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Comparison of the Albizzia® with other internal lengthening nails

Some other nails exist, but none has a control, security and a weight-bearing capacity like the Guichet® nail:

Inventors

Lengthening nail inventors

Picture above: From left to right, Drs : Paley (Baltimore), Baumgart (Munich), Shevskov (Kurgan), Cole (Orlando), Soubeiran (Paris), Guichet (Nancy), Herzenberg (Baltimore)

Number of basic operations (complications are not counted) to get a 10 cm (4 inches) gain with various nails :

Nail complication chart

Albizzia® and Guichet® nail special features

The Albizzia® nail requires a patient to perform a voluntary 20 degree leg rotation or maneuver. For best results, patients must learn to complete this ratcheting maneuver, which they may find intimidating at first. This can be a criticism of the Albizzia® nail, but with good preparation and practice, patients are able to perform the rotation or 'click' without pain. Experience has shown that patients are able to realize the gain in length once the ratcheting maneuver has been mastered and can manage the lengthening themselves.

The lengthening process can be modified as required to prevent neurological complications or premature fusion. If required, lengthening may be stopped at any time, such as in cases of nerve complication, or may be advanced further than originally planned, for example, with good soft tissue tolerance. Ratcheting maneuvers cannot be performed randomly; counting the number of ratchets performed or 'clicks' heard allows an accurate determination of gain in length and is preferred to measurement using x-rays, which may be distorted.

The 'dynamization' action generally obtained with regular intramedullary nails by removal of a screw (requiring a new operation) is not necessary, as the Albizzia® nail has an automatic 'dynamization' system in its mechanism. The more weight the nail supports during weight-bearing and walking, the more bone formation is stimulated. When the bone strengthens, the loading force is gradually transferred to the bone and load through the nail decreases. Thus, the bone becomes stronger, which eliminates the need to remove some screws to remove axial load from the nail to the bone.

Insertion of the Albizzia® nail is percutaneous; i.e., it utilizes stab incisions. This method of insertion is not currently available to competitors as their devices are not designed for such an insertion process.

For a 10-cm gain with no complications, only two surgical operations are required with the Albizzia® nail:

Weight bearing is generally authorized during lengthening (see relevant chapter on post-operative care), allowing patients to attain a better functional recovery quicker. Certain sports are authorized during lengthening.

To date, more than 3000 Albizzia® nails have been used in 30 countries worldwide.

The Judet nail

Professor Robert Judet had already constructed the 'Distractor.' However, use of an adjustable screw that transfixed the skin, while permitting gradual increase in length, resulted in a high rate of wound infections, so its use was discontinued. (Judet R. [Presentation of the distractor for limb bone lengthening] Chirurgie. 1971;Nov 10;97(11):777-8. In French)

The Bliskunov nail

Professor Bliskunov from Sinferopel, Russia, invented a gradual mechanical nail that he used for several years on more than 100 patients. Although development of this device stopped with Professor Bliskunov's death, the nail is still in use by a few surgeons in Russia.

The Bliskunov nail

In addition to a primary femoral part that is set inside the bone cavity, the Bliskunov nail includes a pelvic part that connects the femoral part to the pelvis, resulting in a pelvic scar. The insertion of the nail is not percutaneous, resulting in longer scars. Lengthening is achieved by rotatory motion between the femoral and pelvic parts. Lengthening can be stopped in case of complication by stopping hip motion but this is not always easy to enforce. It is not known if a tibial nail is in use as the setting of the mechanism may be more difficult.

For 10-cm gain with no complications, 5 to 6 surgical procedures are required:

  • Insertion of the nail
  • Removal of the pelvic part and locking of the nail
  • Removal of the pelvic part
  • 1 to 2 exchanges of the nail (not more than 10-cm are allowed at one time)
  • Dynamization' (removal of the upper or lower femoral screws to allow loading through the newly formed bone rather than through the nail; 'dynamization' can create a 2 to 7 mm loss in the gain)
  • Removal of the nail.

