TORNIER AEQUALIS ADJUSTABLE REVERSEDexternal border of the coraco-brachialis, and the axillary nerve...

TORNIER

AEQUALIS ADJUSTABLE REVERSEDShoulder System

SURGIC AL TECHNIQUE

Table of Contents:

3

Indications/Contraindications .......................................................................................................................................................................5

Pre-Operative Planning ....................................................................................................................................................................................6

Delto-Pectoral Humeral Exposure ................................................................................................................................................................7

Supero-Lateral Humeral Exposure ................................................................................................................................................................8

Humeral Head Preparation and Resection ............................................................................................................................................8-9

Metaphyseal Reaming ................................................................................................................................................................................... 10

Sizing and Positioning the Distal Trial ..................................................................................................................................................... 11

Assembly and Insertion of the Final Humeral Implant ................................................................................................................12-14

Selection of the Humeral Insert .................................................................................................................................................................. 15

Reduction, Trial and Closure ........................................................................................................................................................................ 16

Instrumentation .........................................................................................................................................................................................17-23

4

Surgical Technique

Distal stems are available with proximal PTC coating in 9, 11, 13, 15 and 17 mm diameters designed to provide .5 mm of proximal press-fit.

Spacers are available in 15, 20, 25, 50 and 100 mm lengths. This maximizes intra-operative flexibility and acilitates height adjustments.

The design between the distal stem and spacer provides rotational stability as well as version adjustments following stem placement.

5

Intended Use

The AEQUALIS™ ADJUSTABLE REVERSED Shoulder System is indicated for patients with a functional deltoid muscle and a massive and non-repairable rotator cuff tear as a replacement of Shoulder joints disabled by:

• Rheumatoid arthritis with pain.

• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis).

• Correction of functional deformity.

• Fractures of the humeral head.

• Traumatic arthritis.

• Revision of the devices if sufficient bone stock remains.

Known Contraindications to Date:

Common Contraindications for the AEQUALIS ADJUSTABLE REVERSED Shoulder:

• Poor quality and insufficient quantity of glenoid bone stock.

• Pre or per-operative glenoid fracture.

• Acromion fracture.

• Non-functional deltoid or external rotator muscles.

• Systemic infection, fever and/or local inflammation.

• Rapid joint destruction or bone resorption apparent on roentgenograms.

• Elevation of sedimentation rate unexplained by other disease, elevation of WBC count, or marked shift in WBC differential count.

• Distant foci of infection from genitourinary, pulmonary, skin and other sites, dental focus infection which may cause hematogenous spread to the implant site. The foci of infection should be treated prior to, during and after implantation.

• Use of this implant is contraindicated in the presence of significant injury to the upper brachial plexus.

• Paralysis of the axillary nerve.

• Neuromuscular disease (e.g. joint neuropathy).

• Known allergy to one of the materials.

• Patient pregnancy.

• Insufficient metaphyseal bone stock making the stable securing of humeral components impossible.

Note: All components are single use. The humeral stem*:

• The titanium plasma spray coated stems are for cemented or cementless use.

• The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

*Remark: these fixations notes are for titanium plasma spray coated stems listed in this surgical technique.

6

Preoperative Planning

• Pre-operative planning is performed utilizing x-ray templates on the frontal and sagittal views.

• Appropriate implant size and positioning is determined.

• The use of CT scan or MRI is recommended to better determine the orientation of the glenoid, the quality of the glenoid bone stock and to confirm the integrity of the rotator cuff.

• Scans are also used to determine the length of the humeral stem.

Patient Positioning

Position the patient in beach chair position with the operative arm draped free. For optimal access the patient should be in a position near the edge of the operating table, so the shoulder can be fully extended. A bump can also be placed under the operative shoulder to help in stabilizing the scapula.

7

Humeral Exposure

Delto-Pectoral Approach

An incision is made from the tip of the coracoid along the delto-pectoral groove, (slightly lateral to the axillary fold) the pectoralis major is identified at this point. The deltoid and cephalic veins are retracted laterally to open the delto-pectoral groove and the coracoid process is identified. A Hohmann retractor is positioned behind the coracoid, care should be taken to preserve the origin and insertion of the deltoid. Next, the clavipectoral fascia is incised at the external border of the coraco-brachialis, and the axillary nerve is identified before opening the subscapularis. With the arm externally rotated, a conservative anterior and inferior capsule release from the humerus to the glenoid may be performed. When adequate releases are made, the humeral head is dislocated into the deltopectoral interval by abduction and progressive external rotation and extension.

