Spinal TumorNCT03893110
Carbon PEEK Versus Titanium Pedicle Screws in the Treatment of Spinal Tumors
A study testing surgical stabilization of the spine due to primary and secondary spinal tumors in people with Spinal Tumor, run by Balgrist University Hospital at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Spinal Tumor
- What is being tested?
- surgical stabilization of the spine due to primary and secondary spinal tumors
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 Jun 2018to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 to 99 years of Age
- Primary and secondary spinal tumors of the thoracolumbar spine requiring posterior instrumentation and radiation therapy
Who cannot join
- Need of cement augmentation or anterior cage support (corpectomy)
- Patients with contraindication against surgical resection
- Patients with incomplete medical records or insufficient imaging
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Balgrist
Zurich, Canton of Zurich, 8008
About this study
Official title: 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.
- Conditions
- Spinal Tumor
- Being tested
- surgical stabilization of the spine due to primary and secondary spinal tumors
- Medical subject headings
- Spinal Cord Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical stabilization of the spine due to primary and secondary spinal tumorsProcedure or surgery
Posterior instrumentation with pedicle screw system
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: surgical stabilization of the spine due to primary and secondary spinal tumors |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiation dose
The total radiation dose administered is measured in Gray
Measured: 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
Measured: before radiation therapy
Secondary outcomes (2)
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
Measured: during radiation therapy
time to recurrence
monitoring of recurrence using radiological imaging is performed routinely according to clinical standards
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start27 Jun 2018
- Primary completion31 Jan 2022
- Study completion31 Mar 2022
Why it stopped: Absence of Co-investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mazda Farshad, Prof., Principal investigator, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893110
- Sponsor's protocol ID
- Carbon PEEK
- Status last verified
- Apr 2020
- First submitted
- 4 Feb 2019
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD only available to study personnel. statistical analysis will be done with encoded data only. study results will be published
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbon PEEK Versus Titanium Pedicle Screws in the Treatment of Spinal Tumors - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03893110
- Acronym / sponsor ID
- Carbon PEEK
- Conditions
- Spinal Tumor
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Absence of Co-investigator
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 28 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Instrumentation with Carbon/PEEK pedicle screw system | Experimental | Procedure: surgical stabilization of the spine due to primary and secondary spinal tumorsPosterior 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. |
| Instrumentation with titanium pedicle screw system | Active comparator | Procedure: surgical stabilization of the spine due to primary and secondary spinal tumorsPosterior 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 to 99 years of Age
- Primary and secondary spinal tumors of the thoracolumbar spine requiring posterior instrumentation and radiation therapy
Key exclusion criteria (3 listed)
- Need of cement augmentation or anterior cage support (corpectomy)
- Patients with contraindication against surgical resection
- Patients with incomplete medical records or insufficient imaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical stabilization of the spine due to primary and secondary spinal tumorsPosterior instrumentation with pedicle screw system | Procedure or surgery | Instrumentation with Carbon/PEEK pedicle screw system, Instrumentation with titanium pedicle screw system |
Primary outcome
radiation dose
Time frame: within 6 weeks of radiation therapy
The total radiation dose administered is measured in Gray
feasibility of planning the radiation therapy
Time frame: before radiation therapy
evaluated by a subjective score (0-10) stated by an independent radiooncologist using a visual analogue scale from 0 to 10
2 secondary outcomes
radiological visualization of the area of interest
Time frame: during radiation therapy
time to recurrence
Time frame: up to 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No. IPD only available to study personnel. statistical analysis will be done with encoded data only. study results will be published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mazda Farshad, Prof. principal investigator
Balgrist University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgical stabilization of the spine due to primary and secondary spinal tumors in people with Spinal Tumor, run by Balgrist University Hospital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radiation dose (time frame: within 6 weeks of radiation therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.