Spinal Fusion Surgery with PEEK-OPTIMA™ HA Enhanced for Degenerative Disc Disease
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Invibio Ltd
Must not be taking: Bone metabolism drugs
Disqualifiers: Previous spinal surgery, Tumour, Osteoporosis, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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 Interbody Fusion Device.
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 data supports the effectiveness of the treatment Keos Lumbar Interbody Fusion Device, Keos Lumbar IBFD for degenerative disc disease?
Research shows that using PEEK (a type of plastic) rods and cages in spinal fusion surgeries can improve quality of life and reduce the need for additional surgeries. This suggests that the Keos Lumbar Interbody Fusion Device, which uses similar materials, may also be effective for treating degenerative disc disease.
12345Is the PEEK-OPTIMA™ HA Enhanced device safe for spinal fusion surgery?
Research shows that PEEK devices used in spinal fusion are generally safe, with no device degradation or harmful debris observed. Mild inflammation was noted, but PEEK systems are considered a safe alternative to traditional materials, reducing the need for further surgeries and preserving adjacent discs.
12356How is the Keos Lumbar Interbody Fusion Device treatment different from other treatments for degenerative disc disease?
The Keos Lumbar Interbody Fusion Device uses PEEK-OPTIMA™ HA Enhanced material, which is designed to improve bone fusion and reduce the risk of adjacent segment disease compared to traditional metal implants. This material is more flexible, potentially leading to better load distribution and less stress on surrounding areas, which may decrease the need for additional surgeries.
13789Eligibility Criteria
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 18 years old or older.
I am of childbearing age and have a negative pregnancy test.
+6 more
Exclusion Criteria
I have rheumatoid arthritis, ankylosing spondylitis, or a weakened immune system.
I have been diagnosed with cancer.
I currently have an infection.
+9 more
Trial Timeline
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: DeviceExperimental Treatment1 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)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Neurosurgical Associates of LancasterLancaster, PA
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Who Is Running the Clinical Trial?
Invibio LtdLead Sponsor
Keos LLCCollaborator
Medical Metrics Diagnostics, IncIndustry Sponsor
Technomics ResearchIndustry Sponsor
Viedoc TechnologiesCollaborator
References
100 consecutive cases of degenerative lumbar conditions using a non-threaded locking screw system with a 90-degree locking cap. [2020]This prospective study analyzes the perioperative outcomes and long-term fusion success of 100 consecutive lumbar degenerative cases. The cases were managed using a non-threaded locking screw system, in conjunction with polyetheretherketone (PEEK) cages, for posterior lumbar interbody fusion (PLIF) procedures. These 100 cases were compared to another prospective study treating patients with the same inclusion and exclusion criteria using conventional plate-based pedicle screw spinal instrumentation augmented with carbon fiber interbody cages.
The in vivo response to a novel Ti coating compared with polyether ether ketone: evaluation of the periphery and inner surfaces of an implant. [2023]Increasing bone ongrowth and ingrowth of polyether ether ketone (PEEK) interbody fusion devices has the potential to improve clinical outcomes.
Flexible Stabilisation of the Degenerative Lumbar Spine Using PEEK Rods. [2020]Posterior lumbar interbody fusion using cages, titanium rods, and pedicle screws is considered today as the gold standard of surgical treatment of lumbar degenerative disease and has produced satisfying long-term fusion rates. However this rigid material could change the physiological distribution of load at the instrumental and adjacent segments, a main cause of implant failure and adjacent segment disease, responsible for a high rate of further surgery in the following years. More recently, semirigid instrumentation systems using rods made of polyetheretherketone (PEEK) have been introduced. This clinical study of 21 patients focuses on the clinical and radiological outcomes of patients with lumbar degenerative disease treated with Initial VEOS PEEK(®)-Optima system (Innov'Spine, France) composed of rods made from PEEK-OPTIMA(®) polymer (Invibio Biomaterial Solutions, UK) without arthrodesis. With an average follow-up of 2 years and half, the chances of reoperation were significantly reduced (4.8%), quality of life was improved (ODI = 16%), and the adjacent disc was preserved in more than 70% of cases. Based on these results, combined with the biomechanical and clinical data already published, PEEK rods systems can be considered as a safe and effective alternative solution to rigid ones.
