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P r o d u c t R a t i o n a l e S u r g i c a l T e c h n i q u e - Biomet

P r o d u c t R a t i o n a l e S u r g i c a l T e c h n i q u e - Biomet

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P r o d u c t<br />

S u r g i c a l<br />

R a t i o n a l e<br />

T e c h n i q u e<br />

ELASTIC STABLE<br />

INTRAMEDULLARY<br />

NAILING


The Nancy and ECMES Nails Philosophy<br />

Elastic Stable Intramedullary Nailing (ESIN) is an established philosophy for treatment of long bone<br />

fractures in children. Pioneered at the Hopital des Enfants in Nancy, France, ESIN relies on the<br />

flexibility of Titanium to provide a stable reduction and dynamisation of long bone fractures in<br />

children. ESIN uses Two Small Diameter Titanium Nails which are pre-bent and inserted in<br />

either a retrograde or antegrade fashion into the fractured bone.<br />

M/L Stability (Figure 1)<br />

The Bend in the nails causes the nails to act as springs which<br />

stabilise the two bone fragments in the medio-lateral plane.<br />

Axial and Rotational Stability (Figure 2)<br />

Figure 1<br />

The Sharp Flattened Extremities penetrate the distal or proximal<br />

cancellous bone to provide both axial and rotational stability to the<br />

bone fragments.<br />

Figure 2<br />

Minimally Invasive Approach (Figure 3)<br />

The Small Diameter of the nails (maximum 4 mm) allows for a<br />

minimally invasive approach (2 cm incision).<br />

Figure 3<br />

Continuous Dynamisation (Figure 4)<br />

Titanium provides flexibility to the nails, thus allowing continuous<br />

dynamic loading of the fracture site.<br />

The Results<br />

These design and biomechanical factors combine to benefit the<br />

child by enabling:<br />

• Early Weight Bearing<br />

• Rapid Return to Normal Activities<br />

Figure 4<br />

2


Clinical Results<br />

Case 1 Case 2 Case 3<br />

Femoral Spiral Comminuted Fracture<br />

Retrograde Nailing<br />

Femoral Transverse Fracture<br />

Antegrade Nailing<br />

Ulna and Radial Diaphyseal Fracture<br />

Bifocal Nailing<br />

Case 4 Case 5 Case 6<br />

Radial Head Fracture<br />

Retrograde Nailing<br />

Spiral Tibial Fracture<br />

Antegrade Nailing<br />

Proximal Humeral Fracture<br />

Retrograde Nailing<br />

3


Design<br />

ESIN can be achieved very effectively with either the Nancy<br />

or ECMES Nails. Both Nails present specific advantages<br />

(Table 1) and the selection of nail type is at the physician’s<br />

discretion.<br />

Indications<br />

The Nancy and ECMES Nails are indicated for the treatment<br />

of diaphyseal fractures of long bones where:<br />

• Minimal growth plate disturbance is paramount<br />

• Dynamisation is required<br />

• The medullary cavity is narrow<br />

Nancy Nail<br />

ECMES Nail<br />

5 diameters<br />

(2.0, 2.5, 3.0, 3.5 and 4.0 mm)<br />

Ti6Al4V Alloy<br />

Curved, Flattened Tip<br />

Atraumatic End<br />

5 diameters<br />

(2.0, 2.5, 3.0, 3.5 and 4.0 mm)<br />

Ti6Al4V Alloy<br />

Curved, Flattened Tip<br />

Atraumatic Cap<br />

Various Pre-cut Lengths Cut to Length Intra-operatively<br />

Table 1. The main features of the Nancy and ECMES nails.<br />

Both paediatric and adult indications are therefore included,<br />

although limited to:<br />

• Paediatric diaphyseal femoral fractures<br />

• Paediatric diaphyseal tibial fractures<br />

• Paediatric diaphyseal humeral fractures<br />

• Paediatric proximal humeral fractures<br />

• Paediatric and adult diaphyseal forearm fractures<br />

• Paediatric radial head fractures<br />

• Adult stable diaphyseal humeral fractures<br />

Contra-Indications<br />

