Bioabsorbable bone fixation plates for X-ray imaging diagnosis by a radiopaque layer of barium sulfate and poly(lactic-co-glycolic acid)
Sung Yoon Choi
Interdisciplinary Program in Bioengineering, College of Engineering, Seoul National University, Seoul, 152-742 Republic of Korea
These authors contributed equally as first author to this work.
Search for more papers by this authorWoojune Hur
Biomedical Research Institute, Seoul National University Hospital, Seoul, 110-744 Republic of Korea
Department of Plastic and Reconstructive Surgery, Institute of Human-Environment Interface Biology, College of Medicine, Seoul National University, Seoul, 110-799 Republic of Korea
These authors contributed equally as first author to this work.
Search for more papers by this authorByeung Kyu Kim
Biomedical Research Institute, Seoul National University Hospital, Seoul, 110-744 Republic of Korea
Department of Plastic and Reconstructive Surgery, Institute of Human-Environment Interface Biology, College of Medicine, Seoul National University, Seoul, 110-799 Republic of Korea
These authors contributed equally as first author to this work.
Search for more papers by this authorCatherine Shasteen
Department of Materials Science and Engineering, College of Engineering, Seoul National University, Seoul, 151-744 Republic of Korea
Search for more papers by this authorMyung Hun Kim
Interdisciplinary Program in Bioengineering, College of Engineering, Seoul National University, Seoul, 152-742 Republic of Korea
Search for more papers by this authorLa Mee Choi
Biomedical Research Institute, Seoul National University Hospital, Seoul, 110-744 Republic of Korea
Department of Plastic and Reconstructive Surgery, Institute of Human-Environment Interface Biology, College of Medicine, Seoul National University, Seoul, 110-799 Republic of Korea
Search for more papers by this authorSeung Ho Lee
Interdisciplinary Program in Bioengineering, College of Engineering, Seoul National University, Seoul, 152-742 Republic of Korea
Search for more papers by this authorChun Gwon Park
Interdisciplinary Program in Bioengineering, College of Engineering, Seoul National University, Seoul, 152-742 Republic of Korea
Search for more papers by this authorMin Park
Interdisciplinary Program in Bioengineering, College of Engineering, Seoul National University, Seoul, 152-742 Republic of Korea
Search for more papers by this authorHye Sook Min
Department of Preventive Medicine, Graduate School of Public Health, Seoul National University College of Medicine, Seoul, 110-799 Republic of Korea
Search for more papers by this authorSukwha Kim
Department of Plastic and Reconstructive Surgery, Institute of Human-Environment Interface Biology, College of Medicine, Seoul National University, Seoul, 110-799 Republic of Korea
Search for more papers by this authorCorresponding Author
Tae Hyun Choi
Department of Plastic and Reconstructive Surgery, Institute of Human-Environment Interface Biology, College of Medicine, Seoul National University, Seoul, 110-799 Republic of Korea
Correspondence to: Y. B. Choy (e-mail: [email protected]) or T. H. Choi (e-mail: [email protected])Search for more papers by this authorCorresponding Author
Young Bin Choy
Interdisciplinary Program in Bioengineering, College of Engineering, Seoul National University, Seoul, 152-742 Republic of Korea
Department of Biomedical Engineering, Seoul National University College of Medicine, Seoul, 110-799 Republic of Korea
Institute of Medical and Biological Engineering, Medical Research Center, Seoul National University, Seoul, 110-799 Republic of Korea
Correspondence to: Y. B. Choy (e-mail: [email protected]) or T. H. Choi (e-mail: [email protected])Search for more papers by this authorSung Yoon Choi
Interdisciplinary Program in Bioengineering, College of Engineering, Seoul National University, Seoul, 152-742 Republic of Korea
These authors contributed equally as first author to this work.
Search for more papers by this authorWoojune Hur
Biomedical Research Institute, Seoul National University Hospital, Seoul, 110-744 Republic of Korea
Department of Plastic and Reconstructive Surgery, Institute of Human-Environment Interface Biology, College of Medicine, Seoul National University, Seoul, 110-799 Republic of Korea
These authors contributed equally as first author to this work.
Search for more papers by this authorByeung Kyu Kim
Biomedical Research Institute, Seoul National University Hospital, Seoul, 110-744 Republic of Korea
Department of Plastic and Reconstructive Surgery, Institute of Human-Environment Interface Biology, College of Medicine, Seoul National University, Seoul, 110-799 Republic of Korea
These authors contributed equally as first author to this work.
