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

Spinal Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03893110
• Other study ID #: Carbon PEEK
• Status: Withdrawn
• Phase: N/A
• Start date: June 27, 2018
• Est. completion date: March 31, 2022

Study information

• Verified date: April 2020
• Source: Balgrist University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Neoplasms
• Spinal Neoplasms
• Spinal Tumor

Intervention

Procedure:
• surgical stabilization of the spine due to primary and secondary spinal tumors
Posterior instrumentation with pedicle screw system

Locations

Country	Name	City	State
Switzerland	University Hospital Balgrist	Zürich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	radiation dose	The total radiation dose administered is measured in Gray	within 6 weeks of radiation therapy
Primary	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	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
Secondary	time to recurrence	monitoring of recurrence using radiological imaging is performed routinely according to clinical standards	up to 1 year