Leeds-Kuff Patch TM. For Rotator Cuff Reinforcement. Surgical Technique Manual

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Bernadette Rice
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1 Leeds-Kuff Patch TM For Rotator Cuff Reinforcement Surgical Technique Manual 0086

2 Introduction Leeds-Kuff Patch TM This technique utilizes a non-absorbable polyester patch which is sutured over the torn rotator cuff. It thus provides reinforcement of incompletely repaired rotator cuff tears and those at high risk of re-tear due to weakness in the soft tissue. The patch reduces the load placed on the repair, and acts as a scaffold to encourage tissue growth and incorporation into the patient s surrounding tissue. The Leeds-Kuff Patch has the following advantages: Coloured reinforced perimeter provides high suture retention strength, and helps identify correct suture placement during surgery No need to soak before use Easy to handle Soft edges to reduce buckling and consequently the patch being proud of the repair, which can otherwise cause irritation Strength and consistency; unlike allograft material, there is no concern with variation of donor tissue quality, and no quick degradation during the healing phase Readily available and easy to store, with a long shelf life; no freezer or defrosting procedures are required Cost effective compared to traditional tissue patches Porous structure acts as a scaffold for tissue ingrowth Reduces the risk of excess tension being applied to the repair, which can otherwise cause failure We would like to thank Mr. R. G. Hackney, Consultant Orthopaedic Surgeon, Chapel Allerton Hospital, Leeds, UK, and Mr. M. Ravenscroft, Consultant Orthopaedic Surgeon, Stepping Hill Hospital, Stockport, UK, for their work in developing this product and the techniques. Additionally: Unlike allograft and xenograft materials, the Leeds- Kuff Patch is a synthetic material and poses no risk of collagen rejection or donor disease transmission

OPEN TECHNIQUE INDICATIONS The Leeds-Kuff Patch is a single use device indicated for patients requiring reinforcement of the rotator cuff following or during repair by suture or suture anchors, where

3 OPEN TECHNIQUE INDICATIONS The Leeds-Kuff Patch is a single use device indicated for patients requiring reinforcement of the rotator cuff following or during repair by suture or suture anchors, where one or more of the following exist: The tear cannot be completely repaired using normal methods The quality of the soft tissue is poor Contraindications to surgery include: Known hypersensitivity to implant materials. If the patient is suspected of having any foreign body sensitivity, appropriate tests should be made prior to implantation. Infections or any structural or pathological condition of the bone or soft tissue that would be expected to impair healing or secure fixation. Patients unable or unwilling to restrict activities to prescribed levels or follow a rehabilitation programme during the healing period. Any repair that requires rolling, folding, or layering, and which may create a space impermeable to fluid, cells, and blood vessels. Such uses may result in excessive inflammation, drainage, extrusion or infection. The Leeds-Kuff Patch should not be used to provide full mechanical strength to the rotator cuff as it is intended to reinforce tears that are repaired with sutures and/or bone anchors. The Leeds-Kuff Patch integrates well with soft tissue so may not be suitable where eventual removal of the device is anticipated. The Leeds-Kuff Patch is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the repair. The Leeds-Kuff Patch reinforces the repaired rotator cuff where weakness exists and provides a scaffold that is incorporated into the patient s own tissue. ARTHROSCOPIC TECHNIQUE

Product Overview Scaffold for tissue ingrowth Supplementary reinforcement provides anterior-posterior stability IMPLANT The Leeds-Kuff Patch is an implantable device constructed from a knitted

The perimeter reinforcement increases the security of suture attachment providing high suture retention strength.

4 Product Overview Scaffold for tissue ingrowth Supplementary reinforcement provides anterior-posterior stability IMPLANT The Leeds-Kuff Patch is an implantable device constructed from a knitted polyester fabric with integral reinforcement around its perimeter and across its width. The perimeter reinforcement increases the security of suture attachment providing high suture retention strength. It is available in three sizes to suit varying patient anatomy, size of tear, or extent of poor quality tissue and must not be cut to size. The device is supplied sterile. Scaffold construction provides intrinsic strength in the medial-lateral direction INSTRUMENTATION No specialized instrumentation is needed for this operation. However, the user should ensure that the standard shoulder instruments for rotator cuff repair are available before starting surgery. An optional Leeds-Punch is recommended when using an arthroscopic technqiue. This can be ordered from Neoligaments. The Leeds-Punch is intended to create openings in tissue reinforcement patches, by expanding the knitted structure, to facilitate implantation. Primary perimeter reinforcement to provide high suture retention strength Secondary reinforcement to stabilize the patch Results taken from: a. Barber FA, Herbert MA, Coons DA. Tendon augmentation grafts: biomechanical failure loads and failure patterns. Arthroscopy. 2006;22(5): b. Biomet. SportMesh Sales brochure. Data on file at Artimplant. 2007;BSM0112.0, REV c. Neoligaments. Data on file. d. Barber FA, Aziz-Jacobo J. Biomechanical testing of commercially available soft-tissue augmentation materials. Arthroscopy. Soft edges are pliable to conform to the underlying anatomy, and to minimize buckling or the patch raising up between adjacent suture stitches Correct: Suture placed through the patch, next to the inner edge of the reinforcement Incorrect: Suture through the reinforcement Incorrect: Suture through the outer edge

