To evaluate the feasibility and accuracy of a robotic device used clinically in soft tissues (abdomen and lung), modified in design and workflow, to perform needle insertion in percutaneous bone procedures. The primary objective was safety (severe complications) of robotic-assisted insertion in this new application. Secondary objectives were feasibility (placement technical success), performance (acceptable insertions rate), accuracy (lateral deviation), number of intermediate CT-scans and tolerance (minor/moderate complications). Robotic-assisted insertions were performed by six interventional radiologists on three male pigs under general anaesthesia. Needle trajectory was planned on the device software, then needles were inserted with robotic guidance to reach the cortical bone; an intermediate CT-scan was then performed to verify needle direction; if needed, the trajectory was modified, and robotic-assisted modified insertion to target was performed. As many intermediate CT scans and trajectory modifications as needed by the operator were allowed. 28 needles were inserted (10 spine, 18 pelvis). No complication was reported. Technical success rate was 96.4% (27/28). One insertion was not feasible after several robotic attempts. The placement success rate was 100% (27/27). After the planned intermediate CT-scan, 13/27 (48.1%) trajectories did not require any modification, and 11/27 trajectories (40.7%) required a single modification. One needle was removed and replaced to achieve correct placement. Placement accuracy was similar for spinal and pelvic insertions, with a mean lateral deviation of 2.1 mm (±1.3). Pre-clinical robotic-assisted needle insertions in bone were safe and feasible, with satisfactory accuracy. A multicentre first-in-human study is on-going to evaluate feasibility and safety for percutaneous bone ablation and consolidation procedures.
Background: Evaluation of local anesthesia for perioperative pain control in patients undergoing CT-guided percutaneous osteosynthesis. Methods: A total of 12 patients underwent percutaneous osteosynthesis under local anesthesia. Intraoperative pain was assessed after the procedure using numerical rating scale (NRS). Patients were also asked to rate their overall experience of the operation using the following scale: “highly comfortable, comfortable, hardly comfortable, uncomfortable” and, finally, “Would you be willing to repeat this intervention again under the same conditions if necessary?” Patients were also clinically followed up at 1 month, 3 months, and 6 months using the EQ5D5L scale to assess their pain and quality of life. Results: Patients underwent percutaneous osteosynthesis for osteoporotic (n = 9), pathological (n = 2), or traumatic fractures (n = 1), including the thoraco-lumbar spine (n = 8) or the pelvis (n = 4). The mean of NRS value experienced during the procedure was 3.4/10 (0–8). The overall feeling was highly comfortable (42%), comfortable (50%), hardly comfortable (8%), and uncomfortable (0%). Finally, 75% of patients answered “YES” to the question of repeating the operation under the same conditions if necessary. At follow-up, a significant reduction in pain was observed postoperatively. According to the EQ5D5L scale, there was a significant improvement in pain, mobility, self-activities, autonomy, and perceived quality of life at 3 and 6 months. Conclusion: Radiological percutaneous osteosynthesis is an effective technique that can be performed under local anesthesia with a comfortable experience for most of the patients.
14 May 2024 in Journal of Vascular and Interventional Radiology