Original Research

Evaluation of 3 Fixation Devices for Tibial-Sided Anterior Cruciate Ligament Graft Backup Fixation

Am J Orthop. 2015 July;44(7):E225-E230

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Each of the 30 tibiae was tested once. Each testing group consisted of 10 porcine tibiae. The tendons were kept moist during the entire testing procedure by spraying them thoroughly with saline 0.9% solution. Mechanical testing was performed with an Instron 8871 system with a 5-kN load cell secured to the crosshead. A fixed-angle aperture, attached to the testing surface, was adjusted so that the tendon would be pulled in line with the tibial tunnel. A hook fixture suspended from clevis and dowel was used to secure the tendon to the crosshead (Figure 3). A small preload of 5 N manually applied to each sample was followed by a precycling regimen of 10 cycles between 10 N and 50 N at 1 Hz. Precycling was performed to remove slack from the system. Mechanical testing consisted of 500 cycles between 50 N and 250 N at 1 Hz followed by pull to failure at 20 mm per minute. Load and displacement data were recorded at 500 Hz.

An a priori power analysis was not performed because 6 specimens per group in the study from which the testing protocol was adapted demonstrated sufficient power among 3 testing categories.³ In addition, other studies have demonstrated similar testing protocols using 10 specimens per testing group.^7,12,13,18 The data for each sample were analyzed with OriginPro 8.0 software (OriginLab). Ultimate load, yield load, stiffness, and cyclic displacement of the 3 sample groups were compared with 1-way analysis of variance (α = 0.05). Holm-Sidak tests were used for post hoc analysis.¹⁹P < .05 was statistically significant.

Results

None of the 30 specimens failed during preloading. Modes of failure were consistent among groups. All 10 specimens in the interference-screw-only group failed by graft slippage past the screw in the tibial tunnel. Nineteen of the 20 specimens in the backup-fixation groups failed by graft slippage past the screw and suture cutout through the distal graft tail. In the bicortical-post backup group, 1 failure was attributed to tendon tearing proximal to whip-stitching. There were no instances of hardware breakage or failure of either titanium screw or SwiveLock anchor.

Mean (SD) cyclic displacement was higher in the interference-screw-only group, 3.5 (2.2) mm, than in the SwiveLock backup group, 2.6 (0.5) mm, and the bicortical-post backup group, 2.1 (0.6) mm; no statistical significance was demonstrated between any 2 of these groups alone (P = .12) (Figure 4). Mean (SD) pullout stiffness was higher in the bicortical-post backup group, 192 (48) N/mm, than in the SwiveLock backup group, 164 (53) N/mm, and the screw-only group, 163 (64) N/mm (P = .42) (Figure 5). Mean (SD) initial load at 5 mm of displacement was higher in the bicortical-post backup group, 482 (156) N, and the SwiveLock backup group, 423 (94) N, than in the screw-only group, 381 (169) N (P = .30).

Mean (SD) yield load was higher in the bicortical-post backup group, 829 (253) N, than in the SwiveLock backup group, 642 (172) N, and the interference-screw-only group, 496 (133) N (P = .003). Statistical significance was demonstrated between the screw-only and bicortical-post groups (P = .002) and between the screw-only and SwiveLock groups (P = .048). There was no statistical difference between the bicortical-post and SwiveLock groups (P = .07).

Mean (SD) ultimate load to failure was higher in the bicortical-post backup group, 1148 (186) N, than in the SwiveLock backup group, 1007 (176) N, and the interference-screw-only group, 778 (139) N (Figure 6). The difference was statistically significant, whereby the screw-only group failed at a lower load compared with the bicortical-post group (P < .001) and the SwiveLock group (P = .005). The 2 backup groups were not statistically different (P = .1).

Discussion

We investigated whether a fully threaded bio-interference screw backed with a 4.75-mm SwiveLock anchor would provide mechanically equivalent pullout strength within the tibial tunnel during ACL reconstruction with soft-tissue allografts in comparison either with a fully threaded bio-interference screw backed with a bicortical post or with a fully threaded bio-interference screw without backup fixation. The results of the study support this hypothesis. With SwiveLock used for backup fixation, there was no significant difference in stiffness or cyclic load displacement between the screw-only, SwiveLock, and bicortical-post groups. However, adding backup fixation could particularly help improve fixation consistency. Specifically, although after only 500 cycles there was no statistically significant difference in cyclic displacement, continued cycling may be clinically relevant if graft slippage exceeded limits to allow for healing within the tibial tunnel. Conversely, a significantly larger difference was found between the SwiveLock, bicortical-post, and screw-only groups in yield load and ultimate load to failure. However, there was no significant difference between the SwiveLock and bicortical-post groups.