The Nancy and ECMES Nails may not be used for the<br />

treatment of unstable fractures such as long oblique or long<br />

spiral fractures. Comminuted fractures should also be<br />

adequately reduced prior to inserting the nails.<br />

The Nancy and ECMES Nails are not indicated for the<br />

treatment of lower extremity fractures in the adult.<br />

4


Nail Selection<br />

Nail diameter and length are critical in achieving effective<br />

fracture stabilisation.<br />

Length<br />

The length of the nail is equal to the distance separating the<br />

proximal and distal growth plates (Figure 5).<br />

Always ensure that the length of the nail is such that it will<br />

protude one or two centimetres outside the entry portal area.<br />

Diameter<br />

The nail diameter can be chosen either by calculation<br />

Nail Length<br />

Calculation<br />

Nail Diameter = Minimum Canal Diameter x 0.4<br />

1 - 2 cm<br />

or by adopting a typical size as illustrated in Table 2.<br />

Always select the largest diameter nail possible.<br />

Figure 5.<br />

Typical Sizes<br />

Bone Age Nail Diameter<br />

Femur 6 -8 years 3.0 mm<br />

9 - 11 years 3.5 mm<br />

12 - 14 years 4.0 mm<br />

Tibia 8 - 14 years 2.5 to 4.0 mm<br />

Humerus 8 - 14 years 2.5 to 3.5 mm<br />

Forearm 8 - 14 years 2.0 to 2.5 mm<br />

Table 2.<br />

5


Pre-Bending the Nail<br />

Pre-bend each nail to an angle of 30˚, ensuring that<br />

the tip lies in the same plane as the plane formed by the<br />

bend. The pre-bend can be achieved by hand or by using the<br />

Cannulated T-Handle (M21897) as a lever arm.<br />

Caution 1<br />

Ensure that the apex of curvature lies at the level of the fracture site.<br />

✔ ✖ ✖ ✔<br />

Caution 2<br />

In order to achieve optimum reduction, stabilisation and alignment of the fracture, the curvature must be identical in both nails.<br />

6


Surgical Technique<br />

Femoral Fractures<br />

Paediatric femoral fractures are typically treated with two nails inserted in a retrograde<br />

fashion from medial and lateral entry portals located above the epiphysis. Very distal<br />

fractures should be treated with an antegrade approach.<br />

Positioning and Fracture Reduction<br />

The patient is positioned on an orthopaedic traction table (Figure 6). An image<br />

intensifier is positioned so that it can be rotated to obtain AP and lateral views. It<br />

should also be possible to visualise the whole femur from the knee to the hip joint.<br />

The entire thigh including the knee is prepared as an operative field. External<br />

manipulation is conducted until adequate reduction is obtained and confirmed by<br />

flouroscopy.<br />

Figure 6<br />

Approach<br />

Make a 2 cm skin incision distally to the required entry hole to provide access for the<br />

instruments, and to prevent any trauma to the skin (Figure 7). You may start either<br />

on the medial or the lateral side. An oblique drill hole is made 2 - 4 cm above the<br />

growth plate by applying a careful angulation movement of the drill bit until the<br />

entry hole is at an angle of at least 60˚ with the axis of the medullary canal (Figure 8).<br />

Make the the entry hole slightly larger than the diameter of the chosen nail.<br />

Figure 7<br />

Figure 8<br />

7


Figure 9 Figure 10 Figure 11<br />

Nail Insertion<br />

The nail is held in a Cannulated T-Handle Inserter (M21897). Align the horizontal<br />

bar of the T-Handle and the curved tip of the nail in the same plane. This will enable<br />

you to identify the position of the curved tip as it is passed along the medullary canal.<br />

Pass the nail through the entry hole with the curved tip pointing downwards.<br />

