Inion Freedom Resorbable Fixation System Version 5, 01/2020 & - - PowerPoint PPT Presentation

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Inion Freedom Resorbable Fixation System Version 5, 01/2020 & - - PowerPoint PPT Presentation

Inion Freedom Resorbable Fixation System Version 5, 01/2020 & Clinical considerations Inion Freedom Inion Freedom is composed of: Inion FreedomScrew and Inion FreedomPlate One screw and one plate ideology offers:


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SLIDE 1

Inion Freedom™ Resorbable Fixation System

Version 5, 01/2020 & Clinical considerations

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SLIDE 2

Inion Freedom™

Inion Freedom™ is composed of: Inion FreedomScrew™ and Inion FreedomPlate™ “One screw and one plate” ideology offers:

  • Low inventory costs and decreased warehouse items
  • Multiple variations for multiple indications
  • Polyaxial and free screw placement
  • Low profile construct (fully customizable plate which contours to all

anatomies and fixation screws which interlock with the plate)

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SLIDE 3

Inion Freedom™

Product Message: Strong and effective fixation system to several different Orthopaedic & Trauma indications.

“Freedom to Operate”

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SLIDE 4

Where? – Indications 1/3

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SLIDE 5

Where? – Indications 2/3

Inion FreedomPlate™ Maintenance of aligment and fixation of

  • bone fractures
  • osteotomies
  • arthrodesis
  • f long bones, flat bones, short bones, irregular bones, appendicular

skeleton and thorax, in the presence of appropriate additional immobilization or fixation. Maintenance of relative position of weak bony tissue in trauma and reconstructive procedures, i.e:

  • bone grafts
  • bone grafts substitutes
  • bone fragments in comminuted fractures
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SLIDE 6

Where? – Indications 3/3

Inion FreedomScrew™ Maintenance of aligment and fixation of bone fractures, comminuted fractures, osteotomies, arthrodesis, or bone grafts (i.e., autografts or allografts) in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast or brace). In addition, the Inion FreedomScrew™ 3.5/4.0/4.5 mm products are specifically intended for use in following indications:

  • A. General indications: maintenance of reduction and fixation of

cancellous bone fractures, osteotomies or arthrodesis of the upper extremity, ankle and foot in the presence of appropriate brace and/or immobilization

  • B. Specific indications: fractures and osteotomies of the malleoli, and

ankle fractures

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SLIDE 7

Inion FreedomPlate™

  • Plates
  • Ref. No.

Description FRF-1065 20x65 mm concave plate FRF-1066 20x100 mm concave plate Polymer composition: Copolymer blend of LPLA/DLPLA/TMC. Bioresorption takes place within two to four years.

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SLIDE 8

Inion FreedomScrew™ - Fully threaded

  • Art. No.

Description OSA-2014 FreedomScrew 2.0 x 14 mm OSA-2020 FreedomScrew 2.0 x 20 mm OSA-2716 FreedomScrew 2.7 x 16 mm OSA-2740 FreedomScrew 2.7 x 40 mm OSA-3530 FreedomScrew 3.5 x 30 mm OSA-3545 FreedomScrew 3.5 x 45 mm OSA-4540 FreedomScrew 4.5 x 40 mm OSA-4555 FreedomScrew 4.5 x 55 mm Inion FreedomScrew™ - Partially threaded (LAG), Cannulated

  • Art. No.

Description OSD-3530 FreedomScrew 3.5 x 30 mm (LAG) , Cannulated OSD-3535 FreedomScrew 3.5 x 35 mm (LAG), Cannulated OSD-3540 FreedomScrew 3.5 x 40 mm (LAG), Cannulated OSD-3545 FreedomScrew 3.5 x 45 mm (LAG), Cannulated OSD-4535 FreedomScrew 4.5 x 35 mm (LAG), Cannulated OSD-4540 FreedomScrew 4.5 x 40 mm (LAG), Cannulated OSD-4545 FreedomScrew 4.5 x 45 mm (LAG), Cannulated OSD-4550 FreedomScrew 4.5 x 50 mm (LAG), Cannulated OSD-4555 FreedomScrew 4.5 x 55 mm (LAG), Cannulated

Polymer composition: Oriented copolymer of LPLA/DLPLA Bioresorption takes place within two to four years.

