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1 »póëíéã For Acute Achilles Tendon Reconstruction mêççìåí=pìééçêí

2 Contents Background Anatomy Injury Classification Incidence Product Overview Indications Features and benefits Comparison with Poly-Tape Surgical technique Overview Tips and tricks Rehabilitation Surgeon feedback Key competitors Synthetic ligaments Suture Patches Conservative treatment Various surgical techniques Biomechanics Strength Clinical data Overview Clinical papers Useful information 2 Product Support

3 Background 3 Product Support

4 Anatomy Background Location The Achilles tendon is the tendon that connects the calf muscle (gastrocnemius) to the heel bone (calcaneus) Function Flexor of the ankle (point foot or raise the heal) Gastronemius, medial and lateral head Soleus Achilles tendon Calcaneus 4 Product Support Flexes ankle

5 Injury Background The Achilles tendon (AT) is the 3rd most frequently injured tendon in the body Amongst the causes of injury are: Advanced age resulting in decreased blood supply to the inside of the tendon Prolonged treatment with steroids weakening body connective tissue, sometimes resulting in spontaneous rupture of the AT, occasionally bilateral spontaneous rupture can occur Strenuous physical activity by those who are not well conditioned (middle-aged athletes) Direct trauma Unexpected forcing of the sole of your foot upward (dorsiflexion of the ankle) as in landing on your feet after jumping from a height Excessive loading of the tendon while pushing off with weight bearing foot The site of rupture in the Achilles tendon is typically 2 to 6 cm from its attachment on the calcaneus 2 to 6 cm 5 Product Support

6 Classification Background Tears of the Achilles tendon may be described as either partial or complete ruptures, the latter of which may be further divided into acute traumatic ruptures, chronic ruptures or chronic attritional ruptures It is also possible to group tears into 4 types according to their severity and degree of retraction: Type I: partial ruptures consisting of less than half the width of the tendon typically treated with conservative management Type II: complete ruptures with a gap of less than 3 cm typically treated with end to end anastomosis Type III: complete ruptures with a gap between 3 to 6 cm often treated with a tendon or synthetic graft Type IV: complete ruptures with a gap of greater than 6 cm often treated with a tendon or synthetic graft and gastrocnemius recession 6 Product Support

7 Incidence Background There is little data on the incidence of Achilles tendon tears, although it is reported to be the most frequently ruptured tendon in the body The few reports available refer largely to incidences of Achilles tendonitis in athletes, which have significant rates, whilst ruptures in the wider population are rarer but no less relevant Achilles tendonitis occurs in about 10% of runners, but the condition also occurs in dancers, gymnasts, and tennis players [1] The true incidence of Achilles tendinitis is unknown, although there is a reported incidence of % in runners [2] Achilles tendon ruptures have been reported in the literature to have an incidence of 18 in 100,000 per year and are believed to be increasing in incidence [3] 7 Product Support 1. James SL, Bates BT, Osternig LR. Injuries to runners. Am J Sports Med. 1978;6: Gottschlich LM. Achilles Tendonitis. Accessed on 14/01/11 3. Costa ML, Macmillan K, Halliday D, Chester R, Shepstone L, Robinson AHN, Donell ST. Randomised controlled trials of immediate weight-bearing mobilisation for rupture of the tendo Achillis. J Bone Joint Surg. 2006;88-B:69-77.

8 Product 8 Product Support

9 Product Overview The AchilloCord PLUS System comprises an implant and associated disposable instrument, all provided in a single box Implant: 5 mm x 800 mm AchilloCord PLUS Disposable instruments: Probe AchilloCord PLUS construction Densely woven flexible tubular structure with flat ends It has a diameter of 5 mm and an overall length of 800 mm Manufactured from polyester, a biocompatible material that has been used for ligament and tendon reconstruction for over 25 years Poly-Tape availability One size fits all anatomy 9 Product Support

