Are Biodegradable Osteosyntheses Still an Option for Midface Trauma? Longitudinal Evaluation of Three Different PLA-Based Materials

BioMed Research International

Volumn 2015, Issue , 2015, Pages

  Kolk, Andreas ^a   Köhnke, Robert ^b,c   Saely, Christoph H ^d   Ploder, Oliver ^c,e  

^a TECHNICAL UNIVERSITY OF MUNICH   (Germany)

^b UNIVERSITY MEDICAL CENTER HAMBURG EPPENDORF   (Germany)

^c ACADEMIC TEACHING HOSPITAL FELDKIRCH   (Austria)

^d Landeskrankenhaus Feldkirch   (Austria)

^e MEDICAL UNIVERSITY OF VIENNA   (Austria)

Author keywords

[No Author keywords available]

Indexed keywords

POLYLACTIC ACID; BONE PROSTHESIS; LACTIC ACID; POLYESTER; POLYLACTIDE; POLYMER;

ADOLESCENT; ADULT; AGED; ARTICLE; CHILD; CONTROLLED STUDY; FACE FRACTURE; FACIAL NERVE DISEASE; FEMALE; FOLLOW UP; FRONTAL BONE; HUMAN; LONGITUDINAL STUDY; MAJOR CLINICAL STUDY; MALE; MAXILLARY SINUS; MAXILLARY SINUS FRACTURE; MEDICAL DEVICE COMPLICATION; MULTICENTER STUDY; OSTEOSYNTHESIS; OSTEOSYNTHESIS MATERIAL; PAIN; PARANASAL SINUS; PH; RANDOMIZED CONTROLLED TRIAL; SKULL FRACTURE; SWELLING; VERY ELDERLY; ZYGOMA ARCH FRACTURE; BIODEGRADABLE IMPLANT; BONE PROSTHESIS; CLINICAL TRIAL; MIDDLE AGED; PATHOLOGY; ZYGOMATIC FRACTURES;

ABSORBABLE IMPLANTS; ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; BONE SUBSTITUTES; CHILD; FEMALE; FOLLOW-UP STUDIES; FRONTAL BONE; HUMANS; LACTIC ACID; MALE; MIDDLE AGED; POLYESTERS; POLYMERS; ZYGOMATIC FRACTURES;

EID: 84944199827     PISSN: 23146133     EISSN: 23146141     Source Type: Journal    
DOI: 10.1155/2015/621481     Document Type: Article

References (60)