Search for more papers by this authorCatherine Shasteen
Department of Materials Science and Engineering, College of Engineering, Seoul National University, Seoul, 151-744 Republic of Korea
Search for more papers by this authorMyung Hun Kim
Interdisciplinary Program in Bioengineering, College of Engineering, Seoul National University, Seoul, 152-742 Republic of Korea
Search for more papers by this authorLa Mee Choi
Biomedical Research Institute, Seoul National University Hospital, Seoul, 110-744 Republic of Korea
Department of Plastic and Reconstructive Surgery, Institute of Human-Environment Interface Biology, College of Medicine, Seoul National University, Seoul, 110-799 Republic of Korea
Search for more papers by this authorSeung Ho Lee
Interdisciplinary Program in Bioengineering, College of Engineering, Seoul National University, Seoul, 152-742 Republic of Korea
Search for more papers by this authorChun Gwon Park
Interdisciplinary Program in Bioengineering, College of Engineering, Seoul National University, Seoul, 152-742 Republic of Korea
Search for more papers by this authorMin Park
Interdisciplinary Program in Bioengineering, College of Engineering, Seoul National University, Seoul, 152-742 Republic of Korea
Search for more papers by this authorHye Sook Min
Department of Preventive Medicine, Graduate School of Public Health, Seoul National University College of Medicine, Seoul, 110-799 Republic of Korea
Search for more papers by this authorSukwha Kim
Department of Plastic and Reconstructive Surgery, Institute of Human-Environment Interface Biology, College of Medicine, Seoul National University, Seoul, 110-799 Republic of Korea
Search for more papers by this authorCorresponding Author
Tae Hyun Choi
Department of Plastic and Reconstructive Surgery, Institute of Human-Environment Interface Biology, College of Medicine, Seoul National University, Seoul, 110-799 Republic of Korea
Correspondence to: Y. B. Choy (e-mail: [email protected]) or T. H. Choi (e-mail: [email protected])Search for more papers by this authorCorresponding Author
Young Bin Choy
Interdisciplinary Program in Bioengineering, College of Engineering, Seoul National University, Seoul, 152-742 Republic of Korea
Department of Biomedical Engineering, Seoul National University College of Medicine, Seoul, 110-799 Republic of Korea
Institute of Medical and Biological Engineering, Medical Research Center, Seoul National University, Seoul, 110-799 Republic of Korea
Correspondence to: Y. B. Choy (e-mail: [email protected]) or T. H. Choi (e-mail: [email protected])Search for more papers by this authorAbstract
Bone fixation systems made of biodegradable polymers are radiolucent, making post-operative diagnosis with X-ray imaging a challenge. In this study, to allow X-ray visibility, we separately prepared a radiopaque layer and attached it to a bioabsorbable bone plate approved for clinical use (Inion, Finland). We employed barium sulfate as a radiopaque material due to the high X-ray attenuation coefficient of barium (2.196 cm2/g). The radiopaque layer was composed of a fine powder of barium sulfate bound to a biodegradable material, poly(lactic-co-glycolic acid) (PLGA), to allow layer degradation similar to the original Inion bone plate. In this study, we varied the mass ratio of barium sulfate and PLGA in the layer between 3:1 w/w and 10:1 w/w to modulate the degree and longevity of X-ray visibility. All radiopaque plates herein were visible via X-ray, both in vitro and in vivo, for up to 40 days. For all layer types, the radio-opacity decreased with time due to the swelling and degradation of PLGA, and the change in the layer shape was more apparent for layers with a higher PLGA content. The radiopaque plates released, at most, 0.5 mg of barium sulfate every 2 days in a simulated in vitro environment, which did not appear to affect the cytotoxicity. The radiopaque plates also exhibited good biocompatibility, similar to that of the Inion plate. Therefore, we concluded that the barium sulfate-based, biodegradable plate prepared in this work has the potential to be used as a fixation device with both X-ray visibility and biocompatibility. © 2014 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 103B:596–607, 2015.
REFERENCES
- 1 Malekani J, Schmutz B, Gu Y, Schuetz M, Yarlagadda PK. Biomaterials in orthopedic bone plates: A review. Proceedings of the 2nd Annual International Conference on Materials Science, Metal & Manufacturing. Bali, Indonesia: Global Science and Technology Forum; 2011. pp. 71–77.
- 2 Goodrich JT, Sandler AL, Tepper O. A review of reconstructive materials for use in craniofacial surgery bone fixation materials, bone substitutes, and distractors. Child's Nervous Syst 2012; 28: 1577–1588.
- 3 Hintermann B, Trouillier H, Schäfer D. Rigid internal fixation of fractures of the proximal humerus in older patients. J Bone Jt Surg Br Vol 2000; 82: 1107–1112.
- 4 Uhthoff HK, Poitras P, Backman DS. Internal plate fixation of fractures: Short history and recent developments. J Orthop Sci 2006; 11: 118–126.
