®SIDEKICKCORETRAK® Fixator

SURGIC AL TECHNIQUE

Design Rationale and Specifications

General Principles

Basic CoreTrak Application

Articulating CoreTrak Application

Arthrodiastasis for Hallux Limitus

1st Metatarsal-Phalangeal Joint Arthrodesis

1st Metatarsal-Cuneiform Joint Arthodesis (Lapidus)

Additional Applications

Osteosynthesis

Arthrodesis

Arthrodiastasis

Callotasis

Ordering Information

Chapter 1 2

Chapter 2 3

Chapter 3 4

Chapter 4 6

Chapter 5 13

Appendix 15

Proper surgical procedures and techniques are the responsibility of the medical professional. The following guidelines are furnished for information purposes only. Each surgeon must evaluate the appropriateness of the procedures based on his or her personal medical training and experience. Prior to use of the system, the surgeon should refer to the product package insert for complete warnings, precautions, indications, contraindications and adverse effects. Package inserts are also available by contacting Wright Medical Technology, Inc.

Contents

1

The CORETRAK® family of fixators is designed to simplify basic external fixation procedures. While most fixators use pin clamps that attach to the outside of a bar, the CORETRAK® design features clamps captured within a tube. This creates a smooth low profile device that is more patient friendly and easier for the surgeon to apply with no assembly required. At the heart of the CORETRAK® design is a unique internal screw-drive mechanism that provides compression or distraction capability. The system is designed with titanium nitride coated stainless steel pins to reduce friction, and enhance biocompatibility. For convenience, the fixator, half pins and instrumentation are also available in sterile packaged kits.

Chapter 1 Design Rationale and Specifications

Design Rationale

2

Specifications

SIZE CAT. NO. LENGTH C/D RANGE WIDTH EXTRA HOLE

Short EFSR1002 80mm 25mm 16mm No

Standard EFSR1300 105mm 40mm 16mm Yes

Long EFSR1303 140mm 70mm 16mm Yes*

Articulating EFSR1200 102mm 20mm 16mm No*Also includes 3rd locking hole on compression/distraction clamp

Half Pin Cat. No. DiameterThread Length

Overall Length

Titanium Nitride Coated

Sterile Packaged

RR251580 2.5mm 15mm 80mm No No

RR301580 3.0mm 15mm 80mm No No

EF301580 3.0mm 15mm 80mm Yes No

XP320100 3.0mm 20mm 100mm Yes Yes

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Length

Compression/Distraction

Range2.0mm Hex

Extra Locking Hole

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3 Chapter 2 General Principles

2General Principles

» “Rule of Thirds” – The half pin diameter should not exceed 1/3 of the diameter of bone into which it is placed.

» Structures at Risk - Pin sites should be chosen carefully. Avoid areas containing neurovascular structures or tendons which may become impinged by the half pins.

» Bicortical Purchase - For optimum stability, half pins should be inserted through both cortices of the bone. Due to soft tissue risks, avoid over-insertion of the half pin.

» Minimum Two Pins Per Segement – For rotational stability, at least two pins should be inserted into each bone segment.

» Fixator-to-Skin Distance- The fixator should not contact the skin. Place the fixator far enough from the body to allow for postoperative swelling.

» Pin/Skin Tension - To minimize the risk of pin site infection, avoid excessive tension between the half pin and surrounding soft tissues.

4Chapter 3 Basic CORETRACK® Application

Basic CORETRAK® Application ch

apter

3The first pin is placed perpendicular to the long axis of the bone. Use the fixator as a template to ensure proper alignment. | Figure 1 The pin diameter should not exceed 1/3 of the bone diameter.

Figure 1 |

Figure 2A |

Figure 3 |

Figure 2B |

Align the fixator so that the distal internal pin clamp is positioned over the bone. | Figure 2A The internal clamp should be adjusted along the length of the fixator to position the pin holes in the desired location. | Figure 2B

Insert the second pin through the fixator which is used as a guide. | Figure 3 Use fluoroscopy to check pin penetration through the far cortex. Pins should not penetrate more than 2mm beyond the far cortex of bone.