Once in the medullary canal rotate the curved tip so that it is pointing in the<br />

direction in which the nail is to be passed (Figure 9). Drive the nail up the<br />

canal by rotating the the T-Handle Inserter back and forth. Avoid using a<br />

mallet to force the passage of a nail which has become stuck as a secondary<br />

fracture may occur.<br />

Advance the nail to the fracture site (Figure 10). With a mallet, lightly<br />

tap the nail across the fracture taking care not to rotate the tip as this<br />

may cause the nail to slip behind or in front of the opposite<br />

fragment. Advance the nail towards the metaphysis and anchor it<br />

into the cancellous bone (Figure 11). Advance the second nail<br />

using the same backward and forward movements. Do not rotate<br />

the second nail through a full 360˚ as this may result in the<br />

second nail wrapping itself round the first nail. Again tap the<br />

nail across the fracture site and advance it towards the<br />

metaphysis and anchor it into the cancellous bone.<br />

8


Figure 12 Figure 13 Figure 14<br />

Final Impaction and Cutting<br />

It is at this stage of surgery that the Nancy and ECMES Nails<br />

must be differentiated. The Nancy Nail is already the<br />

correct length and should now be impacted in its final<br />

position. The ECMES Nail must be cut to length prior to<br />

being impacted in its final position.<br />

ECMES Nail<br />

Once the ECMES Nail is located in the cancellous bone,<br />

impact it in its final position by lightly tapping the<br />

Cannulated T-Handle. Remove the Cannulated T-Handle<br />

and cut the nail using the cutter (M21840), ensuring that<br />

1 to 2 cm of the nail remains outside the entry hole, as for<br />

the Nancy Nail, the tip of the nail can be moderately<br />

Nancy Nail<br />

curved using surgical forceps.<br />

The Impactor/Extractor (M21898) is used to impact the nail<br />

in its final position. By lightly tapping the hammer pad of<br />

the Impactor/Extractor with a mallet the tip of the nail<br />

inserted medially should finally rest against the cortex above<br />

Optional: In order to minimise the risks of soft tissue irritation<br />

caused by the cut tip of the nail, Polyethylene End Caps<br />

(M21941 to M21946) are provided to cover the tip.<br />

the medial femoral condyle (Figure 12).<br />

Post Operative Care<br />

Caution: Do not make unnecessary rotational movements whilst<br />

the Impactor/Extractor holds the nail as it may cause the rounded<br />

tip to snap off.<br />

No immobilisation is required. Once the patient can<br />

straighten the leg, partial weight bearing may commence. As<br />

soon as the patient feels ready, full weight bearing is allowed.<br />

Physiotherapy should reinforce the quadriceps muscle and the<br />

At this stage the atraumatic rounded tip of the nail can be<br />

moderately curved to facilitate its future retrieval (Figure 13).<br />

extension of the knee. Do not force the knee into flexion as<br />

the extremities of the nail may cause some discomfort.<br />

If distraction of the fracture is evident this may be overcome<br />

by exerting pressure on the knee. If the nail is too long, it<br />

may be shortened by using the Nail Cutter (M21840).<br />

Nail Retrieval<br />

The removal of the nails should be undertaken at around<br />

4 - 6 months depending upon the appearance of the X-rays.<br />

For the Nancy Nail, use the Impactor/Extractor (M21898).<br />

For the ECMES Nails, use the Extraction Clamp (M21900).<br />

9


Tibial Fractures<br />

Paediatric tibial fractures are typically treated with two nails inserted in an antegrade<br />

fashion from anteromedial and anterolateral entry portals below the physis. The<br />

recommended age for treating fractures is over 8 years in children or in younger<br />

patients when conservative treatment has failed.<br />

Positioning<br />

The patient is positioned supine on a standard table.<br />

Approach<br />

Make the skin incision proximally to the entry hole to provide better access for the<br />

instruments, and to prevent trauma to the skin. You may start either on the medial or<br />

lateral side. An oblique drill hole is prepared in the proximal metaphysis anteromedial<br />

and anterolateral faces. During the approach the tibialis anterior muscle is pushed<br />

