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

NCT03893110 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-04-30

No results posted yet for this study

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

PROCEDURE

surgical stabilization of the spine due to primary and secondary spinal tumors

Posterior instrumentation with pedicle screw system

Sponsors & Collaborators

  • Balgrist University Hospital

    lead OTHER

Principal Investigators

  • Mazda Farshad, Prof. · Balgrist University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-27
Primary Completion
2022-01-31
Completion
2022-03-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03893110 on ClinicalTrials.gov