vira the definitive solution for severe calcaneal …when the calcaneal fracture is impacted, or if...

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Page 1: VIRA The definitive solution for severe calcaneal …when the calcaneal fracture is impacted, or if the distraction of the calcaneal tuberosity is required to restore the length of
Page 2: VIRA The definitive solution for severe calcaneal …when the calcaneal fracture is impacted, or if the distraction of the calcaneal tuberosity is required to restore the length of
Page 3: VIRA The definitive solution for severe calcaneal …when the calcaneal fracture is impacted, or if the distraction of the calcaneal tuberosity is required to restore the length of

1

VIRA� The definitive solution for severe calcaneal fractures?

Chronic residual pain is the most common consequence following comminuted thalamicfracture of the calcaneus. A number of factors may account for this problem: compartmentalsyndrome, reflex sympathetic dystrophy, plantar pad syndrome, tarsal and fibular canalsyndrome, and subtalar arthritis. The latter disorder has been defined as the main causeof poor long-term fracture treatment results.

The treatment of severe calcaneal fractures is a controversial topic. Many authors defendconservative fracture management because open reduction and osteosynthesis aretechnically difficult, biologically aggressive and do not always achieve a satisfactory clinicaloutcome.

The VIRA� SYSTEM offers a solution for the treatment of displaced calcaneal fractures,with rapid clinical and functional recovery, along with a low risk of complication.

What does VIRA� offer?

• Minimally invasive surgery: a closed reconstruction

of the foot anatomy using cannulated screw combined

with a guided percutaneous technique.

• Rigidity and calcaneal support via two tubero-talar

P/A locking screws.

• Reconstruction of the calcaneus and restoration

of the foot to its normal anatomy.

• Avoidance of chronic residual pain through the fusion

of the subtalar joint.

• Early mobility and weight bearing, as early as

two weeks after surgery.

• Avoids long-term degenerative changes in the subtalar

joint such as atrophy and osteoporosis.

• Specific and simple instrumentation, guiding the

surgeons through each stage of the operation.

Surgical Technique

Page 4: VIRA The definitive solution for severe calcaneal …when the calcaneal fracture is impacted, or if the distraction of the calcaneal tuberosity is required to restore the length of

Vira® Calcaneal System

2

In which cases can it be used?

• Displaced intra-articular calcaneal fractures.• Consequences of intra-articular calcaneal fractures: subtalar arthrosis and defective consolidation.

Contraindications:

a) Absolute Contraindications: Heel Infection, patientswith immature skeleton, extra articular fracture of thecalcaneus, hypersensitivity to stainless steel.

b) Factors increasing the risk of surgical failure: non-cooperative patients, or patients suffering fromneurological disorders, unable to follow medicalinstructions; metabolic disorders.Factors affecting wound healing (decubitus ulcers,diabetic patient, severe protein deficiency and/ormalnutrition).

How does VIRA� work?

The implant consists of a nail seated into the calcanealgreater tuberosity along with two cannulated tubero-talar locking screws. These screws are inserted throughthe nail and into the talus. The strong and stable constructgenerates ligamentotaxis allowing for the reduction andconsolidation of the fractured calcaneus. The VIRA1system stabilizes the subtalar joint via an acute subtalararthrodesis, restoring and maintaining the normalbiological function of the hind foot.

Page 5: VIRA The definitive solution for severe calcaneal …when the calcaneal fracture is impacted, or if the distraction of the calcaneal tuberosity is required to restore the length of

3- Omoto technique

3

Surgical technique

Patient positioning

A prone position on a radioluscent table isrecommended. The injured lower limb should bepositioned higher than the contra lateral limb, to avoidinterferences when taking X-rays. Figure 1 & 2.

Fracture reduction using the Omototechnique

Before the first incision, it is recommended tomanipulate the heel to reduce the bony fragments,narrow the lateral canal and improve the axialalignment of the calcaneus. This can be achieved byusing the Omoto technique: Using both hands thesurgeon grasps the heel, applying compression,traction and oscillation movements Figure 3.

Note: This fracture reduction technique is generallyindicated in the case of severely displaced fractures orwhen the inferior cortex of the calcaneus is fractured.

