Carbon PEEK Versus Titanium Pedicle Screws in the Treatment of Spinal Tumors

Study Overview
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Brief Summary
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Radiation therapy is a cornerstone in the treatment of spinal neoplasms as radical resections are often limited anatomically. Frequently, a surgical stabilization with implants is required. However, metallic implants not only make the CT-based planning of a subsequent radiation therapy more difficult, but might also have an uncontrolled dose modulating effect in adjuvant radiotherapy. At the spine, radiation is limited by the effective dose posed to the relatively radiosensitive spinal cord. While metallic implants might result in an inhomogeneous and uncontrollable dose distribution due to the interface effect, the use of new radiolucent implants consisting of carbon/polyether ether ketone (PEEK) might allow a more homogeneous and predictable dose distribution. This study aims to evaluate the potential benefits of the use of carbon/PEEK pedicle screws during adjuvant radiation therapy and follow-up imaging of spinal tumors. 60 patients will randomized 1:1 into either treatment arm (Pedicle System Carbon/PEEK vs. Pedicle System Titanium). The feasibility of planning the radiation therapy will be evaluated. The postoperatively administered total radiation dose is documented. The radiological visualization of the area of interest will be evaluated The surgical outcome is evaluated by fusion rate, implant integrity and anchorage. Patients will be followed up for 12 months according to local standards.

Official Title
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Carbon PEEK Versus Titanium Pedicle Screws in the Treatment of Spinal Tumors - A Randomized Controlled Trial

Conditions
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Spinal Tumor

Intervention / Treatment
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* Procedure: surgical stabilization of the spine due to primary and secondary spinal tumors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 to 99 years of Age Primary and secondary spinal tumors of the thoracolumbar spine requiring posterior instrumentation and radiation therapy Exclusion Criteria: Need of cement augmentation or anterior cage support (corpectomy) Patients with contraindication against surgical resection Patients with incomplete medical records or insufficient imaging

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Instrumentation with Carbon/PEEK pedicle screw system<br>Posterior instrumentation using a Carbon/PEEK pedicle screw system two levels above and below the affected segment(s). The medical device is a commercial product, bears a conformity marking and is used in accordance with the instructions. | Procedure: surgical stabilization of the spine due to primary and secondary spinal tumors<br>* Posterior instrumentation with pedicle screw system<br>|
| Active Comparator: Instrumentation with titanium pedicle screw system<br>Posterior instrumentation using a titanium pedicle screw system two levels above and below the affected segment(s). The medical device is a commercial product, bears a conformity marking and is used in accordance with the instructions. | Procedure: surgical stabilization of the spine due to primary and secondary spinal tumors<br>* Posterior instrumentation with pedicle screw system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radiation dose | The total radiation dose administered is measured in Gray | within 6 weeks of radiation therapy | 
| feasibility of planning the radiation therapy | evaluated by a subjective score (0-10) stated by an independent radiooncologist using a visual analogue scale from 0 to 10 | before radiation therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radiological visualization of the area of interest | evaluated by a subjective score stated by an independent radiologist using a visual analogue scale from 0 to 10 | during radiation therapy | 
| time to recurrence | monitoring of recurrence using radiological imaging is performed routinely according to clinical standards | up to 1 year |