Inion FreedomScrew™ - Fully threaded, Cannulated OSC-3530 FreedomScrew 3.5 x 30 mm, Cannulated OSC-3545 FreedomScrew 3.5 x 45 mm, Cannulated OSC-4540 FreedomScrew 4.5 x 40 mm, Cannulated OSC-4555 FreedomScrew 4.5 x 55 mm, Cannulated Inion FreedomScrew™ - Fully threaded, Cannulated - Syndesmosis Screw

  • Art. No.

Description OSC-4090 FreedomScrew 4.0 x 90 mm, Cannulated

Inion FreedomScrew™

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SLIDE 9

Inion FreedomScrew™ - Fully threaded

  • Art. No.

Description OSA-2010 FreedomScrew 2.0 x 10 mm OSA-2012 FreedomScrew 2.0 x 12 mm OSA-2016 FreedomScrew 2.0 x 16 mm OSA-2018 FreedomScrew 2.0 x 18 mm OSA-2712 FreedomScrew 2.7 x 12 mm OSA-2714 FreedomScrew 2.7 x 14 mm OSA-2718 FreedomScrew 2.7 x 18 mm OSA-2720 FreedomScrew 2.7 x 20 mm OSA-2725 FreedomScrew 2.7 x 25 mm OSA-2730 FreedomScrew 2.7 x 30 mm OSA-2735 FreedomScrew 2.7 x 35 mm OSA-3520 FreedomScrew 3.5 x 20 mm OSA-3525 FreedomScrew 3.5 x 25 mm OSA-3535 FreedomScrew 3.5 x 35 mm OSA-3540 FreedomScrew 3.5 x 40 mm OSA-4535 FreedomScrew 4.5 x 35 mm OSA-4545 FreedomScrew 4.5 x 45 mm OSA-4550 FreedomScrew 4.5 x 50 mm OSA-4590 FreedomScrew 4.5 x 90 mm Inion FreedomScrew™ - Fully threaded, Cannulated - Syndesmosis Screw

  • Art. No.

Description OSC-3520 FreedomScrew 3.5 x 20 mm, cannul. OSC-3525 FreedomScrew 3.5 x 25 mm, cannul. OSC-3535 FreedomScrew 3.5 x 35 mm, cannul. OSC-3540 FreedomScrew 3.5 x 40 mm, cannul. OSC-4535 FreedomScrew 4.5 x 35 mm, cannul. OSC-4545 FreedomScrew 4.5 x 45 mm, cannul. OSC-4550 FreedomScrew 4.5 x 50 mm, cannul. OSC-4590 FreedomScrew 4.5 x 90 mm, cannul.

Inion FreedomScrew™ (C-categorized products)

Inion FreedomScrew™ - Partially threaded (LAG)

  • Art. No.

Description OSB-3520 FreedomScrew 3.5 x 20 mm (LAG) OSB-3525 FreedomScrew 3.5 x 25 mm (LAG) OSB-3530 FreedomScrew 3.5 x 30 mm (LAG) OSB-3535 FreedomScrew 3.5 x 35 mm (LAG) OSB-3540 FreedomScrew 3.5 x 40 mm (LAG) OSB-3545 FreedomScrew 3.5 x 45 mm (LAG) OSB-4535 FreedomScrew 4.5 x 35 mm (LAG) OSB-4540 FreedomScrew 4.5 x 40 mm (LAG) OSB-4545 FreedomScrew 4.5 x 45 mm (LAG) OSB-4550 FreedomScrew 4.5 x 50 mm (LAG) OSB-4555 FreedomScrew 4.5 x 55 mm (LAG) Inion FreedomScrew™ - Partially threaded (LAG), Cannulated

  • Art. No.