10 Indications Product The AchilloCord PLUS is a single use device intended to be used for Achilles tendon repair in patients with acute rupture of the of Achilles tendon, particularly suited to the following situations Acute rupture during sport where an extended period of post-operative immobilization is undesirable For the elderly or patients following steroid treatment where wound healing is often a problem after ankle surgery 10 Product Support

11 Features and benefits Product No need to immobilize the leg in a cast post-operatively, allowing for early rehabilitation Increased potential for retaining full range of motion Partial weight bearing and early mobilization of the leg in the immediate post-operative phase helps retain muscle bulk and strength Fast return to activities of daily living retaining independence Return to work after an average of 6 weeks and return to driving after 7 weeks, reducing loss of earnings (sedentary workers can return earlier to work) Fast return to sport after 4 months, retaining fitness 11 Product Support

12 Features and benefits Product Made from polyester (polyethylene terephthalate) which has been used for ligament and tendon reconstruction for over 25 years Tubular shape with no sharp edges to limit cutting through tendon when loaded invivo Flat ends Smooth surface for easy passage through tendon Flat ends for easy threading through the eye of the probe Flat ends 12 Product Support

13 Features and benefits Product Strong proximal fixation achieved via figure-of-eight weave through tendon Strong distal fixation via calcaneus bone tunnel, which also allows for repair of distally located ruptures Implanted percutaneously through small stab incisions to minimize scar length and so improve cosmesis 13 Product Support

14 Comparison with Poly-Tape Product Each product has procedure specific advantages and so we promote them as follows Acute cases = AchilloCord PLUS, 5 mm x 800 mm INJURY: No gap between the ends of the ruptured tendon FUNCTION: Implant only needs to hold the ends of the tendon next to each other while they heal STRUCTURE: Dense structure as tissue ingrowth not required (dense structure slides easily through tunnels/tissue) Chronic cases = Poly-Tape, 20 mm x 800 mm INJURY: Gap between the ends of the ruptured tendon FUNCTION: Poly-Tape spans the gap between the tendon ends and acts as a bridge for tissue to grow and fill the gap STRUCTURE: The open mesh scaffold structure is required to encourage tissue in-growth 14 Product Support

15 Surgical technique 15 Product Support

16 Overview Surgical technique Please do not use the information summarised hereafter to perform the surgical technique, always refer to the Surgical Technique Manual LAB 117 which contains detailed information and essential warnings and precautions A DVD containing the surgical technique Animation and Video of a live operation is also available 16 Product Support

17 Overview Surgical technique We would like to thank Mr G. K. Sefton FRCS, Consultant Orthopaedic Surgeon, Harrogate District Hospital, UK, and Mr A. G. Jennings FRCS, Consultant Orthopaedic Surgeon, University Hospital of North Durham, UK, for their work in developing this product and technique from the original technique of Professor K. Fujikawa MD, MPhil, National Defense College, Japan A posteromedial incision is made 2.5 to 3 cm long at the site of rupture, parallel to the medial border of the Achilles tendon In addition, during later steps in surgery four stab incisions proximal to the injury site are made, two on the lateral side and two on the medial A 3.2 mm drill bit (not provided) is used to make the bone tunnel horizontally from the lateral side to the medial 17 Product Support

18 Overview Surgical technique The AchilloCord PLUS is threaded through the bone tunnel using the probe (supplied) The probe is pulled through until approximately 25 cm of the AchilloCord PLUS emerges through the stab incision on the medial side of the os calcis 18 Product Support The probe is used to make a subcutaneous path from the medial stab wound running as close as possible to the bone surface and exiting at the centre of the ruptured distal end of the Achilles tendon The AchilloCord PLUS is pulled through so that it disappears under the skin on the medial wall of the os calcis The probe is removed and re-threaded onto the other end of the AchilloCord PLUS The probe is used to make a similar subcutaneous path on the lateral side and is used to pull the AchilloCord PLUS through the tendon The two ends of the AchilloCord PLUS are tensioned to remove any slackness from its distal location within the tendon

