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A Prospective, Randomized, Multicenter Clinical Study in Elderly Chinese Subjects to Compare the Safety and Efficacy of the SS Bipolar Head and SL-TWIN Stem With Bipolar Head and SL-PLUS Stem in Hemiarthroplasty of the Hip

This is a prospective, randomized, multicenter clinical study in elderly Chinese subjects to compare the safety and efficacy of the SS Bipolar Head and SL-TWIN Stem with Bipolar Head and SL-PLUS Stem in hemiarthroplasty of the hip

开始日期2015-04-29

申办/合作机构

Smith & Nephew Orthopaedics Ltd.

NCT02347384 / CompletedN/A

A Prospective, Randomized, Multicenter Clinical Study in Chinese Subjects to Compare the Safety and Efficacy of the Delta PLUS Femoral Head and SL-TWIN Stem With BIOLOX Forte Ball Head and SL-PLUS Stem in Total Hip Arthroplasty

This is a prospective, randomized, multicenter clinical study in Chinese subjects to compare the safety and efficacy of the Delta PLUS Femoral Head and SL-TWIN Stem with BIOLOX forte ball head and SL-PLUS Stem in total hip arthroplasty

开始日期2015-04-20

申办/合作机构

Smith & Nephew Orthopaedics Ltd.

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2011-09-01·Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine4区 · 工程技术

A hip simulator study of metal-on-metal hip joint device using acetabular cups with different fixation surface conditions

4区 · 工程技术

Article

作者: Li, C X ; Kamali, A ; Hussain, A

In vitro wear data for hip joint devices reported in the literature vary in a wide range from one simulator study to another sometimes for the same type of device tested under identical physiological testing conditions. We hypothesized that non-bearing surface condition of the testing components could be an important factor affecting the simulator wear results. To confirm this hypothesis, fifteen 50 mm metal-on-metal hip resurfacing devices with identical bearing specifications were tested in a ProSim hip wear simulator for 5 million cycles. The heads were standard Birmingham Hip Resurfacing (BHR) heads; whilst the pairing acetabular cups were identical to the standard BHR cup except their different back surface conditions, including: (a) off-the-shelf products after removing the hydroxyapatite (HA) coating; (b) semi-finished products without HA coating; and (c) purposely-made cups without cast-in beads and HA coating. Results showed that the different back surfaces of the cups used indeed caused significantly large variations in the gravimetrically measured wear loss. We postulated that materials loss from the non-bearing surface of the testing components could contribute to the gravimetrically measured wear loss during a wear simulator test both directly and indirectly. The results presented in this paper pertain to In vitro wear simulator study and have little clinical relevance to the performance of any implant in vivo.

2010-03-01·The Journal of Bone and Joint Surgery. British volume

Analysis of wear of retrieved metal-on-metal hip resurfacing implants revised due to pseudotumours

Article

作者: McLardy-Smith, P. ; Kwon, Y. -M. ; Simpson, D. J. ; Kamali, A. ; Murray, D. W. ; Glyn-Jones, S. ; Gill, H. S.

The presence of pseudotumours, which are soft-tissue masses relating to the hip, after metal-on-metal hip resurfacing arthroplasty has been associated with elevated levels of metal ions in serum, suggesting that pseudotumours occur when there is increased wear. We aimed to quantify the wear in vivo of implants revised for pseudotumours (eight) and of a control group of implants (22) revised for other reasons of failure. We found that the implant group with pseudotumours had a significantly higher rate of median linear wear of the femoral component at 8.1 μm/year (2.75 to 25.4) than the 1.79 μm/year (0.82 to 4.15; p = 0.002) of the non-pseudotumour group. For the acetabular component a significantly higher rate of median linear wear of 7.36 μm/year (1.61 to 24.9) was observed in the pseudotumour group compared with 1.28 μm/year (0.81 to 3.33, p = 0.001) in the other group. Wear of the acetabular component in the pseudotumour group always involved the edge of the implant, indicating that edge-loading had occurred. Our findings are the first direct evidence that pseudotumour is associated with increased wear at the metal-on-metal articulation. Furthermore, edge-loading with the loss of fluid-film lubrication may be an important mechanism of generation of wear in patients with a pseudotumour.

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