Comparison of the PEEK cage and an autologous cage made from the lumbar spinous process and laminae in posterior lumbar interbody fusion. [2022]A prospective cohort study was performed to evaluate the clinical and radiological outcomes following posterior lumbar interbody fusion (PLIF) in patients treated with a PEEK cage compared to those treated with an autologous cage using the lumbar spinous process and laminae (ACSP).
Polyetheretherketone (PEEK) Rods for Lumbar Fusion: A Systematic Review and Meta-Analysis. [2022]The purpose of this systematic review is to evaluate the safety and effectiveness of polyetheretherketone (PEEK) rod systems in patients receiving lumbar interbody fusion treatment. Meta-analyses of relevant clinical data were also conducted when possible.
Polyetheretherketone as a biomaterial for spinal applications. [2022]Threaded lumbar interbody spinal fusion devices (TIBFD) made from titanium have been reported to be 90% effective for single-level lumbar interbody fusion, although radiographic determination of fusion has been intensely debated in the literature. Using blinded radiographic, biomechanic, histologic, and statistical measures, we evaluated a radiolucent polyetheretherketone (PEEK)-threaded interbody fusion device packed with autograft or rhBMP-2 on an absorbable collagen sponge in 13 sheep at 6 months. Radiographic fusion, increased spinal level biomechanical stiffness, and histologic fusion were demonstrated for the PEEK cages filled with autograft or rhBMP-2 on a collagen sponge. No device degradation or wear debris was observed. Only mild chronic inflammation consisting of a few macrophages was observed in peri-implant tissues. Based on these results, the polymeric biomaterial PEEK may be a useful biomaterial for interbody fusion cages due to the polymer's increased radiolucency and decreased stiffness.
Posterior lumbar fusion by peek rods in degenerative spine: preliminary report on 30 cases. [2022]Pre-curved peek rods to support posterior lumbar fusion have been available in the market since 4 years. Potential advantages using this new technology are increased load sharing on the anterior column promoting interbody fusion, reduced stress on bone-screw interface decreasing the rate of screw mobilization and, in the long term, reduced incidence of adjacent level disc degeneration.
Do PEEK Rods for Posterior Instrumented Fusion in the Lumbar Spine Reduce the Risk of Adjacent Segment Disease? [2021]Polyetheretherketone (PEEK) rods were clinically introduced in the mid-2000s as an alternative to titanium (Ti) rods for posterior instrumented lumbar spine fusion, theorized to reduce the risk of adjacent segment disease (ASD). However, few studies have follow-up beyond 2 years. Consequently, we conducted a matched cohort study using data from Kaiser Permanente's spine registry to compare the 2 rod systems and risk for outcomes.
Posterior spinal fusion using pedicle screws. [2022]Few clinical studies have reported polyetheretherketone (PEEK) rod pedicle screw spinal instrumentation systems (CD-Horizon Legacy PEEK rods; Medtronic, Minneapolis, Minnesota). This article describes a clinical series of 52 patients who underwent posterior spinal fusion using the PEEK Rod System between 2007 and 2010. Of the 52 patients, 25 had degenerative disk disease, 10 had lateral recess stenosis, 6 had degenerative spondylolisthesis, 6 had lumbar spine vertebral fracture, 4 had combined lateral recess stenosis and degenerative spondylolisthesis, and 1 had an L5 giant cell tumor. Ten patients had 1-segment fusion, 29 had 2-segment fusion, and 13 had 3-segment fusion. Mean follow-up was 3 years (range, 1.5-4 years); no patient was lost to follow-up. Clinical evaluation was performed using the Oswestry Disability Index and a low back and leg visual analog pain scale. Imaging evaluation of fusion was performed with standard and dynamic radiographs. Complications were recorded. Mean Oswestry Disability Index scores improved from 76% preoperatively (range, 52%-90%) to 48% at 6 weeks postoperatively, and to 34%, 28%, and 30% at 3, 6, and 12 months postoperatively, respectively. Mean low back and leg pain improved from 8 and 9 points preoperatively, respectively, to 6 and 5 points immediately postoperatively, respectively, and to 2 points each thereafter. Imaging union of the arthrodesis was observed in 50 (96%) patients by 1-year follow-up. Two patients sustained screw breakage: 1 had painful loss of sagittal alignment of the lumbar spine and underwent revision spinal surgery with pedicle screws and titanium rods and the other had superficial wound infection and was treated with wound dressing changes and antibiotics for 6 weeks. No adjacent segment degeneration was observed in any patient until the time of this writing.