1. D. G. Bowers Jr. and J. B. Lynch, "Management of facial fractures, " Southern Medical Journal, vol. 70, no. 8, pp. 910-918, 1977.
2. R. Schmelzeisen, T. McIff, and B. Rahn, "Further development of titanium miniplate fixation for mandibular fractures. Experience gained and questions raised from a prospective clinical pilot study with 2.0mm fixation plates, " Journal of Cranio-Maxillofacial Surgery, vol. 20, no. 6, pp. 251-256, 1992.
3. T. G. S. Fiala, R. A. Novelline, andM. J. Yaremchuk, "Comparison of CT imaging artifacts from craniomaxillofacial internal fixation devices, " Plastic and Reconstructive Surgery, vol. 92, no. 7, pp. 1227-1232, 1993.
4. E. Wiener, C. Pautke, T. M. Link, A. Neff, and A. Kolk, "Comparison of 16-slice MSCT and MRI in the assessment of squamous cell carcinoma of the oral cavity, " European Journal of Radiology, vol. 58, no. 1, pp. 113-118, 2006.
5. J. C. Yu, S. P. Bartlett, D. S. Goldberg et al., "An experimental study of the effects of craniofacial growth on the long-term positional stability of microfixation, " The Journal of Craniofacial Surgery, vol. 7, no. 1, pp. 64-68, 1996.
6. C. P. Case, V. G. Langkamer, C. James et al., "Widespread dissemination of metal debris from implants, " The Journal of Bone& Joint Surgery - British Volume, vol. 76, no. 5, pp. 701-712, 1994.
7. E. N. Siniscalchi, L. Catalfamo, A. Allegra, C. Musolino, and F. S. De Ponte, "Titanium miniplates: a new risk factor for the development of the bisphosphonate-related osteonecrosis of the jaw, " Journal of Craniofacial Surgery, vol. 24, no. 1, pp. e1-e2, 2013.
8. A. U. Daniels, M. K. Chang, and K. P. Andriano, "Mechanical properties of biodegradable polymers and composites proposed for internal fixation of bone, " Journal of Applied Biomaterials, vol. 1, no. 1, pp. 57-78, 1990.
9. W. H. Harris, B. J. L. Moyen, E. L. Thrasher II et al., "Differential response to electrical stimulation: a distinction between induced osteogenesis in intact tibiae and the effect on fresh fracture defects in radii, " Clinical Orthopaedics and Related Research, vol. 124, pp. 31-40, 1977.
10. R. K. Kulkarni, E. G. Moore, A. F. Hegyeli, and F. Leonard, "Biodegradable poly(lactic acid) polymers, " Journal of Biomedical Materials Research, vol. 5, no. 3, pp. 169-181, 1971.
11. L. K. Cheung, L. K. Chow, and W. K. Chiu, "A randomized controlled trial of resorbable versus titanium fixation for orthognathic surgery, " Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology and Endodontology, vol. 98, no. 4, pp. 386-397, 2004.
12. R. K. Kulkarni, K. C. Pani, C. Neuman, and F. Leonard, "Polylactic acid for surgical implants, " Archives of Surgery, vol. 93, no. 5, pp. 839-843, 1966.
13. K. L. Gerlach, "Resorbablepolymers asosteosynthesismaterial, " Mund Kiefer Gesichtschir, vol. 4, supplement 1, pp. S91-S102, 2000.
14. K. L. Gerlach, "In-vivo and clinical evaluations of poly(Llactide) plates and screws for use in maxillofacial traumatology, " Clinical Materials, vol. 13, no. 1-4, pp. 21-28, 1993.
15. S. J. Gourlay, R. M. Rice, A. F. Hegyeli et al., "Biocompatibility testing of polymers: in vivo implantation studies, " Journal of Biomedical Materials Research, vol. 12, no. 2, pp. 219-232, 1978.
16. A. Kolk, C. Haczek, C. Koch et al., "A strategy to establish a gene-activated matrix on titanium using gene vectors protected in a polylactide coating, " Biomaterials, vol. 32, no. 28, pp. 6850-6859, 2011.
17. A. Kolk, J. Handschel, W. Drescher et al., "Current trends and future perspectives of bone substitute materials - from space holders to innovative biomaterials, " Journal of Cranio-Maxillofacial Surgery, vol. 40, no. 8, pp. 706-718, 2012.
18. J. Vasenius, S. Vainionpää, K. Vihtonen et al., "Comparison of in vitro hydrolysis, subcutaneous and intramedullary implantation to evaluate the strength retention of absorbable osteosynthesis implants, " Biomaterials, vol. 11, no. 7, pp. 501-504, 1990.
19. J. A. Goldstein, F. A. Quereshy, and A. R. Cohen, "Early experience with biodegradable fixation for congenital pediatric craniofacial surgery, " Journal of Craniofacial Surgery, vol. 8, no. 2, pp. 110-115, 1997.
20. K. D. Kiely, K. S. Wendfeldt, B. E. Johnson, B. S. Haskell, and R. C. Edwards, "One-year postoperative stability of LeFort I osteotomies with biodegradable fixation: a retrospective analysis of skeletal relapse, " American Journal of Orthodontics and Dentofacial Orthopedics, vol. 130, no. 3, pp. 310-316, 2006.
