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

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.

Study Overview

• Status: Withdrawn
• Conditions: Spinal Tumor
• Intervention / Treatment: Procedure: surgical stabilization of the spine due to primary and secondary spinal tumors

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich
    • Zürich, Zurich, Switzerland, 8008
      • University Hospital Balgrist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Instrumentation with Carbon/PEEK pedicle screw system; 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.	Procedure: surgical stabilization of the spine due to primary and secondary spinal tumors; Posterior instrumentation with pedicle screw system
Active Comparator: Instrumentation with titanium pedicle screw system; 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.	Procedure: surgical stabilization of the spine due to primary and secondary spinal tumors; Posterior instrumentation with pedicle screw system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	monitoring of recurrence using radiological imaging is performed routinely according to clinical standards	up to 1 year

Collaborators and Investigators

• Sponsor: Balgrist University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2018
• Primary Completion (Anticipated): January 31, 2022
• Study Completion (Anticipated): March 31, 2022

Study Registration Dates

• First Submitted: February 4, 2019
• First Submitted That Met QC Criteria: March 26, 2019
• First Posted (Actual): March 28, 2019

Study Record Updates

• Last Update Posted (Actual): April 30, 2020
• Last Update Submitted That Met QC Criteria: April 28, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Musculoskeletal Diseases; Spinal Cord Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Spinal Diseases; Bone Diseases; Bone Neoplasms; Spinal Cord Neoplasms; Spinal Neoplasms
• Other Study ID Numbers: Carbon PEEK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD only available to study personnel. statistical analysis will be done with encoded data only. study results will be published

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No