Carbon Fiber Transpedicular Screws in Treatment of Spinal Metastatic Disease

NCT06293157 | Recruiting

• 1 other identifier: 2023/ABM/01/00013
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 5

Brief Summary

Background: Spinal metastatic disease constitute a serious clinical problem in oncology. Bones are the third most common organ where metastases are located, and the spine is the place where they are most often located. Due to the complexity of the clinical problem, metastatic spine disease remains of interest to many medical specialties: neurosurgery, orthopedics, clinical oncology, radiotherapy and rehabilitation. With the development of modern diagnostic methods and wider access to them, the demand for neurosurgical treatment in this group of patients is growing. Surgical treatment is undertaken in cases of spinal cord compression, instability, spinal deformation or pain that is resistant to radiotherapy. The standard treatment in most cases is posterior instrumentation of the spine using titanium pedicle screws. Unfortunately, these systems cause numerous artifacts in diagnostic imaging, both in CT and MRI. These distortions make it difficult to plan radiotherapy and determine the optimal dose that would avoid healthy tissues. Moreover, artifacts could make difficult postoperative follow-ups aimed at assessing local recurrence. The solution to these problems is the use of radiolucent implants. There are systems based on carbon fibers embedded in PEEK which do not cause typical artifacts for titanium implants. Study plan: The open, three-arm, prospective randomized study is planned to involve 226 patients with metastatic disease of the spine, with a known or undiagnosed primary site. Patients will be qualified for 2 types of interventions. The first one includes treatment with stereotactic radiotherapy (SBRT) in the first stage of treatment and early instrumentation of the spine with titanium implants. The second type of intervention includes patients qualified for surgical treatment using spine stabilization and postoperative SBRT. Patients within this arm will be randomized into two groups differing in the type of material the instrumentation is made of: carbon-PEEK or titanium. The study group will be patients stabilized with carbon implants, and the control group will be those who will have titanium implants. Study population: The study includes adult patients with metastatic spine disease, with a known or unknown primary tumor, qualified for SBRT and surgical treatment. Assumed effects: It is assumed that the treatment proposed in the project would extend progression free survival by several months or achieve local control in an additional 5% of patients. Moreover, by improving the quality of imaging, earlier diagnosis of local recurrences and implementation of appropriate locoregional treatment would be possible.

Conditions

Metastatic Spinal Cord Compression; Metastasis Spine

Keywords

metastatic spinal disease; stereotactic body radiotherapy; spinal cord compression; carbon fiber reinforced implants

Outcome Measures

Primary Outcomes (2)

• The assessment of time to local recurrence after treatment with SBRT.

  5 years

• The assessment of frequency of local recurrence after treatment with SBRT.

  5 years

Secondary Outcomes (11)

• DICE convergence factor evaluation between groups of patients.

  1 day

• The subjective difficulty of planning radiotherapy treatment.

  1 day

• The frequency of radiation complications assessed according to the National Cancer Institute Common Toxicity Criteria (NCI CTC).

  5 years

• Failure rate of stabilizing systems.

  5 years

• Pain assessment on the VAS scale between groups.

  5 years

Study Arms (3)

Transpedicular spinal stabilization using carbon system + SBRT

EXPERIMENTAL

Transpedicular spinal stabilization using a radiolucent composite system made of carbon fibers and PEEK followed by stereotactic radiotherapy of the spine at a dose of 5x5 Gy (25 Gy in the total dose)

Procedure: Transpedicular spinal stabilization - carbon fibers-based implants; Radiation: Stereotactic body radiotherapy

Transpedicular spinal stabilization using titanium system + SBRT

ACTIVE COMPARATOR

Transpedicular spinal stabilization using a titanium system followed by stereotactic radiotherapy of the spine at a dose of 5x5 Gy (25 Gy in the total dose)

Procedure: Transpedicular spinal stabilization - titanium implants; Radiation: Stereotactic body radiotherapy

SBRT + Transpedicular spinal stabilization using titanium system

SHAM COMPARATOR

Transpedicular spinal stabilization using a titanium system preceded with stereotactic spine radiotherapy at a dose of 5x5 Gy (25 Gy in the total dose) as the first stage of treatment

Procedure: Transpedicular spinal stabilization - titanium implants; Radiation: Stereotactic body radiotherapy

Interventions

Transpedicular spinal stabilization - titanium implants PROCEDURE

Transpedicular stabilization with titanium implants in one of the two possible variants - first involves a large skin incision and separation of the back extensor muscles; second is associated with minimally invasive, which is percutaneous procedure that allows the stabilization with implants without the need to detach the muscles, using only a small skin incision.

SBRT + Transpedicular spinal stabilization using titanium system; Transpedicular spinal stabilization using titanium system + SBRT

Stereotactic body radiotherapy RADIATION

Spinal tumors will be treated with stereotactic body radiotherapy at a dose of 5x5 Gy (25 Gy in a total dose); either prior to or post-surgical treatment, accordingly the allocation to one of the study arms.

