There has been a tremendous amount of research in the past decade to optimize the mechanical properties and degradation behavior of the biodegradable Mg alloy for orthopedic implant. Despite the feasibility of degrading implant, the lack of fundamental understanding about biocompatibility and underlying bone formation mechanism is currently limiting the use in clinical applications. Herein, we report the result of long-term clinical study and systematic investigation of bone formation mechanism of the biodegradable Mg-5wt%Ca-1wt%Zn alloy implant through simultaneous observation of changes in element composition and crystallinity within degrading interface at hierarchical levels. Controlled degradation of Mg-5wt%Ca-1wt%Zn alloy results in the formation of biomimicking calcification matrix at the degrading interface to initiate the bone formation process. This process facilitates early bone healing and allows the complete replacement of biodegradable Mg implant by the new bone within 1 y of implantation, as demonstrated in 53 cases of successful long-term clinical study.biodegradable implant | bone formation | clinical application T he century-old concept of the fixation device that holds the fractured bones in place to allow repair through the natural bone remodeling process is still being practiced today without alteration (1-5). The recent rapid growth of the elderly demographic of physically active adults has tremendously intensified the occurrence of bone trauma cases, highlighting once again the major drawbacks of current surgical approaches and osteosynthesis systems, such as inevitable secondary surgery to remove the inert fixation devices after complete bone healing and inflammatory response due to the release of metal ions. In the past decade, countless studies have been performed to control and optimize the mechanical and corrosion properties of magnesium-based alloys (6-9), which, thanks to their degradation in the physiological environment, could overcome the limitations of inert implant materials and shift the paradigm of conventional bone fixation devices toward new horizons. Driven by these new possibilities, important findings regarding, among others, the degradation mechanism of Mg-based alloys (10, 11), the formation of corrosion protective layers by degradation products (12, 13), and the osteogenetic properties of Mg ions (14, 15) have been reported in the literature. However, such findings are based on the observation of degradation products and of bone healing at the macroscale level. Due to lack of fundamental understanding on biocompatibility and underlying bone formation mechanism of the degradation product, there is so far only one known case of statistically insignificant clinical study result (16) with a short-term follow-up. In our previous study, we reported successful development and long-term in vivo study of uniformly slowly degrading Mg-5wt%Ca-1wt%Zn alloy system (SI Appendix, Figs. S1 and S2) featuring adequate mechanical strength [ultimate tensile strength (UTS) ∼250 MPa] (17) a...
The University Institutional Review Board approved the study protocol. Forty consecutive patients with unruptured, previously untreated, small (<10 mm) aneurysms treated with PED (2011PED ( -2013 at our institution were identified from a prospectively maintained database. Patients treated with PED and adjunctive coiling were not included in the analysis. Every patient treated with the PED was matched to 4 control patients treated with stent-assisted coiling (2004-2011) based on patient age, sex, aneurysm location, and aneurysm size. Patients were excluded from this study if the aneurysm had previously ruptured, was located in the posterior circulation, or was fusiform in morphology.Patients undergoing PED therapy received 75 mg/d of clopidogrel and 81 mg/d of aspirin for 10 days before the intervention. Platelet Background and Purpose-Flow diverters are currently indicated for treatment of large and complex intracranial aneurysms.The purpose of this study was to determine whether the indications of flow diversion can be safely extended to unruptured, small, saccular aneurysms (<10 mm) of the anterior circulation. Methods-Forty patients treated with the pipeline embolization device (PED) were matched in a 1:4 fashion with 160 patients treated with stent-assisted coiling based on patient age, sex, aneurysm location, and aneurysm size. Procedural complications, angiographic results, and clinical outcomes were analyzed and compared. Results-The rate of periprocedural complications was 5% in the PED group and 3% in the stent-coil group (P=0.7). In multivariable analysis, increasing age was the only predictor of complications. At follow-up, a higher proportion of aneurysms treated with PED (80%) achieved complete obliteration compared with stent-coiled aneurysms (70%) but the difference did not reach statistical significance (P=0.2). In multivariable analysis, increasing aneurysm size and aneurysm location were predictors of nonocclusion. The rate of favorable outcome (modified Rankin Scale, 0-2 and modified Rankin Scale, 0-1) was similar in the PED group and the coil group. Conclusions-The PED was associated with similar periprocedural risks, clinical outcomes, and angiographic results compared with stent-assisted coiling. These findings suggest that the indications of PED can be safely extended to small intracranial aneurysms that are amenable to conventional endovascular techniques. Larger studies with long-term follow-up are necessary to determine the optimal treatment that leads to the highest rate of obliteration and best clinical outcomes. (Stroke. 2014;45:54-58.)
Crystalline Mg-based alloys with a distinct reduction in hydrogen evolution were prepared through both electrochemical and microstructural engineering of the constituent phases. The addition of Zn to Mg-Ca alloy modified the corrosion potentials of two constituent phases (Mg + Mg2Ca), which prevented the formation of a galvanic circuit and achieved a comparable corrosion rate to high purity Mg. Furthermore, effective grain refinement induced by the extrusion allowed the achievement of much lower corrosion rate than high purity Mg. Animal studies confirmed the large reduction in hydrogen evolution and revealed good tissue compatibility with increased bone deposition around the newly developed Mg alloy implants. Thus, high strength Mg-Ca-Zn alloys with medically acceptable corrosion rate were developed and showed great potential for use in a new generation of biodegradable implants.
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