Description OSD-3520 FreedomScrew 3.5 x 20 mm (LAG), cannul. OSD-3525 FreedomScrew 3.5 x 25 mm (LAG), cannul.

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SLIDE 10

IFS-2001 Drill bit Ø1.5 mm IFS-2002 Tap Ø2.0 mm IFS-2006 Drill tap Ø2.0 mm IFS-2701 Drill bit Ø2.0 mm IFS-2702 Tap Ø2.7 mm IFS-2706 Drill tap Ø2.7 mm IFS-3501 Drill bit Ø2.5 mm IFS-3502 Tap Ø3.5 mm IFS-3503 Drill bit Ø2.7 mm, cannulated IFS-3504 Tap Ø3.5 mm, cannulated IFS-3506 Drill tap Ø3.5 mm IFS-3508 Drill tap Ø3.5 mm, cannulated IFS-4004 Tap Ø4.0 mm, cannulated IFS-4008 Drill tap Ø4.0 mm, cannulated IFS-4501 Drill bit Ø3.2 mm IFS-4502 Tap Ø4.5 mm IFS-4503 Drill bit Ø3.2 mm, cannulated IFS-4504 Tap Ø4.5 mm, cannulated IFS-4506 Drill tap Ø4.5 mm IFS-4508 Drill tap Ø4.5 mm, cannulated IFS-9001 Screwdriver shaft, hex 2.5 mm IFS-9002 Screwdriver shaft, hex 3.5 mm, cannulated IFS-9011 Holding sleeve for Ø2.0/2.7 mm screws IFS-9012 Holding sleeve for Ø3.5 - 4.5 mm screws IFS-9021 Drill sleeve Ø1.5/2.0 mm, for Ø2.0 mm screws IFS-9022 Drill sleeve Ø2.0/2.7 mm, for Ø2.7 mm screws IFS-9023 Drill sleeve Ø2.5 - 3.5 mm, for Ø3.5 mm screws IFS-9024 Drill sleeve Ø3.2 - 4.5 mm, for Ø4.0/4.5 mm screws IFS-9031 Countersink for Ø2.0/2.7 mm screws IFS-9032 Countersink for 3.5 - 4.5 mm screws, cannulated IFS-9041 Depth gauge for Ø2.7/3.5 mm screws IFS-9042 Depth gauge for Ø2.7 - 4.5 mm screws ,with K-wire IFS-9043 K-wire Ø1.6 mm (used with depth gauge) IFS-9051 Screw cutting pliers IFS-9052 Scale for Ø2.0/2.7 mm screws IFS-9053 Scale for Ø3.5 - 4.5 mm screws INS-9093 Small handle, cannulated (set contains two pieces

  • f INS-9093)

INS-9120 Large handle, cannulated IFS-9801 Instrument tray IFS-9901 FULL - FreedomScrew Instrument set with tray HTC-0000 Low Temperature Cautery (10 pcs.) ACC-9802 Inion Thermo drape (5 drapes) ACC-9810 Inion Thermo+ water bath (230 V+EU plug) ACC-9840 Inion Thermo+ water bath (110V+US plug) IFS-9061 K-wire Ø1.25 mm (10 pieces) IFS-9062 K-wire Ø1.6 mm (10 pieces)

Inion FreedomScrew™ Instruments 1/2

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SLIDE 11

Inion FreedomScrew™ Drill Taps and Bone taps:

Drill tap - Drill and tap combined:

  • Drilling and tapping performed simultaneously

with one instrument

  • The additional step of manual tapping removed
  • Yellow stripe to separate the Drill tap from the

Bone tap Use of the Bone taps and Drill taps:

  • The Drill tap and Bone tap are designed to be

used with the Drill sleeve instrument

  • The depth markings can be read on the tap shaft

at 5 mm increments, when used with the Drill sleeve

  • The Drill sleeve prevents instrument-wobble and

protects surrounding soft tissues. It can be used to press the plate tightly against the bone to ensure continuous thread through the plate and to the bone.