5 The Leeds-Kuff Patch provides high suture retention strength compared to other commercially available graft materials 250 Failure Load for Commercially Available Reinforcement Graft Materials Mattress Stitch: Single Horizontal Configuration with #2 FIBERWIRE Suture 200 Designed for use with a simple stitch A simple stitch or mattress stitch is used to attach the Leeds-Kuff Patch to the tissue. Failure Laod (N) Limited joint space often restricts access, so the easier to place simple stitch is typically used instead of the mattress stitch. The Leeds-Kuff Patch has therefore been designed with integral reinforcement that allows a high suture retention strength to be achieved with a simple stitch. A simple stitch through the Leeds-Kuff Patch can thus provide comparable suture retention strength to a mattress stitch placed in other commercially available graft materials of similar thickness CuffPatch a (1.0) Restore a (1.0) TissueMend a (1.1) SportMesh b (0.8) Permacol a (1.0) GraftJacket a (1.0) Simple Stitch: Single Horizontal Configuration with #2 FIBERWIRE Suture GraftJacket MaxForce a (1.4) GraftJacket Extreme a (2.0) Leeds-Kuff Patch c (1.25) All sutures used to attach the Leeds-Kuff Patch to soft tissue and bone for the purpose of load transfer must be placed through the patch, next to the inner border of the perimeter reinforcement. Failure Laod (N) Sutures must not pierce the perimeter reinforcement. 50 Load bearing sutures placed in the area between the perimeter reinforcement and the outer edge of the patch, or towards the centre of the patch, may break or pull through the device. 0 OrthAdapt d (0.5) RC Allograft d (2.5) SportMesh d (0.8) Allopatch HD d (2.0) GraftJacket MaxForce d (1.4) GraftJacket Extreme d (2.0) Leeds-Kuff Patch c (1.25) NOTE: Graft thickness in mm is given in brackets

Surgical Technique Acromion Infraspinatus Supraspinatus Rotator cuff tear Subscapularis 1 Long head of biceps FUNCTIONAL ANATOMY/PATHOPHYSIOLOGY The function of the rotator cuff is to centralize the

6 Surgical Technique Acromion Infraspinatus Supraspinatus Rotator cuff tear Subscapularis 1 Long head of biceps FUNCTIONAL ANATOMY/PATHOPHYSIOLOGY The function of the rotator cuff is to centralize the humeral head into the glenoid and to assist in motion of the glenohumeral joint. Rotator cuff tears usually start in the supraspinatus and extend posteriorly. The aetiology seems largely to be related to age. The majority of tears start on the articular side and become full thickness. Small and moderate sized tears, less than 3 cm in diameter, can be effectively repaired using arthroscopic, mini-open or open techniques. Large tears, 3-5 cm maximum diameter, and massive tears, greater than 5 cm in diameter, are not always repairable. An incomplete repair is at increased risk of re-tearing. Poor quality of tendon in an older patient with muscle atrophy is also at risk of re-tearing following conventional repair. CLINICAL PRESENTATION Symptoms of rotator cuff tears include significant night pain with an inability to lie on the affected side, loss of overhead activity, weakness, and difficulty dressing and undressing. Large and massive tears tend to present with weakness in external rotation, hitching of the shoulder in abduction, and in extreme cases, a flail shoulder. POSITIONING The procedure is performed with the patient in the beach chair position. A hydraulic shoulder positioner (e.g. Spider Limb Positioner, Smith & Nephew) is useful in applying traction and to vary the position of the arm to gain access to the rotator cuff. A protective covering such as an Ioban is applied. Preoperative antibiotics should be given. RECOMMENDED OPEN APPROACH The shoulder is arthroscopically evaluated through standard portals. If the tear appears small and the quality of the cuff is good, it should be repaired using appropriate sutures and anchors. Otherwise an incision is made and the cuff is repaired using appropriate sutures and anchors, and is reinforced with the Leeds-Kuff Patch. The Leeds-Kuff Patch is used in a mini-open approach to cover the gap which remains when a tear cannot be completely repaired using normal methods. An open approach is used when the tear is extensive and requires aggressive mobilization. A lateral deltoid splitting approach is recommended to achieve maximum access to a posteriorly subluxed infraspinatus. The anterior-lateral deltoid is dissected subperiosteally from the acromion. The deltoid is carefully incised in the line of its fibres. The lower limit of this dissection is the axillary nerve. The majority of cases will not require dissection to this level, which is a minimum of 5 cm from the lateral edge of the acromion. A stay suture can be applied across the deltoid to prevent any further splitting. A self retaining retractor is applied gently.

