Spinal Fusion Surgery with PEEK-OPTIMA™ HA Enhanced for Degenerative Disc Disease

Overseen By Sheryl O'Farrell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Invibio Ltd

Must not be taking: Bone metabolism drugs

Disqualifiers: Previous spinal surgery, Tumour, Osteoporosis, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: Surgical procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the outcomes of spinal fusion surgery using the Keos Lumbar Interbody Fusion Device for individuals with degenerative disc disease. The researchers aim to assess the device's effectiveness in improving back pain and function, as well as its appearance on x-rays and CT scans. It suits individuals who have experienced back pain due to degenerative disc disease, despite trying other treatments for at least six months, and who have not undergone previous spine surgery at the affected area. Participants should not smoke or have conditions like osteoporosis or rheumatoid arthritis. As an unphased trial, this study offers an opportunity to contribute to valuable research that could enhance future treatment options.

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 any drug treatment that affects bone metabolism, you may not be eligible to participate.

What prior data suggests that the Keos Lumbar Interbody Fusion Device is safe for spinal fusion surgery?

Research has shown that PEEK devices, such as the Keos Lumbar Interbody Fusion Device, are generally safe for spinal fusion surgeries. Previous studies found that these devices did not break down or release harmful particles in the body, suggesting that the Keos device is likely well-tolerated by patients. Although every medical procedure carries some risks, these findings provide reassurance for those considering participation in a clinical trial with this device. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Keos Lumbar Interbody Fusion Device for degenerative disc disease because it uses PEEK-OPTIMA™ HA Enhanced material, which is a major step forward. Unlike traditional metal implants, this material is designed to encourage bone growth and integration, potentially leading to a more stable fusion. The device's design may also allow for better load distribution and alignment, addressing some limitations of current spinal fusion options like metal cages or bone grafts. This innovative approach could improve recovery times and long-term outcomes for patients suffering from degenerative disc disease.

What evidence suggests that the Keos Lumbar Interbody Fusion Device is effective for degenerative disc disease?

Studies have shown that the Keos Lumbar Interbody Fusion Device performs well in spinal fusion surgeries for degenerative disc disease. Research indicates that this device helps achieve successful fusion at one or two spinal levels, specifically between the L2 and S1 vertebrae. Previous patients demonstrated improvements in their condition, as seen in X-ray and CT scan results. Regulatory bodies have approved the device, supporting its safety and effectiveness for this procedure. ^{1 2 3 4 6}

Who Is on the Research Team?

Louis A Marotti, M.D. PhD

Principal Investigator

Neurosurgical Associates of Lancaster

Are You a Good Fit for This Trial?

This trial is for adults over 18 with lower back issues like degenerative disc disease, spondylolisthesis, or retrolisthesis needing spinal fusion surgery. Participants must have tried non-surgical treatments for at least 6 months and be able to follow study procedures. Pregnant women, smokers, drug/alcohol abusers, those with certain diseases or bone metabolism-affecting drugs are excluded.

Inclusion Criteria

I have back pain caused by a disc problem.

I am of childbearing age and have a negative pregnancy test.

I have completed 6 months of non-surgical treatment.

Exclusion Criteria

I have rheumatoid arthritis, ankylosing spondylitis, or a weakened immune system.

I have been diagnosed with cancer.

I currently have an infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo spinal fusion using the Keos Lumbar Interbody Fusion Device

Surgical procedure

1 visit (in-person)

Post-operative Follow-up

Participants are monitored for clinical outcomes, radiographic and CT outcomes

24 months

Multiple visits at 6 weeks, 3, 6, 12, and 24 months post-operatively

What Are the Treatments Tested in This Trial?

Interventions

• Keos Lumbar Interbody Fusion Device

Trial Overview The Keos Lumbar Interbody Fusion Device is being tested in patients requiring spinal fusion surgery. The study aims to assess the safety and performance of this device by monitoring clinical outcomes through radiographic and CT scans post-surgery.

How Is the Trial Designed?

Group I: Device Experimental Treatment 1 Intervention

All subjects who are entered into this trial will receive the Keos Lumbar Interbody Fusion Device.

Keos Lumbar Interbody Fusion Device is already approved in United States for the following indications:

Approved in United States as Keos Lumbar IBFD for:

• Spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD)

Who Is Running the Clinical Trial?

Invibio Ltd

Lead Sponsor

Trials

11

Recruited

380+

Keos LLC

Collaborator

Trials

1

Recruited

30+

Medical Metrics Diagnostics, Inc

Industry Sponsor

Trials

14

Recruited

1,800+

Technomics Research

Industry Sponsor

Trials

5

Recruited

880+

Viedoc Technologies

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

In a study of 100 patients undergoing posterior lumbar interbody fusion (PLIF) with a non-threaded locking screw system and PEEK cages, the procedure successfully restored disc height and maintained fusion rates similar to traditional methods, with only a 2% rate of pseudarthrosis.

The non-threaded locking screw system resulted in significantly shorter operative times, less blood loss, and fewer dural tears compared to conventional bilateral cage systems, making it a safer and more efficient option for treating lumbar degenerative conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

100 consecutive cases of degenerative lumbar conditions using a non-threaded locking screw system with a 90-degree locking cap. McAfee, PC., Cunningham, BW., Tortolani, PJ., et al.[2020]

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]

In a clinical study of 21 patients with lumbar degenerative disease, the use of PEEK rods in the Initial VEOS PEEK(®)-Optima system resulted in a low reoperation rate of 4.8% over an average follow-up of 2.5 years.

