gms | German Medical Science

Deutscher Kongress für Orthopädie und Unfallchirurgie (DKOU 2017)

24.10. - 27.10.2017, Berlin

Bio-ISOS – a novel biodegradable intramedullary osteosynthesis device to treat diaphyseal fractures of small hollow bones

Meeting Abstract

  • presenting/speaker Felix Massen - LMU Unfallchirurgie, München, Germany
  • Axel Greiner - LMU Unfallchirurgie, München, Germany
  • Maximillian Bauer - UKSH Kiel, Kiel, Germany
  • Philipp Paprotka - LMU Radiologie, München, Germany
  • Oliver Pieske - Evangelisches Krankenhaus Oldenburg, Oldenburg, Germany

Deutscher Kongress für Orthopädie und Unfallchirurgie (DKOU 2017). Berlin, 24.-27.10.2017. Düsseldorf: German Medical Science GMS Publishing House; 2017. DocGR22-791

doi: 10.3205/17dkou566, urn:nbn:de:0183-17dkou5663

Veröffentlicht: 23. Oktober 2017

© 2017 Massen et al.
Dieser Artikel ist ein Open-Access-Artikel und steht unter den Lizenzbedingungen der Creative Commons Attribution 4.0 License (Namensnennung). Lizenz-Angaben siehe http://creativecommons.org/licenses/by/4.0/.


Gliederung

Text

Fragestellung: The treatment of displaced diaphyseal fractures of small hollow bones is dominated by classical fracture fixation devices such as locking plates or k-wires which need a second surgical intervention to remove. We developed a novel biodegradable intramedullary osteosynthesis to treat these kinds of fractures named Bio-ISOS (Bioresorbierbare, intramedulläre Spannosteosynthese). Bio-ISOS provides all the advantages of an intramedullary stabilization system, compression on the fracture site and is completely absorbable as it is made of PLLA/PDLLA 70:30, Resomer 704S®. After prior biomechanical evaluation a rabbit model was conducted to proof that Bio-ISOS is an easy to use osteosynthesis device and provides enough stability to treat fractures under in vivo conditions.

Methodik: To evaluate the implantation technique of Bio-ISOS, bone healing and osteolytic reactions an experimental prospective animal study was conducted. 24 mature female New Zealand white rabbits in 4 groups with different follow up periods (8, 16, 24 and 48 weeks) were treated using Bio-ISOS to stabilize standardized osteotomies of one femoral bone.

Computed tomography (CT) was performed on every rabbit at the end of the follow up. Osteolytic reactions, bone healing and malposition were evaluated using the open source imaging viewer Osirix®. The untreated femoral bones served as the control. Descriptive statistical analysis was used as well as the Man-Whitney-U-Test to discover significant differences (p < 0,05).

Ergebnisse und Schlussfolgerung: During a follow up period of 48 weeks no relevant implant related foreign body or osteolytic reactions could be observed. 95.7% of all osteotomies healed without complications via external callus formation. Malposition was minimal in 67% of the treated animals with less than 10° of angulation. No major complications were observed in all treated animals.

Conclusion

This experimental study on rabbits is the first in vivo evaluation of the novel Bio-ISOS stabilization system. It shows good results for bone healing, alignment and cortical thickness of the treated standardized osteotomies on rabbit femurs compared to similar studies with different kinds of osteosynthesis techniques. Further it provides important information on implant behaviour over a follow up period of 48 weeks.

The promising results of this study may indicate a future clinical use on humans with the potential economic and patient associated benefit of a minimal invasive procedure and a lack of a second surgery for implant removal.