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Fixion nails
Ортопедия и травматология Отправлено Alexander Chelnokov 11 Март 2006, 11:22
Дорогие коллеги,Как Ваше мнение насчет нынешнего места и роли надувных интрамедуллярных стержней Fixion в лечении переломов?
Широко ли они используются в Ваших условиях и по каким показаниям?
Предпочитаете ли Вы использовать эти стержни вместо обысных с рассверливанием и запиранием винтами при нестабильных по оси переломах бедра и голени?
Dear All,
Pls can you share your opinion about current place and role of Fixion inflatable nails in fracture treatment? Are they widely used in your settings and for what indications? Do you now prefer the nails instead of interlocking reamed nails for axially unstable femoral and tibial shaft fractures? THX!

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    Re: Fixion nails
    Lew Zircle 11 Март 2006, 19:16
    Alex
    I prefer Sign interlocking nails for axially unstable femoral and tibial shaft fractures

    Lew Zirkle
    [ Ответить ]

    • Re: Fixion nails
      Отправитель: Alexander Chelnokov 12 Март 2006, 00:33
      THX for your reply.
      A colleague of mine from another town yesterday called me with the questions. Closed nailing is now being introduced in their unit, and he is attacked by sales reps which convince him that Fixion is now N1 everywhere in the Western world, and the old system with interlocking screws is shutting down. I told him about my view (BTW how did you guess my answer? ;-) but decided to have opinions of more advanced independent experts in the technique. Thx in advance.

      [ Ответить ]
    Re: Fixion nails
    Devender Khurana 11 Март 2006, 20:15
    We use them for fixation of Humeral Fractures/Pathological fractures.

    Havn't tried for Tibia/Femur.

    devender khurana
    Assoc Specialist Trauma & Orthopaedics
    James Paget Hospital , Norfolk
    UK
    [ Ответить ]

    Re: Fixion nails
    Erden Kilic 11 Март 2006, 20:19
    Mr. Chelnokov and group members,

    I have graduated three months ago as an orthopedic
    surgeon from Gülhane Military Medical Academy in
    Turkey and my thesis was about the fixion nail in long bone fractures. So I would like to share my opinions about the fixion nail.

    Fixion nails biomechanically behave as classic Küntscher nails because its stability depends on friction force between the bone and the nail surface.
    Fixion nails have a contact surface much more than the classic Küntscher nail where its contact is just around the isthmus. Therefore it has better axial loading capabilities. Also inflation under pressure somewhat improves the axial stability. Rotational stability is achieved by for longitudinal bars.
    Inflation of the nail forces and collapses the cancellous bone and embeds the bars in to the cancellous bone, preventing rotation.

    Its main indication is long bone diaphyseal fractures, mainly AO type 1 and 2 fractures; it may not provide enough stability in type 3 fractures and fractures distal to the isthmus. Proximal fractures can be treated with proximal interlocking fixion nails and distal fractures with retrograde locking supracondylar nails.

    I may list the advantages chronically as follows:
    Deflated nail when inserting, optional reaming, bullet shaped tip, manipulation with its insertion handle favors closed nailing. Humeral and tibial closed nailing can be possible even without fluoroscopy.
    Minimal incision can be used in femur fractures.
    Operation time is really shortened because distal
    locking is not required and reaming is optional. Full endosteal contact increases its stability, therefore early rehabilitation is possible. Its biomechanics allowing axial loading favors callus maturation.

    Special considerations when using these nails can be expressed as follows. It is important to examine preoperative radiographs carefully because a missed fissure can turn out to be a spiral fracture when nail is inflated. Axially unstable fractures are not suitable for fixion nails because it cannot provide enough stability, it can separate fracture fragments when inflated, may result in limb shortening. So locking nails or ECF are still possible solutions for these fractures. When treating proximal and distal fractures fixion nails should be used cautiously because its stability decreases as fracture line comes closer to joints.

    It is really an expensive implant which renders its use. Its expense and advantages for the patient and the surgeon should be weighed to decide the treatment. But it is not a candidate to replace locking nails.
    Rather it has expanded the indications of Künstcher nails.

    Those were my personal opinions which are mostly in theory because we do not yet have evidence based trials of these nails. Studies are mostly case series as our study, and it formed our basic experience about the fixion nail.

    I would welcome any specific question about the nail.

    Erden KILIC
    Konya Military Hospital,
    Konya, Turkey
    (City of Mevlana, great philosophier of Anatolia, UN has accepted 2007 as "Mevlana" year.)
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    • Re: Fixion nails
      Отправитель: Alexander Chelnokov 12 Март 2006, 18:31
      EK> mainly AO type 1 and 2 fractures; it may not provide
      EK> enough stability in type 3 fractures and fractures
      EK> distal to the isthmus.

      Looks very reasonable.

      EK> I may list the advantages chronically as follows:
      EK> Minimal incision can be used in femur fractures.

      What specific is in this for Fixion nails? Skin incision in interlocking nailing can be limited to nail diameter - it depends on the insertion handle design not a nail itself.