Weight bearing is generally not authorized before bone healing, which can delay recovery and weaken muscles.

To date, approximately 200-300 nails have been set in Russia. Site web du clou Bliskunov : www.lengthening.ukrpack.net/method-e.htm

The nail from Baumgart and Betz (Fitbone®)

An electronic nail was designed by Betz and Baumgart in Germany but to date its application is not widespread, due to both financial constraints and concerns about its reliability. The nail's reliability is being improved but is still not extremely high. Costs also limit its use outside Germany.

The Fitbone® nail is electronic. The lengthening procedure requires connection to an electrical supply through a contact antenna, which provides transfer energy for the motor. This technology increases manufacturing costs. Achievable gain is 80 mm in femurs and 60 in tibias (80 with custom-made nails)

Recovery capacities of the patient are similar to that of other nails. Lengthening is produced at night and can be stopped in case of complication; further lengthening beyond that expected can be performed within the limit of gain of the nail (6 cm).

For a 10-cm gain with no complications, a minimum of 3 surgical operations are required:

Weight bearing is partial, and full weight-bearing (free walking, and sports) are generally not authorized before the end of lengthening and bone fusion, thus allowed far later than with the Guichet® nail (walking and non-contact/impact sports from the operative day, and contact/impact sports from the 4th post-operative month), which can delay a full and quick functional recovery and induce muscle force decrease.

Approximately a few hundred nails have been set, primarily in Germany and Asia.

The nail from Dean Cole (ISKD®, Orthofix®)

Although designed more than 20 year ago, experience is still limited (i.e., approximately 300-500 cases).

ISKD Nail Orthofix Nail

Picture above : Figure showing a section of the ISKD (Orthofix®) nail with its verification device (for controlling the polar position of a marker inside the nail during lengthening).

With the Orthofix® nail, lengthening occurs with an alternate rotatory motion randomly performed and limited to 10 degrees (9 degrees, according to the manufacturer). An electronic device permits daily gain to be estimated via positioning of a rotatory marker, which is moved during lengthening. However, it does not control the lengthening and cannot certify how many turns have been performed or an accurate count of gain obtained. Therefore, a patient may gain 5 mm in 1 day. Presetting the gain required provides some security; the nail stops after the gain is fully obtained, regardless of the rate of distraction.

Length gain in mm per day cannot accurately be modified; for example, increasing length voluntarily to avoid a premature bone fusion, or slowing lengthening to favor weak ossification or manage a nerve lesion. In an emergency condition, the only way to neutralize the implant and to stop it from gaining length is to perform additional surgery to set an external fixator around the nail to lock rotation. Ratcheting maneuvers are less difficult and more comfortable than ones with the Albizzia® nail, as they are not really perceived by the patient. Because the nail requires presetting the gain in length, once this has been reached length can be increased only by exchanging the nail, requiring an additional surgical operation.

For a 10-cm gain with no complications, 4 to 5 surgical procedures are required:

Weight-bearing is not authorized before the end of lengthening; correct bone formation, full weight-bearing, and sports are resumed much later, which can delay functional recovery.

The BetzBone® nail

The BetzBone<sup>®</sup> nail

The BetzBone is a modified copy of the Version 1 of the Albizzia Nail, with a system of bone fixation fragile and at risk of fractures, which often makes necessary its replacement with a static intramedullary nail. This induces a larger number of surgery for each patient. It did not spread to other surgeons yet.

Please note on the x-rays the hypotrophic healing 11 months after the surgery.

The Precice®nail

The Precice® nail works with magnetic induction. However, weight bearing is limited to 25% of body weight, which decreases muscle force for the long period of healing and prevents to do early sports. People who want to regain full strength and function early after surgery prefer the Guichet nail (bilateral cosmetic and non-cosmetic cases).

Other nails

Other lengthening nails are currently experimental, as none have passed the mechanical, preclinical, or clinical investigations required and none have been validated in large numbers of patients.

The nails of the future will certainly be different from those currently available.