Tissue Anterior Cruciate Ligament Reconstruction Research Articles

A Biomechanical Comparison of Femoral Cortical Suspension Devices for Soft Tissue Anterior Cruciate Ligament Reconstruction Under High Loads

Background: Graft healing after soft tissue anterior cruciate ligament (ACL) reconstruction requires rigid fixation to allow for soft tissue healing. Cortical suspension devices for femoral fixation should be biomechanically tested under high loads representative of early rehabilitation to evaluate whether they provide sufficient fixation. Purpose/Hypothesis: To biomechanically compare current fixed-loop and adjustable-loop cortical suspension devices for soft tissue femoral fixation under high loads. The hypotheses were that there would be significant differences in cyclic displacement between devices, independent of loop type, and that retensioning of the adjustable-loop devices would not significantly alter the biomechanical properties of these devices. Study Design: Controlled laboratory study. Methods: Five different femoral ACL graft cortical suspension devices (3 fixed and 2 adjustable) were compared under high cyclic forces (100-400 N for 1000 cycles) and then pulled to failure at 50 mm/min. In addition, the effect of retensioning after simulated preconditioning was evaluated for the 2 adjustable-loop devices. Results: On average, the least amount of cumulative peak cyclic displacement (mean ± SD) was observed for the ENDOBUTTON (1.05 ± 0.05 mm), followed by the RIGIDLOOP (1.09 ± 0.16 mm), XO Button (1.65 ± 0.43 mm), TightRope with retensioning (1.81 ± 0.51 mm), TightRope without retensioning (2.20 ± 0.62 mm), ToggleLoc with retensioning (3.22 ± 1.41 mm), and ToggleLoc without retensioning (3.69 ± 2.39 mm). The ENDOBUTTON displaced significantly less after cyclic loading than all adjustable-loop devices (TightRope and ToggleLoc, both with and without retensioning) and the XO Button. The RIGIDLOOP displaced significantly less than the TightRope without retensioning and ToggleLoc with and without retensioning. There was no significant difference in biomechanical properties after retensioning for both adjustable-loop devices. Conclusion: Significant differences were observed between current fixed-loop and adjustable-loop cortical suspension devices for soft tissue femoral fixation when subjected to high loads experienced during rehabilitation. Retensioning did not significantly alter the biomechanical properties of adjustable-loop devices. Clinical Relevance: Early rehabilitation protocols subject the graft construct to higher forces than what has been previously tested biomechanically. Biomechanical testing of cortical suspension devices under simulated high rehabilitation loads demonstrated significant differences between devices. Future studies should investigate the clinical implications of these time zero results.

Biomechanical Comparison of Interference Screws and Combination Screw and Sheath Devices for Soft Tissue Anterior Cruciate Ligament Reconstruction on the Tibial Side