Surgical exposure

A 3 cm para-Achilles tendon incision is made laterallytaking care to avoid damaging the sural nerve. Throughthis incision the upper surface of the calcaneus isexposed permiting access to the posterior aspect ofthe subtalar joint. Figure 4

1-Patient position

2- Position of the foot

4- Surgical incision

Surgical Technique

Page 6: VIRA The definitive solution for severe calcaneal …when the calcaneal fracture is impacted, or if the distraction of the calcaneal tuberosity is required to restore the length of

Vira® Calcaneal System

4

Preparation of the subtalar joint

The debridement of both the subtalar facet of the talusand the fractured calcaneal facet is undertaken toeliminate all the cartilage. Figure 5. It is important thatboth prepared bony surfaces are kept in contact tofacilitate the fusion. In some cases, a curette may haveto be used to elevate the collapsed remains of thefractured calcaneus so that contact with the denudedsurfaces of the talus is achieved.

Placement of the guide wire in the centre ofthe neck of the talus.

Note: The surgical technique using the talar K-wire toposition the VIRA1 instruments is only recommendedwhen the calcaneal fracture is impacted, or if thedistraction of the calcaneal tuberosity is required torestore the length of the heel.

The 2.5mm K-wire is the spatial reference point of theVira1 guide. Using radioscopic guidance, the K-wiremust be inserted from the medial side of the foot intothe centre of the talar neck. In the coronal plane the wiremust be positioned parallel to the interarticular line ofthe ankle, and in the sagittal plane perpendicular to theaxis of the foot. It is recommended to maintain the footin a neutral position during this step of the surgicalprocedure. Surgery should not be continued until correctpositioning of the guide wire has been achieved. Figures6 and 7.

5- Subtalar debridement

7- Placement of the K-wire

6- Placement of the K-wire (X-Ray)

Page 7: VIRA The definitive solution for severe calcaneal …when the calcaneal fracture is impacted, or if the distraction of the calcaneal tuberosity is required to restore the length of

11- Nail positioning intothe calcaneal greatertuberosity

5

Initial positioning of the VIRA� guide

The VIRA1 guide is initially placed with the anterior armsahead of the talar K-wire, and with the posterior graspingarms over the heel. The guide must be adjusted in orderto leave the posterior grasping arms completely open.Figures 8 and 9

The posterior arms of the VIRA1 guide are radioluscent.At each extremity of these posterior arms an imbeddedradio opaque marker is found which will help in locatingthe future positioning of the tip of the nail on X-Ray(lateral view). Figure 10

Under lateral radioscopic imaging, the radioluscentposterior arms are positioned over the greater tuberosityof the calcaneus, so that the nail entry point is locatedimmediately above the posterior superior process, andthe tip of the nail in the posterior inferior process. Thispositioning can be achieved by adjusting the bolt at theend of the guide handle. Figure 11

In this initial position, two K-wires are inserted in thelateral holes of the posterior arms. These wires allowthe future location of the tubero-talar screws to beestimated via lateral X-ray. Figure 12

Depending on the nature of the fracture and the anticipateddistraction/ reduction that must be achieved, these K-wireswill reach the talus in different positions. Where it is anticipatedthat little distraction is needed, the superior wire should bepositioned in the posterior third of the subtalar facet. In thecase of more comminuted or impacted fractures where it isanticipated that a greater degree of distraction will benecessary, the K-wires should lie in the anterior third of thesubtalar facet. Figure 13

Note: In impacted or comminuted fractures, this is Notthe anticipated final position of the cannulated screws.

8- Positioning ofthe guide clamp

10- Lateral view of the position of thenail and guide

12- Placement of thelateral K-wires

13- Location of the wiresin the talus (X-ray)

Surgical Technique

9- Adjustment ofthe guide

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Vira® Calcaneal System

6

Capture of the greater tuberosity

The surgeon’s assistant should maintain the VIRA1 guidein position while the lateral bolt of the guide is tightened toclose the posterior arms onto the greater tuberosity of thecalcaneus. No incision is needed, since the capturing pinsperforate the skin. The lateral screw is tightened until firmgrasp of the calcaneus is achieved. Figure 14. The assistantmust continue to maintain the position of the VIRA1 guideuntil the complete insertion of the nail is achieved.

Drilling

In order to prepare the calcaneal tuberosity a 10 mm drillbit is inserted through the upper nail insertion hole of theVIRA1 guide. The drill bit should be inserted until the stopimpacts the VIRA1 guide. Care should be taken to avoiddamaging the Achilles tendon. Figure 15In some cases, the severely comminuted nature of thefracture necessitates drilling through the bony fragments.This will not alter the clinical or functional outcomes of theoperation.

