28. Jahrestagung der Deutschen Assoziation für Fuß und Sprunggelenk e.V. (D.A.F.)

PD Dr. med.

Prof.

Surgical fixation of ankle fractures with bioresorbable magnesium implants (ZX00): 2.5 year long term results of a first-in-man study with an HR-pQCT assessment of the implantation site

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Abstract-Text (inkl. Referenzen und Bildunterschriften) Background and Aim Bone fractures represent an important segment of public health and related injuries are usually treated with conventional permanent implants. The search for new treatment options and alternative implants is being strongly pursued, and magnesium (Mg)-based implants in particular have come into focus. Previous use of these implants demonstrated their favorable characteristics including biodegradability, mechanical strength, biocompatibility and most importantly, the avoidance of implant removal surgery. However, investigation of long-term degradation of these implants is still missing. Our aim was to investigate the long-term degradation behavior of Mg-zinc-calcium (ZX00) screws in clinical setting. Methods: In a clinical study, 20 patients with medial malleolar fracture were treated with bioresorbable screws (Magnesium 99.1%, Calcium 0.45%, Zinc 0.45%,ZX00). Clinical examinations and standardized plain radiographs were performed to assess the postoperative outcome and screw degradation 2.5 years after implantation. Additionally HR-pQCT-scans were performed in 6 patients. Evaluations included total volume, bone volume, and screw residuals. Results The screws degraded without implant-related revision surgery or degradation-related complications. Plain radiographs after 2.5 years showed a homgeneous bony texture at the site of screw implantation after disintegration of the screws. All patients achieved excellent clinical results 2.5 years after use in medial malleolar fractures, with disappearance of the screws on plain radiographs. All observed implants were resorbed for the most part in the HRCT assessement. Of 11 implants, 3 were dissolved without visible residuals. Minor residuals were present in 10% of slices. Conclusion In humans, the screws achieved excellent clinical results 2.5 years after use in medial malleolar fractures with disappearance of the screws on plain radiographs. This study confirms that bioresorbable screws have promising features regarding biocompatibility, biodegradability and osteoconductivity without long-term complications.

Surgical fixation of ankle fractures with bioresorbable magnesium implants (ZX00): 2.5 year long term results of a first-in-man study with an HR-pQCT assessment of the implantation site

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