Note: In cases of severely restricted external rotation (0° or less), it is recommended to further release the upper pectoralis insertion.

8

Humeral Exposure

Superior-Lateral Approach

The incision is made from the acromioclavicular joint along the anterior border of the acromion and downward approximately 4 cm. The deltoid is split in line with its fibers (Extra care should be taken to avoid any damage to the axillary nerve, which is located approximately 4 cm distal to the acromion). The anterior part of the deltoid and the coracoacromial ligament are then carefully detached from their acromial insertion up to the acromioclavicular joint. The humeral head will become visible at the anterior border of the acromion. Next, the subscapularis bursa is released and the humeral head is dislocated by placing the arm in flexion and external rotation. To optimize the exposure, the anterior border and the remaining superior cuff can be resected. In some cases, the remaining subscapularis tendon may be resected.

Preparation of the Humerus

If desired, prior to resecting the humeral head, the BIO-RSA™ technique can be utilized to graft bone from the humerus to be used on the backside of the baseplate.

Identification of the Humeral Entry Point

The humeral entry point is located at the diaphyseal axis at the highest point of the humeral head. This is determined after examination of the sagittal and anterior-posterior x-rays. The humeral head is generally deformed and anatomic reference points may be missing or distorted. The entry point is marked with a starter awl (Figure 1) and if necessary, the entry point can also be enlarged with an osteotome before inserting the starter awl down the diaphyseal axis.

Figure 1

9

Humeral Head Resection

Two cutting guides are available:

• One for the Delto-Pectoral approach (Figure 2)

• One for the Superior-Lateral approach. - Upon request only (Figure 3)

The shaft of the monobloc cutting guide is inserted into the medullary canal at the previously determined entry point. The shaft is then driven down until the ring contacts the humeral head.

To define the prosthetic retroversion, a retroversion rod is positioned into one of the holes along the axis which allows for retroversion between 0° and 20° (R for right arm and L for left arm). (Figure 4)

Once the retroversion has been determined, the head is then resected with an oscillating saw, below the ring of the cutting guide. (Figure 5)

The cutting guide is then removed and the cut is completed. (Figure 6-7)

Figure 7

Figure 5

Figure 3

Figure 6

Figure 4

Figure 2

Note: The cutting guide is turned until the retroversion rod is aligned with the patient’s forearm.

10

Metaphyseal Reaming

This system uses one metaphyseal size to accommodate both a 36 mm and 42 mm glenoid sphere. The metaphysis is then paired with the appropriate diameter stem: Ø9 mm, 11 mm, 13 mm, 15 mm or 17 mm.

The desired metaphyseal reamer is assembled to the pilot tip and connected to the metaphyseal reamer shaft. (Figure 8) The pilot tip is positioned in the center of the humeral cut and the metaphyseal region is reamed. (Figure 9)

Reaming is complete when the depth of the reamer head is at the level of the cut surface. (Figure 10)

Figure 9

Figure 8

Note: It is recommended to prepare the metaphysis at a size Ø36 mm to avoid risk of perioperative fracture.

Note: A special angulated reamer for superolateral approach is available on upon request only.

Figure 10

11

Sizing and Positioning the Distal Trial

Assemble the distal trial stem to the distal trial stem inserter. (Figure 11)

Once the distal trial is assembled to the distal inserter treat distal trial sizes like sounders and progressively increase until you find a distal trial with a snug fit where there is not rotation of the joint. Once this trial is found you can progress to positioning the distal trial.

Insert the distal trial into the diaphysis. (Figure 12a) Note that the sole purpose of this trial step is to test the press-fit. The surgeon may decide to increase the size of the definitive implant as necessary depending upon the fit of the distal stem trial. In the same manner, this step can help the surgeon assess the stem size required for cemented application. Remove both the distal trial and distal trial inserter, making sure to measure the height using the markings on the distal trial inserter (A zero denotes that no spacer will be required). (Figure 12b) Use of the slap hammer is encouraged to remove the distal trial and trial inserter. (Figure 12c)

Before After

Figure 11

Figure 12a

Figure 12b

Figure 12c

10

0

12

Assembly and Insertion of the Final Humeral Implant

Select the final distal humeral stem and matching metaphyseal component based on the trialing step. (Figure 13)

If the use of a distal spacer was determined during the distal trialing stage, assemble the spacer to the distal stem and matching metaphyseal component then insert the locking screw. (Figure 14)

The length of the locking screw used is determined by the sum of spacers selected. (e.g. if using a 15 mm spacer, then a 15 mm locking screw is selected. If no spacer is required, then a “0” locking screw is selected.)

