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Landes C, Ballon A, Ghanaati S, et al. Evaluation of the Fatigue Performance and Degradability of Resorbable PLDLLA-TMC Osteofixations. Open Biomed Eng J. 2013;7:133-46doi: 10.2174/1874120701307010133.
Landes, C., Ballon, A., Ghanaati, S., Ebel, D., Ulrich, D., Spohn, U., Heunemann, U., Sader, R., & Jaeger, R. (2013). Evaluation of the Fatigue Performance and Degradability of Resorbable PLDLLA-TMC Osteofixations. The open biomedical engineering journal, 7133-46. https://doi.org/10.2174/1874120701307010133
Landes, Constantin, et al. "Evaluation of the Fatigue Performance and Degradability of Resorbable PLDLLA-TMC Osteofixations." The open biomedical engineering journal vol. 7 (2013): 133-46. doi: https://doi.org/10.2174/1874120701307010133
Landes C, Ballon A, Ghanaati S, Ebel D, Ulrich D, Spohn U, Heunemann U, Sader R, Jaeger R. Evaluation of the Fatigue Performance and Degradability of Resorbable PLDLLA-TMC Osteofixations. Open Biomed Eng J. 2013 Nov 29;7:133-46. doi: 10.2174/1874120701307010133. eCollection 2013. PMID: 24363786; PMCID: PMC3869107.
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Open Biomed Eng J. 2013 Nov 29;7:133-46. doi: 10.2174/1874120701307010133. eCollection 2013.

Evaluation of the Fatigue Performance and Degradability of Resorbable PLDLLA-TMC Osteofixations.

The open biomedical engineering journal

Constantin Landes, Alexander Ballon, Shahram Ghanaati, Daniel Ebel, Dieter Ulrich, Uwe Spohn, Ute Heunemann, Robert Sader, Raimund Jaeger

Affiliations

  1. Oral, Craniomaxillofacial and Plastic Facial Surgery, The Center of Surgery, Goethe University Medical Centre, Frankfurt, Theodor-Stern-Kai 7, 60596 Frankfurt am Main, Germany.
  2. Fraunhofer Institute for Mechanics of Materials IWM, Wöhlerstraße 11, 79108 Freiburg, Germany.
  3. Fraunhofer Institute for Mechanics of Materials IWM, Biological and Biocompatible Materials - group, Fraunhofer-IWM, Walter-Hülse-Str. 1, 06120 Halle.

PMID: 24363786 PMCID: PMC3869107 DOI: 10.2174/1874120701307010133

Abstract

The fatigue performance of explanted in-situ degraded osteofixations/osteosyntheses, fabricated from poly (70L-lactide-co-24DL-lactide-6-trimethylane-carbonate or PLDLLA-TMC) copolymer was compared to that of virgin products. The fatigue test was performed on 21 explants retrieved from 12 women and 6 men; 16-46 years by a custom-designed three-point bend apparatus using a staircase method and a specified failure criterion (an increase of the deflection of the specimen > 1 mm) with run-out designated as "no failure" after 150,000 loading cycles. While all the virgin products showed run-out at 38N, all of the specimens fabricated from explants failed at this load level. For the explant specimens, although there was a trend of decreased failure load with increased in-situ time, this decrease was pronounced after 4 months in-situ, however, not yet statistically significant, while a 6-month in-situ explant had significantly less failure load. Three and four month in-situ explants had highly significant differences in failure load between measurements close and distant to the osteotomy line: p=0.0017 (the region of maximum load in-situ). In the virgin products, there were only traces of melt joining and cooling, left from a stage in the manufacturing process. For the implants retrieved after 4.5 months in-situ, the fracture surfaces showed signs of degradation of the implants, possibly caused by hydrolysis, and for those retrieved after 9 months in-situ, there were cracks and pores. Thus, the morphological results are consistent with those obtained in the fatigue test. The present results suggest that resorbable osteofixations fabricated from PLDLLA-TMC are stable enough to allow loading of the healing bone and degrade reliably.

Keywords: PLDLLA-TMC; PLLA; Polylactic acid; fatigue.; in-patient degradation; in-situ degradation; resorbable craniofacial implants; resorbable osteofixation; resorbable osteosyntheses; strength retention

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