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Background: Bone staples have been shown previously to be a viable modality for cortical tendon graft fixation in ligament knee surgery. However, soft tissue reactions have been reported, making implant removal necessary. Magnesium alloys are a promising material for biodegradable orthopaedic implants, with mechanical properties closely resembling those of human bone. Purpose: To compare the primary stability of a biodegradable bone staple prototype made from magnesium to bone staples made from metal in the cortical fixation of tendon grafts during knee surgery. Study Design: Controlled laboratory study. Methods: Primary stability of peripheral tendon graft fixation was assessed in a porcine model of medial collateral ligament reconstruction. Two commercially available metal bone staples (Richards fixation staple with spikes [Me1] and spiked ligament staple [Me2]) were compared with a magnesium bone staple prototype for soft tissue fixation. Primary stability was assessed using a uniaxial materials testing machine. Cyclic loading at 50 and 100 N was applied for 500 cycles each, followed by load-to-failure testing. Results: After 500 cycles at 50 N, elongation was 1.5 ± 0.5 mm in the Me1 group, 1.9 ± 0.5 mm in the Me2 group, and 1.8 ± 0.4 mm in the magnesium group. After 1000 cycles of loading (500 cycles at 50 N and 500 at 100 N), elongation was 3.6 ± 0.9 mm in the Me1 group, 3.5 ± 0.6 mm in the Me2 group, and 4.1 ± 1.0 mm in the magnesium group. No significant differences regarding elongation were found between the groups. Load to failure was 352 ± 115 N in the Me1 group, 373 ± 77 N in the Me2 group, and 449 ± 92 N in the magnesium group, with no significant difference between the groups. Conclusion: In this study, the magnesium bone staples provided appropriate time-zero biomechanical primary stability in comparison with metal bone staples and may therefore be a feasible alternative for cortical fixation of tendon grafts in knee surgery. Clinical Relevance: The biodegradability of magnesium bone staples would eliminate the need for later implant removal. [ABSTRACT FROM AUTHOR]

Background: The promising biomechanical stability of bone staples (BSs) in cortical fixation of tendon grafts for medial collateral ligament (MCL) reconstruction has been revealed by a previous investigation. However, it is currently unknown if the biomechanical stability of cortical fixation of tendon grafts depends on the BS design. Purpose: To assess the biomechanical stability of cortical fixation of tendon grafts in knee surgery using 4 different BS designs. Study Design: Controlled laboratory study. Methods: Cortical fixation of tendon grafts was performed in a porcine knee model at the tibial insertion area of the MCL using 4 different BS designs (n = 40): 8-mm width without spikes (n = 10), 8-mm width with spikes (n = 10), 14-mm width with spikes (n = 10), and 13 mm–wide 4-prong staples with spikes (n = 10). Specimens were mounted in a materials testing machine, and cyclic loading was applied to the tendon graft (500 cycles at 50 and 100 N, respectively), followed by load-to-failure testing. The Kruskal-Wallis test was performed for statistical analysis (P <.05), and the post hoc Dunn test was performed for multiple comparisons. Results: In 4 of 10 specimens with graft fixation using BSs without spikes, slippage of the tendon underneath the BS led to failure of the construct during cyclic loading to 100 N. In the other groups, no fixation failure was observed during cyclic loading. Furthermore, graft fixation using BSs without spikes was found to have significantly more elongation during cyclic loading (8.2 ± 1.9 mm) and a lower ultimate failure load (170 ± 120 N) compared with graft fixation using narrow BSs with spikes (3.4 ± 1.2 mm [ P <.0001] and 364 ± 85 N [ P <.05], respectively) and graft fixation using broad BSs with spikes (4.5 ± 1.4 mm [ P <.05] and 429 ± 67 N [ P <.001], respectively). No statistical differences in elongation during cyclic loading or ultimate failure load were found between 4-prong staples with spikes (5.0 ± 1.3 mm and 304 ± 85 N) and narrow or broad staples with spikes. Conclusion: The biomechanical stability of cortical fixation of an MCL graft was comparable between each BS design with spikes (narrow, broad, and 4-prong) in a porcine knee model, whereas BSs without spikes led to failure of the fixation construct during cyclic loading in 4 of 10 specimens and increased elongation and lower ultimate failure loads in the remainder of the group. BSs without spikes may therefore not be recommended for graft fixation. Clinical Relevance: The use of BSs can help to avoid the conflict of converging tunnels in multiligament reconstruction surgery. An implant design with spikes yields significantly higher biomechanical stability than BSs without spikes. [ABSTRACT FROM AUTHOR]

