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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-27

Study Completion Date

2022-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Spinal Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

Posterior instrumentation with pedicle screw system

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

Posterior instrumentation with pedicle screw system

Interventions

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

Posterior instrumentation with pedicle screw system

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No