5 Chapter 3 Basic CORETRACK® Application

Lock the distal pins by tightening the set screws located within the fixator slot. | Figure 5

Figure 5 |

Figure 6 |

Figure 7 |

Figure 4 |

Insert the third and fourth pins through the fixator in the same manner as the first two pins. An AO adaptor can be used to connect to the pins to assist with the insertion. | Figure 4 A hole in the adaptor allows the screwdriver to manually advance or retract the pins (inset). Proximal pins can be positioned in either a vertical or horizontal configuration depending upon the anatomy.

Leave adequate clearance between the fixator and skin to allow for post-operative swelling.

Lock the proximal pins by tightening the set screw in the proximal end of the fixator. | Figure 6

Compression or distraction can be obtained by turning the set screw located within the distal end of the fixator. | Figure 7 For compression, turn clockwise. For distraction, turn counterclockwise. For bone lengthening with a callotasis technique, the distraction should be divided into ¼ turn increments. One full turn of the screwdriver will result in 1mm of distraction. The screwdriver is marked with a directional arrow and turn indicators to assist with distraction. A graduated scale along the pin slot can be used to gauge overall length achieved.

After fixator application, the protruding ends of the pins should be cut short and capped with pin covers or if possible, the fixator pin clamps can be temporarily loosened so that the fixator can be moved slightly away from the body to cover the cut ends of the pins. Perform a final check of all fixator components to ensure that they are tightened before completing the surgery.

6Chapter 4 Articulating CORETRACK® Application

Articulating CORETRAK® Application1st MPJ Arthrodiastasis ch

apter

4

A 1.6mm Kirschner wire is placed in the metatarsal head, through the approxi-mate center of rotation of the 1st MPJ, from medial to lateral.1 | Figure 1 Radiographic images should be obtained to verify placement. | Figure 2 The cannulated hinge is then placed over the K-wire, making sure the medial locking hex screw is away from the skin and the distraction segment of the fixator is distal. | Figure 3

The most proximal half pin should then be inserted into the midshaft of the 1st metatarsal using the fixator as a guide. Avoid bending the K-wire to prevent movement of the center of rotation. Half pins should be placed in a bicortical fashion and can be drilled in with the quick connect AO pin adaptor | Figure 4 or inserted manually using the adaptor and the hex driver 3.5mm. | Figure 6

Position the distal portion of the fixator and insert the most distal half pin into the proximal phalanx. Be sure to leave enough space for the insertion of the proximal phalangeal half pin. | Figure 5

Figure 4 |

Figure 1 | Figure 2 | Figure 3 |

Figure 5 |

1 MJ Shereff et al. Kinematics of the first metatarsophalangeal joint. JBJS Am. 1986;68:392-398

7 Chapter 4 Articulating CORETRACK® Application

Insert the two remaining half pins. This photograph shows the manual or gradual insertion method for proper adjustment of half pin depth. | Figure 6

The proximal half pins are locked using the hex driver 3.5mm. | Figure 7 The distal half pins are locked using the 2.0mm Allen wrench. | Figure 8

The proximal half pins are clamped with an internal Quad Lok™ mechanism. The image on the left shows the indicator pin in the unlocked position. | Figure 9 Clockwise rotation of the mechanism moves the indicator towards the locked position, clamping the half pins in place. | Figure 10 The indicator will not fully traverse the slot with half pins in the fixator.

Figure 6 |

Figure 7 | Figure 8 |

Figure 9 | Figure 10 |

8Chapter 4 Articulating CORETRACK® Application

Remove the K-wire. Adjust the medial/lateral alignment of the toe and lock down the dorsal/plantar hex screws. | Figure 11

Adjust the toe for proper dorsal/plantar alignment and lock the medial/lateral hex screw. | Figure 12

Document the current location of the Indicator on the graduated scale at the distal end of the movable half pin carriage. | Figure 13 Use the hex driver 3.5mm to distract the 1st MPJ per your protocol.2 | Figure 14 Once the patient has reached the distraction goal you may unlock the medial/lateral hex screw to allow for range of motion exercises. | Figure 15

Figure 11 |

Figure 12 |

Figure 13 |

Figure 14 | Figure 15 |

2 Talarico et al. Management of Hallux Limitus with Distraction of the First Metatarsophalangeal Joint. J Am Podiatr Med Assoc. 2005;95(2):121-129.

