Benazzo_edit.qxp 28/9/07 05:13 Page 62
Orthopaedic Surgery Knee
Figure 1: Intra-operative View – Femoral Cuts
osteolysis, post-operative complications and early implant loosening, and
may be involved in poor implant performance or in implant failure.
28–31
The BIOLOX ceramic has demonstrated high biocompatibility both in vitro
and in vivo. Hypersensitivity tests with epicutaneous applications in vivo
and lymphocyte-transforming tests (LTTs) in vitro have as yet shown no
allergic reactions to BIOLOX delta, indicating that the material is totally
bio-inert.
8,20
This biocompatibility and bio-inertia – in association with the
well-known tribological advantages of ceramics, such as hardness,
lubrication and wettability – has led researchers to develop solutions that
could enable the use of this material on a large scale in TKA, especially
after the optimal results achieved in THA.
For this reason the aforementioned international study group founded
in collaboration with Lima-Lto has created a protocol for a prospective
study on 200 patients undergoing TKA with a Multigen Plus prosthesis
with a ceramic BIOLOX delta femoral component – a Ti
6
Al
4
V alloy
tibial plate and a UHMWPE liner sterilised with EtO in the absence of
Figure 2: Intra-operative View – Final Implant
oxygen, implanted with the use of a high-quality, high-viscosity
cement – to evaluate long-term results with this implant (see Figures 1
and 2). The protocol includes intra-, peri- and short- and long-term
post-operative evaluations – either clinical or radiological – according
to well-established, standardised and scientifically recognised and
approved criteria.
32,33
The study is being conducted in Germany by Prof. W Mittelmeier
(Universität Rostock, Rostock), Dr D Ganzer (Dietrich-Bonhoeffer-
Klinikum, Altentreptow) and Prof. W Rüther and Prof. CH Lohmann
(Universitätsklinikum Hamburg-Eppendorf); in Italy by Prof. F Benazzo
(Fondazione IRCCS, Policlinico San Matteo, Università di Pavia), Prof. A
Giunti and Dr D Tigani (Istituti Ortopedici Rizzoli, IOR) and Dr C Zorzi
(Ospedale Sacro Cuore Don Calabria, Negrar, VR); and in Spain by Dr E
Garcia Cimbrelo and Dr C Rodriguez Merchan (Hospital Universitario La
Paz, Madrid), Dr E Saura Mendoza (Hospital General Universitario, Elche),
Dr A Lizaur Utrilla (Hospital General ‘Virgen de la Salud’, Elda), Prof. J
Couceiro Follente (Hospital Clinico Universitario, Santiago de
Compostela) and Mrs S Burrelli and Ing. Paolo Dalla Pria (Scientific
promising preliminary results, the project was never completed and the Adviser and Implant Designer, respectively, Lima Lto).
debate on alternative solutions is still open.
Ceramic knee arthroplasties are providing good results from both the
Discussion and Conclusions functional and reliability point of view.
14–16,18,34
The strong tribological
The prevalence of metal sensitivity among the general population is characteristics of these implants are now becoming evident and, with the
approximately 10–15%, with nickel sensitivity having the highest prevalence support of other clinical results, it will hopefully be possible to expand the
in the presence of a common cross-reactivity between nickel and cobalt.
26
indications for their use. Today, research and development have definitely
Immunological metallic-specific responses are cited as possible causes for resolved the limitations caused by the brittleness of the ceramic. ■
1. Scuderi GR, et al., J Bone Joint Surg Br, 1989;71B:798–803. 13. Langer G, Procedings, 7th International BIOLOX
®
Symposium, 23. Yasuda, et al., Bull Hosp Jt Dis, 1993;53(2):15–21.
2. Rodriguez JA, et al., Clin Orthop, 2001;388:10–17. Stuttgard, 15–16 March, Thieme Verlag. 24. Tsukamoto R, et al., Acta Orthop, 2006;77(3):505–11.
3. Gioe TJ, et al., Clin Orthop Relat Res, 2004;428:100–106. 14. Koshino T, et al., J Arthroplasty, 2002;17(8):1009–15. 25. Lancaster JG, et al., Prost Inst Mech Eng (H), 1997;211(1):
4. Jones SM, et al., J Bone Joint Surg Br, 1992;74:18–22. 15. Akagi M, et al., J Bone Joint Surg Br, 2000;82:1626. 17–24.
5. Greenwald AS, Grino JP, J Bone Joint Surg Br, 2001;83A:68–72. 16. Yasuda, et al., American Academy of Orthopaedic Surgeons 26. Hallab N, et al., J Bone Joint Surg Am, 2001;83-A(3):428–36.
6. Merril A, Ritter M, Current Concepts in Joint Replacament, Winter Meeting, San Francisco, 2004. 27. Badorf D, Proceedings, 3rd International Symposium on Ceramic
2002. 17. Oonishi H, et al., Clin Orthop, 1992;282:95–104. Wear Couple, Stuttgard, 14 February 1998, Enkle Verlag.
7. Minoda Y, et al., Biomaterials, 2005;26:6034–40. 18. Tateishi H, et al., Bull Hosp JT Dis, 1993;53(2):35–40. 28. Hallab NJ, et al., J Orthop Res, 2005;23(2):384–91.
8. Sedel L, Proceedings 5th International Biolox Symposium 2000, 19. Oonishi H, et al., J Biomed Mater Res B Appl Biomater, 29. Gawkrodger DJ,Br J Dermatol, 2003;148(6):1089–93.
Thieme Verlag. 2005;74(2):754–9. 30. Visuri T, et al., Clin Orthop Relat Res, 1996;329(Suppl.):
9. Boutin P, Rev Chir Orthop, 1972;58:229–46. 20. Dalla Pria P, Burger W, Una nuova ceramica per l’ortopedia il S280–89.
10. Ezzet KA, et al., Clin Orthop Relat Res, 2004;428:120–24. BIOLOX
®
Delta Rivista di Patologia dell’Apparato Locomotore, 31. Witzleb WC, et al., Acta Orthop, 2006;77(5):697–705.
11. White SE, et al., Clin Orthop Relat Res, 1994;(309):176–84. Vol II – Fasc 1 e 2 – 2003. 32. Ranawat CS, Shine JJ, Clin Orthop Relat Res, 1973;94:185–95.
12. Spector M, et al., J Bone Joint Surg Br, 2001;83A(Suppl. 2): 21. Davidson JA, et al., Biomed Mater Eng, 1994;4(3):213–29. 33. Ewald FC, Clin Orthop Relat Res, 1989;248:9–12.
80–86. 22. Fehring TK, et al., Clin Orthop Relat Res, 2004;428:40–50. 34. Bal BS, et al., J Knee Surgery, 2006;19:89–93.
62 EUROPEAN MUSCULOSKELETAL REVIEW 2007
Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60  |  Page 61  |  Page 62  |  Page 63  |  Page 64  |  Page 65  |  Page 66  |  Page 67  |  Page 68  |  Page 69  |  Page 70  |  Page 71  |  Page 72  |  Page 73  |  Page 74  |  Page 75  |  Page 76  |  Page 77  |  Page 78  |  Page 79  |  Page 80  |  Page 81  |  Page 82  |  Page 83  |  Page 84  |  Page 85  |  Page 86  |  Page 87  |  Page 88  |  Page 89  |  Page 90  |  Page 91  |  Page 92  |  Page 93  |  Page 94  |  Page 95  |  Page 96  |  Page 97  |  Page 98  |  Page 99