Background: The tibial fixation site has been reported to be the weakest point in anterior cruciate ligament (ACL) reconstructions. Numerous interference screws and combination screw and sheath devices are available for soft tissue fixation, and a biomechanical comparison of these devices is necessary. Hypothesis: Combination screw and sheath devices would provide superior soft tissue fixation properties compared with interference screws in a porcine model. Study Design: Controlled laboratory study. Methods: Eight different intratunnel tibial soft tissue fixation devices were biomechanically tested in a porcine model with bovine tendons, with 10 specimens per group. The soft tissue fixation devices included 3 interference screws—the Bio-Interference Screw, BIOSURE PK, and RCI Screw—and 5 combination screw and sheath devices (combination devices)—the AperFix II, BIOSURE SYNC, ExoShape, GraftBolt, and INTRAFIX. The specimens were subjected to cyclic (1000 cycles, 50-250 N, 0.5 Hz) and pull-to-failure loading (50 mm/min) with a dynamic tensile testing machine. Ultimate failure load (N), cyclic displacement (mm), pull-out stiffness (N/mm), displacement at failure (mm), load at 3 mm displacement (N), and mechanism of failure were recorded. Results: The ultimate failure loads were highest for the GraftBolt (1136 ± 115.6 N), followed by the INTRAFIX (1127 ± 155.0 N), AperFix II (1122 ± 182.9 N), BIOSURE PK (990.8 ± 182.1 N), Bio-Interference Screw (973.3 ± 95.82 N), BIOSURE SYNC (829.5 ± 172.4 N), RCI Screw (817.7 ± 113.9 N), and ExoShape (814.7 ± 178.8 N). The AperFix II, GraftBolt, and INTRAFIX devices were significantly stronger than the BIOSURE SYNC, RCI Screw, and ExoShape. Although the 3 strongest devices were combination screw and sheath devices, no significant differences were observed between the ultimate failure strengths of the screw and combination devices when compared as groups. The least amount of cyclic displacement after 1000 cycles was observed for the GraftBolt (1.38 ± 0.27 mm), followed by the AperFix II (1.58 ± 0.21 mm), Bio-Interference Screw (1.61 ± 0.22 mm), INTRAFIX (1.63 ± 0.15 mm), ExoShape (1.68 ± 0.30 mm), BIOSURE PK (1.72 ± 0.29 mm), BIOSURE SYNC (1.92 ± 0.59 mm), and RCI Screw (1.97 ± 0.39 mm). The GraftBolt allowed significantly less displacement than did the BIOSURE SYNC and RCI Screw. Similarly, no significant differences were observed between the cyclic displacements of the screws and combination devices when compared as groups. Conclusion: The combination screw and sheath devices did not provide superior soft tissue fixation properties compared with the interference screws alone in a porcine model. Although the highest ultimate failure loads and least amounts of cyclic displacement were observed for combination devices, group comparisons of screw and combination devices did not result in any significant differences for ultimate failure load and cyclic displacement. Clinical Relevance: It is important to consider that these results represent device performance in an in vitro animal model and are not directly transferrable to an in vivo clinical situation. The combination of a sheath and screw did not consistently result in improved fixation characteristics compared with interference screw fixation.

Femoral Cortical Suspension Devices for Soft Tissue Anterior Cruciate Ligament Reconstruction

Background: Optimization of anterior cruciate ligament (ACL) fixation is desired to improve graft healing. New soft tissue cortical suspension devices for femoral tunnel fixation should be biomechanically evaluated. Hypothesis: All femoral fixation devices would prevent a clinically significant amount of displacement and support loads significantly larger than in situ forces experienced by the ACL during early rehabilitation. Study Design: Controlled laboratory study. Methods: Four cortical soft tissue ACL graft suspension devices were tested under cyclic and pull-to-failure loading conditions in both an isolated device-only setup and as a complete bone-device-tendon construct in porcine femurs using a tensile testing machine. Results: There were significant differences in the ultimate failure loads among the devices. The highest ultimate failure loads when tested as a construct were observed for the XO Button (1748 N), followed by the Endobutton CL (1456 N), ToggleLoc with ZipLoop (1334 N), and TightRope RT (859 N). Cyclic displacement after 1000 cycles during isolated device testing was less than 1 mm for all devices. Cyclic displacements after 1000 cycles in the porcine construct were 1.88 mm, 2.74 mm, 3.34 mm, and 1.82 mm for the Endobutton, TightRope, ToggleLoc, and XO Button, respectively; all were significantly different from each other except when the Endobutton was compared with the XO Button. The ToggleLoc exceeded the 3.0-mm displacement threshold defined as a clinical failure. The most displacement occurred during the first cycle, especially for the adjustable-length loop devices. Stiffness reapproximated the native ACL stiffness for all constructs. Conclusion: The Endobutton, TightRope, and XO Button have the necessary biomechanical properties with regard to ultimate failure strength, displacement, and stiffness for initial fixation of soft tissue grafts in the femoral tunnel for ACL reconstruction. The ToggleLoc had sufficient ultimate failure strength but crossed our 3.0-mm clinical failure threshold for cyclic displacement. Although this study was not designed to compare fixed and adjustable-length loop devices, it was noted that both fixed-loop devices allowed less cyclic displacement and initial displacement. Clinical Relevance: Adjustable-length loop devices may need to be retensioned after cycling the knee and fixing the tibial side to account for the increased initial displacement seen with these devices.