19 Overview Surgical technique 2 cm 2 cm 2 cm Where possible, the proximal end of the Achilles tendon is held with forceps and pulled down to approximate it to the end of the distal tendon stump The probe is passed through the centre of the tendon, so that it emerges about 2 cm proximal to the site of injury The probe and AchilloCord PLUS are pulled through the tendon 19 Product Support The probe is positioned close to the exit point of the AchilloCord PLUS and passed through the Achilles tendon to the lateral side, about 4 cm proximal to the site of injury The majority of the tape is thus contained within the tendon, resulting in less chance of adhesions The probe and AchilloCord PLUS are pulled through the tendon The probe is pushed back through the stab incision horizontally so that it exits on the medial side

20 Overview Surgical technique The probe is used to make two further passes to complete the figure-of-eight configuration of the AchilloCord PLUS in the tendon 20 Product Support With the ankle in a plantar flexion position, the proximal end of the AchilloCord PLUS is tensioned to take up any slack and approximate the two ends of the Achilles tendon Then the distal end of the AchilloCord PLUS is pulled so that any bunching of the cord at the rupture site is made taut This also pulls the proximal stump closer to the distal stump On achieving the appropriate tension and length of reconstruction, the two ends of the AchilloCord PLUS are tied with a surgeon s knot at the site of injury Ensure that the knot is well buried in the Achilles tendon Care is taken to ensure the knot is locked The Simmond s test is performed to ensure adequate repair Excess AchilloCord PLUS is cut with scissors

21 Tips and tricks Surgical technique Technique It is important to avoid trapping or damaging the sural nerve, the course of which is along the lateral border of the Achilles Tendon It should be identified before making the two lateral stab incisions which are used for passage of the AchilloCord PLUS through the proximal stump of the Achilles tendon Drilling the transverse tunnel in the Os Calcis A 2.5 mm diameter Drill Bit (available from Neoligaments) can be used to create a smaller tunnel that gives a snug fit between the AchilloCord PLUS and the tunnel wall However, the Probe supplied will not fit through such a small tunnel Therefore, the hospital will need to supply a Suture Passer to pass the AchilloCord PLUS through the tunnel 21 Product Support

22 Tips and tricks Surgical technique Threading the AchilloCord PLUS through the tendon distal to the injury It is important to avoid trapping subcutaneous tissue with the AchilloCord PLUS when making the second pass through each stab incision This can be checked by pulling on the AchilloCord PLUS and confirming that there is no puckering of the skin Should the skin pucker, use an artery forceps to loosen the tissue around the AchilloCord PLUS Threading the AchilloCord PLUS through the tendon proximal to the injury It helps to make a small stab incision centrally within the ruptured end of the tendon, to act as a pilot hole to guide the probe to the correct location It is important to avoid catching the AchilloCord PLUS on subcutaneous tissue around each stab incision, which is indicated by puckering of the skin On the last pass where the probe comes lateral to medial and exits out of the tendon stump at the site of rupture, it is advantageous for the probe to emerge through the deep portion of the tendon stump to help place the knot deep and hence away from the skin 22 Product Support

23 Surgical technique Tips and tricks Knotting the AchilloCord PLUS Some surgeons may prefer to use different types of knots with or without an extra throw Which ever knot is chosen it is very important to check that the knot is locked before trimming the ends of the AchilloCord PLUS to length A strong non-absorbable suture is used to stitch the ends of the tendon together over the top of the knot, so that the knot is covered by tissue and remains buried in the tissue 23 Product Support

24 Rehabilitation Surgical technique Immediate post-operative actions Active and passive plantar flexion Partial weight bearing with elbow crutches emphasize heel-toe gait to reduce swelling ~ 25% body weight (BW) Rehabilitation programme The following programme provides an overview of what is performed for a full description refer to the document entitled AchilloCord PLUS System Rehabilitation Programme for Acute Achilles Tendon Reconstruction (LAB 118) This Rehabilitation Programme was developed in conjunction with Ian Horsley MSc, MCSP, Clinical Lead Physiotherapist, English Institute of Sport (EIS) North West, of BackinAction Physiotherapy and Sports Injury Clinic, Wakefield, UK Days 1 3 Active plantar flexion No dorsiflexion allowed 2 cm heel raise in situ Resting with leg elevated (not in plantar flexion) Days 4 7 Partial weight bearing with elbow crutches increase weight bearing as tolerable ~ 40% BW Begin exercise programme 24 Product Support