Background: The use of the interference screw (IFS) for the cortical fixation of tendon grafts in knee ligament reconstruction may lead to converging tunnels in the multiligament reconstruction setting. It is unknown whether alternative techniques using modern suture anchor (SA) or bone staple (BS) fixation provide sufficient primary stability. Purpose: To assess the primary stability of cortical fixation of tendon grafts for medial collateral ligament (MCL) reconstruction using modern SA and BS methods in comparison with IFS fixation. Study Design: Controlled laboratory study. Methods: Cortical tendon graft fixation was performed in a porcine knee model at the tibial insertion area of the MCL using 3 different techniques: IFS (n = 10), SA (n = 10), and BS (n = 10). Specimens were mounted in a materials testing machine, and cyclic loading for 1000 cycles at up to 100 N was applied to the tendon graft, followed by load-to-failure testing. Statistical analysis was performed using 1-way analysis of variance. Results: There were no statistical differences in elongation during cyclic loading or peak failure load during load-to-failure testing between BS (mean ± standard deviation: 3.4 ± 1.0 mm and 376 ± 120 N, respectively) and IFS fixation (3.9 ± 1.2 mm and 313 ± 99.5 N, respectively). SA fixation was found to have significantly more elongation during cyclic loading (6.4 ± 0.9 mm; P <.0001) compared with BS and IFS fixation and lower peak failure load during ultimate failure testing (228 ± 49.0 N; P <.01) compared with BS fixation. Conclusion: BS and IFS fixation provided comparable primary stability in the cortical fixation of tendon grafts in MCL reconstruction, whereas a single SA fixation led to increased elongation with physiologic loads. However, load to failure of all 3 fixation techniques exceeded the loads expected to occur in the native MCL. Clinical Relevance: The use of BS as a reliable alternative to IFS fixation for peripheral ligament reconstruction in knee surgery can help to avoid the conflict of converging tunnels. [ABSTRACT FROM AUTHOR]

In this work, severe plastic deformation (SPD) of the newly designed Ti-Nb-Zr-Ta-Fe-O GUM metal was successfully conducted at room temperature using high speed high pressure torsion (HSHPT) followed by cold rolling (CR) to exploit the suitability of the processed alloy for bone staples. The Ti-31.5Nb-3.1Zr-3.1Ta-0.9Fe-0.16O GUM alloy was fabricated in a levitation melting furnace using a cold crucible and argon protective atmosphere. The as-cast specimens were subjected to SPD, specifically HSHPT, and then processed by the CR method to take the advantages of both grain refinement and larger dimensions. This approach creates the opportunity to obtain temporary orthopedic implants nanostructured by SPD. The changes induced by HSHPT technology from the coarse dendrite directly into the ultrafine grained structure were examined by optical microscopy, scanning electron microscopy and X-ray diffraction. The structural investigations showed that by increasing the deformation, a high density of grain boundaries is accumulated, leading gradually to fine grain size. In addition, the in vitro biocompatibility studies were conducted in parallel on the GUM alloy specimens in the as-cast state, and after HSHPT- and HSHPT+CR- processing. For comparative purposes, in vitro behavior of the bone-derived MC3T3-E1 cells on the commercially pure titanium has also been investigated regarding the viability and proliferation, morphology and osteogenic differentiation. The results obtained support the appropriateness of the HSHPT technology for developing compression staples able to ensure a better fixation of bone fragments.

In this work, severe plastic deformation (SPD) of the newly designed Ti-Nb-Zr-Ta-Fe-O GUM metal was successfully conducted at room temperature using high speed high pressure torsion (HSHPT) followed by cold rolling (CR) to exploit the suitability of the processed alloy for bone staples. The Ti-31.5Nb-3.1Zr-3.1Ta-0.9Fe-0.16O GUM alloy was fabricated in a levitation melting furnace using a cold crucible and argon protective atmosphere. The as-cast specimens were subjected to SPD, specifically HSHPT, and then processed by the CR method to take the advantages of both grain refinement and larger dimensions. This approach creates the opportunity to obtain temporary orthopedic implants nanostructured by SPD. The changes induced by HSHPT technology from the coarse dendrite directly into the ultrafine grained structure were examined by optical microscopy, scanning electron microscopy and X-ray diffraction. The structural investigations showed that by increasing the deformation, a high density of grain boundaries is accumulated, leading gradually to fine grain size. In addition, the in vitro biocompatibility studies were conducted in parallel on the GUM alloy specimens in the as-cast state, and after HSHPT- and HSHPT+CR- processing. For comparative purposes, in vitro behavior of the bone-derived MC3T3-E1 cells on the commercially pure titanium has also been investigated regarding the viability and proliferation, morphology and osteogenic differentiation. The results obtained support the appropriateness of the HSHPT technology for developing compression staples able to ensure a better fixation of bone fragments. [ABSTRACT FROM AUTHOR]