Apex suture 2 3 4 The subacromial bursa may need to be excised to improve vision of the rotator cuff. If there is limited joint space a subacromial decompression may be performed.

7 Apex suture The subacromial bursa may need to be excised to improve vision of the rotator cuff. If there is limited joint space a subacromial decompression may be performed. Care should be taken to avoid damaging the suprascapular nerve. The shoulder is distracted and rotated to access the anterior and posterior aspects of the cuff repair. Stay sutures are placed in the cuff. Where space permits access of the integral curved J-shaped needle, #2 Ethibond or preferably a #2 high strength suture is used. With limited access a smaller #1 suture and needle are used. The stay sutures are used to pull the rotator cuff towards the tuberosities. The needles are left attached, as the sutures can be used to attach the rotator cuff to the patch. The defect in the rotator cuff is repaired as far as possible, tying the stay sutures for a side to side repair where achievable. The tension should be moderate at most. Once partial closure is achieved, or even full closure where the quality of the tendon is poor, then the patch can be applied over the tendon. Take care to select the most suitable size of Leeds-Kuff Patch for the repair based on patient anatomy, size of tear, or extent of poor quality tissue. NOTE: The Leeds-Kuff Patches must not be cut to size. The edges of the patch are sewn over the superior edges of the rotator cuff tendon so that it sits flush with the tendon. The Leeds-Kuff Patch is first fixed at the apex with a vertical stitch. A #2 high strength suture is preferably used. NOTE: When handling the Leeds-Kuff Patch (and appropriate sutures used to repair the tear and attach the Leeds-Kuff Patch to soft tissue and bone), care should be taken to avoid damage from handling. Avoid excessive crushing or crimping damage due to the application of surgical instruments such as forceps or needle holders.

8 Two additional medial sutures One or more sutures are placed down each side of the patch Dotted lines show the outline of the repaired cuff Two stitches are placed anterior to and posterior to the apex suture. Stitches are then placed on the anterior and posterior edges of the patch. If the size of tear is large or the quality of the tendon is weak, more than one stitch on each side may be required to distribute the load. The stay sutures placed in Step 2 may be used to provide supplementary attachment to ensure apposition of the patch to the underlying cuff. Appropriate tension is applied to avoid over- or undertensioning. Under-tensioning may allow billowing of the patch and over-tensioning may cause premature failure of the repair. The repair is pulled laterally over the tuberosities. The patch and tendon are then anchored to the tuberosity. Depending on the size of the patch it is recommended to place up to three per-osseous sutures in the tuberosity. It is recommended to use #5 Ethibond with an integral needle of appropriate size to withstand insertion through the bone. Each suture is placed with a simple stitch through the patch, next to the inner border of the perimeter reinforcement, and through the tendon. NOTE: Take care to leave an adequate bone thickness between adjacent per-osseous sutures, and between the embedded suture and bone surface, to provide sufficient bony bridge to resist expected forces that will be exerted on the bone by the reconstruction. Take into account the quality of the bone. Alternatively, suture anchors using one of the high strength suture materials can be used in place of the perosseous sutures. Appropriate tension is applied to ensure the length of the reconstruction is physiological. Over- or under-tensioning is avoided to ensure adequate joint function is achieved and premature failure of the repair is avoided. Supplementary sutures used to ensure apposition of the patch to the underlying cuff may be placed within the centre of the patch. The previously placed stay sutures can be used to provide such a function. WOUND CLOSURE The deltoid is carefully repaired proximally using #1 Ethibond sutures with a mattress stitch. The edges of the incision in the deltoid are repaired. A #2-0 Vicryl suture with a stitch for fat can be used if applicable and a subcuticular suture to skin.

1 2 3 RECOMMENDED ARTHROSCOPIC TECHNIQUE With the patient in the beach chair or lateral decubitus position apply gentle traction to distract the subacromial space to facilitate viewing.

Enter the subacromial space and under direct vision use a needle to identify the lateral port to allow optimal direct vision of the cuff tear.

