Evaluation of the compatibility of ceramic ball head and femoral stem taper on the new type THR

• Autorzy: Rehak L. , Zitnansky M.
• Języki publikacji: EN

Abstrakty

EN

Purpose: of this paper was follow up of compatibility of femoral component taper from TiAl6V4 ELI acc.ISO5832-3 and ceramic head of the new type of total hip join replacement THR - ZRM in vitro. Design/methodology/approach: from december 2006 to august 2007 we have tested THR taper component and ball ceramic head. On the base of our patents ( SK, CZ, EU, USA) from 1999 to 2006 we have designed and developed the new type of cementlesss THR - ZRM. These total hip replacements were tested in our prospective study. We have evaluated compatibility and loading resistance of taper of THR ZRM made from TiAl6V4alloy ELI and ceramic ball head Biolox forte (28-12/14L) by tests of burst strength, pull out, rotational stability, fatigue and post-fatigue. Tests were monitored independent observer. Findings: in the burst test were tested 7 parts and average loading was 54 kN. The reached values comply with the requirements according to CeramTec procedure VA 02 04 4129 and the FDA Guidance document for the preparation of premarket notifications for ceramic ball hip systems. In the fatigue test all specimens test at a maximum load of 14 kN reached 10 million cycles without mechanical failure. The post fatigue test was performed with load of 46 kN and no failure of head and taper system was observed. The pull-off tests were made with pull out strength of 1439 N has been used on 5 parts and no pullout of ceramic ball head of taper femoral component was observed. Last was the test of rotational stability, where ball head was rotational stable under strength of 1254 Ncm. Research limitations/implications: this study was performed on the small group of spices but enough relevant according FDA and international ISO prescriptions. Originality/value: this study is original by publishing first results of the new cementless THR- ZRM tests of compatibility and fatigue of metal taper and ceramic ball head. Value of this paper is in vitro testing and prepares ZRM cementless THR for clinical use in human.

Słowa kluczowe

EN

THR; compatibility; fatigue; pull out; burst; rotational stability

PL

THR; zgodność; zmęczenie; wyciąganie; stabilność obrotowa

• Wydawca: International OCSCO World Press
• Czasopismo: Archives of Materials Science and Engineering
• Rocznik: 2010
• Tom: Vol. 44, nr 1
• Strony: 58--61
• Opis fizyczny: Bibliogr. 10 poz.

Twórcy

autor

Rehak L.

autor

Zitnansky M.

• I-st Department of Orthopaedics and Traumatology of Faculty of Medicine of Comenius University and UHB, Ruzinovska 6, 82606 Bratislava, Slovak Republic,

Bibliografia

• [1] M. Žitňansky, Ľ. Rehák, F. Makai, Patent SK No: 284754/2005.
• [2] M. Žitňansky, Ľ. Rehák, F. Makai, Patent CZ No: 299986/2008.
• [3] M. Žitňansky, Ľ. Rehák, F. Makai, US Patent 6, 652, 590/2003.
• [4] M. Žitňansky, Ľ. Rehák, F. Makai, European Patent No:1178765/2004.
• [5] A. Walter, On the material and the tribology of alumina / alumina couplings for hip joint prostheses, Clinical Orthopaedics 282 (1992) 31-46.
• [6] D. Hannouche, M. Hamadouche, R. Nyard, Ceramics in total hip arthroplasty, Clinical Orthopaedics 430 (2005) 62-71.
• [7] C.H. Roabeck, Ceramic/ceramic bearings in THA, The next gold standard - in opposition, Orthopedics 25 (2002) 935-936.
• [8] P.S. Christel, Biocompatibility of surgical-grade dense polycristalline alumina, Clinical Orthopaedics 20 (2002) 9-15.
• [9] Grant VEGA SR 1/1081/04.
• [10] Grant APVT-20-0507/02, Development of method for preparation human body anatomical implants.