25 Rehabilitation Surgical technique Days 7 14 Walking with elbow crutches ~ 50% BW Stitches are removed if satisfactory wound healing Days Walking with elbow crutches ~ 75% BW Passive dorsi flexion begins Days Walking with elbow crutches ~ 100% BW Active plantar and dorsi-flexion begins Days Mobilizing with 1 elbow crutch in opposite arm to operated leg Remove heal raise Days 42 onwards Increase walking frequency Commence function training Note Patients should only return to driving when they can achieve full weight bearing without suffering discomfort 25 Product Support

26 Surgeon feedback Surgical technique Mr Jonathan Walzcak Orpington Hospital, UK Advantages Has used it for both chronic and acute No immobilisation, stiffness, or muscle wastage post-operatively for acute ruptures Significant gaps can be bridged without major muscle dissection turn down in chronic cases Disadvantages None Other uses I have been using the AchilloCord PLUS on selected patients with chronic tendonitis (but no rupture), who have failed to respond to protracted conservative treatment, with some excellent results (Neoligaments is working towards producing a STM for this procedure, but at this moment it is unsure whether an AchilloCord PLUS or a Poly-Tape would be used) 26 Product Support

27 Surgeon feedback Surgical technique Mr Andrew Jennings North Durham University, UK Advantages I just use it for acute cases (In chronics I want tissue ingrowth in the gap so use Poly-Tape) It passes easier than the Poly-Tape Disadvantages The nickel silver probe is too flimsy (Neoligaments is aware of this fact and has sourced a stainless steel rigid probe) 27 Product Support

28 Surgeon feedback Surgical technique Mr Graham Sefton Harrogate District Hospital, UK Advantages Fixation is immediate, no need to place the patient into a protective plaster In the acute ruptures the operation can be done by a minimally invasive incision Disadvantages Infection The greatest disadvantage is that wound healing can be fraught and the fear amongst most orthopaedic surgeons is that if infection occurs how do you actually remove the AchilloCordPLUS without causing tremendous damage to the underlying Achilles tendon If infection occurs soon after the operation (so that the tendon has not healed), treat by washing out and antibiotics Need to leave the ligament in place to give strength while the tendon heals If the infection is late, ie over 6 weeks, the tendon should have healed and so wash out and cut out any synthetic material that is outside of the tendon Leave the rest of the synthetic in place as difficult to remove Its worth noting that the material in the AchilloCord PLUS is the same as that used for Hernia repair patches Surgeons are familiar with these devices and they also get infected and cannot be removed due to tissue in-growth 28 Product Support

29 Key competitors 29 Product Support

30 Synthetic ligaments Key competitors LARS AT30 Corin Group Plc This device has 60 longitudinal fibres with a failure load of 2600 N The ligament has 3 distinct parts The proximal portion is flat, corresponding to the proximal segment of the ruptured tendon and this is sutured to the Achilles tendon The central portion has open longitudinal fibres which are positioned at the site of rupture, allowing for tissue ingrowth The distal portion is cylindrical, with a diameter of 5.5 mm and is fixed with a 6 mm x 30 mm or a 5.2 mm x 30 mm interference screw into the calcaneum It is made from Polyester Terephthalate Sutured to tendon Ligament Screw 30 Product Support

31 Synthetic ligaments Key competitors LARS AT30 Corin Group Plc Advantages (taken from their literature) Quick return to sporting and normal activities Active-passive mobilisation of the ankle commencing on day one Partial weight bearing started with caution immediately Returning to full weight bearing on day 35 Sutured to tendon Ligament Advantages/Disadvantages (Neoligaments View) More complex technique Large incision, could be up to 11 cm long Such large incisions can lead to increase risk of infections and healing problems Need to use hardware a metal interference screw Screw 31 Product Support