Inion FreedomScrew™ Instruments 2/2

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SLIDE 12

100 200 300 400 500 600 700 800 900 1000 Inion FreedomScrew™ 4.5 mm Inion OTPS™ Screw 4.5 mm

Maximum Shear Load Capacity (N)

Measured after 24 hours in 37oC

Inion FreedomScrew™ Features 1/9

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SLIDE 13

20 40 60 80 100 120 140 160 180 Inion FreedomScrew™ 2.7 mm Inion OTPS™ Screw 2.8 mm

Max pull-out load capacity (N)

Measured after 24 hours in 37oC

Tested with sawbones (failure mechanism = sawbones)  Improved pull-out strength also in less dense bone.

Inion FreedomScrew™ Features 2/9

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SLIDE 14

Full compatibility with generic O&T Instrumentation Inion FreedomScrewTM is compatible with most of the universal instrumentation used in hospitals around the world: ISO, ASIF, AO

Universal disposable metallic adapter Universal tap/screw profile

Inion FreedomScrew™ Features 3/9

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SLIDE 15

Inion FreedomScrewTM (LAG) provides:

  • High fixation strength
  • Compression to fracture line
  • No material creeping within

healing period, compression will be maintained

  • Due to the thread profile,

screw bites in the walls of the drilled/tapped screw hole

Inion FreedomScrew™ Features 4/9

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SLIDE 16

Inion FreedomScrewTM can be cut into specific lengths after the insertion: When Inion FreedomScrewTM is cut by temperature cautery it will automatically generate a new screw head to the screw shaft. This phenomenal feature is inherent to polymer structure generated during the Inion FreedomScrewTM manufacturing process.

With scissors With temperature cautery

Inion FreedomScrew™ Features 5/9

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SLIDE 17

Featur es

Creating a new screw head with Temperature Cautery: Use Heat – Not Force!

Inion FreedomScrew™ Features 6/9

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SLIDE 18

Creating a low profile plate fixation with Temperature Cautery: Cut Inion FreedomScrewTM about 1-2 mm above the plate surface and heat will generate a new screw head and locking effect to the plate.

Inion FreedomScrew™ Features 7/9

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SLIDE 19

Resorbable Locking Plate When used with Inion FreedomPlateTM, screw can be inserted into the plate in different places at multible insertion angles, and locked to the plate.  Always optimal fixation!

Inion Freedom™ Features 8/9

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SLIDE 20

Multiple variations for multiple indications: Modified plate/screw combination creates a 3D fixation device with strong anatomical fit.

Inion Freedom™ Features 9/9

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Operational technique Inion Freedom™

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Open the sterile drape peel pouch and unfold the sterile drape onto a sterile table. The scrub nurse places both hands inside the sterile drape pouch while the circulating assistant inserts the water bath against the drape’s closed end. The sterile drape pouch is turned inside out. The

  • pening of the sterile pouch remains around the

power cable.

Water bath set-up instructions (1/3)

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SLIDE 23

The water bath is now ready to be placed on a sterile table close to the operating surgeon. After placing the draped water bath on the sterile table, make a depression into which sterlile water or saline can be poured. Ensure that the drape lines the bottom of the water bath and that no air is left between the drape and the water bath basin. This is important to ensure correct temperature of the sterlie fluid during procedure. Note! Use Inion Thermo + water bath with Inion FreedomPlate™ (T: 70°C / 158°F).

6 6

Water bath set-up instructions (2/3)

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SLIDE 24

Pour sterile water or saline into the bath. Fill the bath just over half full (ca. 0.5l). Remember to ensure that this amount of fluid is in the bath during the procedure. Once more ensure there is no air between the bath and the sterile drape. Once fluid is in the bath, plug the cable in. The water bath can now be switched on. Note! Heating of the water takes ~30minutes.

7

7

9

9

Water bath set-up instructions (3/3)

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SLIDE 25
  • After preconditioning in Inion Thermo+TM waterbath for 1 minute, the plate

is malleable for approximately 10 seconds.

