TTA Wedge System INSTRUCTIONS FOR USE

TTA Wedge System INSTRUCTIONS FOR USE

1 INSTRUCTIONS FOR USE The OssAbility TTA Wedge System consists of the following products: Wedge Implants Osteotomy Guide Advancement Levers Osteotomy Planning Overlay

COPYRIGHT Copyright 2016 OssAbility Limited. All rights reserved. The information contained herein is protected by copyright and contains trade secrets of the copyright owners. No part of this work may be reproduced, published, used, disclosed or disseminated in any form or by any means including without limitation graphic, electronic, or mechanical (including without limitation photocopying, recording, any digital format, any information storage or retrieval systems, or via the internet) without the prior written permission of OssAbility Limited. This notice does not imply publication. 2

DISCLAIMER OssAbility has taken every effort to ensure that the information in these notes are accurate. OssAbility does not assume any liability for any injury or damages whatsoever to persons, animals or property arising out of or related to any use of the material contained in these proceedings, nor through use of instrumentation and power tools during or after any courses, nor through complications arising from the clinical use of OssAbility technologies. Readers are advised to check the most current information provided on procedures described and manufacturers of each product recommended. The user is responsible for the correct and safe use and outcome, clinical or otherwise, of recommended techniques, applications, administrations, methods, pharmaceuticals and contra-indications. The OssAbility TTA Wedge System assumes a high level of orthopaedic expertise and experience and this can not be achieved in a one-day course. Users are advised that use of the system requires knowledge and skill in application of standard orthopaedic principles. Discussion with and/or referral to a specialist small animal surgeon is advised where a particular patient is predisposed to a complication or if a complication arises. Excellence in analgesia and aseptic technique is paramount. 3

SAFETY This procedure contains potential hazards involving sharp instruments and patient fluids. Effective eye protection must be worn during the procedure. 4

PRODUCT LABEL SYMBOLS The following symbols instruct users on how to effectively and safely use OssAbility products: Catalog number This symbol is accompanied by the catalogue number of the device. Batch code This symbol is accompanied by the batch code of the device. Caution, consult documents This symbol instructs the user to consult the instructions for warnings and safety precautions that could not be presented on the device. Non-sterile Re-use is not allowed Manufacturer This symbol is accompanied by the name and address of the manufacturer. 5

TTA WEDGE SYSTEM The OssAbility TTA Wedge System is a guided osteotomy, advancement and implant procedure to treat lameness secondary to cranial cruciate ligament disease in the canine. The following document outlines the intended use of the OssAbility TTA Wedge System instrumentation and implants. All OssAbility implants and instruments are provided non-sterile and must be sterilised prior to use. OssAbility recommends using a second inner sterile pouch for aseptic presentation to the surgeon that is opened immediately prior to use. The surgeon must be thoroughly familiar with this document prior to surgical application. 6

INDICATIONS AND CONTRA- INDICATIONS Tibial tuberosity advancement (TTA) is indicated for the treatment of dogs with cranial cruciate ligament (CCL) disease. Do not use in dogs with infection or an excessive tibial plateau angle. Seek advice for dogs with, or predisposed to, patellar luxation, or that have multi-ligament stifle trauma. Additional techniques may be necessary. 7

OSTEOTOMY PLANNING Planning the osteotomy is critical to maintaining the integrity of the tibial tuberosity and body of the tibia during recovery. The Osteotomy Planning Overlay is a simple representation of the Osteotomy Guide and must be used to plan an appropriate osteotomy for each patient. The Osteotomy Guide is calibrated to deliver a tibial crest that is 11 mm thick at the level of patellar tendon insertion and 5 mm thick at the level of the Maquet hole. Tibial crest thickness can be increased by moving the offset pins in a distal direction. Use Gerdy s tubercle as a limit for tibial crest thickness. Wedge Implants are designed to fit in the corresponding osteotomy size indicated on the Osteotomy Guide. The osteotomy can be adjusted by one size smaller or larger than the selected implant, if required. Adjusting the osteotomy length may affect implant fit. When using a larger osteotomy, a small gap should be expected at the distal aspect of the implant. When placed in a smaller osteotomy the distal aspect of the osteotomy may have to be opened further (using a periosteal elevator) to allow the implant to be inserted. Always ensure Wedge Implants are positioned within 3 mm of the proximal termination of the osteotomy to avoid tibial crest fracture. 8