Also known as: SBRT

SBRT + Transpedicular spinal stabilization using titanium system; Transpedicular spinal stabilization using carbon system + SBRT; Transpedicular spinal stabilization using titanium system + SBRT

Transpedicular spinal stabilization - carbon fibers-based implants PROCEDURE

Transpedicular stabilization with carbon fiber and PEEK-based implants in one of the two possible variants - first involves a large skin incision and separation of the back extensor muscles; second is associated with minimally invasive, which is percutaneous procedure that allows the stabilization with implants without the need to detach the muscles, using only a small skin incision.

Transpedicular spinal stabilization using carbon system + SBRT

Eligibility Criteria

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

You may qualify if:

• Metastatic spinal disease,
• ECOG quality of life of 0-2,
• Eligibility for SBRT treatment,
• Expected survival time \>3 months,
• Signed informed consent to participate in the study,
• Sufficient organ capacity allowing to survive the perioperative period.

You may not qualify if:

• Primary tumor of the spine,
• Age \<18 years old,
• Expected survival time \<3 months,
• Eligibility for palliative radiotherapy,
• No informed consent to participate in the study,
• Pregnancy or breastfeeding,
• The advancement of the disease preventing the technical use of implants.

Sponsors & Collaborators

• Copernicus Memorial Hospital: lead
• Medical Research Agency, Poland: collaborator

Study Sites (5)

Department of Neurosurgery, Functional Neurosurgery and Stereotaxy, Dr. Jan Biziel University Hospital No. 2 in Bydgoszcz

Bydgoszcz, Poland

ACTIVE NOT RECRUITING

Professor Franciszek Łukaszczyk Oncology Center in Bydgoszcz - National Research Institute

Bydgoszcz, Poland

ACTIVE NOT RECRUITING

Department of Teleradiotherapy, Lower Silesian Center of Oncology, Pulmonology and Hematology

Wroclaw, Poland

ACTIVE NOT RECRUITING

University Center of Neurology and Neurosurgery, Jan Mikulicz-Radecki University Clinical Hospital in Wrocław

Wroclaw, Poland

ACTIVE NOT RECRUITING

Copernicus Memorial Hospital in Łódź, Poland

Lodz, Łódź Voivodeship, 93-513, Poland

RECRUITING

Related Publications (6)

• Cofano F, Di Perna G, Monticelli M, Marengo N, Ajello M, Mammi M, Vercelli G, Petrone S, Tartara F, Zenga F, Lanotte M, Garbossa D. Carbon fiber reinforced vs titanium implants for fixation in spinal metastases: A comparative clinical study about safety and effectiveness of the new "carbon-strategy". J Clin Neurosci. 2020 May;75:106-111. doi: 10.1016/j.jocn.2020.03.013. Epub 2020 Mar 12.

  PMID: 32173153 BACKGROUND

• Boriani S, Tedesco G, Ming L, Ghermandi R, Amichetti M, Fossati P, Krengli M, Mavilla L, Gasbarrini A. Carbon-fiber-reinforced PEEK fixation system in the treatment of spine tumors: a preliminary report. Eur Spine J. 2018 Apr;27(4):874-881. doi: 10.1007/s00586-017-5258-5. Epub 2017 Aug 16.

  PMID: 28815357 BACKGROUND

• Nevelsky A, Borzov E, Daniel S, Bar-Deroma R. Perturbation effects of the carbon fiber-PEEK screws on radiotherapy dose distribution. J Appl Clin Med Phys. 2017 Mar;18(2):62-68. doi: 10.1002/acm2.12046. Epub 2017 Feb 7.

  PMID: 28300369 BACKGROUND

• Ringel F, Ryang YM, Kirschke JS, Muller BS, Wilkens JJ, Brodard J, Combs SE, Meyer B. Radiolucent Carbon Fiber-Reinforced Pedicle Screws for Treatment of Spinal Tumors: Advantages for Radiation Planning and Follow-Up Imaging. World Neurosurg. 2017 Sep;105:294-301. doi: 10.1016/j.wneu.2017.04.091. Epub 2017 May 3.

  PMID: 28478252 BACKGROUND

• Neal MT, Richards AE, Curley KL, Patel NP, Ashman JB, Vora SA, Kalani MA. Carbon fiber-reinforced PEEK instrumentation in the spinal oncology population: a retrospective series demonstrating technique, feasibility, and clinical outcomes. Neurosurg Focus. 2021 May;50(5):E13. doi: 10.3171/2021.2.FOCUS20995.

  PMID: 33932921 BACKGROUND

• Lindtner RA, Schmid R, Nydegger T, Konschake M, Schmoelz W. Pedicle screw anchorage of carbon fiber-reinforced PEEK screws under cyclic loading. Eur Spine J. 2018 Aug;27(8):1775-1784. doi: 10.1007/s00586-018-5538-8. Epub 2018 Mar 1.

  PMID: 29497852 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Compression; Spinal Diseases

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Injuries; Wounds and Injuries; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Kamil Krystkiewicz, PhD

  Department of Neurosurgery and Neurooncology, Copernicus Memoriał Hospital in Łódź

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kamil Krystkiewicz, PhD

CONTACT

+48426895341; kamil.krystkiewicz@gmail.com

Marcin Tosik, PhD

CONTACT

+48426895341; sekretariat.neurochirurgia@kopernik.lodz.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 17, 2024
• First Posted: March 5, 2024
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2033
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (5)