Bone Grafting

The morselised bones produced by the drilling of thecalcaneus should be carefully removed and retained, itwill be used as graft material for the subtalar arthrodesisprior to the insertion of the nail. Thus eliminating the needto harvest autologous bone. Figure 16

Nail Insertion

The nail is placed onto the nail insertion adapter. The driverbolt is passed through the nail inserter and tightened tofirmly lock the nail to the inserter. The nail is passed throughthe VIRA1 guide and into the patient.

NOTE: A tuning fork impactor may be used to fully insertthe nail. Do not directly impact the top of the insertionadapter with any type of mallet. This could damage theinsertion adapter and cause problems in nail insertion.Utilize the tuning fork impactor for impacting.

Final positioning is achieved when the stop of the nailinserter contacts the top of the VIRA1 guide. Figure 17. Thenail should be fully seated; this can be achieved using thetuning fork impactor. The nail insertion adapter will remainin place until the end of surgery. It will be used by thesurgeon’s assistant as a lever to adjust the alignment andangulation of the guide and nail in relation to the talus.

14- Capture of thegreater tuberosity

15- Drilling of thegreater tuberosity

16- Bone grafting

17- Nail insertion

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7

Definitive positioning of the guide

a) Using the guide and talar k-wireIf the technique using the talar K-wire has beencarried out, the anterior arms of the VIRA� guide areanchored over the talar K-wire by a simple fingertippressure. Figure 18. This generates an initialdistraction and extension of the calcaneus that helpsreduce the fracture. Should further distraction andextension be required to restore the normal footanatomy, the bolt at the extremity of the guide handlecan be adjusted increasing the relative distancebetween the posterior and anterior arms. Figure 19

b) Using the free-hand techniqueIf a free-hand surgical technique (without the talar k-wire) has been carried out, the surgeon manipulatesthe guide handle while the assistant holds the nailinsertion adapter. Distraction, varus/valgus angulationcorrections and sagittal alignment corrections canbe achieved. Figure 20 and 21.

Check the proper positioning of the guide with X-ray.The lateral K-wires indicating the future position of thescrews should be located in the body of the talus, goingthrough the posterior subtalar zone. Figure 22. If this isnot the case, further extension and distraction shouldbe applied until the desired position is achieved.

18- Anchoring of theguide over the talarwire

19- Distraction andextension applied bythe guide

20- Control of thedistraction andangulation of the heel

21- Control of thesagittal alignment ofthe heel

22- X-ray with theexternal referencesk-wires

Surgical Technique

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Vira® Calcaneal System

8

Insertion of the tubero-talar screws

The superior cannulated screw must be fully positionedbefore starting the procedure with the inferior screw. Bothscrews are inserted thru the same 3cm incision. Figure 23Thread the trocar into the soft tissue guide and insert themthrough the upper screw target hole of the VIRA� guide.Mark the position of the trocar on the skin and make a 3cmvertical incision. Push the trocar and tissue guide through.Tap lightly to rest against the bone.

Remove the trocar. Thread the 2.5mm wire bushing intothe soft tissue guide. Under radioscopy, pass the 2.5mmk-wire through the wire bushing reaching the talar done.Figure 24. The tip of the wire should be positioned 5mmfrom the talus subarticular surface. Check the sagittalposition of the wire via an A/P X-Ray. Replace the wirebushing with the 4.5mm drill bushing. Place the 4.5mmdrill bit over the 2.5mm wire and advance through thebone. Figure 25. Remove the drill and drill bushing fromthe upper target hole.In order to achieve the correct seating of the cannulatedscrews into the posterior aspect of the calcaneus andVIRA� nail, it is necessary to countersink the bone.Pass the 8mm countersink drill bit over the K-wire until thestop of the countersink drill contacts the VIRA� guide, thuspreventing over drilling. Figure 26Remove the 8mm drill bit and drill bit sleeve. Pass thedepth gauge over the 2.5mm wire. The correct screwlength can be read from the target hole. Figure 27The 6.5mm screw is then inserted using the T-handlescrewdriver until the posterior thread is locked into the nail.At least 1 thread must be engaged in the nail. The differencebetween the two thread pitches of the screw will assist inthe compression of the subtalar joint.The above procedure is then repeated with the inferiorcannulated screws. Figure 28

23- Tubero-talarscrews incision

27- Depth gauge

Figure 24- 2.5mmk-wire insertion

Figure 25- 4.5mmdrill bit insertion

Figure 26- 8mmcountersink drill bitinsertion

28- Screw positioned(X-ray)

