Titanium vs Polymer Spinal Cages for Spinal Conditions
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ohio State University
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing two different types of spinal implants in patients needing back surgery to see which one works better. The implants help stabilize the spine and promote bone growth to fuse the vertebrae together.
What safety data exists for titanium and PEEK spinal cages?The safety data for titanium and PEEK spinal cages includes studies on bacterial adhesion characteristics, fusion rates, and biomechanical properties. Titanium cages may have lower nonunion rates compared to PEEK cages, which are favored for their radiologic visibility. However, PEEK cages have been associated with higher nonunion rates. Research also explores the use of composite titanium/PEEK cages and synthetic bone graft substitutes, indicating a need for further long-term studies. Additionally, PEEK has been used in spinal implants since 1999, with ongoing investigations into new porous versions.12589
What data supports the idea that Titanium vs Polymer Spinal Cages for Spinal Conditions is an effective treatment?The available research shows that titanium-coated PEEK cages may be more effective than plain PEEK cages because they have lower rates of nonunion, which means the bones are more likely to heal together properly. Additionally, titanium and calcium phosphate nanocoated PEEK cages have shown positive results in terms of safety and effectiveness up to one year after surgery. This suggests that titanium coatings can improve the performance of spinal cages compared to uncoated PEEK cages.34589
Is the Medtronic CAPSTONE PEEK Cage a promising treatment for spinal conditions?The Medtronic CAPSTONE PEEK Cage is a promising treatment because it offers better visibility in MRI scans compared to titanium cages, which helps doctors see how well the treatment is working. It is also widely used in spinal surgeries due to its good compatibility with the body.56789
Do I need to stop taking my current medications for the trial?The trial protocol 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.
Eligibility Criteria
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 need bone grafting materials beyond local autograft bone or GRAFTON™.
I currently have an infection.
I have an open wound near my surgery area or severe joint/bone issues.
I have had spine fusion surgery in my lower back.
My BMI is over 45, classifying me as morbidly obese.
I have insufficient tissue over my surgery area.
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Medtronic Adaptix™ titanium implantsExperimental Treatment1 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 cageActive Control1 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).
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
The Ohio State University Wexner Medical Center Neurological SurgeryColumbus, OH
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Who is running the clinical trial?
Ohio State UniversityLead Sponsor
References
Biomechanical rigidity of an all-polyetheretherketone anterior thoracolumbar spinal reconstruction construct: an in vitro corpectomy model. [2022]Polyetheretherketone (PEEK) is gaining favor as a spinal implant material for interbody and corpectomy cages as well as stabilizing rods. However, there has been little correlation to a relevant and reproducible clinical model. Biomechanical data on PEEK rod constructs have not been reported.
Mechanical and in vitro investigation of a porous PEEK foam for medical device implants. [2021]Implantable-grade polyetheretherketone (PEEK-OPTIMA®) is a high-performance thermoplastic that has been used in implant devices such as spinal-fusion cages since its introduction in 1999. Here, a new porous PEEK version was investigated.
Comparative Study between a Curved and a Wedge PEEK Cage for Single-level Anterior Cervical Discectomy and Interbody Fusion. [2020]This study evaluated the efficiency of a curved polyetheretherketone (PEEK) cage in comparison with a wedge PEEK cage according to radiologic and clinical outcomes in patients with cervical degenerative disease.
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. [2022]Polyetheretherketone (PEEK) is a popular material for posterior lumbar interbody fusion (PLIF) cages, although osseointegration remains limited. To optimize PEEK cage characteristics, titanium (Ti) and calcium phosphate (CaP) nanocoatings have been developed with proven mechanical safety. This multicenter randomized controlled trial compared the clinical and radiological outcome parameters of nanocoated and uncoated PEEK cages, up to 1 year after surgery.
Bacterial adhesion characteristics on implant materials for intervertebral cages: titanium or PEEK for spinal infections? [2021]Surgical intervention with intercorporal stabilisation in spinal infections is increasingly needed. Our aim was to compare titanium and polyetheretherketon (PEEK) cages according to their adhesion characteristics of different bacteria species in vitro.
Vacuum plasma sprayed porous titanium coating on polyetheretherketone for ACDF improves the osteogenic ability: An in vitro and in vivo study. [2021]Cervical degenerative disease is a common and frequently occurring disease, which seriously affects the health and quality of the life of patients worldwide. Anterior cervical decompression and interbody fusion is currently recognized as the gold standard for the treatment of degenerative cervical spondylosis. Polyetheretherketone (PEEK) has become the prevailing material for cervical fusion surgery. Although PEEK has excellent biocompatibility, it is difficult to form bone connection at its bone-implant interface due to its low surface hydrophilicity and conductivity. It is widely accepted that Ti has excellent osteogenic activity and biocompatibility. In this study, a Ti-PEEK composite cage was prepared by coating Ti on the surface of a PEEK cage using a vacuum plasma spraying technique to enhance the osteogenic property of PEEK. The Ti-PEEK samples were evaluated in terms of their in vitro cellular behaviors and in vivo osteointegration, and the results were compared to a pure PEEK substrate. The skeleton staining and MTS assay indicated that the MC3T3-E1 cells spread and grew well on the surface of Ti-PEEK cages. The osteogenic gene expression and western blot analysis of osteogenic protein showed upregulated bone-forming activity of MC3T3-E1 cells in Ti-PEEK cages. Furthermore, a significant increase in new bone formation was demonstrated on Ti-PEEK implants in comparison with PEEK implants at 12 weeks in a sheep cervical spine fusion test. These results proved that the Ti-PEEK cage exhibited enhanced osseointegrative properties compared to the PEEK cage both in vitro and in vivo.
Comparison of Outcomes Between Cage Materials Used for Patients Undergoing Anterior Cervical Discectomy and Fusion with Standalone Cages: A Systematic Review and Meta-Analysis. [2022]Interbody cages are currently being used to address diseases of the vertebra requiring surgical stabilization. Titanium cages were first introduced in 1988. Polyetheretherketone (PEEK) cages are used frequently as one of the alternatives to titanium cages in current practice. This study aimed to compare available cage materials by reviewing the surgical and radiographic outcomes following anterior cervical discectomy and fusion.
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]Despite increasing promising reports regarding composite titanium (Ti)/PolyEtherEtherKetone (PEEK) cages, further longer-term, quality research is required. Synthetic bone graft substitutes are another rapidly developing area of spinal surgical research.
PEEK Cages versus Titanium-Coated PEEK Cages in Single-Level Anterior Cervical Fusion: A Randomized Controlled Study. [2023]The implantation of a spacer is a common practice after anterior diskectomy in cervical spine. Polyether ether ketone (PEEK) cages have replaced titanium implants due to their better radiologic visibility and appearance in postoperative magnetic resonance imaging (MRI) scans. However, PEEK showed apparently higher nonunion rates than titanium cages. The aim of the study was to evaluate the fusion behavior of plain PEEK cages in comparison to titanium-coated PEEK (TiPEEK) cages.