32 Synthetic ligaments Key competitors The Tendor Biolig Cousin-Biotech The Tendor fixation system is composed of an 800 mm long ligament with straight needles and 4 button There are 2 versions Tendor Biolig: Non resorbable ligament made of polyethylene terephthalate (polyester) and 4 resorbable buttons Tendor Resorbable: Resorbable ligament and buttons made of Poly L Lactid Acid (PLLA), which resorb after 6 months The Tendor is placed in a figure-of-eight through the Achilles Tendon and the buttons are used to prevent the thin implant cutting through the tendon 32 Product Support

33 Synthetic ligaments Key competitors The Tendor Biolig Cousin-Biotech Advantages (taken from their literature) The system gives to the patient the possibility to have a nearly normal life No plaster is planned after the surgery Advantages/disadvantages (Neoligaments view) The ligament is braided, so less chance of tissue in-growth Both variants have strengths equal to or less than 300 N The strength of the device is low, even assuming that the strength will be double that of a single strand since a figure-of-eight arrangement is used in the repair procedure The device is very thin, hence the need for the buttons to stop the device cheese wiring through the Achilles tendon These buttons are also designed to resorb and so will place degradation products into the surrounding tissue The elongation at 20% or 30% is high 33 Product Support

34 Synthetic ligaments Key competitors TenoLig Surgicraft The Tenolig device consists of a thin braided ligament with a 5 mm wide barb crimped onto it It has a 120 mm long needle crimped onto one end to aid implantation through the tendon The device is passed through the tendon proximal to distal The barb is located in the proximal tendon to provide fixation It is supplied with a silastic disk and a metal retainer which is used to achieve distal fixation It is made from polyester The device is removed once the tendon has healed Two devices are required, one placed medial and one lateral 34 Product Support

35 Synthetic ligaments Key competitors TenoLig Surgicraft Advantages (taken from their literature) On average, patients can return to normal activities in just 75 days minimal aggression Simple and rapid operation accessible to all surgeons The shortest possible period of hospitalisation Rapid and efficient re-education, giving a satisfactory result as regards to reliability and patient comfort The technique is less invasive than direct orthopaedic surgery Avoiding immobilisation by plaster and minimise hospitalisation Partial weight bearing begins after 2 to 3 weeks and full weight bearing at 6 weeks Advantages/disadvantages (Neoligaments view): One disadvantage is that the harpoon barb can rip through the tendon requiring re-placement of the device The ligament can break in the 4 to 5 week period post-op before they are removed The ligament needs to be removed, which is an extra visit to the hospital 35 Product Support

36 Synthetic ligaments Key competitors Ligadon - Teknimed Teknimed manufacture the Ligadon for percutaneous repair of the Achilles tendon This is a polyester thread 1.4 mm in diameter and 800 mm long This has specially designed needles crimped to each end to aid implantation The thread has a failure load of 63 dan (630 N) and an extension to failure of 22 % 36 Product Support

37 Synthetic ligaments Key competitors Ligadon - Teknimed Advantages (taken from their literature) Allows immediate active motion No additional increased work of flexion A mechanical and repeatable repair Minimal tendon handling A velcro boot is used for immobilization during the first 6.5 weeks Partial weight bearing and return to work is not until 12.9 weeks Advantages/disadvantages (Neoligaments view) No cast required, but rehabilitation is slow It has useful needles on the ends to aid insertion The thread has a small diameter and may be prone to cheese wiring through the tissue It has a low strength Surgical technique is similar to the Kessler technique that is used with sutures, so it will not be as strong as the modified Bunnell technique as used with the Neoligaments products Its distal pass is also made through the tendon rather than through a bone tunnel so may not have a high fixation strength 37 Product Support

