Patient specific implants for amputation prostheses: Design, manufacture and analysis

P. DeVasConCellos; V. K. Balla; S. Bose; R. Fugazzi; W. S. Dernell; A. Bandyopadhyay

doi:10.3415/VCOT-11-03-0043

Veterinary and Comparative Orthopaedics and Traumatology, Inhaltsverzeichnis

Vet Comp Orthop Traumatol 2012; 25(04): 286-296
DOI: 10.3415/VCOT-11-03-0043

Original Research

Schattauer GmbH

Patient specific implants for amputation prostheses: Design, manufacture and analysis

Authors

P. DeVasConCellos

¹W. M. Keck Biomedical Materials Research Laboratory, School of Mechanical and Materials Engineering Washington State University, Pullman, WA, USA
V. K. Balla

¹W. M. Keck Biomedical Materials Research Laboratory, School of Mechanical and Materials Engineering Washington State University, Pullman, WA, USA

³Current: Bioceramics and Coatings Division, Central Glass and Ceramic Research Institute, Kolkata, India
S. Bose

¹W. M. Keck Biomedical Materials Research Laboratory, School of Mechanical and Materials Engineering Washington State University, Pullman, WA, USA
R. Fugazzi

²Department of Veterinary Clinical Sciences, College of Veterinary Medicine, Washington State University, Pullman, WA USA
W. S. Dernell

²Department of Veterinary Clinical Sciences, College of Veterinary Medicine, Washington State University, Pullman, WA USA
A. Bandyopadhyay

¹W. M. Keck Biomedical Materials Research Laboratory, School of Mechanical and Materials Engineering Washington State University, Pullman, WA, USA

Abstract

Summary

Objectives: To design, manufacture and analyze custom implants with functional gradation in macrostructure for attachment of amputation prostheses.

Methods: The external shape of the implant was designed by extracting geometrical data of canine cadavers from computed tomography (CT) scans to suit the bone cavity. Three generations of implant designs were developed and were optimized with the help of fit/fill and mechanical performance of implant-cadaver bone assembly using CT analysis and compression testing, respectively. A final optimized, custom Ti6Al4V alloy amputation implant, with approximately 25% porosity in the proximal region and approximaltely zero percent porosity in the distal region, was fabricated using Laser Engineered Net Shaping (LENS™) – a laser based additive manufacturing technology.

Results: The proposed design changes in the second generation designs, in terms of refining thresholds, increased the average fill of the bone cavity from 58% to 83%. Addition of a flange between the stem and the head in the second generation designs resulted in more than a seven-fold increase in the compressive load carrying capacity of the assembly. Application of LENS™ in the fabrication of present custom fit Ti6Al4V alloy implants enabled incorporation of 20 to 30% porosity in the proximal region and one to two percent residual porosity in the distal portion of the implant.

Clinical significance: Patient specific prostheses having direct connection to the skeletal structure can potentially aid in problems related to load transfer and proprioception in amputees. Furthermore, application of LENS™ in the fabrication of custom implants can be faster to incorporate site specific porosity and gradients for improving long-term stability.

Keywords

Custom implant - amputation prosthesis - solid freeform fabrication - rapid prototyping - laser engineered net shaping