- 5 Voggenreiter G, Leiting S, Brauer H, Leiting P, Majetschak M, Bardenheuer M, Obertacke U. Immuno-inflammatory tissue reaction to stainless-steel and titanium plates used for internal fixation of long bones. Biomaterials 2003; 24: 247–254.
- 6 Lee JH, Park JH. The Clinical Usefulness of Ultrasound-Aided Fixation Using an Absorbable Plate System in Patients with Zygomatico-Maxillary Fracture. Arch Plast Surg 2013; 40: 330–334.
- 7 Richards R, Palmer J, Clarke N. Observations on removal of metal implants. Injury 1992; 23: 25–28.
- 8 Rokkanen PU, Böstman O, Hirvensalo E, Mäkelä EA, Partio EK, Pätiälä H, Vainionpää S, Vihtonen K, Törmälä P. Bioabsorbable fixation in orthopaedic surgery and traumatology. Biomaterials 2000; 21: 2607–2613.
- 9 Ambrose CG, Clanton TO. Bioabsorbable implants: Review of clinical experience in orthopedic surgery. Ann Biomed Eng 2004; 32: 171–177.
- 10 Chaushu G, Manor Y, Shoshani Y, Taicher S. Risk factors contributing to symptomatic plate removal in maxillofacial trauma patients. Plast Reconstruct Surg 2000; 105: 521–525.
- 11 Daniels A, Chang MK, Andriano KP, Heller J. Mechanical properties of biodegradable polymers and composites proposed for internal fixation of bone. J Appl Biomater 1990; 1: 57–78.
- 12 Losken HW, van Aalst JA, Mooney MP, Godfrey VL, Burt T, Teotia S, Dean SB, Moss JR, Rahbar R. Biodegradation of Inion fast-absorbing biodegradable plates and screws. J Craniofac Surg 2008; 19: 748–756.
- 13
Ikada Y,
Shikinami Y,
Hara Y,
Tagawa M,
Fukada E. Enhancement of bone formation by drawn poly (l-lactide). J Biomed Mater Res 1996; 30: 553–558.
10.1002/(SICI)1097-4636(199604)30:4<553::AID-JBM14>3.0.CO;2-I CAS PubMed Web of Science® Google Scholar
- 14 Athanasiou KA, Agrawal CM, Barber FA, Burkhart SS. Orthopaedic applications for PLA-PGA biodegradable polymers. Arthroscopy 1998; 14: 726–737.
- 15 Tokiwa Y, Calabia BP. Biodegradability and biodegradation of poly (lactide). Appl Microbiol Biotechnol 2006; 72: 244–251.
- 16 Böstman OM, Pihlajamäki HK. Adverse tissue reactions to bioabsorbable fixation devices. Clin Orthop Relat Res 2000; 371: 216–227.
- 17 Mainil-Varlet P, Rahn B, Gogolewski S. Long-term in vivo degradation and bone reaction to various polylactides. 1. One-year results. Biomaterials 1997; 18: 257–266.
- 18 Middleton JC, Tipton AJ. Synthetic biodegradable polymers as orthopedic devices. Biomaterials 2000; 21: 2335–2346.
- 19 Fouad H. Effects of the bone-plate material and the presence of a gap between the fractured bone and plate on the predicted stresses at the fractured bone. Med Eng Phys 2010; 32: 783–789.
- 20 Blokhuis T, de Bruine J, Bramer J, den Boer F, Bakker F, Patka P, Haarman HTM, Manoliu R. The reliability of plain radiography in experimental fracture healing. Skeletal Radiol 2001; 30: 151–156.
- 21 Gefen A. Optimizing the biomechanical compatibility of orthopedic screws for bone fracture fixation. Med Eng Phys 2002; 24: 337–347.
- 22 Hume MC, Wiss DA. A clinical and radiographic comparison of tension band wiring and plate fixation. Clin Orthop Relat Res 1992; 285: 229–235.
- 23 Sanger C, Soto A, Mussa F, Sanzo M, Sardo L, Donati PA, Di Pietro G, Spacca B, Giordano F, Genitori L. Maximizing results in craniofacial surgery with bioresorbable fixation devices. J Craniofac Surg 2007; 18: 926–930.
- 24 Waris E, Ninkovic M, Harpf C, Ninkovic M, Ashammakhi N. Self-reinforced bioabsorbable miniplates for skeletal fixation in complex hand injury: Three case reports. J Hand Surg 2004; 29: 452–457.
- 25 Shasteen C, Kwon SM, Park KY, Jung SY, Lee SH, Park CG, Kim MH, Kim S, Son WC, Choi TH. Biodegradable internal fixation plates enabled with X-ray visibility by a radiopaque layer of β-tricalcium phosphate and poly(lactic-co-glycolic acid). J Biomed Mater Res Part B Appl Biomater 2013; 101: 320–329.
