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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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.

Examination of a biodegradable magnesium screw for the reconstruction of the anterior cruciate ligament: A pilot in vivo study in rabbits.

The reconstruction of the anterior cruciate ligament is, for the most part, currently performed with interference screws made of titanium or degradable polymers. The aim of this study was to investigate the use of biodegradable magnesium interference screws for such a procedure because of their known biocompatibility and reported osteoconductive effects. The left tibiae of each of 18 rabbits were implanted with a magnesium-based (MgYREZr-alloy) screw, and another 18 with a titanium-based control. Each group was divided into observation periods of 4, 12 and 24weeks. After sacrifice, µCT scans were acquired to assess the amount of the gas liberated and the degradation rate of the implant. Histological evaluations were performed to investigate the local tissue response adjacent to the implant and to assess the status of the attachment between the tendon and the bone tissue. The µCT scans showed that liberation of gas was most prominent 4weeks after implantation and was significantly decreased by 24weeks. All screws remained in situ and formed a sufficient connection with the tendon and sufficient osseous integration at 24weeks. Histological evaluations showed neither inflammatory reactions nor necrosis of the tendon. The results of this pilot study in rabbits indicate that this magnesium-based interference screw should be considered as an alternative to conventional implant materials.

Magnesium-containing layered double hydroxides as orthopaedic implant coating materials--An in vitro and in vivo study.

The total hip arthroplasty is one of the most common artificial joint replacement procedures. Several different surface coatings have been shown to improve implant fixation by facilitating bone ingrowth and consequently enhancing the longevity of uncemented orthopaedic hip prostheses. In the present study, two different layered double hydroxides (LDHs), Mg-Fe- and Mg-Al-LDH, were investigated as potential magnesium (Mg)-containing coating materials for orthopaedic applications in comparison to Mg hydroxide (Mg(OH)2). In vitro direct cell compatibility tests were carried out using the murine fibroblast cell line NIH 3T3 and the mouse osteosarcoma cell line MG 63. The host response of bone tissue was evaluated in in vivo experiments with nine rabbits. Two cylindrical pellets (3 × 3 mm) were implanted into each femoral condyle of the left hind leg. The samples were analyzed histologically and with µ-computed tomography (µ-CT) 6 weeks after surgery. An in vitro cytotoxicity test determined that more cells grew on the LDH pellets than on the Mg(OH)2-pellets. The pH value and the Mg(2+) content of the cell culture media were increased after incubation of the cells on the degradable samples. The in vivo tests demonstrated the formation of fibrous capsules around Mg(OH)2 and Mg-Fe-LDH. In contrast, the host response of the Mg-Al-LDH samples indicated that this Mg-containing biomaterial is a potential candidate for implant coating.

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.

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.