Carbon Fiber Transpedicular Screws in Treatment of Spinal Metastatic Disease

NARecruitingINTERVENTIONAL
Enrollment

226

Participants

Timeline

Start Date

December 1, 2023

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2033

Conditions
Metastatic Spinal Cord CompressionMetastasis Spine
Interventions
PROCEDURE

Transpedicular spinal stabilization - carbon fibers-based implants

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.

PROCEDURE

Transpedicular spinal stabilization - titanium implants

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.

RADIATION

Stereotactic body radiotherapy

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.

Trial Locations (1)

93-513

RECRUITING

Copernicus Memorial Hospital in Łódź, Poland, Lodz

Sponsors
All Listed Sponsors
collaborator

Medical Research Agency, Poland

OTHER_GOV

lead

Copernicus Memorial Hospital

OTHER

NCT06293157 - Carbon Fiber Transpedicular Screws in Treatment of Spinal Metastatic Disease | Biotech Hunter | Biotech Hunter