38 Synthetic ligaments Key competitors The Styx Fixano The Styx is a biosorbable ligament The device consists of an anchor which locates in the calcansous Four strands (possibly braids) emit from this, each is 25 cm long The strands are tied over two round buttons which locate against the ligament and stop the strands cheese wiring through it (these are similar to the buttons used with the Tendor by Cousin-Biotech) The device resorbs in 3 months 38 Product Support

39 Synthetic ligaments Key competitors The Styx Fixano Advantages/disadvantages (Neoligaments view) The disadvantage is that the braided strands are thin, hence the need for the disks to stop the braids cheese wiring through the ligament These discs are also designed to resorb and that will place degradation products into the surrounding tissue 39 Product Support

40 Suture/instrumentation PARS and FiberWire Arthrex The PARS is an instrument used to guide #2 FiberWire sutures through the proximal and distal aspects of the Achilles tendon It is a reusable instrument The repair technique places 6 strands of #2 FiberWire through the site of rupture Advantages/disadvantages (Neoligaments view) This device may well aid the placement of the sutures, but the disadvantages associated with using sutures for the repair of Achilles tendon still apply the sutures can cheese wire through the tendon due to the small diameter of suture 40 Product Support

41 Suture/instrumentation Key competitors Achillon NewDeal The Achillon is an instrument which allows sutures to be placed via a miniinvasive and percutaneous procedure It is a plastic disposable instrument Its aim is to enable #0 or #1 sutures to be placed in the tendon without trapping the sural nerve It places 3 sutures in a lateral to medial direction in both the proximal and distal tendon stumps These sutures are knotted at the site of rupture to effectively provide 6 strands of suture across the site of rupture Advantages/disadvantages (Neoligaments view) The strength of knotted USP 1 suture depends on the type of suture and the type of knot, but has been reported to be about 85 to 120 N for a closed loop of Ethibond and between 55 to 135 N for PDS II depending on knot type [1] Even assuming that multiple sutures will increase the total strength, the maximum strength of such 6 sutures would be 720 N No matter how well this device aids the placement of the sutures, the disadvantages associated with using suture for the repair of Achilles tendons still apply (low strength, cheese wire effect due to small diameter of suture) 41 Product Support 1. Lee TQ, Matsuura PA, Fogolin RP, Lin AC, Kim D, McMahon PJ. Arthroscopic suture tying: A comparison of knot types and suture materials. Arthroscopy. 2001;17(4):

42 Suture Key competitors ITS Tendon - Orthomed The ITS tendon reinforcements have been developed for tendon surgery and help to suppress functional instability It is available in two sizes and has fitted needles at both ends Material is polyethylene terephthalate Advantages (taken from their literature) The ITS is flexible and atraumatic whether in contact with bone or tissue They are fully biocompatible Fitted with needles Available in different diameters 42 Product Support

43 Patches Key competitors GraftJacket Wright Medical This is a tissue based patch that is not used alone, but used for extra support when using sutures for Achilles tendon repair Used for chronic ruptures, muscle flap reinforcement It provides a biologic matrix of collagens, elastin, blood vessel channels, and bioactive proteins that support natural revascularization, cell repopulation, and tissue remodelling Advantages (taken from their literature) A below the knee cast is used for 3 weeks Weight bearing begins after 5 weeks Advantages/disadvantages (Neoligaments view) This is a high cost product that can only be used as an augmentation device for the primary method of repair, i.e. sutures They may therefore add function to a suture repair, as sutures themselves do not provide a scaffold It does not have a high strength, being used only as a scaffold for tissue to build upon 43 Product Support

44 Patches Key competitors Artelon Tissue Reinforcement Artimplant (also sold as SportsMesh Biomet) Artelon Tissue Reinforcement is a knitted fabric made from Artelon fibres The construction permits the mesh to be cut into any desired shape or size without unravelling It is not intended to provide the full mechanical strength, but to support a repair preformed with sutures Strength Pull out strength of 30 N using a simple stitch Pull out strength of 82 N using a mattress stitch Ball burst strength of 500 N Advantages/Disadvantages (taken from their literature) Serves as a temporary scaffold for the body's own cells while it degrades and integrates with the body over a six year period Stabilizes and relieves load during the healing period long term support for healing tissue Excellent biocompatibility Synthetic, eliminates risk of disease transmission or collagen reactions Easy to cut and handle Advantages/Disadvantages (Neoligaments view) It has a relatively low strength so it cannot be used alone and therefore the repair needs additional sutures which further increases the cost and complexity of the procedure 44 Product Support