Tibial Fixation of Anterior Cruciate Ligament Allograft Tendons

Background In sum, 1-, 2-, and 4-stranded allografts are used for soft tissue anterior cruciate ligament reconstruction; however, the fixation properties of fixation devices are not well assessed. Hypothesis There are no differences in the biomechanical characteristics of 1 (Achilles)-, 2 (posterior tibialis)-, and 4 (semitendinosus)-stranded allograft tibial fixation. Study Design Controlled laboratory study. Methods Sixty-three fresh-frozen porcine tibiae were used to evaluate the fixation of 1-, 2-, and 4-stranded human tendon allografts (Achilles, posterior tibialis, and semitendinosus) with 3 fixation devices (Delta, Intrafix, and Calaxo screws). With use of a materials testing system, each graft was subjected to 500 cycles of loading (50-250 N, 0.75 mm/sec) to determine displacement and cyclic stiffness, followed by a monotonic failure test (20 mm/min) to determine maximum load and pullout stiffness. Results For each graft type, there were no significant biomechanical differences between fixation devices. However, the 1-stranded graft (Achilles) construct demonstrated significantly higher mean displacement (3.17 ± 1.62 mm), lower cyclical stiffness (156 ± 25 N/mm), lower load to failure (479 ± 87 N), and lower pullout stiffness (140 ± 28 N/mm). In comparison with the 2-stranded graft (posterior tibialis), the 4-stranded graft (semitendinosus) exhibited lower displacement (0.86 ± 0.44 to 1.12 ± 0.51 mm) and higher ultimate failure load (832 ± 255 to 656 ± 168 N). Numerous differences in fixation properties were noted when comparing a device to each of the 3 grafts. Conclusion The 1-stranded allograft demonstrated inferior biomechanical tibial fixation properties when compared with 2 (posterior tibialis)- and 4 (semitendinosus)-stranded allograft constructs for all fixation devices tested. Clinical Relevance This study demonstrated that not all tibial fixation devices are designed to adequately accommodate different types of anterior cruciate ligament allografts. Biomechanical evidence suggests that caution is warranted when using an Achilles allograft fixated solely with an interference device.

Initial and 6 Weeks Postoperative Structural Properties of Soft Tissue Anterior Cruciate Ligament Reconstructions With Cross-Pin or Interference Screw Fixation: An In Vivo Study in Sheep

The purpose of this study was to evaluate the detrimental effects of interference screw fixation on soft tissue anterior cruciate ligament (ACL) reconstruction after 6 weeks and compare them with a cross-pin technique. In an intra-articular model, ovine soft tissue grafts were fixed with two 3.3-mm biodegradable pins or with interference screws. Maximum load, yield load, and stiffness of the femur-graft-tibia complex were evaluated immediately after surgery and 6 weeks postoperatively. For knees with interference screw fixation, strength deteriorated by 81% and stiffness deteriorated by 67%. For knees with double cross-pin fixation, strength deteriorated by 48% and stiffness improved by 52%. These differences were statistically significant. At the time of surgery, all grafts failed by slippage of the graft past the screw or by cross-pin failure. At 6 weeks postoperatively, the grafts of both groups failed at the tibial or femoral tunnel entrance. After 6 weeks, the biomechanical characteristics of grafts that were fixed with cross-pins were superior to those of grafts after interference screw fixation. Because of significantly inferior biomechanical stability after interference screw fixation, a less aggressive program of rehabilitation might be recommended.