Tighten the locking screw with the locking screw screwdriver to ensure a secure fit. (Figure 15)

Figure 14

Figure 15

Figure 13

Figure 17

Figure 16

13

Assemble the securitization system onto the securitization system inserter. (Figure 16)

Insert the entire securitization system over the locking screw to prevent the locking screw from backing out. (Figure 17) Remove the securitization system inserter by turning counter clockwise while leaving the securitization system firmly in place.

14

Insert the 2.0 mm locking screw into the securitization system with the 2.0 mm hex driver. (Figure 18) Turn clockwise until tight. (Figure 19) Insert the definitive implant into the humerus and impact to the desired depth. For cemented use, insert a cement restrictor and insert cement prior to placing the implant.

2.0 mm Securitization Screw

Figure 19

Figure 18

15

Selection of the Humeral Insert

The chosen trial insert of with desired thickness is inserted into the definitive implant metaphysis for trial reduction. (Figure 20) The humeral trial component is then reduced into the joint to check deltoid tension, stability and range of motion.

The selected polyethylene insert is then positioned by aligning the orientation notch on the insert with the metaphyseal tab. Final fixation is achieved by impacting the insert into the cup (Figure 21) according to the Rev II Surgical Technique addendum (CAW-6087).

Figure 21

Figure 20

Note: Version can be adjusted by loosening/removing the securitization system and turning the metaphysis. Each notch equals 10°. Additionally, spacers (15, 20, 25, 50 and 100 mm) can be added if height needs to be adjusted.

16

Glenoid Preparation

For glenoid preparation, AEQUALIS™ REVERSED II Instrumentation and Technique is utilized. Please refer to AEQUALIS REVERSED II Technique (CAW-2145) and REV II technique addendum (CAW-6087).

The instrumentation allows either a standard glenoid preparation or a cannulated preparation referencing a guide pin positioned at a chosen orientation.

Reduction, Trial And Closure

Reduction

The prosthesis is then reduced using the reducer (Figure 22) and stability is checked. (Figure 23)

Peri-Operative Function

Pull the arm away from the body after reduction to ensure the appropriate soft tissue balance. A complete separation indicates inadequate tensioning of the deltoid. Next, abduction of the arm is performed to check there is no impingement and that anterior elevation and abduction have been restored. After abduction, externally rotate the arm with the elbow at the side to check for mobility and subluxation. Then internally rotate the arm with the elbow at the side making sure the forearm is parallel to the thorax. Finally, adduct the arm to check that there is no impingement between the pillar of the scapula and the humeral implant. The goal is that after the arm is reduced, the conjoined tendon should show sufficient muscular tension (similar to the deltoid).

Closure

In the superior-lateral approach, the deltoid is reattached to the acromion with trans-osseous suture. In the delto-pectoral approach, a full or partial re-insertion of the subscapularis is performed, if possible.

Figure 22

Figure 23

17

Necessary Instrumentation:

AEQUALIS™ ADJUSTABLE REVERSED Instruments

AEQUALIS REVERSED II Instruments

Instrumentation

1 2

3

4

5

6

7

8

9

10

11

12

17

13 14 15

16

18

19

20

27

2326

28

29

30

31

32

33

34

2225

2124

AEQUALIS™ REVERSED II Humeral Instruments YKAD82 36 mm Instrumentation

# Reference Description Quantity

1 MWB210 Ø36 mm metaphyseal spherical reamer 1

2 MWB213 Ø36 mm metaphyseal reamer pilot 1

3 MWB495 Ø36 mm metaphyseal reamer 1

4 MWB175 Ø36 mm metaphyseal trial 1

5 MWB190 Ø36 mm trial spacer +9 mm 1

6 MWB180 Ø36 mm trial insert / lateralized + 6 mm 1



9 MWB970 Ø36 mm trial insert / lateralized + 6 mm / offset 2 mm 1



12 MWB192 Ø36 mm humeral cut protector 1

13 MWB088 36/42 trial combination insert for Ø36 mm metaphysis/lateralised + 6 mm 1



Note: Items highlighted in dark gray are utilized from the AEQUALIS REVERSED II Instrumentation in conjunction with the AEQUALIS ADJUSTABLE REVERSED Instrumentation.

