A new paradigm for staging pedicle screw-based spinal procedures: rationale, feasibility, safety, and efficacy.

Object: The aims of this study were to present the rationale for and the evolution of a staged, two-procedure paradigm for spinal surgery requiring pedicle screw instrumentation, and to evaluate the feasibility, safety, and efficacy of the technique.

Methods: The rationale for the new algorithm is presented for consideration in the form of unproven hypotheses subject to verification by subsequent studies. The first stage of the two-staged algorithm, performed in an interventional radiology (IR) setting, involves percutaneous placement of either headless pedicle screws or K-wire fragment placeholders of the trajectory for pedicle screws. The second stage, performed days or weeks later, involves open surgical completion of instrumentation placement and other surgical objectives. The techniques for IR percutaneous K-wire fragment and percutaneous screw placement evolved over the duration of the study. Instrumentation was placed in 126 pedicles in 25 patients. Efficacy was equated to the accuracy of screw placement, which was evaluated using computed tomography (CT). Algorithms incorporating correction for metal artifact were developed to determine deviation of the screws and K-wire fragments from proper position. Over 1500 measurements were made to evaluate K-wire fragment and screw position in the 116 instrumented pedicles for which CT data were available.

Results: Accuracy of placement (relative to both cortical and pedicle breaches or to only pedicle breaches) was 98 to 100% for K-wire fragments, 96 to 98% for screws following K-wire fragments, and 100% for percutaneous screws. The only adverse consequence of pedicle screw placement by this method was one infection that occurred 8 months postoperatively.

Conclusions: The staged, two-procedure paradigm for pedicle screw placement proved, within the limits of this study, to be feasible, safe, and effective; therefore, the unproven rationale behind the new paradigm merits further evaluation in a larger cohort of patients with randomized, matched controls.