  • Mold the plate along the anatomy and shape with scissors, if needed.
  • Water bath treatment can be repeated up to three times, if additional

contouring is required (for max. 30 minutes).

Plate customization

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SLIDE 26

A - Traditional technique

(screw with a head, similar to metallic screws)

B - Screw cutting after the insertion

(using temperature cautery or cutting pliers)

C - Use with Inion FreedomPlate™

Summary of operation techniques Inion FreedomScrew ™ (A, B, C)

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SLIDE 27

A - Traditional technique

(screw with a head, similar to metallic screws)

  • A1. Select an appropriate screw diameter for indication
  • A2. Drill a screw channel through the

fracture/osteotomy line using appropriate drill or drill tap size

  • A3. When applicable, tap the screw channel manually

with appropriate tap. Use irrigation!

  • Note the difference between the bone qualities;
  • steoporotic vs. hard bone
  • A4. If needed, countersink a space for the screw head
  • A5. Measure the depth of the screw channel and cut

the screw to the correct length with screw cutting pliers

  • A6. Use irrigation to flush out the bone debris
  • A7. Insert the screw fully into the screw channel using

appropriate screwdriver

  • Note! In case the friction rises too much during

insertion, screw must be removed and the screw channel must be rinsed and/or re-tapped

  • A8. Remove the disposable metallic insertion adapter

from the screw with the screwdriver

Summary of operation techniques Inion FreedomScrew ™ (A, B, C)

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SLIDE 28

B - Screw cutting after the insertion

(using temperature cautery or cutting pliers)

  • B1. Insert the screw into the drilled/tapped screw channel

without countersinking

  • B2. Measure the depth of the screw hole with a depth gauge
  • r a drill tap or bone tap with depth markings
  • B3. Mark the depth on the screw shaft
  • B4. Insert the screw up to the marked depth and cut with

regular cutting pliers or with temperature cautery

  • B5. Cut the screw 1-2 mm above the bone surface with low

temperature cautery letting the heat reform a smooth new screw head while cutting

  • B5. Optional: Cutting with regular cutting pliers: Cut the

screw along the bone surface trying to avoid protruding sharp corners which could cause soft tissue irritation Cutting with temperature cautery is recommended because heat is generating a new smooth surface on the screw head (Inion FreedomScrew™ expands from its shaft because of the memory effect created during the manufacturing) and enables even more stable and secured fixation.

Summary of operation techniques Inion FreedomScrew ™ (A, B, C)

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SLIDE 29

B - Using one long screw as two short screws

After on insertion technique B, remaining screw can be sharpened with screw cutting pliers and re-inserted into a new screw channel.

  • B2. Sharpen the distal end of the remaining screw with screw cutting pliers
  • B3. Prepare a new screw channel according to the previously instructed steps (drill

+ tap, or drill tap) and insert the sharpened screw to the channel

Summary of operation techniques Inion FreedomScrew ™ (A, B, C)

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SLIDE 30

C - Use with Inion FreedomPlate™

  • C1. Modify the Inion FreedomPlate™ according to instructions and select appropriate

screw diameter for the indication C2-C3. Drill and tap, or use the drill tap to create a screw channel through the Inion FreedomPlate™ into the bone (and fracture line if needed) using appropriate drill size

  • C4. Use irrigation to flush out the bone debris
  • C5. The depth of the screw hole is measured and marked on the screw.
  • C6. Insert the screw to the marked depth using appropriate screwdriver
  • C7. Cut the screw 1-2mm above the plate surface with temperature cautery, allowing the

temperature to create a smooth screw head above the plate and lock screw to the plate

Summary of operation techniques Inion FreedomScrew ™ (A, B, C)

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SLIDE 31
  • Set up the water bath before the operation begins
  • Reduce fracture
  • Precondition the plate
  • Customize of the plate (cutting, shaping, contouring)
  • Fasten the plate:
  • Create the drill hole with a drill or drill tap
  • Measure the drill hole depth
  • When applicable, tap the screw hole
  • Insert the screw
  • Customize the screw by removing the screw head
  • Ensure the patient has appropriate postoperative instructions

Summary of operation technique steps with Inion FreedomPlate ™

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SLIDE 32
  • Select appropriate Inion Freedom™ screw(s) for the

indication.

