Carbon Fiber Transpedicular Screws in Treatment of Spinal Metastatic Disease and Stereotactic Radiotherapy - a Prospective, Randomized Trial

What this Trial Is About

Researchers are studying the treatment of metastatic spinal disease, a serious condition where cancer spreads to the spine, causing pain, spinal cord compression, instability, and deformation. This trial focuses on comparing different surgical and radiotherapy approaches to improve patient outcomes. It aims to evaluate the use of carbon fiber implants versus traditional titanium implants to reduce imaging artifacts and enhance treatment planning and follow-up. The study involves adult patients with spinal metastases who are eligible for stereotactic radiotherapy (SBRT) and surgery. The trial includes three groups: one receiving spinal stabilization with carbon fiber and PEEK implants followed by SBRT, another with titanium implants followed by SBRT, and a third group receiving SBRT first, then stabilization with titanium implants. Surgical procedures may be either open with a large incision or minimally invasive using small incisions. Radiotherapy is delivered as a total dose of 25 Gy in five fractions. Patients are randomly assigned to these treatment groups to compare outcomes. Participants will be monitored for up to five years to assess the time and frequency of local cancer recurrence after SBRT. Researchers will also evaluate radiation treatment planning difficulty, radiation side effects, implant failure, infection rates, and pain levels. Dosimetric parameters related to radiation dose distribution will be measured shortly after treatment. Patient health, imaging quality, and long-term treatment effects will be closely followed through regular assessments and clinical evaluations.

Carbon Fiber Transpedicular Screws in Treatment of Spinal Metastatic Disease