9 1 2 3 RECOMMENDED ARTHROSCOPIC TECHNIQUE With the patient in the beach chair or lateral decubitus position apply gentle traction to distract the subacromial space to facilitate viewing. NOTE: A minimum 8 mm cannula should be used. Make a standard posterior viewing port referencing from the postero-lateral corner of the acromion. Enter the subacromial space and under direct vision use a needle to identify the lateral port to allow optimal direct vision of the cuff tear. Repair the defect in the rotator cuff as far as possible with moderate tension at most. Leave sutures from the suture anchors used in the repair for later fixation of the anterior and posterior edges of the patch. For the small patch use these for medial corner fixation. Select the most suitable size of Leeds-Kuff Patch for the repair based on patient anatomy, size of tear or extent of poor quality tissue. For arthroscopic insertion and fixation the patch is positioned with the apex oriented laterally. Use the Neoligaments Leeds-Punch (supplied separately) to pierce holes in the patch in the preferred locations for sutures. Ensure load bearing sutures are placed through the patch, inside and adjacent to the reinforced perimeter. Generally the small patch will only need openings at the medial corners and the lateral apex. Prior to insertion of the patch place two #2 high strength polyester sutures through the rotator cuff such that once tied to the patch one will form the antero-medial and one the postero-medial corner suture fixation. Retrieve one limb of each of the passed sutures through the lateral cannula and tie to the respective anterior or posterior corner of the medial border of the patch taking care not to twist the sutures. The free limbs of the passed sutures are taken out through accessory antero-medial and postero-medial ports respectively. Fold or pleat the patch along its length and alternately tension the free ends of the sutures to pull the patch into the subacromial space via the lateral cannula.

The patient should be warned not to exceed the prescribed activity levels or to overload the repair before complete healing has occurred. The shoulder is held in an immobilizer for 3 weeks.

10 POSTOPERATIVE MANAGEMENT The rehabilitation programme described below should be supervised by a specialist physiotherapist. All mobilization and exercises should be performed within the pain free range of movement. As in any implant surgery, satisfactory wound healing is of paramount importance. The patient should be warned not to exceed the prescribed activity levels or to overload the repair before complete healing has occurred. The shoulder is held in an immobilizer for 3 weeks. During this time, only passive movements are permitted. These may include pendular exercises and passive movements to shoulder height in forward flexion and abduction. Passive assisted motion can commence following this, progressing to gentle strengthening work at 6 weeks postoperatively. 4 4 These patients often have significant muscle atrophy preoperatively, and a prolonged period of recovery of power and range of motion is to be anticipated. Manipulate the patch into the required position and tie the free ends of the sutures (the post suture) to the corresponding suture previously tied to the corners of the patch. Avoid over- or under-tensioning. WOUND CLOSURE Close the lateral port with an appropriate interrupted skin suture. Place a suture anchor laterally. Pass sutures from it through the lateral edge of the patch and tension. Apply appropriate tension to ensure the length of the reconstruction is physiological. Avoid over-or undertensioning to ensure adequate joint function is achieved and premature failure of the repair does not occur. For medium and large patches use the sutures from the previously placed suture anchors to secure the anterior and posterior edges of the patch to the underlying cuff. Alternatively, separate stay sutures may be used. If the size of tear is large or the quality of the soft tissue is weak, more than one stitch on each side may be required to distribute the load. Add an additional medial suture if required.

Ordering Information Leeds-Kuff Patch (supplied sterile) 102-1071 Leeds-Kuff Patch, 20 mm x 20 mm 102-1072 Leeds-Kuff Patch, 30 mm x 30 mm 102-1073 Leeds-Kuff Patch, 35 mm

for Use leaflet packaged with the Leeds-Kuff Patch and Leeds-Punch for essential information including Use, Sterility, Indications, Contraindications, Warnings and

11 Ordering Information Leeds-Kuff Patch (supplied sterile) Leeds-Kuff Patch, 20 mm x 20 mm Leeds-Kuff Patch, 30 mm x 30 mm Leeds-Kuff Patch, 35 mm x 40 mm Instrument (required for arthroscopic technique - supplied separately): Leeds-Punch (supplied sterile) Please refer to the Instructions for Use leaflet packaged with the Leeds-Kuff Patch and Leeds-Punch for essential information including Use, Sterility, Indications, Contraindications, Warnings and Precautions, Potential Adverse Effects and Storage. Additional copies may be obtained from the Neoligaments Sales Department, or downloaded from

12 Developed and manufactured by Neoligaments A division of Xiros Springfield House Whitehouse Lane Leeds LS19 7UE Tel. +44 (0) Fax. +44 (0) enquiries@neoligaments.com Xiros Limited, registered in England No All rights reserved. Neoligaments Worldwide patents and patents pending. Neoligaments, Leeds-Kuff Patch and Xiros are trademarks of Xiros. FiberWire is a registered trademark of Arthrex, Inc. Ethibond and Vicryl are registered trademarks of Ethicon LAB

Leeds-Kuff Patch TM. For Rotator Cuff Reinforcement. Surgical Technique Manual

Leeds-Kuff Patch TM. For Rotator Cuff Reinforcement. Surgical Technique Manual Leeds-Kuff Patch TM For Rotator Cuff Reinforcement Surgical Technique Manual 0086 Introduction Leeds-Kuff Patch TM This technique utilizes a non-absorbable polyester patch which is sutured over the torn