  • Use the Drill sleeve with the Drill tap. Press the

instruments firmly against the bone. Drill through the fracture/osteotomy line using slow speed on a slow- speed drill, which has a reverse function. Use irrigation.

  • Follow the depth markings on the Drill tap shaft to

determine the correct screw length. Use intraoperative X-ray to confirm the location of the Drill

  • tap. Set the power drill to reverse when removing the

Drill tap from the bone.

  • Alternatively, use the depth gauge to confirm the

needed screw length.

  • Mark the required screw length on the screw shaft

with a sterile marker (measured from the tip of the screw).

Surgical technique with the Drill tap 1/2

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SLIDE 33
  • Insert the screw into the drill hole using

appropriate screwdriver until the mark reaches the bone surface.

  • Cut and trim the screw using a Low

temperature cautery instrument 1–2 mm above the bone surface.

Surgical technique with the Drill tap 2/2

Fixation of Inion FreedomPlateTM with the Drill tap

  • Select appropriate Inion Freedom™ implant(s) for the indication.
  • Use the Drill sleeve instrument with the Drill tap. Press the plate tightly

against the bone to allow proper plate-bone contact.

  • Drill through the plate using slow speed on a slow-speed drill. Use irrigation.
  • Set the drill machine to reverse when removing the Drill tap from the bone.
  • Determine and mark the required screw length on the screw shaft as

described above.

  • Insert the screw until the mark reaches the plate surface.
  • Cut, trim, and lock the screw to the plate using a Low temperature cautery

instrument 1–2 mm above the plate surface.

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SLIDE 34

Appropriate, additional immobilisation (e.g. a plaster cast) should be used during bone healing. Immobilisation and weight bearing schedules are always based on the indication and surgeons consideration

  • One example of the immobilisation times with bimalleolar ankle

fracture:

  • Weeks 0-3 no loading
  • Weeks 3-5 partial weight bearing
  • Weeks 5-6 loading within pain tolerance
  • Full load bearing is allowed only after fracture/osteotomy healing has

been confirmed

Postoperative management

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SLIDE 35

Considerations for optimal fixation 1/2

  • Make the plate shape and size optimal for the surgical site. When

cutting the plate, do not cut too close to the pilot holes intended to be used for screw insertion. Trim all sharp edges before implantation.

  • Use irrigation during drilling to prevent enlarging the plate hole due to

the heat.

  • Use the pilot holes in the plate for optimal fixation. Additional holes

can also be drilled between the pilot holes if needed.

  • When drilling and tapping through the plate, press the plate tightly

against the bone to ensure proper plate-bone contact for optimal fixation.

  • Always insert screws through the pilot holes closest to the

fracture/osteotomy line. However, the minimal distance to the fracture/osteotomy line must be equal to the diameter of the screw shaft.

  • Insert at least 4 screws on both sides of the fracture line

(recommendation).

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SLIDE 36

Considerations for optimal fixation 2/2

  • Insert the screws bicortically for optimal fixation.
  • Insert the screws at different angles for improved biomechanical

stability.

  • Place one of the screws across the fracture line (when applicable) to

increase fixation strength of the plate-screw construct.

  • Place screws close to the edges of the plate to ensure that the plate

edges remain tightly against the bone to allow three-dimensional locking.

  • Cut the screw heads off (of fully threaded screws) and lock the screws

to the plate by using a temperature cautery. Cutting the screw heads

  • ff interlocks the screws to the plate, as well as reduces the construct

profile and the risk of soft tissue irritation.

