEEK, potentially improving bone growth and stability compared to traditional PEEK cages. The porous structure of the titanium cage allows for better bone ingrowth, while the titanium coating on the PEEK cage enhances its ability to bond with bone. ^{2 3 5 8 9}

Research Team

Francis Farhadi, MD, PhD

Principal Investigator

University of Kentucky

Craig van Horne, MD, PhD

Principal Investigator

University of Kentucky

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

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 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 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]

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]

References

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

Radiological and clinical outcomes of novel Ti/PEEK combined spinal fusion cages: a systematic review and preclinical evaluation. [2021]

2. China 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]. [2022]

3. 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]

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. Japan pubmed.ncbi.nlm.nih.gov

Radiological Outcomes of Posterior Lumbar Interbody Fusion Using a Titanium-coated PEEK Cage. [2021]

6. 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]

7. Germany 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. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

PLIF surgery with titanium-coated PEEK or uncoated PEEK cages: a prospective randomised clinical and radiological study. [2021]

9. United States 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. [2022]