The PEEK rod system improved patients' quality of life by 16% and preserved the adjacent disc in over 70% of cases, suggesting it is a safe and effective alternative to traditional rigid instrumentation systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flexible Stabilisation of the Degenerative Lumbar Spine Using PEEK Rods. Benezech, J., Garlenq, B., Larroque, G.[2020]

In a study of 69 patients undergoing posterior lumbar interbody fusion (PLIF), both PEEK cages and autologous cages from the lumbar spinous process and laminae (ACSP) showed successful radiographic fusion with no significant differences in clinical outcomes after a minimum follow-up of 2 years.

Both treatment methods demonstrated similar safety profiles, with no complications such as pedicle screw loosening or hypermobility, indicating that ACSP is as effective and safe as PEEK cages for this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the PEEK cage and an autologous cage made from the lumbar spinous process and laminae in posterior lumbar interbody fusion. Lin, B., Yu, H., Chen, Z., et al.[2022]

In a retrospective review of 30 cases using pre-curved peek rods for posterior lumbar fusion, the results showed satisfactory clinical and radiographic outcomes after an average follow-up of 18 months, with only one case needing surgical revision.

The use of these semi-rigid peek rods may offer advantages such as improved load sharing for interbody fusion and reduced stress on the bone-screw interface, potentially leading to lower rates of screw mobilization and adjacent level disc degeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posterior lumbar fusion by peek rods in degenerative spine: preliminary report on 30 cases. De Iure, F., Bosco, G., Cappuccio, M., et al.[2022]

The use of polyetheretherketone (PEEK) rod systems in lumbar interbody fusion showed a high fusion success rate of 95.6% and significant improvements in functional outcomes and pain relief, with average improvements of 67.4% in function and 68.9% to 76.6% in pain scores.

Safety data indicated no rod fractures and low rates of screw fractures (2.6%) and loosening (2.0%), suggesting that PEEK rods are a safe option for spinal stabilization, comparable to traditional titanium rods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polyetheretherketone (PEEK) Rods for Lumbar Fusion: A Systematic Review and Meta-Analysis. Selim, A., Mercer, S., Tang, F.[2022]

In a study of 52 patients undergoing spinal fusion with PEEK rods, significant improvements were observed in disability and pain scores over a 12-month follow-up, indicating the efficacy of the PEEK Rod System for treating various spinal conditions.

Imaging showed a 96% fusion rate within one year, although there were some complications, including two cases of screw breakage and one superficial infection, suggesting that while the system is effective, careful monitoring for complications is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posterior spinal fusion using pedicle screws. Athanasakopoulos, M., Mavrogenis, AF., Triantafyllopoulos, G., et al.[2022]

The study evaluated a radiolucent PEEK-threaded interbody fusion device in 13 sheep over 6 months, showing successful radiographic fusion and increased spinal stiffness when filled with either autograft or rhBMP-2.

The PEEK device demonstrated no degradation or significant inflammation, suggesting it is a safe and effective alternative to traditional titanium devices for spinal fusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polyetheretherketone as a biomaterial for spinal applications. Toth, JM., Wang, M., Estes, BT., et al.[2022]

In a study involving eight adult sheep, implants coated with NanoMetalene (NM) showed significantly greater bone ingrowth and ongrowth compared to uncoated polyether ether ketone (PEEK) implants, indicating that NM enhances bone integration.

At both 4 and 8 weeks post-surgery, the NM-coated implants demonstrated new bone formation that tracked along the titanium layer, while PEEK implants exhibited nonreactive fibrous tissue, suggesting that NM may improve clinical outcomes for bone fusion devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The in vivo response to a novel Ti coating compared with polyether ether ketone: evaluation of the periphery and inner surfaces of an implant. Walsh, WR., Pelletier, MH., Christou, C., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04416321

A Clinical Study to Evaluate Safety and Performance of ... The purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo spinal fusion using the Keos Lumbar ...

2. ctv.veeva.com ctv.veeva.com/study/a-clinical-study-to-evaluate-safety-and-performance-of-peek-optima-ha-enhanced

A Clinical Study to Evaluate Safety and Performance of PEEK ... The purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo spinal fusion using ...

3. app.trialscreen.org app.trialscreen.org/trials/degenerative-disc-disease-clinical-to-evaluate-safety-performance-peek-trial-nct04416321

A Clinical Study to Evaluate Safety and Performance ... Participation in this study will contribute to the evaluation of a spinal fusion device, potentially leading to improved treatment options for patients with ...

4. withpower.com withpower.com/trial/phase-spondylolisthesis-6-2021-0449f

Spinal Fusion Surgery with PEEK-OPTIMA™ HA Enhanced ... The purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo spinal fusion using the Keos Lumbar ...

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf16/K163386.pdf

510(k) Summary of Safety and Effectiveness: Keos Lumbar IBFD is indicated for spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with ...

6. trial.medpath.com trial.medpath.com/clinical-trial/b14454b456527897/nct04416321-post-market-study-peek-optima-lumbar-spine

A Clinical Study to Evaluate Safety and Performance of PEEK ... The purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo spinal fusion using the Keos Lumbar ...