Spinal Tumor
Conditions
Brief summary
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.
Interventions
PROCEDUREsurgical stabilization of the spine due to primary and secondary spinal tumors
Posterior instrumentation with pedicle screw system
Sponsors
Balgrist University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| radiation dose | within 6 weeks of radiation therapy | The total radiation dose administered is measured in Gray |
| feasibility of planning the radiation therapy | before radiation therapy | evaluated by a subjective score (0-10) stated by an independent radiooncologist using a visual analogue scale from 0 to 10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| radiological visualization of the area of interest | during radiation therapy | evaluated by a subjective score stated by an independent radiologist using a visual analogue scale from 0 to 10 |
| time to recurrence | up to 1 year | monitoring of recurrence using radiological imaging is performed routinely according to clinical standards |
Countries
Switzerland
Outcome results
None listed