Volltext

Referenzen

References
1 Statistics about Amputation. [website]. RD; Rightdiagnosis.com[cited on 2011 June 02]. Available from: http://www.rightdiagnosis.com/a/amputation/stats.htm.
2 Kathryn ZG, Ellen JM, Patti LE. et al. Estimating the prevalence of limb loss in the United States - 2005 to 2050. Arch Phys Med Rehabil 2008; 89: 422-429.
3 Allende MF, Levy SW, Barnes GH. Epidermoid cysts in amputees. Acta Derm Venereol 1963; 43: 56-67.
4 Levy SW. Amputees: skin problems and prostheses. Curtis 1995; 55: 297-301.
5 Levy SW. Skin problems of the leg amputee. Prosthet Orthot Int 1980; 4: 37-44.
6 Lyon CC, Kulkarni J, Zimerson E. et al. Skin disorders in amputees. J Am Acad Dermatol 2000; 42: 501-507.
7 Gallagher P, Allen D, MacLachlan MI. Phantom limb pain and residual limb pain following lower limb amputation: a descriptive analysis. Disabil Rehabil 2001; 23: 522-530.
8 Hagberg K, Branemark R. Consequences of non-vascular transfemoral amputation: a survey of quality of life, prosthetic use and problems. Prosthet Orthot Int 2001; 25: 186-194.
9 Arthur FTM, Ming Z, David AB. State-of-the-art research in lower-limb prosthetic biomechanics-socket interface: A review. J Rehab Res Dev 2001; 38: 161-174.
10 Hagberg K, Haggstrom E, Uden M. et al. Socket versus bone-anchored trans-femoral prostheses: hip range of motion and sitting comfort. Prosthet Orthot Int 2005; 29: 153-163.
11 Branemark R, Branemark PI, Björn R. et al. Osseointegration in skeletal reconstruction and rehabilitation: A review. J Rehab Res Dev 2001; 38: 175-181.
12 Robinson KP, Branemark R, Ward DA. Future developments: osseointegration in transfemoral amputees. In: Smith DG, Michael JW, Bowker JH. editors. Atlas of Amputations and Limb Deficiencies: Surgical, Prosthetic and Rehabilitation Principles. Rosemont (IL, USA): America Academy of Orthopaedic Surgeons; 2004. pg. 673.
13 Sullivan J, Uden M, Robinson KP. et al. Rehabilitation of the trans-femoral amputee with an osseointegrated prosthesis: the United Kingdom experience. Prosthet Orthot Int 2003; 27: 114-120.
14 Hagberg K, Brånemark R. One hundred patients treated with osseointegrated transfemoral amputation prostheses-rehabilitation perspective. J Rehabil Res Dev 2009; 46: 331-344.
15 Sooriakumaran S, Robinson KP, Ward DA. Pattern of infection of transfemoral osseointegration. In: Proceedings of the International Society for Prosthetics and Orthotics, 11th World Congress. 2004. August 1-6 Wanchai, Hong Kong; Hong Kong: pg. 252.
16 Holgers KM. Characteristics of the inflammatory process around skin-penetrating titanium implants for aural rehabilitation. Audiology 2000; 39: 253-259.
17 Shin Y, Akao M. Tissue reactions to various percutaneous materials with different surface properties and structures. Artif Organs 1997; 21: 995-1001.
18 Chehroudi B, Gould TR, Brunette DM. Effects of a grooved epoxy substratus on epithelial cell behavior in vitro and in vivo. J Biomed Mater Res 1988; 22: 459-473.
19 Nowicki B, Runyan RS, Smith N. et al. Kinetics of colonization of a porous vitreous carbon percutaneous implant. Biomaterials 1990; 11: 389-392.
20 Pendegrass CJ, Gordon D, Middleton CA. et al. Sealing the skin barrier around transcutaneous implants: in vitro study of keratinocyte proliferation and adhesion in response to surface modifications of titanium alloy. J Bone Joint Surg 2008; 90B: 114-121.
21 Chimutengwende-Gordon M, Pendegrass C, Blunn G. Enhancing the soft tissue seal around intraosseous transcutaneous amputation prostheses using silanized fibronectin titanium alloy. Biomed Mater. 2011 6. 025008 [Epub].
22 Pendegrass CJ, Goodship AE, Blunn GW. Development of a soft tissue seal around bone-anchored transcutaneous amputation prostheses. Biomaterials 2006; 27: 4183-4191.
23 Fitzpatrick N, Smith TJ, Pendegrass CJ. et al. Intraosseous Transcutaneous Amputation Prosthesis (ITAP) for Limb Salvage in 4 Dogs. Vet Surg 2011; 40: 909-925.
24 Fitzpatrick N, Ash K, Pendegrass CJ. et al. Application of novel endo- and exo-prostheses to the calcaneus of the dog and cat following distal limb amputation. Abstracts of the 38th Veterinary Orthopedic Society Annual Symposium. 2011. March 5-12 Snowmass, Colorado, USA: pg. A14.
25 Kang NV, Pendegrass C, Marks L. et al. Osseocutaneous integration of an intraosseous transcutaneous amputation prosthesis implant used for reconstruction of a transhumeral amputee: case report. J Hand Surg Am 2010; 35: 1130-1134.