45 Patches Key competitors ArthroFlex Arthrex This is a acellular dermal extracellular matrix intended for supplemental support and covering for soft tissue repair It is available in 3 sizes Advantages/Disadvantages (Neoligaments view) It has a relatively low strength so it cannot be used alone and therefore the repair needs additional sutures which further increases the cost and complexity of the procedure 45 Product Support

46 Conservative treatment Key competitors Non-operative treatment Usually indicated for patients who are elderly and/or inactive and for those with systemic illnesses or poor skin integrity Patients with diabetes, wound healing problems, vascular disease, neuropathies, or serious systemic comorbidities are encouraged to opt for nonoperative treatment because of significant risks of operative treatment (eg, infection, wound breakdown, repair dehiscence, perioperative complications) Advantages of non-operative treatment No wound complications (eg, skin breakdown, infection, scar formation, neurovascular injury), decreased hospital costs and physician fees, lower morbidity, and no exposure to anesthesia Disadvantages of nonoperative treatment Higher incidence of rerupture (up to 40%) and more difficult surgical repair following rerupture The tendon edges may heal in an elongated position because of a gap in the unapposed tendon ends resulting in decreased plantar flexion power and endurance 46 Product Support

47 Various surgical techniques Key competitors Open and percutaneous (via stab incisions) repair techniques have been described in the literature using sutures Open techniques allow accurate apposition of the ruptured tendon ends, earlier motion and it has a low risk of rerupture But open techniques are associated with a significant rate of wound healing problems Percutaneous techniques were therefore introduced to reduce the risk of infection, and reduce the incidence of adhesion of the skin to the underlying tendon They are also used for patients who have cosmetic concerns of open repair But it is associated with a reduced strength and hence a higher risk of re-rupture compared to open repair and also has a higher risk of damage to the sural nerve Suture techniques Some techniques pass multiple sutures through at the same time Common techniques include Ma-Griffith, Kessler, Bunnell, Locking loop Each has advantages and disadvantages, but typically those repairs which can be placed percutaneous are not so strong, and those which do provide a strong repair require an open repair An advantages is that sutures are relatively inexpensive 47 Product Support

48 Biomechanics 48 Product Support

49 Strength Biomechanics The AchilloCord PLUS is not as strong as some of the competitive devices However, it is strong enough to provide a repair The failure load shown for the AchilloCord PLUS is based on a single strand The rupture would have 2 strands across the repair site and so may be stronger Failure for competitive devices Only LARS is a single strand repair All other synthetics use 2 strands Sutures would need about 4-6 strands to provide equivalent strength (maybe even more as they are prone to cheese-wiring) Some are stronger but (probably) too bulky (LARS) or too thin (Tenolig) Product Support AchilloCord Plus (Neoligaments) LARS Biolig (Tendor) Resorbaid (Tendor) Tenolig (Surgicraft) Ligadon (Teknimed) Ethibond (Ethicon) PDS II (Ethicon)

50 Clinical data 50 Product Support

51 Overview Clinical data Clinical data for acute repair using AchilloCord PLUS is based on the predicate 20 mm Poly-Tape, which has been used for repair of acute Achilles tendon ruptures for many years 51 Product Support