21. G. Wittwer, W. L. Adeyemo, M. Voracek et al., "An evaluation of the clinical application of three different biodegradable osteosynthesis materials for the fixation of zygomatic fractures, " Oral Surgery, OralMedicine, Oral Pathology, Oral Radiology and Endodontology, vol. 100, no. 6, pp. 656-660, 2005.
22. G. Wittwer, W. L. Adeyemo, K. Yerit et al., "Complications after zygoma fracture fixation: Is there a difference between biodegradable materials and how do they compare with titaniumosteosynthesis?" Oral Surgery, OralMedicine, Oral Pathology, Oral Radiology and Endodontology, vol. 101, no. 4, pp. 419-425, 2006.
23. B. L. Eppley, C. D. Prevel, A. M. Sadove, and D. Sarver, "Resorbable bone fixation: its potential role in craniomaxillofacial trauma, " Journal of Cranio-Maxillofacial Trauma, vol. 2, no. 1, pp. 56-60, 1996.
24. G. Enislidis, G. Lagogiannis, G. Wittwer, C. Glaser, and R. Ewers, "Fixation of zygomatic fractures with a biodegradable copolymer osteosynthesis system: short-and long-termresults, " International Journal ofOral&Maxillofacial Surgery, vol. 34, no. 1, pp. 19-26, 2005.
25. L. Yang, M. Xu, X. Jin et al., "Complications of absorbable fixation in maxillofacial surgery: a meta-analysis, " PLoS ONE, vol. 8, no. 6, Article ID e67449, 2013.
26. D. E. Cutright, E. E. Hunsuck, and J. D. Beasley, "Fracture reduction using a biodegradable material, polylactic acid, " Journal of Oral Surgery, vol. 29, no. 6, pp. 393-397, 1971.
27. B. L. Schmidt, D. H. Perrott, D. Mahan, and G. Kearns, "The removal of plates and screws after Le Fort I osteotomy, " Journal of Oral and Maxillofacial Surgery, vol. 56, no. 2, pp. 184-188, 1998.
28. B. R. Simon, S. L.-Y. Woo, M. McCarty, S. Lee, and W. H. Akeson, "Parametric study of bone remodeling beneath internal fixation plates of varying stiffness, " Journal of Bioengineering, vol. 2, no. 6, pp. 543-556, 1978.
29. J. S. Orringer, V. Barcelona, and S. R. Buchman, "Reasons for removal of rigid internal fixation devices in craniofacial surgery, " Journal of Craniofacial Surgery, vol. 9, no. 1, pp. 40-44, 1998.
30. P. Schumann, D. Lindhorst, M. E. H. Wagner, A. Schramm, N.-C. Gellrich, and M. Rücker, "Perspectives on resorbable osteosynthesis materials in craniomaxillofacial surgery, " Pathobiology, vol. 80, no. 4, pp. 211-217, 2013.
31. B. L. Eppley and A. M. Sadove, "Effects of resorbable fixation on craniofacial skeletal growth: a pilot experimental study, " The Journal of Craniofacial Surgery, vol. 3, no. 4, pp. 190-196, 1992.
32. R. B. Bell and C. S. Kindsfater, "The use of biodegradable plates and screws to stabilize facial fractures, " Journal of Oral and Maxillofacial Surgery, vol. 64, no. 1, pp. 31-39, 2006.
33. P. U. Rokkanen, "Absorbable materials in orthopaedic surgery, " Annals of Medicine, vol. 23, no. 2, pp. 109-115, 1991.
34. A. A. Ignatius and L. E. Claes, "In vitro biocompatibility of bioresorbable polymers: poly(L, DL-lactide) and poly(Llactide-co-glycolide), " Biomaterials, vol. 17, no. 8, pp. 831-839, 1996.
35. B. Saad, G.Ciardelli, S.Matter et al., "Characterization of the cell response of cultured macrophages and fibroblasts to particles of short-chain poly[(R)-3-hydroxybutyric acid], " Journal of BiomedicalMaterials Research, vol. 30, no. 4, pp. 429-439, 1996.
36. M. C. Wake, P. D. Gerecht, L. Lu, and A. G. Mikos, "Effects of biodegradable polymer particles on rat marrow-derived stromal osteoblasts in vitro, " Biomaterials, vol. 19, no. 14, pp. 1255-1268, 1998.
37. H. Pihlajamäki, J. Kinnunen, and O. Böstman, "In vivo monitoring of the degradation process of bioresorbable polymeric implants using magnetic resonance imaging, " Biomaterials, vol. 18, no. 19, pp. 1311-1315, 1997.
38. R. A.Miller, J.M. Brady, and D. E. Cutright, "Degradation rates of oral resorbable implants (polylactates and polyglycolates): rate modification with changes in PLA/PGA copolymer ratios, " Journal of Biomedical Materials Research, vol. 11, no. 5, pp. 711-719, 1977.
39. D. E. Cutright, B. Perez, J. D. Beasley III, W. J. Larson, and W. R. Posey, "Degradation rates of polymers and copolymers of polylactic and polyglycolic acids, " Oral Surgery, Oral Medicine, Oral Pathology, vol. 37, no. 1, pp. 142-152, 1974.
40. W. S. Pietrzak, "Principles of development and use of absorbable internal fixation, " Tissue Engineering, vol. 6, no. 4, pp. 425-433, 2000.
41. W. S. Pietrzak, D. R. Sarver, and M. L. Verstynen, "Bioabsorbable polymer science for the practicing surgeon, " Journal of Craniofacial Surgery, vol. 8, no. 2, pp. 87-91, 1997.