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9

SPECIAL SITUATIONS

Bone Defect

The bone graft formerly harvested during the drilling isintroduced in the subtalar joint. The graft should beimpacted to ensure good graft filling between the talusand the fractured calcaneus.In the case of a severely impacted calcaneus, theharvested bone graft may not be sufficient to fill theresultant defect. In such cases, it may be necessary toharvest autologous bone from the iliac crest. Figure 29

Tongue Fractures

In case of Tongue fracture, Figure 30, a secondaryfracture line appears beneath the facet and exitsposteriorly through the tuberosity. It creates an importantbone defect which can compromise the arthrodesis. Itis recommended to manipulate the bony fragment viaa percutaneous approach with a curette and position itas close a possible to its normal anatomical location.

29- Bone defect afterfracture requiringadditional bonegrafting

30- Tonguefractures

Surgical Technique

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Vira® Calcaneal System

10

Wound Suturing

The para-Achilles tendon incision is sutured in two layers.A single layer suturing of the heel incision isrecommended.

Postoperative Care

The foot should be kept raised, with the necessary levelof antithrombotic medication and exercises beingprescribed. Hospital stay should be adapted to thedegree of inflammation of the foot.

In most cases, weight bearing can be allowed followingsuture removal. In some cases this can be as early asearly as two weeks after surgery. Initial weight bearingshould be partial, with a progressive return to normalactivity.

Nail removal

Nail removal is not compulsory. Should nail removal bedesirable, the following steps should be undertaken:

• First, an incision over the screws is done until reachingthe bone. Secondly, the bone that has grown overthe heads of the tubero-talar screws should beremoved. A wire is inserted through the cannulatedscrews and the 8mm cannulated drill bit, Figure 31,is threaded over in order to remove the bony debris.Finally a curette may be used to complete the removalof the bony ongrowth.

• The T-handle screwdriver is inserted onto the screwsand the screws are removed.

• To remove the nail, a second para-achilles incision isused over the previous scar. The bone covering theupper end of the nail is eliminated. The driver bolt ispassed through the nail inserter and tightened to lockthe nail to the inserter. The tuning fork impactor isused to ease the removal of the nail.

31- 8mm cannulateddrill

Page 13: VIRA The definitive solution for severe calcaneal …when the calcaneal fracture is impacted, or if the distraction of the calcaneal tuberosity is required to restore the length of

11

Surgical Technique

1

1

1

1

1

2

8134-30

8134-31

8134-32

8134-33

8134-34

8134-35

Vira Guide Device

Vira Drill Bit D 10 mm

Vira Nail Insertion Adapter

Vira Driver Bolt

Vira Tuning Fork Impactor

Vira Soft Tissue Guide

IMPLANT

39 mm

50 mm

55 mm

60 mm

65 mm

70 mm

75 mm

80 mm

85 mm

90 mm

8134-10

8134-18

8134-19

8134-20

8134-21

8134-22

8134-23

8134-24

8134-25

8134-26

Ø L

10 mm

6.5 mm

6.5 mm

6.5 mm

6.5 mm

6.5 mm

6.5 mm

6.5 mm

6.5 mm

6.5 mm

NAIL

SCREWS

8134SIC VIRA INSTRUMENTATION SET

INSTRUMENTATION

Page 14: VIRA The definitive solution for severe calcaneal …when the calcaneal fracture is impacted, or if the distraction of the calcaneal tuberosity is required to restore the length of

Vira® Calcaneal System

12

INSTRUMENTATION

1

2

6

2

2

1

1

1

1

8134-36

8134-37

4152-125-250U

8134-38

8134-39

8134-40

8134-41

8134-42

8134-00

Vira Trochar

Vira 2.5mm Wire bushing

K-Wire threaded 2.5mm x250mm

Vira Drill Bushing 4.5mm

Vira 4.5mm Drill Bit

Vira Depth Gauge

Vira Hexalobe 30 screwdriver

Vira Cannulated Drill 8.0mm

Vira Instrument Case only

w/ T-handle

Page 15: VIRA The definitive solution for severe calcaneal …when the calcaneal fracture is impacted, or if the distraction of the calcaneal tuberosity is required to restore the length of

13

Notes

Page 16: VIRA The definitive solution for severe calcaneal …when the calcaneal fracture is impacted, or if the distraction of the calcaneal tuberosity is required to restore the length of