APPROACH Prepare the patient for surgery. 1. Position the patient in dorsolateral recumbency on the affected side with the operable limb laying flat. 2. Assess and treat meniscal disease if present. 3. Expose the medial surface of the tibia. 9

GUIDE PLACEMENT Set up and apply the Osteotomy Guide. 1. Configure the Osteotomy Guide to either left or right handed operation. 2. Position the offsets to the bone contact points determined using the Osteotomy Planning Overlay. 3. Apply the Osteotomy Guide to the proximo-medial surface of the tibia. 10

GUIDE ALIGNMENT Align the Osteotomy Guide with anatomical landmarks of the tibia. 1. Insert a short 2.5 mm diameter single trocar Steinman pin through the proximal pin hole, under the stifle fat pad, and caudal to the patellar tendon. 2. Position the Osteotomy Guide such that the 2.5 mm Steinman pin and both offset pins are in intimate contact with the proximal tibia. 3. Ensure that the Osteotomy Guide is positioned such that the osteotomy will be perpendicular to the plane of stifle motion. 11

MAQUET HOLE Drill the Maquet hole. 1. Drill the Maquet hole using a 2.5 mm diameter drill bit through the Osteotomy Guide at the planned position. 2. Leave the drill bit in place. 12

LOCKING BIT Lock the Osteotomy Guide to the patient. 1. Place a bicortical locking bit using a 2.0 mm diameter drill bit through the oblique locking hole. Always use the locking hole that directs the bit away from the stifle. 2. Leave the drill bit in place. 13

OSTEOTOMY Saw the tibial osteotomy. 1. Incise the periosteum using a scalpel through the osteotomy channel. 2. Saw the osteotomy using an oscillating saw with copious saline lavage through the osteotomy channel. 14

REMOVE GUIDE Remove the Osteotomy Guide and ensure the osteotomy is complete. 1. Remove the locking drill bit. 2. Remove the Maquet hole drill bit. 3. Remove the proximal pin. 4. Remove the Osteotomy Guide. 5. Ensure the osteotomy is complete. 15

INTRODUCE ADVANCEMENT LEVER Introduce the Advancement Lever to the osteotomy. 1. Place pointed reduction forceps to compress the tibia immediately distal to the Maquet hole. 2. Insert a periosteal elevator into the osteotomy. 3. Gently open the osteotomy by rotating the elevator. 4. Introduce the Advancement Lever corresponding to the planned Wedge Implant size. 5. Align the Advancement Lever 3 mm distal to the proximal aspect of the osteotomy. 6. Remove the periosteal elevator. 16

ADVANCE THE TUBEROSITY Advance the osteotomy. 1. Gently and slowly rotate the Advancement Lever handle cranially until it is perpendicular with the osteotomy. 2. Palpate the proximal aspect of the osteotomy using a periosteal elevator. 3. Position the Advancement Lever flush with the proximal aspect of the osteotomy. 4. Leave the Advancement Lever in place. 17

PLACE IMPLANT Place the Wedge Implant into the osteotomy. 1. Lavage the surgical site with copious saline. 2. Remove the Wedge Implant from the inner sterile pouch. At all times handle the Wedge Implant with an instrument to ensure meticulous asepsis. 3. Place the Wedge Implant into the osteotomy immediately distal to the Advancement Lever and inline with the medial surface of the tibia. 4. If bony impingement occurs while attempting to place the implant, a periosteal elevator can be used in the osteotomy distal to the implant to gently open the gap. 18