      EK> preoperative radiographs carefully because
      EK> a missed fissure can turn out to be a spiral fracture when nail is
      EK> inflated. Axially unstable fractures are not suitable for fixion
      EK> nails because it cannot provide enough stability, it can separate
      EK> fracture fragments when inflated, may result in limb shortening.

      THX, it is what i mainly was interested to confirm.

      EK> theory because we do not yet have evidence based
      EK> trials of these nails.

      Many of your statements about the nails looks self-evident so RCT hardly ever are necessary to confirm that the missed fissure can expand
      with inflating or that subisthmal fractures are less sable for this sort of nails.

      [ Ответить ]
      • Re: Fixion nails
        Отправитель: Erden Kilic 12 Март 2006, 18:35
        You are right. Diameter of unreamed locking nails is less than diameter of the isthmus. But these nails have a high incidence of delayed union, non-union and secondary procedures for union.

        I meant that fixion's deflated diameter which is at least 2-3 mm less than the diameter of the bone, helps its insertion. In classic Kьnstcher or reamed locking nails, nail is inserted by force through the medullary canal and with some resistance. With fixion nails you can easily insert without reaming; actually it is the
        same in unreamed nails.

        I emphasized to use minimal incision through the fracture site in femoral fractures to help reduction and insertion of nail when surgeon does not have fluoroscopy. In fact the inventory you need to achieve operation is reasonably reduced, three nails, one you need, one longer and one shorter to be used in case, and the small insertion set.

        Fractures proximal and distal to isthmus can be
        managed by these nails, as it increases the contact area. Fractures very close to joints can be fixed with locking types of fixion nails.

        I believe that important issues about these nails are: reduced operation time by easy insertion, optional reaming and no distal locking, reduced inventory, no floroscopy so no radiation to patient and to us.

        I also want to add that biomechanics of these nails allow axial compression like Kьntscher nails. It resolves the stability problems of Kьnstcher nails and expands its indications. But indications of these fixion nails stand still between Kьntscher and locking nails.

        Best regards.

        Erden KILIC, MD
        Konya Military Hospital

        [ Ответить ]
    Re: Fixion nails
    Peter Trafton 11 Март 2006, 23:34
    Dear Alex,

    No experience with insertion, or initial care of patient thereafter, but I have had to take several out as part of treatment for nonunion with profound rotary instability.

    Ken Johnson used to say that the brand of nail wasn't important - it was how you used it, and he thought he could treat most femoral fractures with the equivalent of a broom-stick (he probably could!).


    I suspect the benefits of the fixion nail are very limited, in comparison to its presumably "inflated" costs. I'm unaware of any valid comparative studies, and very much appreciate Erden KILIC's comments.

    Best Wishes,

    PGT
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    Re: Fixion nails
    Barry Riemer 12 Март 2006, 00:22
    I have had similar experiences to Peter.

    The cost per case is significant, and the additional inventory costs are also a consideration.

    In an environment without fluoroscopy, this would be a valuable device. I see no advantages over our current locked nail otherwise.

    Locking is now a universal skill. Why add the problems of rotational deformity or inadvertant comminution leading to shortening . Both of these problems are preventable with our current devices.

    Barry Riemer
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    Re: Fixion nails
    Manuel Azevedo 12 Март 2006, 13:41
    Some years ago i used them in Portugal.
    Never had any problem with them and I think be very important respect the inform about the pressure that must be use

    Greetings
    Manuel Azevedo
    [ Ответить ]

    Re: Fixion nails
    Nuno Craveiro Lopes 12 Март 2006, 14:30
    Alex,

    We use Fixion nail since 2000 and reviewed our results two years ago on the treatment of 60cases of tibial, femoral and umeral close and open
    fractures, pseudarthrosis and pathologic fractures and found:
    8% complication rate, including: bending (5%) fissuration (3%). Both because of bad technique

    Best indications are:
    - Fractures within 10 cm of the extremities, transverse, oblique, segmental or with butterfly fragment but with cortical contact. Must have
    not longitudinal fissures or comminution.

    Advantages are:
    -Can be used unreamed or reamed
    -Fast surgical procedure (15 min)
    -Less blood loss and radiological exposure
    -Same price as an interlocking nail

    Best regards,

    Nuno Craveiro Lopes
    Head of Orthopedic and Trauma Department
    Garcia de Orta Hospital
    Almada, Portugal
    Web Page: http://clientes.netvisao.pt/nfrancac/
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    • Re: Fixion nails
      Отправитель: Nuno Craveiro Lopes 12 Март 2006, 14:58
      Alex,

      Some more comments:

      -As interlocking nail we use Grosse-Kempf nails. Fixion nail has here an
      equivalent price to a Grosse nail plus 4 interlocking screws.
      - We found Fixion nail superior to interlocking nail on the indication I
      mentioned on the previous mail, because it permits axial compression with
      a good stability on bending and rotational forces at the fracture site and
      consolidation is fast.

      We continue using it on those cases.

      Best regards

      Nuno Craveiro Lopes

      [ Ответить ]
    • Re: Fixion nails
      Отправитель: Alexander Chelnokov 12 Март 2006, 15:13
      THX for the detailed comment!

