Abstract

Ensuring the accuracy of transclavicular-transcoracoid drilling in the anatomical reconstruction of the coracoclavicular ligament complex with minimally invasive incisions remains a major problem for inexperienced surgeons. The purpose of this study was to design an assembly guide device for transclavicular-transcoracoid drilling with minimally invasive incisions, to manufacture the finished product, and to compare its feasibility and accuracy with the existing C-shape guide devices and free-hand techniques. An assembly-type guide device was designed and produced using computer-aided design and three-dimensional printing. The specimen data of 54 human shoulders from 27 gross specimen (14 males and 13 females) treated by free-hand drilling, C-shape device drilling, and assembly-type guide device drilling from October 2018 to January 2021 were analyzed in a controlled laboratory study. Fifty-four human shoulder specimens were randomly assigned into free-hand (n=18), C-shape (n=18), and assembly (n=18) groups by drawing lots for transclavicular-transcoracoid drilling by three inexperienced surgeons. After the drilling procedure was completed and the devices were removed, the operation outcomes were assessed and evaluated. Distances from the tunnel edge to the coracoid's medial (dm ) and lateral (dl ) edges, operation time, and tunnel location zones on the coracoid's inferior surface of all specimens in the three groups were measured to evaluate the surgical accuracy and efficiency. All specimens in the three groups completed the drilling operation successfully and were correctly measured. The distance differences (dd ) between dm and dl in the free-hand, C-shape, and assembly groups were 3.2± 1.8 mm, 1.8± 1.0 mm, 1.0 ± 0.8 mm, respectively. The dd of the free-hand group was higher than that of the other two groups (p< 0.001). The tunnel exit points on the inferior coracoid surface located in undesired zones were six (33%), one (6%), and zero in the free-hand group, C-shape group, and assembly-type group, respectively (p= 0.012). The operation time in the free-hand, C-shape, and assembly groups were 198 ± 36 s, 256 ± 64 s, and 353 ± 88 s, respectively. The operation time of each group significantly differed from that of the others (p< 0.001). The assembly-type devices may be the first choice for inexperienced surgeons while both the C shape devices and assembly-type guide devices achieved higher accuracy than free-hand techniques.

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