backwards. The nails are passed as per the instructions for the femur. The nails<br />

should not be impacted into the cancellous bone of the distal tibia until any residual<br />

deformity has been corrected.<br />

Insertion and Impaction<br />

As per femoral technique.<br />

Post Operative Care<br />

A simple dressing is put in place for 48 hours after which walking is allowed using<br />

crutches. Plaster immobilisation is not required unless there is a persistent deformity<br />

that requires correction, in which case a below the knee cast should be worn for 3<br />

weeks. Weight bearing can commence between the 4 th and 6 th post operative week<br />

depending upon the appearance of X-rays.<br />

Nail Retrieval<br />

The removal of the nails should be undertaken at around 4-6 months, depending<br />

upon the appearance of the X-rays.<br />

10


Forearm Fractures<br />

Paediatric forearm fractures typically<br />

require only a single nail inserted in<br />

Positioning<br />

The patient is positioned supine with the affected arm on a radiolucent arm table.<br />

each bone, either in an antegrade or<br />

retrograde fashion depending on fracture<br />

location. The recommended age for<br />

treating forearm fractures is over 8 years<br />

in children and adolescents and when<br />

conservative treatment has failed.<br />

Approach and Insertion - Radius<br />

The entry hole is made at the distal metaphysis of the radius. The incision can be<br />

either a stab wound or a larger incision with blunt dissection to avoid the radial nerve<br />

and extensor tendons. An awl is used to make the entry hole which is enlarged by<br />

circular movements. The nail is passed up the medullary canal to the fracture site.<br />

Once the fracture has been reduced, the nail can be passed into the proximal<br />

fragment. Once into the proximal fragment, rotate the nail by 180˚ thus reducing the<br />

pronation of the curve of radius.<br />

Approach and Insertion - Ulna<br />

The entry hole is made on the medial surface of the proximal ulna through the<br />

muscle. Pass the nail as described above and secure it in the distal metaphysis.<br />

Note: The concavity of the two nails must face each other.<br />

Impaction<br />

As per the femoral technique.<br />

Post Operative Care<br />

Plaster immobilisation is unnecessary. Forearm movements can be started early. Skin<br />

irritation by the nail may occur but can be minimised if the patient is informed<br />

before hand.<br />

Nail Retrieval<br />

In some cases the fracture can be slow to reunite and some cases of recurrent fractures<br />

have been observed. It is therefore recommended that removal of the nail is<br />

undertaken at around 8 months.<br />

11


Humeral Fractures<br />

Paediatric humeral fractures are typically<br />

treated with 2 nails inserted in a<br />

retrograde fashion from a posterior entry<br />

portal. The recommended age for<br />

Positioning and Fracture Reduction<br />

The patient is positioned supine without a tourniquet, with the arm supported by a<br />

radiolucent arm table. An image intensifier is required and is positioned so that the<br />

long axis of the humerus is in view.<br />

treating humeral fractures is over 8 years<br />

in children and adolescents and when<br />

conservative treatment has failed.<br />

Approach<br />

A 3 cm skin incision is prepared on the lateral border of the humerus and distally to<br />

the entry hole in order to provide better access for the instruments and to prevent<br />

any trauma to the skin.<br />

Two retrograde oblique drill holes are created on the lateral supracondylar ridge, one<br />

above the other. Make the entry holes slightly larger than the diameter of the chosen<br />

nail.<br />

Insertion and Impaction<br />

The first nail is introduced through the inferior hole and passed upwards, towards<br />

and beyond the fracture site. Rotate the nail through 180˚ so that the curved tip is<br />

anchored in the medial metaphysis. The second nail is introduced through the<br />

superior hole and passed upwards, and anchored in the lateral metaphysis. Impaction<br />

is conducted as per the femoral technique.<br />

Post Operative Care<br />

A sling is used for 3 weeks at which time the patient can begin to mobilise their<br />

