Study design:

A single-center randomized controlled study.

Objective:

The objective of this study was to introduce a novel robotic system with an independent arm (“Orthbot Intelligent Orthopedic Minimally Invasive System”; Xin Junte Surgical Technologies) that has been developed and tested as a surgical assistant for autoplacement of the Kirschner wire (K-wire) in lumbar fusion, and to evaluate its accuracy by comparing it with the conventional free-hand instrumentation.

Summary of background data:

Robotic technology has performed excellently in spine surgeries and has demonstrated high clinical value and potential. Robot-assisted spinal surgery is now being promoted as a paradigm for technology-led advancement.

Materials and methods:

A total of 24 patients were recruited and assigned randomly to the robotic arm group (RG) or the free-hand group (FG). Deviation distance and deviation angle (DA) of K-wire placement were measured and compared between the RG and the FG.

Results:

The average deviation distance was 0.88±0.08 mm in the RG and 5.13±1.68 mm in the FG (P<0.001). In both coronal and sagittal radiographs, the average DA of K-wire placement was smaller in the RG (P<0.05), and in both axial and sagittal computed tomography scans, the average DA of pedicle screw placement was also lower in the RG (P<0.05), which indicated higher accuracy of the robotic system.

Conclusions:

The novel robotic system in this study has shown certain advantages over the conventional free-hand approach in K-wire placement for lumbar fusion, including being more accurate in K-wire placement, fully automatic, and more adaptive to preoperative plans. Although the robotic arm proves to be promising in our results, the small sample size in this clinical study necessitates further multicenter, large sample follow-up studies to verify its advantages.