[Ortho] Fixion
Mikheev Almir
info на rotormed.ru
Чт Июл 19 20:54:37 YEKST 2007
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
_____________________________________________________________________________
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С уважением,
А. Михеев
Вы писали 14 июля 2007 г., 23:22:41:
> Александр Николаевич, здравствуйте. Скажите, пожалуйста, почему Вы
> выбрали Fixion именно в этом случае- остеопороза нет, патологии кости
> нет. Если без блокированя,то не боитесь ли укорочения? На нашем
> отделении нет опыта применения fixion, но с интересом смотрим на
> пионеров. Спасибо.
> J Orthop Trauma. 2006 May;20(5):310-314.
> Expandable Intramedullary Nailing for Tibial and Femoral Fractures: A
> Preliminary Analysis of Perioperative Complications.
> Smith WR, Ziran B, Agudelo JF, Morgan SJ, Lahti Z, Vanderheiden T,
> Williams A.
> *Department of Orthopaedic Surgery, Denver Health Medical Center
> daggerDepartment of Orthopaedic Surgery, St. Elizabeth's Health
> System, Youngstown, Ohio double daggerDepartment of Orthopaedic
> Surgery, University of Colorado Health Sciences Center.
> OBJECTIVE: To report the results of using the expandable nailing
> system in the treatment of femoral and tibial shaft fractures. DESIGN:
> Prospective, cohort series. SETTING: Two level-1 university trauma
> centers. PARTICIPANTS: Forty-eight patients with acute, traumatic
> diaphyseal fractures of the tibia or femur. INTERVENTION: Internal
> fixation of lower extremity long bone fractures using expandable
> intramedullary nailing. MAIN OUTCOME MEASUREMENTS: Perioperative
> complications and time to healing. RESULTS: Forty-nine long bone
> fractures were treated: 22 femoral fractures (OTA classification: 4
> type A1, 6 A2, 7 A3, 1 B1, and 4 B2) and 27 tibial fractures (OTA
> classification: 4 type A1, 11 A2, 9 A3, 0 B1, and 3 B2). There were 13
> open fractures and 37 closed fractures. Healing occurred in 37 (75%)
> fractures without additional interventions. There were 2 tibial
> delayed unions and 1 femoral and 1 tibial nonunion. Five tibial shaft
> fractures and 6 femoral fractures shortened by 1.0 cm or more
> postoperatively. In 3 tibias and 4 femurs, shortening occurred after
> fractures judged to be length-stable became unstable because of
> fracture propagation during nail expansion. Five tibias and 3 femurs
> were converted to standard locked nails because of shortening. The
> average time to healing, excluding nonunion, was 15 weeks in the tibia
> and 16 weeks in the femur. The expandable nail resulted in an
> unplanned reoperation in 12 cases (25%). CONCLUSION: We found a high
> complication rate because of shortening, which was independent of
> fracture classification. Consequently, we cannot recommend the use of
> an unlocked, expandable nail in diaphyseal fractures of the femur or
> tibia.
> PMID: 16766932 [PubMed - as supplied by publisher]
> Ответить с цитированием
> Andrey Sereda
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