Carbon Fiber Transpedicular Screws in Treatment of Spinal Metastatic Disease

Trial Title: Carbon Fiber Transpedicular Screws in Treatment of Spinal Metastatic Disease

NCT ID: NCT06293157

Condition: Metastatic Spinal Cord Compression
Metastasis Spine

Conditions: Official terms:
Neoplasm Metastasis
Spinal Cord Compression
Carbon Fiber

Conditions: Keywords:
metastatic spinal disease
stereotactic body radiotherapy
spinal cord compression
carbon fiber reinforced implants

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Transpedicular spinal stabilization - carbon fibers-based implants
Description: 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.
Arm group label: Transpedicular spinal stabilization using carbon system + SBRT

Intervention type: Procedure
Intervention name: Transpedicular spinal stabilization - titanium implants
Description: 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.
Arm group label: SBRT + Transpedicular spinal stabilization using titanium system
Arm group label: Transpedicular spinal stabilization using titanium system + SBRT

Intervention type: Radiation
Intervention name: Stereotactic body radiotherapy
Description: 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.
Arm group label: SBRT + Transpedicular spinal stabilization using titanium system
Arm group label: Transpedicular spinal stabilization using carbon system + SBRT
Arm group label: Transpedicular spinal stabilization using titanium system + SBRT

Other name: SBRT

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Copernicus Memorial Hospital in Łódź, Poland

Address:
City: Łódź
Zip: 93-513
Country: Poland

Status: Recruiting

Contact:
Last name: Kamil Krystkiewicz, PhD

Phone: +48426895341
Email: kamil.krystkiewicz@gmail.com

Start date: December 1, 2023

Completion date: December 31, 2033

Lead sponsor:
Agency: Copernicus Memorial Hospital
Agency class: Other

Collaborator:
Agency: Medical Research Agency, Poland
Agency class: Other

Source: Copernicus Memorial Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06293157