REMOVE ADVANCEMENT LEVER Remove the Advancement Lever and check the implant position. 1. Remove the Advancement Lever by continuing to rotate the handle distally. 2. Palpate the proximal aspect of the osteotomy with a periosteal elevator. 3. Ensure the Wedge Implant is positioned 3 mm distal to the proximal most aspect of the osteotomy and flush with the medial surface of the tibia. 4. Reposition the pointed reduction forceps to compress the osteotomy. 19

CONTOUR PLATE Contour the tension band plate using the plate bending recesses of both Advancement Levers. 1. Position the plate fully into the plate bending recesses. 2. Bend the plate to match the contour of the patient s anatomy. 20

FIT PLATE Position the tension band plate. 1. Position the tension band plate to bridge the bone hinge. 2. Ensure a sufficient distance between the Maquet hole and the screws proximal and distal to it to avoid fissure formation between these points. 3. Ensure all screws will be placed in suitable bone stock. Reposition the plate to achieve this. 21

SECURE PLATE Secure the tension band plate to the patient using screws. 1. Drill and place the first proximal screw ensuring that it is centred on the tuberosity. 2. Drill and place the next proximal screw ensuring that it is centred on the tuberosity. 3. Drill and place the remaining screws. 4. Remove the pointed reduction forceps. 22

DONE Application of the Wedge Implant and tension band plate is now complete. 23

2 INSTRUMENT CLEANING Cleaning procedure for OssAbility TTA Wedge System instruments.

INSTRUMENT CLEANING It is critical that instruments are cleaned effectively before sterilisation. In particular small holes and channels may hold organic debris (e.g. dried blood). If this organic material is not removed there is an increased risk of infection. OssAbility strongly advises the use an ultrasonic cleaner to remove stubborn organic debris from its instruments. The following cleaning protocol is suitable for cleaning OssAbility instruments: 1. Completely submerge instruments in enzymatic disinfectant solution and soak for 20 minutes. 2. Use a soft-bristled, nylon brush to gently scrub the device until all visible soil has been removed. Particular attention must be given to crevices, lumens, mated surfaces, connectors and other hard-to-clean areas. Lumens should be cleaned with a long, narrow, soft-bristled brush (i.e. pipe cleaner brush). 3. Remove the device from the enzymatic disinfectant solution and rinse in tap water for a minimum of 3 minutes. Thoroughly and aggressively flush lumens, holes and other difficult-to-reach areas. 4. Place prepared cleaning agents in a sonication unit. Completely submerge device in cleaning solution and sonicate for 10 minutes at 45-50kHz. 5. Rinse instrument in purified water for at least 3 minutes or until there is no sign of blood or soil on the device or in the rinse stream. Thoroughly and aggressively flush lumens, holes and other difficult-to-reach areas. 6. Repeat the sonication and rinse steps above. 7. Remove excess moisture from the instrument with a clean, absorbent and non-shedding wipe. 25

3 CATALOG OssAbility product catalog

PRODUCTS TTA Wedge Implant, 6 mm TTA Wedge Implant, 9 mm TTA Wedge Implant, 12 mm TTA Wedge Implant, 15 mm Osteotomy Guide Advancement Levers Osteotomy Planning Overlay For purchasing information please contact your local distributor: Australia Knight Benedikt Animal Health Email: orders@knightbenedikt.com.au Website: www.knightbenedikt.com.au Phone: 1800 524 883 New Zealand Kahu Veterinary Equipment Limited (Kahuvet) Email: info@kahuvet.co.nz Website: www.kahuvet.co.nz Phone: 0800 524 883 27

OssAbility Limited 150 Heaton Street Christchurch 8052 New Zealand Email: info@ossability.com Phone: +64 3 390 3500 TTA Wedge System Information For Use November 5th 2016 28