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

• Sponsor: Balgrist University Hospital (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT03893110
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 45.1
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Tumor	Procedure: surgical stabilization of the spine due to primary and secondary spinal tumors	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Carbon PEEK Versus Titanium Pedicle Screws in the Treatment of Spinal Tumors - A Randomized Controlled Trial
• Actual Study Start Date: Jun 27, 2018
• Anticipated Primary Completion Date: Jan 31, 2022
• Anticipated Study Completion Date: Mar 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. radiation dose [within 6 weeks of radiation therapy]

   The total radiation dose administered is measured in Gray

2. feasibility of planning the radiation therapy [before radiation therapy]

   evaluated by a subjective score (0-10) stated by an independent radiooncologist using a visual analogue scale from 0 to 10

Secondary Outcome Measures

1. radiological visualization of the area of interest [during radiation therapy]

   evaluated by a subjective score stated by an independent radiologist using a visual analogue scale from 0 to 10

2. time to recurrence [up to 1 year]

   monitoring of recurrence using radiological imaging is performed routinely according to clinical standards

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Balgrist	Zürich	Zurich	Switzerland	8008

Sponsors and Collaborators

• Balgrist University Hospital

Investigators

• Principal Investigator: Mazda Farshad, Prof., Balgrist University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Balgrist University Hospital
• ClinicalTrials.gov Identifier: NCT03893110
• Other Study ID Numbers: Carbon PEEK
• First Posted: Mar 28, 2019
• Last Update Posted: Apr 30, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Spinal Cord Neoplasms; Spinal Neoplasms

Study Results

No Results Posted as of Apr 30, 2020