NCT03893110

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Balgrist University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Tumor

Interventions

Type	Name	Description
PROCEDURE	surgical stabilization of the spine due to primary and secondary spinal tumors	Posterior instrumentation with pedicle screw system

Timeline

• Start date: 2018-06-27
• Primary completion: 2022-01-31
• Completion: 2022-03-31
• First posted: 2019-03-28
• Last updated: 2020-04-30

Locations

1 site across 1 country: Switzerland