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

NCT03893110 | Withdrawn DMC

• 1 other identifier: Carbon PEEK
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Tumor

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• radiological visualization of the area of interest

  during radiation therapy

• time to recurrence

  up to 1 year

Study Arms (2)

Instrumentation with Carbon/PEEK pedicle screw system

EXPERIMENTAL

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

Instrumentation with titanium pedicle screw system

ACTIVE COMPARATOR

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

Interventions

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

Posterior instrumentation with pedicle screw system

Instrumentation with Carbon/PEEK pedicle screw system; Instrumentation with titanium pedicle screw system

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 to 99 years of Age
• Primary and secondary spinal tumors of the thoracolumbar spine requiring posterior instrumentation and radiation therapy

You may not qualify if:

• Need of cement augmentation or anterior cage support (corpectomy)
• Patients with contraindication against surgical resection
• Patients with incomplete medical records or insufficient imaging

Sponsors & Collaborators

• Balgrist University Hospital: lead

Study Sites (1)

University Hospital Balgrist

Zurich, Canton of Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Mazda Farshad, Prof.

  Balgrist University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: March 28, 2019
• Study Start: June 27, 2018
• Primary Completion: January 31, 2022
• Study Completion: March 31, 2022
• Last Updated: April 30, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)