Clinical trial NCT06293157: Carbon Fiber Transpedicular Screws in Treatment of Spinal Metastatic Disease
Official title: Carbon Fiber Transpedicular Screws in Treatment of Spinal Metastatic Disease and Stereotactic Radiotherapy - a Prospective, Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metastatic Spinal Cord Compression
Metastasis Spine
Keywords: metastatic spinal disease
stereotactic body radiotherapy
spinal cord compression
carbon fiber reinforced implants
Lead sponsor: Copernicus Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Medical Research Agency, Poland
First posted: 2024-03-05
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The assessment of time to local recurrence after treatment with SBRT.
timeFrame: 5 years
measure: The assessment of frequency of local recurrence after treatment with SBRT.
timeFrame: 5 years
Secondary outcomes:
measure: DICE convergence factor evaluation between groups of patients.
timeFrame: 1 day
measure: The subjective difficulty of planning radiotherapy treatment.
timeFrame: 1 day
measure: The frequency of radiation complications assessed according to the National Cancer Institute Common Toxicity Criteria (NCI CTC).
timeFrame: 5 years
measure: Failure rate of stabilizing systems.
timeFrame: 5 years
measure: Pain assessment on the VAS scale between groups.
timeFrame: 5 years
measure: Frequency of postoperative infections.
timeFrame: 5 years
measure: Differences in dosimetric parameter Dmin PTV/CTV.
timeFrame: 1 day
measure: Differences in dosimetric parameter D95.
timeFrame: 1 day
measure: Differences in dosimetric parameter D98.
timeFrame: 1 day
measure: Differences in dosimetric parameter D100.
timeFrame: 1 day
measure: Differences in dosimetric parameter conformity index (CI) / homogeneity index (HI)).
timeFrame: 1 day
Other outcomes:
Locations:
city: Łódź
country: Poland
facility: Copernicus Memorial Hospital in Łódź, Poland
state: Łódzkie
Study officials:
affiliation: Department of Neurosurgery and Neurooncology, Copernicus Memoriał Hospital in Łódź
name: Kamil Krystkiewicz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.