shoulder and elbow on their own.<br />

Nail Retrieval<br />

The removal of the nails should be undertaken at 3 months.<br />

12


Ordering Details<br />

Nancy Nail<br />

Instruments<br />

Implants<br />

M21897<br />

Cannulated T-Handle Inserter<br />

M21850<br />

2.0 mm Diameter, 130 mm Length<br />

M21898<br />

Impactor-Extractor<br />

M21851<br />

2.0 mm Diameter, 150 mm Length<br />

M21899<br />

Sliding Hammer<br />

M21852<br />

2.0 mm Diameter, 170 mm Length<br />

M21853<br />

2.0 mm Diameter, 190 mm Length<br />

Delivery Systems<br />

M21860<br />

2.5 mm Diameter, 150 mm Length<br />

M21845<br />

Nancy Nail Tray<br />

M21861<br />

2.5 mm Diameter, 170 mm Length<br />

M21862<br />

M21863<br />

2.5 mm Diameter, 190 mm Length<br />

2.5 mm Diameter, 210 mm Length<br />

ECMES Nail<br />

Implants<br />

M21864<br />

2.5 mm Diameter, 230 mm Length<br />

M21922<br />

2.0 mm Diameter, 400 mm Length<br />

M21870<br />

3.0 mm Diameter, 210 mm Length<br />

M21925<br />

2.5 mm Diameter, 400 mm Length<br />

M21871<br />

3.0 mm Diameter, 230 mm Length<br />

M21930<br />

3.0 mm Diameter, 400 mm Length<br />

M21872<br />

3.0 mm Diameter, 250 mm Length<br />

M21935<br />

3.5 mm Diameter, 400 mm Length<br />

M21873<br />

3.0 mm Diameter, 270 mm Length<br />

M21937<br />

4.0 mm Diameter, 400 mm Length<br />

M21874<br />

3.0 mm Diameter, 290 mm Length<br />

M21880<br />

3.5 mm Diameter, 270 mm Length<br />

Polyethylene End Caps<br />

M21881<br />

3.5 mm Diameter, 290 mm Length<br />

4M21941<br />

2.0 mm Diameter<br />

M21882<br />

3.5 mm Diameter, 310 mm Length<br />

4M21943<br />

2.5 mm Diameter<br />

M21883<br />

3.5 mm Diameter, 330 mm Length<br />

4M21944<br />

3.0 mm Diameter<br />

M21884<br />

3.5 mm Diameter, 350 mm Length<br />

4M21945<br />

3.5 mm Diameter<br />

M21890<br />

4.0 mm Diameter, 330 mm Length<br />

4M21946<br />

4.0 mm Diameter<br />

M21891<br />

4.0 mm Diameter, 350 mm Length<br />

M21892<br />

4.0 mm Diameter, 370 mm Length<br />

Instruments<br />

M21893<br />

4.0 mm Diameter, 390 mm Length<br />

M21897<br />

Cannulated T-Handle Inserter<br />

M21894<br />

4.0 mm Diameter, 410 mm Length<br />

M21840<br />

Nail Cutter<br />

M21895<br />

4.0 mm Diameter, 430 mm Length<br />

M21900<br />

Extraction Clamp<br />

M21896<br />

4.0 mm Diameter, 450 mm Length<br />

13


This publication is not intended for distribution in the USA.<br />

Nancy Nail is a trademark of DePuy Orthopaedics, Inc.<br />

© 2011 DePuy International Limited. All rights reserved.<br />

Registered Office: St. Anthony’s Road, Leeds LS11 8DT, England.<br />

Registered in England No. 3319712<br />

Cat No: 9066-70-000 version 1<br />

DePuy International Ltd<br />

St. Anthony’s Road<br />

Leeds LS11 8DT<br />

England<br />

Tel: +44 (0)113 387 7800<br />

Fax: +44 (0)113 387 7890<br />

DePuy France<br />

24 rue Francis de Pressensé<br />

BP 2175<br />

F-69603 Villeurbanne Cedex<br />

France<br />

Telephone: +33 472 69 96 69<br />

Fax: +33 478 93 12 30<br />

0086<br />

Revised: 05/11

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