9 Chapter 4 Articulating CORETRACK® Application

If desired, one may articulate the fixator in a lateral manner prior to locking the dorsal/plantar hex screw, leaving a slight medial gap at the fusion site. | Figure 16 During compression, the lateral cortex will contact first and then the gap will close down. This provides solid contact across the entire joint surface and prevents lateral gapping. | Figure 17 This method can be utilized for any fusion or osteotomy where gapping might be a concern.

Figure 16 | Figure 17 |

1st MPJ Fusion

10Chapter 4 Articulating CORETRACK® Application

The Lapidus Fusion is a very powerful tool in the management of 1st Metatarsal deformities. Through use of the CORETRAK® Articulating Fixator, one can adjust both the IM angle and the Declination Angle at any point in the surgery. Application of the fixator can be after the joint has been resected. | Figure 19, or the CORETRAK® can be utilized prior to the resection | Figure 20. The later method allows the surgeon to correct the necessary angles by utilizing the fixator as a reduction tool and positioning instrument during joint resection. Regardless of which method is utilized, the first half pin should be inserted in the Medial Cuniform as proximal as possible, without being in the Navicular-Cuniform joint. This will position the hinges as close to the fusion site as possible. The second half pin should be the most distal one in the 1st Metatarsal shaft ensuring that the remaining half pins will be interosseous.

Figure 18 |

Figure 19 |

Figure 20 |

Lapidus Fusion

11 Chapter 4 Articulating CORETRACK® Application

It is necessary to lengthen the fixator to allow for correction of the IM angle. The dorsal/plantar hex screw should loosened | Figure 21 prior to distraction in order to minimize soft tissue stretching. | Figure 22

Figure 21 |

Regardless of when the fixator is placed, a slight overcorrection of the IM angle results in the lateral cortices contacting first, leaving a small medial gap | Figure 23. This gap is addressed during compression. Be certain that the M/L and D/P hex screws are tightened prior to compression.

Figure 23 |

Figure 22 |

12Chapter 4 Articulating CORETRACK® Application

Once compression is applied, the gap will close down providing solid contact across the entire joint surface | Figure 24. This technique prevents the lateral gapping that can occur with monolateral fixators.

Figure 24 |

The Declination Angle | Figure 25 can be adjusted in the same fashion by loosening the medial/lateral hex screw | Figure 26 and making any necessary correction. Again, be certain to retighten this D/P and M/L hex screw to compressing the fusion site.

Figure 25 |

Figure 26 |

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13 Chapter 5 Additional Applications

Osteosynthesis

5Additional Applications

Metarsal FX Jones FX

Cuboid FX Lis Franc Dislocation

Calcaneal FX

14Chapter 5 Additional Applications

Arthrodesis

Lapidus T-N Fusion

1st MPJ C-C Fusion

Arthrodiastasis

Hallux Limitus

Callotasis

Brachymetarsia Evans Lateral Column Lengthening

15

Ordering Information

Part No. Description

CORETRAK® Sterile Packed Kits XPCK1002 CORETRAK® Steripack ShortXPCK1300 CORETRAK® Steripack Standard (D 40mm)XPCK1303 CORETRAK® Steripack Long (D 70mm)XPCK1200 CORETRAK® Steripack ArticulatingEFSR1002 CORETRAK® Fixator ShortEFSR1300 CORETRAK® Fixator Standard (D 40mm)EFSR1303 CORETRAK® Fixator Long (D 70mm)EFSR1200 CORETRAK® Articulating FixatorEFSR5001 CORETRAK® Step Hex Driver 2.0/3.5mmEFSR5002 CORETRAK® Hex Driver 3.5mmEFSR5005 A/O Pin AdaptorEF301580 CORETRAK® Half Pin 3.0 x 80 x 15mm Thread TiN CoatedEF302580 CORETRAK® Half Pin 3.0 x 80 x 25mm Thread TiN CoatedRR101002 Pin Covers Medium 10/boxXP320100 CORETRAK® Halfpin 3.0 x 20 x 100mm Thread TiN Coated (Sterile)RR251580 Half Pin 2.5 x 15 x 80mm ThreadRRM5007 Half Pin Driver Extractor

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