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Re: Fixion
Альмир Михеев 20 Июль 2007, 05:04
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Уважаемый Г-н Середа,
Прошу Вас ознакомиться с ответом клинического специалиста компании Disc-O-Tech (Израиль) на статью, размещенную Вами ранее:
_______________________
Dear Mr. Mikheev
Referring to your e-mail of July 15 to Ms. Borovic regarding the article published in the Journal of Orthopaedic Trauma, 2006, dealing with the Fixion Femoral and Tibial Intramedullary Nailing System, please be advised of the following:
To the best of our knowledge, the 49 cases reported in this article are old cases, from more than five years ago, when the Fixion System was still new on the market and a few problems were discovered during this launching period.
The authors mention that in all cases, the nail diameter was selected preoperatively, prior to reaming. It seems that the authors did not properly carry out the manufacturer’s recommendations. If reaming is performed,
the decision regarding the nail diameter should be taken post-reaming, for a proper nail diameter selection.
A successful treatment and healing of a fracture involves not only the selection of a particular device, but also the correct use of the device selected.
For the expandable nail, this is of crucial importance.
We have seen some cases in which wrong nail diameter selection has led to a high complication rate such as in the above mentioned study.
Please be advised that the new generation Fixion nails distributed now on the market are of a new design and have improved production process. Also, the instrumentation has since been changed and improved.
The Fixion Nailing System has gone through enormous changes, such as:
° Change in production process: double external and internal welding of the proximal end to the nail’s body, and improved proxima end raw material.
° Nail strength was increased by 50%: raw material of the nail was dramatically reinforced, and the bar's cross section were increased.
° Reinforcement of the nail's distal tip.
° Valve working mechanism was improved and the valve size was reduced.
° O-ring is now in the valve instead of the handle, hence protected and preventing leakages.
° All nails were united in term of their proximal end thread, to a unique unified nail, to be used with a unique proprietary instrumentation system Solution:
° The insertion handle was reinforced and its locking mechanism was relocated proximally.
Since the performance of the cases described by Wade et Al, over 50,000 Fixion Nails were implanted worldwide with great success, and some works were published.
For your information:
Nearly 1,000 Fixion cases are reported in the literature and scientific congresses with a successful 97.5% overall union
rate:
Author Country # Patients Union
Bengalim, 2007 US 27 97 %
Steinberg et Al, 2006 Israel 54 99%
BEKMEZCI et Al, 2006 Turkey 20 100 %
Lorich, 2005 US 54 100 %
Louis, 2005 US 22 100 %
Hopp, 2005 Germany 53 94 %
Elliot, 2005 UK 12 92 %
Doig, 2004 Australia 9 100 %
Bekmezci, 2004 Turkey 23 100 %
Ben-Galim, 2004 Israel 27 100 %
Dall’Oca, 2004 Italy 20 100 %
Dare, 2004 UK 17 100 %
Fortis, 2004 Greece 10 100 %
Folman, 2004 Israel 112 98 %
Seligson, 2004 US 24 96 %
Romano, 2004 Italy 82 95 %
Patel, 2004 UK 31 90 %
Foster, 2004 UK 9 89 %
Lorich, 2003 US 9 100 %
Hopp, 2003 Germany 93 100 %
Franck, 2003 Germany 15 100 %
Lepore, 2003 Italy 43 100 %
Capelli, 2003 Italy 40 100 %
Franck, 2003 Germany 25 100 %
Panidis, 2003 Greece 29 79 %
Lepore, 2002 Italy 58 100 %
Franck, 2002 Germany 20 100 %
Boriani, 2002 Italy 20 90 %
Attached, please find an article published in CLINICAL ORTHOPAEDICS AND RELATED RESEARCH,
dealing with the Fixion classic Tibial Nail in the treatment of tibial shaft fractures.
This is a prospective, randomized, comparative clinical trial involving 26 patients who were treated with conventional interlocking IM nails, and 27 patients who had expandable nail fixation.
Note that those cases were also performed between 2000 and 2002 with the same tibial nails.
Patients treated with expandable nails had better clinical outcomes and had reduced operative and postoperative complications than the conventional IM nail group.
Please feel free to contact me for further information.
Best Regards,
David Sabar, MD
Clinical Specialist
Disc-O-Tech
Medical Technologies Ltd.
11 Ha'hoshlim St.
Herzeliya 46724, Israel
Tel: +972-9-9511511 ext.273
Cell: +972-50-6392559, +1-609-4680570
Skype: dsabar
Fax: +972-9-954-8939
www.disc-o-tech.com
_________
Переводить нужно?
Буду рад ответить на все Ваши вопросы.
С уважением,
А. Михеев
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