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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Instrumentation with Carbon/PEEK pedicle screw system | Experimental | 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. |
|
| Instrumentation with titanium pedicle screw system | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| surgical stabilization of the spine due to primary and secondary spinal tumors | Procedure | Posterior instrumentation with pedicle screw system |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mazda Farshad, Prof. | Balgrist University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Balgrist | Zurich | Canton of Zurich | 8008 | Switzerland |
IPD only available to study personnel. statistical analysis will be done with encoded data only. study results will be published
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| ID | Term |
|---|---|
| D013120 | Spinal Cord Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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monitoring of recurrence using radiological imaging is performed routinely according to clinical standards
| up to 1 year |
| D013118 |
| Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |