Acromioclavicular (AC) Device Product Information
Indications Instrumentation Acromio-clavicular dislocation (acute & chronic). 7 Rockwood Type III, IV & V acromio-clavicular joint injury. Lateral clavicle fractures. 8 Failure of a previous stabilisation procedure such as a failed Weaver Dunn. 6 5 4 3 2 1 No. Code Description Quantity This product information is intended solely for use in all markets outside of the United States of America. For US product information, please contact your local LockDown representative. 1 IN630/1 AO Handle with Quick Coupling 1 2 IN629/1 AO Screwdriver Shaft Ø2.5mm 1 3 IN632/1 Screw Holding Sleeve 1 4 IN626/1 Depth Gauge 1 5 IN631/1 Drill Sleeve Ø2.5mm & Tap Sleeve Ø3.5mm 1 6 IN384 Loop Tensioner 1 7 IN386 Tubular Introducer (Medium) 1 8 IN385 Tubular Introducer (Large) 1 Clinical Heritage FRIMLEY PARK HOSPITAL & BRITISH ARMY** 11 soldiers with ACJ disruption All failed medical tests All had LockDown with Weaver Dunn procedure 6 months post-op all soldiers passed medical tests - 16k run with 35lb backpack (17kg) - 45 press ups - 45 sit-ups Allows soldiers to continue careers 1 step procedure - LockDown is strong No second surgery required Early mobility & fast rehabilitation ** Wood T. Preliminary Results Of The 'Surgilig, Synthetic Ligament In The Management Of Chronic Acromioclavicular Joint Disruption (RAMC Journal 155(3): 191-193) GUYS & ST. THOMAS HOSPITAL, LONDON* 50 LockDown cases 45 patients reviewed (5 lost to follow-up) 16 Grade III / 4 Grade IV / 25 Grade V Mean time to follow-up: 26.9 months Mean patient age: 37.6 years Mean time from injury to surgery: 7.2 months 32 males : 13 females 91% of patients satisfied or better The mean Oxford was 45.31 (range 35-48) The UCLA score was 31.38 (range 11-35) The simple shoulder score was 10.92 (range 6-12) *Carlos A. Stabilization of acromioclavicular joint dislocation using the Surgilig technique, (Shoulder & Elbow 2011; 3, pp166-170)
1 2 Preparation The patient is positioned in a deck chair position, and routine surgical preparation of the skin is performed. The lateral end of the clavicle is exposed and the base of the coracoid identified via a shoulder strap incision. 1cm of the lateral end of the clavicle may be excised in the plane of the acromioclavicular joint, especially in chronic cases, to avoid any post operative impingement. 9 10 The clavicle is reduced to its anatomical position and the Length Gauge is held in the planned position of the screw and washer to measure the required LockDown. Note: The markings on the Length Gauge are 1cm apart. The double stitch represents an 11cm LockDown. The metal leader is passed back under the clavicle and back through its loop to undo the anchorage point. The Length Gauge is NOT removed from under the coracoid. 17 18 19 Using the metal leader as a guide, the Length Gauge is passed under the clavicle. The LockDown is tensioned across the superior aspect of the clavicle and the clavicle reduced. The hard loop is anchored to the anterior clavicle using the LockDown screw and washer. The clavicle is prepared for the screw and washer using a 2.5mm drill and 3.5mm cortical tap.
3 4 5 The Tubular Introducer is passed around the base of the coracoid from medial to lateral, staying close to the bone. through the Tubular Introducer from medial to lateral. The Tubular Introducer is removed leaving the Length Gauge around the base of the coracoid. 11 12 13 The soft loop of the Length Gauge is passed through the hard loop of the chosen LockDown. The soft loop of the Length Gauge is then passed over the soft loop of the LockDown. The soft loop of the Length Gauge is then pulled down the length of the LockDown securing itself to the hard loop. 20 Note: Ensure that the LockDown is clear of the drill during the screw preparation step so as not to damage the LockDown material. The screw and washer should be inserted at an angle to avoid possible abrasion of the LockDown by the screw tip. Add an additional 4mm to the measured screw length, to allow for the height of the washer and ensure bicortical fixation.
Surgical Technique AcromioClavicular (AC) Device 6 7 8 through the loop at the other end of the Length Gauge. The Length Gauge is tightened around the coracoid removing any slack. under the lateral end of the clavicle from anterior to posterior. 14 15 16 The LockDown is passed under the coracoid, by pulling the Length Gauge. through the soft loop of the LockDown. This in turn leads the hard loop of the LockDown through the soft loop of the LockDown. The soft loop of the LockDown is positioned around the base of the coracoid. Any slack is removed using the Loop Tensioner. 21 22 SUGGESTED INSTRUCTIONS FOR USING LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICE This recommended surgical technique is designed to serve as a general guideline. It is not intended to supersede institutional protocols or professional clinical judgment concerning patient care. The screw and washer are seated into place. Note: Cut the Length Gauge from the hard loop of the LockDown before the screw and washer are fully seated. All soft tissue is reconstructed over the top of the clavicle and acromioclavicular joint, and the wound closed in layers. The arm is supported for 2 weeks in a polysling. Light exercise can start from 8 weeks and contact sport from 12 weeks. The patient is advised against heavy lifting for 3 months. Rehabilitation should progress at the surgeon s discretion.
Acromioclavicular (AC) Device LockDown is a synthetic device used in acromioclavicular reconstruction to replace the ligament and recreate the anatomy. It is made of double braided polyester with a weave design that acts as a scaffold encouraging tissue in-growth. Over 4500 implantations have been made over a 10 year period across international markets. LockDown allows early mobilisation at 2 weeks and quick rehabilitation, with light exercise at 8 weeks and contact sport at 12 weeks. LockDown is looped around the coracoid, and then passed behind the clavicle where it is secured with a 3.5mm biocortical screw and washer. The LockDown implant has one hard loop for screw fixation and one soft loop which surrounds the coracoid. This product information is intended solely for use in all markets outside of the United States of America. For US product information, please contact your local LockDown representative. LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICE Code Description Code Description LDLG LockDown Length Gauge LDIN627/S AO Drill Ø2.5mm LD050 LockDown 5cm Acromioclavicular (AC) Device* LDIN628/S AO Cortical Tap Ø3.5mm LD060 LockDown 6cm Acromioclavicular (AC) Device* LD070 LockDown 7cm Acromioclavicular (AC) Device LD080 LockDown 8cm Acromioclavicular (AC) Device Code Description LD090 LockDown 9cm Acromioclavicular (AC) Device LDSS14 14mm Cortical Screw (3.5mm Dia) & 1mm Washer (SS) LD100 LockDown 10cm Acromioclavicular (AC) Device LDSS16 16mm Cortical Screw (3.5mm Dia) & 1mm Washer (SS) LD110 LockDown 11cm Acromioclavicular (AC) Device LDSS18 18mm Cortical Screw (3.5mm Dia) & 1mm Washer (SS) LD120 LockDown 12cm Acromioclavicular (AC) Device LDSS20 20mm Cortical Screw (3.5mm Dia) & 1mm Washer (SS) LD130 LockDown 13cm Acromioclavicular (AC) Device LDSS22 22mm Cortical Screw (3.5mm Dia) & 1mm Washer (SS) LD140 LockDown 14cm Acromioclavicular (AC) Device LDSS24 24mm Cortical Screw (3.5mm Dia) & 1mm Washer (SS) LD150 LockDown 15cm Acromioclavicular (AC) Device LDSS26 26mm Cortical Screw (3.5mm Dia) & 1mm Washer (SS) LD160 LockDown 16cm Acromioclavicular (AC) Device* LDSS28 28mm Cortical Screw (3.5mm Dia) & 1mm Washer (SS) LD170 LockDown 17cm Acromioclavicular (AC) Device* LDSS30 30mm Cortical Screw (3.5mm Dia) & 1mm Washer (SS) LD180 LockDown 18cm Acromioclavicular (AC) Device* LDSS32 32mm Cortical Screw (3.5mm Dia) & 1mm Washer (SS) LD190 LockDown 19cm Acromioclavicular (AC) Device* LDSS34 34mm Cortical Screw (3.5mm Dia) & 1mm Washer (SS) LD200 LockDown 20cm Acromioclavicular (AC) Device* LDSS36 36mm Cortical Screw (3.5mm Dia) & 1mm Washer (SS) LDSS38 38mm Cortical Screw (3.5mm Dia) & 1mm Washer (SS) * Special sizes available on request only. LDSS40 40mm Cortical Screw (3.5mm Dia) & 1mm Washer (SS) All items are supplied sterile, complete with end of box labels for convenient record keeping. LockDown is a product of Mandaco 569 Ltd Manufactured by: Mandaco 569 Limited 16 The Oaks, Clews Road, Redditch, Worcestershire, B98 7ST, ENGLAND Tel: +44 1527 555888 Fax: +44 1527 551166 Email: info@lockdown.uk.com Web: www.lockdown.uk.com Distributed by: Copyright 2012 Mandaco 569 Ltd 0086 RM04952 01/12 Issue 1