Robotic-Assisted Computed Tomography-Guided Percutaneous Bone Procedures: A Prospective Multicenter Pilot Study.

PURPOSE: To prospectively evaluate the feasibility, safety, and targeting accuracy of robotic-assisted CT-guided percutaneous bone procedures.

MATERIALS AND

METHODS

This prospective multicenter pilot study included adult patients undergoing CT-guided percutaneous bone consolidation or tumor ablation between September 2024 and January 2025 at three academic institutions. All procedures were planned and performed using the Epione® robotic platform. Targets included the thoracic and lumbar spine and the pelvis. The primary endpoint was feasibility of robotic-assisted needle insertion, defined as successful needle placement without conversion to manual technique. Secondary endpoints included safety, targeting accuracy, procedural time, and radiation dose. Targeting accuracy was measured as lateral tip deviation and angular deviation between planned and final needle positions.

RESULTS

Thirty-four patients underwent 90 needle insertions, including 66 in the spine (73.3%) and 24 in the pelvis (26.7%). Indications were bone consolidation in 87/90 insertions (97%) and tumor ablation in 3/90 (3%). Robotic insertion was feasible in 89/90 insertions (98.9%). Seven adverse events occurred in 6 patients (17.6%), including four serious events, none related to the device or procedure. Mean lateral tip deviation was 2.0 ± 1.4 mm, and mean angular deviation was 3.1° ± 2.7°. Mean dose-length product was 3224 ± 2215 mGy.cm. Mean total procedure time was 03 h 09 min ± 50 min.

CONCLUSIONS

Robotic-assisted CT-guided bone procedures showed high feasibility and satisfactory targeting accuracy, with no device- or procedure-related adverse events. These findings support further evaluation in larger comparative studies.

CLINICAL TRIAL REGISTRATION: NCT06376682.