42. M. J. Imola, D. D. Hamlar, W. Shao, K. Chowdhury, and S. Tatum, "Resorbable plate fixation in pediatric craniofacial surgery: long-term outcome, " Archives of Facial Plastic Surgery, vol. 3, no. 2, pp. 79-90, 2001.
43. J. Wiltfang, H.-A. Merten, S. Schultze-Mosgau, U. Schrell, D. Wénzel, and P. Keßler, "Biodegradable miniplates (LactoSorb): long-termresults in infant minipigs and clinical results, " Journal of Craniofacial Surgery, vol. 11, no. 3, pp. 239-243, 2000.
44. E. J. Bergsma, F. R. Rozema, R. R. M. Bos, andW. C. de Bruijn, "Foreign body reactions to resorbable poly(L-lactide) bone plates and screws used for the fixation of unstable zygomatic fractures, " Journal of Oral andMaxillofacial Surgery, vol. 51, no. 6, pp. 666-670, 1993.
45. R. R. M. Bos, G. Boering, F. R. Rozema, and J. W. Leenslag, "Resorbable poly(L-lactide) plates and screws for the fixation of zygomatic fractures, " Journal of Oral andMaxillofacial Surgery, vol. 45, no. 9, pp. 751-753, 1987.
46. J. E. Bergsma, W. C. de Bruijn, F. R. Rozema, R. R. M. Bos, and G. Boering, "Late degradation tissue response to poly(L-lactide) bone plates and screws, " Biomaterials, vol. 16, no. 1, pp. 25-31, 1995.
47. R. R. M. Bos, F. B. Rozema, G. Boering et al., "Degradation of and tissue reaction to biodegradable poly(L-lactide) for use as internal fixation of fractures: a study in rats, " Biomaterials, vol. 12, no. 1, pp. 32-36, 1991.
48. P. Laine, R. Kontio, C. Lindqvist, and R. Suuronen, "Are there any complications with bioabsorbable fixation devices? A 10 year review in orthognathic surgery, " International Journal of Oral andMaxillofacial Surgery, vol. 33, no. 3, pp. 240-244, 2004.
49. J. E. Bergsma, F. R. Rozema, R. R. M. Bos, G. Boering, W. C. de Bruijn, and A. J. Pennings, "In vivo degradation and biocompatibility study of in vitro pre-degraded as-polymerized polylactide particles, " Biomaterials, vol. 16, no. 4, pp. 267-274, 1995.
50. P. Tormala, J.Vasenius, S.Vainionpaa, J. Laiho, T. Pohjonen, and P. Rokkanen, "Ultra-high-strength absorbable self-reinforced polyglycolide (SR-PGA) composite rods for internal fixation of bone fractures: in vitro and in vivo study, " Journal of Biomedical Materials Research, vol. 25, no. 1, pp. 1-22, 1991.
51. J.Düchting, Chemische und mechanische Eigenschaften bioresorbierbarer Osteosyntheseplatten nach in-vitro Degradation [M.S. thesis], Department of Maxillofacial and Facial Plastic Surgery, University of Rostock, Rostock, Germany, 2008.
52. J. C. Posnick and R. L. Ruiz, "Treacher Collins syndrome: current evaluation, treatment, and future directions, " Cleft Palate-Craniofacial Journal, vol. 37, no. 5, p. 434, 2000.
53. J. C. Posnick and R. L. Ruiz, "The craniofacial dysostosis syndromes: current surgical thinking and future directions, " Cleft Palate-Craniofacial Journal, vol. 37, no. 5, p. 433, 2000.
54. Y. Li, C. Wen, D. Mushahary et al., "Mg-Zr-Sr alloys as biodegradable implantmaterials, " Acta Biomaterialia, vol. 8, no. 8, pp. 3177-3188, 2012.
55. R. Smeets, K. Endres, G. Stockbrink et al., "The innovative application of a novel bone adhesive for facial fracture osteosynthesis - in vitro and in vivo results, " Journal of Biomedical Materials Research A, vol. 101, no. 7, pp. 2058-2066, 2013.
56. C. A. Landes and A. Ballon, "Indications and limitations in resorbable P(L70/30DL)LA osteosyntheses of displaced mandibular fractures in 4.5-year follow-up, " Plastic and Reconstructive Surgery, vol. 117, no. 2, pp. 577-587, 2006.
57. C. M. Agrawal and K. A. Athanasiou, "Technique to control pH in vicinity of biodegrading PLA-PGA implants, " Journal of Biomedical Materials Research, vol. 38, no. 2, pp. 105-114, 1997.
58. R. M. Felfel, I. Ahmed, A. J. Parsons, P. Haque, G. S. Walker, andC.D. Rudd, "Investigation of crystallinity, molecularweight change, and mechanical properties of PLA/PBG bioresorbable composites as bone fracture fixation plates, " Journal of Biomaterials Applications, vol. 26, no. 7, pp. 765-789, 2012.
59. N. A. Weir, F. J. Buchanan, J. F. Orr, D. F. Farrar, and G. R. Dickson, "Degradation of poly-L-lactide. Part 2: increased temperature accelerated degradation, " Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine, vol. 218, no. 5, pp. 321-330, 2004.
60. Y. Shikinami and M. Okuno, "Bioresorbable devices made of forged composites of hydroxyapatite (HA) particles and poly-Llactide (PLLA): part I. Basic characteristics, " Biomaterials, vol. 20, no. 9, pp. 859-877, 1999.