Abstract
Purpose
Although there are a significant number of research publications on the topic of bone morphology and the strength of bone, the clinical significance of a failed pedicle screw is often revision surgery and the potential for further postoperative complications; especially in elderly patients with osteoporotic bone. The purpose of this report is to quantify the mechanical strength of the foam-screw interface by assessing probe/pilot hole diameter and tap sizes using statistically relevant sample sizes under highly controlled test conditions.
Methods
The study consisted of two experiments and used up to three different densities of reference-grade polyurethane foam (ASTM 1839), including 0.16, 0.24, and 0.32 g/cm 3. All screws and rods were provided by K2M Inc. and screws were inserted to a depth of 25 mm. A series of pilot holes, 1.5, 2.2, 2.7, 3.2, 3.7, 4.2, 5.0, and 6.0 mm in diameter were drilled through the entire depth of the material. A 6.5 × 45-mm pedicle screw was inserted and axially pulled from the material (n = 720). A 3.0-mm pilot hole was drilled and tapped with: no tap, 3.5-, 4.5-, 5.5-, and 6.5-mm taps. A 6.5 × 45-mm pedicle screw was inserted and axially pulled from the material (n = 300).
Results
The size of the probe/pilot hole had a nonlinear, parabolic effect on pullout strength. This shape suggests an optimum-sized probe hole for a given size pedicle screw. Too large or too small of a probe hole causes a rapid falloff in pullout strength. The tap data demonstrated that not tapping and undertapping by two or three sizes did not significantly alter the pullout strength of the screws. The data showed an exponential falloff of pullout strength when as tap size increased to the diameter of the screw.
Conclusion
In the current study, the data show that an ideal pilot hole size half the diameter of the screw is a starting point. Also, that if tapping was necessary, to use a tap two sizes smaller than the screw being implanted. A similar optimum pilot hole or tap size may be expected in the clinical scenario, however, it may not be the same as seen with the uniform density polyurethane foam tested in the current study.
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Author disclosures: VP (none); AM (none); RL (none); JR (other from K2M, Inc., during the conduct of the study; other from K2M, Inc., outside the submitted work.); JS (other from K2M Inc., during the conduct of the study).
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Prasad, V., Mesfin, A., Lee, R. et al. Probing and Tapping: Are We Inserting Pedicle Screws Correctly?. Spine Deform 4, 395–399 (2016). https://doi.org/10.1016/j.jspd.2016.06.001
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DOI: https://doi.org/10.1016/j.jspd.2016.06.001