Correction to: Biodegradable magnesium-based screw clinically equivalent to titanium screw in hallux valgus surgery: short term results of the first prospective, randomized, controlled clinical pilot study.

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Biomechanical characteristics of bioabsorbable magnesium-based (MgYREZr-alloy) interference screws with different threads.

PURPOSE: Degradable magnesium implants have received increasing interest in recent years. In anterior cruciate ligament reconstruction surgery, the well-known osteoconductive effects of biodegradable magnesium alloys may be useful. The aim of this study was to examine whether interference screws made of MgYREZr have comparable biomechanical properties to commonly used biodegradable screws and whether a different thread on the magnesium screw has an influence on the fixation strength. METHODS: Five magnesium (MgYREZr-alloy) screws were tested per group. Three different groups with variable thread designs (Designs 1, 2, and 3) were produced and compared with the commercially available bioabsorbable Bioacryl rapid polylactic-co-glycolic acid screw Milagro®. In vitro testing was performed in synthetic bone using artificial ligament fixed by an interference screw. The constructs were pretensioned with a constant load of 60 N for 30 s followed by 500 cycles between 60 N and 250 N at 1 Hz. Construct displacements between the 1st and 20th and the 21st and 500th cycles were recorded. After a 30 s break, a maximum load to failure test was performed at 1 mm/s measuring the maximum pull-out force. RESULTS: The maximum loads to failure of all three types of magnesium interference screws (Design 1: 1,092 ± 133.7 N; Design 2: 1,014 ± 103.3 N; Design 3: 1,001 ± 124 N) were significantly larger than that of the bioabsorbable Milagro® interference screw (786.8 ± 62.5 N) (p < 0.05). However, the greatest maximum load was found with magnesium screw Design 1. Except for a significant difference between Designs 1 and 2, there were no further significant differences among the four groups in displacement after the 20th cycle. CONCLUSIONS: Biomechanical testing showed higher pull-out forces for magnesium compared with a commercial polymer screw. Hence, they suggest better stability and are a potential alternative. The thread geometry does not significantly influence the stability provided by the magnesium implants. This study shows the first promising results of a degradable material, which may be a clinical alternative in the future.

Biodegradation of a magnesium alloy implant in the intercondylar femoral notch showed an appropriate response to the synovial membrane in a rabbit model in vivo.

Degradable magnesium alloys are promising biomaterials for orthopedic applications. The aim of this study was to evaluate the potential effects on both the synovial membrane (synovialis) and the synovial fluid (synovia) of the degradation products of a MgYREZr-pin implanted in the intercondylar femoral notch in a rabbit model. Thirty-six animals were randomized into two groups (MgYREZr or Ti6Al4V alloy) of 18 animals each. Each group was then divided into three subgroups with implantation periods of 1, 4, and 12 weeks, with six animals in each subgroup. The initial inflammatory reaction caused by the surgical trauma declined after 12 weeks of implantation, and elucidated a progressive recovery of the synovial membrane. Compared with control Ti6Al4V pins, there were no significant differences between the groups. However, after 12 weeks, recovery of the synovial membrane was more advanced in the titanium group, in which 92% showed no signs of synovitis, than in the magnesium group. A cytotoxicity test with L929 cells and human osteoblasts (HOB) was also conducted, according to EN ISO 10993-5/12, and no toxic leachable products were observed after 24 h of incubation. In conclusion, the MgYREZr alloy seems to be a suitable material for intra-articular degradable implants.

In vivo study of a biodegradable orthopedic screw (MgYREZr-alloy) in a rabbit model for up to 12 months.

Biodegradable magnesium-based implants are currently being developed for use in orthopedic applications. The aim of this study was to investigate the acute, subacute, and chronic local effects on bone tissue as well as the systemic reactions to a magnesium-based (MgYREZr-alloy) screw containing rare earth elements. The upper part of the screw was implanted into the marrow cavity of the left femora of 15 adult rabbits (New Zealand White), and animals were euthanized 1 week, 12 weeks, and 52 weeks postoperatively. Blood samples were analyzed at set times, and radiographic examinations were performed to evaluate gas formation. There were no significant increased changes in blood values compared to normal levels. Histological examination revealed moderate bone formation with direct implant contact without a fibrous capsule. Histopathological evaluation of lung, liver, intestine, kidneys, pancreas, and spleen tissue samples showed no abnormalities. In summary, our data indicate that these magnesium-based screws containing rare earth elements have good biocompatibility and osteoconductivity without acute, subacute, or chronic toxicity.

Biodegradable magnesium-based screw clinically equivalent to titanium screw in hallux valgus surgery: short term results of the first prospective, randomized, controlled clinical pilot study.

PURPOSE: Nondegradable steel-and titanium-based implants are commonly used in orthopedic surgery. Although they provide maximal stability, they are also associated with interference on imaging modalities, may induce stress shielding, and additional explantation procedures may be necessary. Alternatively, degradable polymer implants are mechanically weaker and induce foreign body reactions. Degradable magnesium-based stents are currently being investigated in clinical trials for use in cardiovascular medicine. The magnesium alloy MgYREZr demonstrates good biocompatibility and osteoconductive properties. The aim of this prospective, randomized, clinical pilot trial was to determine if magnesium-based MgYREZr screws are equivalent to standard titanium screws for fixation during chevron osteotomy in patients with a mild hallux valgus. METHODS: Patients (n=26) were randomly assigned to undergo osteosynthesis using either titanium or degradable magnesium-based implants of the same design. The 6 month follow-up period included clinical, laboratory, and radiographic assessments. RESULTS: No significant differences were found in terms of the American Orthopaedic Foot and Ankle Society (AOFAS) score for hallux, visual analog scale for pain assessment, or range of motion (ROM) of the first metatarsophalangeal joint (MTPJ). No foreign body reactions, osteolysis, or systemic inflammatory reactions were detected. The groups were not significantly different in terms of radiographic or laboratory results. CONCLUSION: The radiographic and clinical results of this prospective controlled study demonstrate that degradable magnesium-based screws are equivalent to titanium screws for the treatment of mild hallux valgus deformities.