26 Drygas KA, Taylor R, Sidebotham CG. et al. Transcutaneous tibial implants: a surgical procedure for restoring ambulation after amputation of the distal aspect of the tibia in a dog. Vet Surg 2008; 37: 322-327.
27 McCarthy JC, Bono JV, O'Donnel PJ. Custom and modular components in primary total hip replacement. Clin Orthop 1997; 344: 162-171.
28 Iwata D, Broun HC, Black AP. et al. Total hip arthroplasty outcomes assessment using functional and radiographic score to compare canine systems. Vet Comp Orthop Traumatol 2008; 21: 221-230.
29 Frankel DJ, Pluhar E, Skurla CP. et al. Radiographic evaluation of mechanically tested cemented total hip arthroplasty femoral components retrieved post mortem. Vet Comp Orthop Traumatol 2004; 17: 216-224.
30 Garrett R, Abhay P, Panagiotis DA. Fabrication methods of porous metals for use in orthopaedic applications. Biomaterials 2006; 27: 2651-2670.
31 Krishna BV, Bose S, Bandyopadhyay A. Low stiffness porous Ti structures for load-bearing implants. Acta Biomater 2007; 3: 997-1006.
32 Xue W, Krishna BV, Bose S. et al. Processing and biocompatibility evaluation of laser processed porous titanium. Acta Biomater 2007; 3: 1007-1018.
33 El-Warrak AO, Olmstead ML, von Rechenberg B. et al. A review of aseptic loosening in total hip arthroplasty. Vet Comp Orthop Traumatol 2001; 14: 115-124.
34 Bandyopadhyay A, Espana F, Balla VK. et al. Influence of porosity on mechanical properties and in vivo response of Ti6Al4V implants. Acta Biomater 2010; 6: 1640-1648.
35 Hing KA, Best SM, Tanner KE. et al. Mediation of bone ingrowth in porous hydroxyapatite bone graft substitutes. J Biomed Mater Res Part A 2004; 68A: 187-200.
36 Balla VK, DeVasConCellos P, Xue W. et al. Fabrication of compositionally and structurally graded Ti-TiO2 structures using laser engineered net shaping (LENS). Acta Biomater 2009; 5: 1831-1837.
37 Vamsi Krishna B, Xue W, Bose S. et al. Engineered porous metals for implants. JOM 2008; 60: 45-48.
38 Vamsi Krishna B, Xue W, Bose S. et al. Functionally graded Co-Cr-Mo coating on Ti6Al4V alloy structures. Acta Biomater 2008; 4: 697-706.
39 Roy M, Vamsi Krishna B, Bandyopadhyay A. et al. Laser processing of bioactive tricalcium phosphate coating on titanium for load-bearing implants. Acta Biomater 2008; 4: 324-333.
40 Balla VK, Xue W, Bose S. et al. Laser-assisted Zr/ZrO(2) coating on Ti for load-bearing implants. Acta Biomater 2009; 5: 2800-2809.
41 Balla VK, Banerjee S, Bose S. et al. Direct laser processing of a tantalum coating on titanium for bone replacement structures. Acta Biomater 2010; 6: 2329-2334.
42 Balla VK, Bodhak S, Bose S. et al. Porous tantalum structures for bone implants: Fabrication, mechanical and in vitro biological properties. Acta Biomater 2010; 6: 3349-3359.
43 Hach V, Delfs G. Initial experience with a newly developed cementless hip endoprosthesis. Vet Comp Orthop Traumatol 2009; 25: 153-158.
44 Tomaszewski P, Verdonschot N, Bulstra S. et al. A Comparative Finite-Element Analysis of Bone Failure and Load Transfer of Osseointegrated Prostheses Fixations. Ann Biomed Eng 2010; 38: 2418-2427.
45 Head WC, Bauk DJ, Emerson Jr. RH. Titanium as the material of choice for cementless femoral components in total hip arthroplasty. Clin Orthop 1995; 311: 85-90.
46 Kroger H, Venesma P, Jurvelin J. et al. Bone density at the proximal femur after total hip arthroplasty. Clin Orthop Relat Res 1998; 352: 66-74.
47 Gotze C, Vieth V, Meier N. et al. CT-based accuracy of implanting custom-made endoprostheses. Clin Biomech 2005; 20: 856-862.
48 Kröger H, Miettinen H, Arnala I. et al. Evaluation of periprosthetic bone using dual-energy x-ray absorptiometry: precision of the method and effect of operation on bone mineral density. J Bone Miner Res 1996; 11: 1526-1530.
49 Martini F, Kremling E, Schmidt B. et al. Bone mineral density of the proximal femur after unilateral cementless total hip replacement. Int Orthop 1999; 23: 104-106.
50 Masri BA, Masterson EL, Duncan CP. The classification and radiographic evaluation of bone loss in revision hip arthroplasty. Orthop Clin North Am 1998; 29: 219-227.
51 Lee WCC, Frossard LA, Hagberg K. et al. Kinetics of transfemoral amputees with osseointegrated fixation performing common activities of daily living. Clinical Biomech 2007; 22: 665-673.
52 Lee WCC, Frossard LA, Hagberg K. et al. Magnitude and variability of loading on the osseointegrated implant of transfemoral amputees during walking. Med Eng & Physics 2008; 30: 825-833.