  • Use depth gauges and radiographic imaging (utilizing K-wires and/or

drill taps and bone taps with depth markings) intraoperatively to ensure correct length and placement of the screw(s).

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SLIDE 37

Clinical considerations

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SLIDE 38

Comparison of costs in ankle fractures treated with absorbable or metallic fixation devices

  • Arch Orthop Trauma Surg. 1997;116(4):204-8.
  • Bostman O et al. 1991.

.

In bimalleolar fractures, the coefficient was 1.04 (cost of absorbable fixation 4% higher than that of metallic fixation) if the removal percentage with metallic fixation was zero and 0.91 (cost of absorbable fixation 9% lower than that of metallic fixation) if the removal percentage was 100%. If removal is required, it can cost between $2,533 and $11,710 or more, according to Saint Elizabeth Regional Medical Center in Lincoln, Nebraska →Total cost of metal plate fixation is 29 % higher than absorbable plate

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Complication rate of the metal implants by removal surgery

  • Injury. 1992;23(1):29-30.

188 patients, an overall 20 per cent complication rate Highest complication rate: 42 per cent with forearm fractures Infection was the most common complication, and was particularly high in those fractures which were originally open (43 per cent) and where infection developed after the initial internal fixation (32 per cent). Ann Plast Surg. 2005 Dec;55(6):608-11. 135 patients with titanium plate fixation for traumatic facial fractures Overall, 33.3% (45/135) removed; 64.4% (29/45) for complications, ie, discomfort, exposure, and infection; The most common complication was discomfort related to palpability, cold intolerance, and pain. This constituted 72.4% (21/29) of all plate removals for complications.

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SLIDE 40

Metal vs. biodegradable plate removals

Per Aspenberg , Bone: Silk, metal and bone: why take implants out?, 2014, Nature

  • Reviews. Rheumatology, (10), 7, 386-387.
  • Implant removal is surprisingly common. In Sweden, 37,000 adult patients received metal

fracture fixation implants in 2011, and 13,000 underwent implant removal.

  • The number of adults undergoing fracture surgery in Sweden increased from 2005 to 2011 by

20 %, but removals increased by 35 %. The highest rate of removal (70%) was reported for the ankle and foot. Kukk et al 2009, A retrospective follow-up of ankle fracture patients treated with a biodegradable plate and screws, Foot and Ankle Surgery

35,1 8,0 0,0 20,0 40,0 60,0 80,0 100,0 Metal Biodegradable

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SLIDE 41

Clinical results

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SLIDE 42
  • Hardware removal 34% in the metal group

0% in the biodegradable group

after average follow-up of 20 months

Clinical results

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SLIDE 43

Metal allergy

Incidence Contact allergy to metals such as nickel, cobalt, and chromium is prevalent in the general population. It is estimated that up to 17% of women and 3% of men are nickel allergic, and that about 1 to 2% are allergic to cobalt, chromium, or both.

  • fibromyalgia
  • hives
  • joint pain
  • muscle pain
  • rash
  • reddening of skin
  • swelling
  • Common symptoms of metal

hypersensitivity include:

  • blistering of the skin
  • chronic fatigue
  • chronic inflammation
  • cognitive impairment
  • depression

Common metal allergy symptoms

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SLIDE 44

Feature Benefit

Fully customisable plating system Always a custom plate Can be used even in the most challenging anatomies Plates can be cut to required shape and size Screws are trimmed to length Low inventory quantities (one plate + one screw code) Low profile construct Low risk of tissue irritation/reaction Variable screw angulation (polyaxial screws) Screw position and direction can be determined based on the anatomy  always optimal fixation Screws interlock with the plate Lower risk of screw back-out Low profile construct (allows screw head removal) Flexible placement of screws Screw position and direction can be determined based on the anatomy Transparent and radiolucent Enables full visualisation of the fracture/osteotomy site both during the operation and postoperatively Drill taps Enables one step drilling and tapping saving insertion time Biodegradable Avoidance of hardware removal

Features and benefits of Inion Freedom™

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SLIDE 45