      NL> - Fractures within 10 cm of the extremities,

      What do you mean?

      NL> Must have not longitudinal fissures or comminution.

      Is there any strong reason to have few systems of nailing instead of one which can cover all indications witout these exclusions?

      [ Ответить ]
      • Re: Fixion nails
        Отправитель: Nuno Craveiro Lopes 13 Март 2006, 00:51
        > NL> - Fractures within 10 cm of the extremities,
        > AC>What do you mean?

        Diaphyseal fractures within 10 cm of the extermities

        > AC> Is there any strong reason to have few systems of nailing instead of
        > one which can cover all indications without these exclusions?

        Our policy is to use the best implant for a particular type of fracture/lesion with a good cost/benefit balance, including direct and
        indirect costs (patient benefit).
        We found fixion superior to interlocking on those fractures where compression forces induced by weight bearing on the fracture site improve the general result, including precocious weight bearing, functional recovering and faster consolidation. By the other side operating time is
        much less: we can almost do two fixion nails on the same time we do an interlocking one, which is important because we have limited operating
        periods.
        By the other side, we fount fixion a great implant to treat pseudarthrosis (reamed) and pathologic fractures (not reamed).
        Of course it does not substitute interlocking at all!

        Other inconvenience of Fixion: Patients cannot be cremated with it, with risk of explosion and destruction of crematory!

        Best regards,

        Nuno Craveiro Lopes
        Head of Orthopedic and Trauma Department
        Garcia de Orta Hospital
        Almada, Portugal

        [ Ответить ]
        • Re: Fixion nails
          Отправитель: Alexander Chelnokov 13 Март 2006, 00:57
          NL> Diaphyseal fractures within 10 cm of the extermities

          I am still uncertain - within what 10 cm and of what extremities? Do you mean lower extremities? And shaft fractures not closer than 10 cm from bone ends? Or zone of shattering not longer than 10 cm? Or something else?

          NL> We found fixion superior to interlocking on those fractures where
          NL> compression forces induced by weight bearing on the fracture site improve

          Really comparative studies are necessary to compare this to dynamically locked nails.

          NL> By the other side operating time is much less: we can almost do

          Yes, this is substantial.

          NL> By the other side, we fount fixion a great implant to treat
          NL> pseudarthrosis (reamed) and pathologic fractures (not reamed).

          Pseudarthroses are successfully treated by interlocking nails. Again comparison is necessary.

          NL> Of course it does not substitute interlocking at all!

          Yes, thx for the clearance about indications.

          NL> Other inconvenience of Fixion: Patients cannot be cremated with it, with
          NL> risk of explosion and destruction of crematory!

          You've made my day.

          [ Ответить ]
          • Re: Fixion nails
            Отправитель: Anthony N Brown 15 Март 2006, 20:37
            Dear Alex and List members,

            I do not have experience with the fixion nail but it sounds like it is well descibed as an extension of a Kuntscher nail and therefore limited to fractures with some inherent stability and diaphyseal in location.
            The gold standard for care of the unstable long bone fx is the locked intramedullary nail. The main drawbacks being cost and the need for reliable fluoroscopic control.

            As you are aware, but I think a lot of the list members might not be, the SIGN nail is a low/no cost, us-fda approved, interlocking nail for the femur, tibia and humerus. Most importantly it was designed specifically for use by surgeons without access to fluoroscopic control. It is used by hundreds of surgeons in more than 40 countries.
            In addition to bringing the gold standard of care of long bone fxs to those who could not previously afford it, the nail comes with the cumulative expertise of a community of surgeons from throughout the world as well as an ever growing database of cases.

            We would like to invite interested/curious surgeons from anywhere to contact us thru the website http://www.sign-post.org/ or at our booth and seminar at AAOS. We are looking for surgeons who will help us toward our goal of creating equality of fracture care throughout the world.

            Thanks,

            Anthony N Brown

            [ Ответить ]
    Re: Fixion nails
    Никита Николаевич Заднепровский 16 Март 2006, 21:34
    Скажите пожалуйста, что представляют из себя "надувные стержни Fixion для интрамедуллярного остеосинтеза"? Из ответов в форуме на Ваш вопрос отреагировали только коллеги зарубежья, сие может говорить о том, что, может быть, не только я не в курсе дела...
    [ Ответить ]

    • Re: Fixion nails
      Отправитель: Alexander Chelnokov 16 Март 2006, 21:37
      Да, пожалуй, надо было задать вопрос более развернуто. Стержни Fixion - полые тонкостенные, с ребрами. В "сдутом" состоянии стенки вогнутые. При нагнетании физраствора они становятся выпуклыми, ребра врезаются в стенки канала. В приложении небольшая статья, там есть иллюстрации, из которых все должно быть ясно. Как раз, видимо, о наиболее актуальных показаниях к использованию этих фиксаторов.

      Кликните для загрузки файла An expandable nailing system for the management of pathological humerus fractures.pdf
      126KB (129455 bytes)

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