- 26 Hubbell JH, Seltzer SM. Tables of X-ray mass attenuation coefficients and mass energy-absorption coefficients 1 keV to 20 MeV for elements Z = 1 to 92 and 48 additional substances of dosimetric interest: National Inst. of Standards and Technology-PL, Gaithersburg, MD (United States). Ionizing Radiation Div.; 1995.
- 27 Nuutinen J-P, Clerc C, Törmälä P. Mechanical properties and in vitro degradation of self-reinforced radiopaque bioresorbable polylactide fibres. J Biomater Sci Polym Ed 2003; 14: 665–676.
- 28 Pepiol A, Teixidor F, Saralidze K, van der Marel C, Willems P, Voss L, Knetsch ML, Vinas C, Koole LH. A highly radiopaque vertebroplasty cement using tetraiodinated o-carborane additive. Biomaterials 2011; 32: 6389–6398.
- 29 Lieberman IH, Togawa D, Kayanja MM. Vertebroplasty and kyphoplasty: Filler materials. Spine J 2005; 5: S305–S316.
- 30 Mottu F, RüFENACHT DA, Doelker E. Radiopaque polymeric materials for medical applications: Current aspects of biomaterial research. Investig Radiol 1999; 34: 323.
- 31 Iso E. 10993-5:2009. Biological evaluation of medical devices. Tests for in vitro cytotoxicity 1999.
- 32 Zhang M, Zhang B, Li X, Yin Z, Guo X. Synthesis and surface properties of submicron barium sulfate particles. Appl Surf Sci 2011; 258: 24–29.
- 33 Xin F, Jian C, Jianming R, Zhongcheng Z, Jianpeng Z. Effects of surface modification on the properties of poly(lactide-co-glycolide) composite materials. Polym Plast Technol Eng 2009; 48: 658–664.
- 34 Shikinami Y, Okuno M. Bioresorbable devices made of forged composites of hydroxyapatite (HA) particles and poly l-lactide (PLLA). Part II: Practical properties of miniscrews and miniplates. Biomaterials 2001; 22: 3197–3211.
- 35 Böstman O, Pihlajamäki H. Clinical biocompatibility of biodegradable orthopaedic implants for internal fixation: A review. Biomaterials 2000; 21: 2615–2621.
- 36 Chan W, Bini T, Venkatraman SS, Boey F. Effect of radio-opaque filler on biodegradable stent properties. J Biomed Mater Res Part A 2006; 79: 47–52.
- 37 Nottelet B, Coudane J, Vert M. Synthesis of an X-ray opaque biodegradable copolyester by chemical modification of poly (ε-caprolactone). Biomaterials 2006; 27(28): 4948-4954.
- 38
Furukawa T,
Matsusue Y,
Yasunaga T,
Nakagawa Y,
Okada Y,
Shikinami Y,
Okuno M,
Nakamura T. Histomorphometric study on high-strength hydroxyapatite/poly (l-lactide) composite rods for internal fixation of bone fractures. J Biomed Mater Res 2000; 50: 410–419.
10.1002/(SICI)1097-4636(20000605)50:3<410::AID-JBM16>3.0.CO;2-Y CAS PubMed Web of Science® Google Scholar
- 39 Aldenhoff YB, Kruft M-AB, Paul Pijpers A, van der Veen FH, Bulstra SK, Kuijer R, Koole LH. Stability of radiopaque iodine-containing biomaterials. Biomaterials 2002; 23: 881–886.
- 40 Coletti DP, Salama A, Caccamese Jr JF. Application of intermaxillary fixation screws in maxillofacial trauma. J Oral Maxillofac Surg 2007; 65: 1746–1750.
- 41 Wimhurst J, Brooks R, Rushton N. The effects of particulate bone cements at the bone–implant interface. J Bone Jt Surg 2001; 83: 588–592.
- 42 Kjellson F, Almen T, Tanner K, McCarthy I, Lidgren L. Bone cement X-ray contrast media: A clinically relevant method of measuring their efficacy. J Biomed Mater Res Part B: Appl Biomater 2004; 70: 354–361.
- 43
Kühn K. Bone Cements. Up-to-date Comparison of Physical and Chemical Properties of Commercial Materials. Berlin: Springer-Verlag; 2000.
10.1007/978-3-642-59762-6 Google Scholar
- 44 Lewis G. Injectable bone cements for use in vertebroplasty and kyphoplasty: State-of-the-art review. J Biomed Mater Res Part B: Appl Biomater 2006; 76: 456–468.
