Spinal Tumor Clinical Trial
Official title:
Carbon PEEK Versus Titanium Pedicle Screws in the Treatment of Spinal Tumors - A Randomized Controlled Trial
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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