52 Clinical papers Clinical data Jennings AG, Sefton GK, Newman RJ. Repair of acute rupture of the Achilles tendon: a new technique using polyester tape without external splintage. Ann R Coll Surg Engl. 2004;86(6): patients (average age 45) with a mean follow up of 3 years Average return to partial and full weight-bearing of 14 and 45 days respectively Average return to sport was 122 days No re-ruptures 3 patients had further surgery - 2 infected wounds, 1 scar release, 1 sural nerve injury 22 patients regained normal range of ankle and subtalar movement, with the mean power of plantar flexion 84% of the contralateral side Of the 22 patients who played sport, 14 were still performing at the same or higher level The authors conclude this new technique which requires no external splintage facilitates rapid rehabilitation and an early return to work and sport. In the long term, the results are maintained and with few complications 52 Product Support

53 Clinical data Jennings AG, Sefton GK, Newman RJ. Acute Achilles tendon ruptures. SA Bone & Joint Surgery. 1999;9(3): This is an early report on the study described in more detail in the previous article published in 2004 The authors give a history of Achilles repair techniques and comment on their results in 30 patients when using the Poly- Tape The advantage of this technique was that no post-operative splintage or bracing was required Follow-up was at a mean of 3 years Full weight bearing was achieved at 6 weeks and return to sport at 5 months There were no re-ruptures The authors conclude that this surgical technique allows for an early return to normal activities of sport and work, and a minimal re-rupture and complication rate 53 Product Support

54 Clinical data Fernandez-Fairen M and Gimeno C. Augmented repair of Achilles tendon ruptures. Am J Sports Med. 1997;25(2): patients (average age 39), with a mean follow up of 3.2 years 9 professional athletes No postoperative immobilization Ankle mobility normal in all but one patient - all were able to do single-limb heel raises without any impairment Average ankle flexion strength 96% of the uninjured side No re-ruptures and few complications, apart from 2 wound healing problems All patients but one were able to resume their sports activities at the pre-injury levels Initially treated with Stryker Dacron ligament but found its size caused problems with healing and perceptibility beneath the skin Switched to the Poly-Tape to avoid these problems and because it allows early rehabilitation Tendon lengthening is thus avoided, as commonly occurs with other procedures The authors compared their results to others in the literature and found them to be superior They also state that the procedure can be performed in difficult cases 54 Product Support

55 Clinical data Perrone V, Mega W, Esposito D. Treatment of acute Achilles tendon rupture with Poly-Tape. G.I.O.T. 2009;35: patients (average age of 47), with a mean follow up time 1.3 years No wound problems, re-ruptures or vascular complications 2 cases of edema after surgery, 1 loss of plantar flexion strength after 15 months, 1 case of infection Patients returned to unassisted walking in 1 month, compared with 3 months for other techniques All patients had normal walking ability after 2 months. 1 patient returned to playing tennis after 3 months The authors state that the Poly-Tape offers numerous advantages Large surface area compared to other devices stops it cutting through the tissue and preserves tension in the tendon Superior anchorage via the calcaneous tunnel Absence of external plaster or splints Fast mobilization of the limb minimises atrophy Patient satisfaction in relation to the short recovery time These benefits have convinced the surgeons to use this product for Achilles repair They also use the Poly-Tape on other injuries including patellar tendon, quadriceps tendon and type III acromioclavicular repair The authors conclude that this technique is effective, simple and safe, compared with traditional and other percutaneous techniques 55 Product Support

56 Useful information Promotional Material LAB 117 Surgical Technique Manual LAB 123 Promotional Flier LAB 118 Rehabilitation Program SD 001 Surgical Technique Animation SD 002 Surgical Technique Video Ordering Information AchilloCord PLUS Implant Set (supplied sterile) 5 mm x 800 mm AchilloCord PLUS Packaged with the following disposable: Probe with eye nickel silver 20 cm (supplied sterile) Other disposables required (not supplied) A 3.2 mm diameter drill is required for drilling the transverse tunnels in the Os Calcis Forceps for maintaining tension on the end of the tendon 56 Product Support

57 Contact Neoligaments A division of Xiros Springfield House Whitehouse Lane Leeds LS19 7UE UK Tel. +44 (0) Fax. +44 (0) enquiries@neoligaments.com Registered in England No Product Support PS AchilloCord PLUS System 1.00