18

AEQUALIS™ REVERSED II Humeral Instruments YKAD82 42 mm Instrumentation


16 MWB211 Ø42 mm metaphyseal spherical reamer 1

17 MWB214 Ø42 mm metaphyseal reamer pilot 1

18 MWB496 Ø42 mm metaphyseal reamer 1

19 MWB176 Ø42 mm metaphyseal trial 1

20 MWB191 Ø42 mm trial spacer +9 mm 1







27 MWB193 Ø42 mm humeral cut protector 1

AEQUALIS™ REVERSED II Humeral Instruments YKAD82 Common Instrumentation


28 MWB497 Metaphyseal reamer handle 1

29 MWB140 Ø6.5 mm Humeral trial stem L 100 mm 1

30 MWB150 Ø9 mm Humeral trial stem L 100 mm 1



33 MWD098 Hemi-prosthesis adapter: trial head 50x19 1

34 MWD099 Hemi-prosthesis adapter: trial head 52x23 1

19

1

2

5

6

3

4

AEQUALIS™ REVERSED II Humeral Instruments YKAD83Lower Tray


1 MWB215 Cutting Guide for Deltopectoral Approach 1

2 MWD040 Metaphyseal Motorized Reamer Handle 1

3 MWB197 Humeral Impactor (including fixation screw MWB201) 1

4 MWD044 Humeral Impactor/Extractor Handle 1

Option for Superlateral Approach5 MWD041 Angled Metaphyseal Motorized Reamer Handle* 1

6 MWD029 Cutting Guide for Superolateral Approach* 1

*Upon Request Only

20

AEQUALIS™ REVERSED II Humeral Instruments YKAD831Upper Tray


1 MWB106 Ø6.5 mm Cylindrical Rasp 1

2 MWB113 Ø9 mm Diaphysis Reamer 1



5 MBO101 Cement Restrictor Inserter 1

6 MWB498 Humeral Extractor 1

7 MWD553 Ø14 mm Wrench 1

8 MWD421 Impaction Handle 1

9 MWD423 Insert Impactor Tip 1

10 MWD424 Hemiprosthesis Adapter Impactor Tip 1

11 MWD425 Anatomic Head Impactor 1

1

2

5

7

6

11

8

10

9

3

4

21

AEQUALIS™ REVERSED II Instruments YKAD97Lower Tray


1 MWA681 Kolbel Retractor - Wide 1

2 MWD046 Kolbel Retractor - Narrow 1

3 MWD001 Favard Retractor 1

4 MWB241 Forked Retractor 1

5 MWD551 8 mm Open-Ended Wrench 1

6 MWD552 12 mm Open-Ended Wrench 1

7 MWB216 Glenoid Sphere Extractor(s) - Ø36 mm 1

7” MWB218 Glenoid Sphere Extractor(s) - Ø42 mm 1

8 MWD148 Screw for Glenoid Sphere Extractor 1

9 MWA118 Glenoid Baseplate Extractor 1

10 MGB390 Screw Caddy 1

11 MDE072 Glenoid Baseplate Extractor Adaptor 1

12 MWB346 3.5 mm Hexagonal Screwdriver Handle 1

12

5

7

6

11

128

10

9

3

4

22

AEQUALIS™ ADJUSTABLE REVERSED Instruments - REVSN REVLower Tray

# Reference Description

A 9763601 Distal Stem Trial – Ø9 mm x 90 mm

B 9763602 Distal Stem Trial – Ø11 mm x 90 mm

C 9763603 Distal Stem Trial – Ø13 mm x 90 mm

D 9763604 Distal Stem Trial – Ø15 mm x 90 mm

E 9763605 Distal Stem Trial – Ø17 mm x 90 mm

F 9763611 Distal Stem Trial Inserter

G 9763612 Assembly Screw Screwdriver

H 9763613 Securitization Bracket Inserter

I MWA124 2.5 mm Hex Securitization Screw Screwdriver

J 9763615 Impaction Head

K 9763616 Impaction Hammer

L 9763617 Metaphysyeal Extractor

M

MWD060 AEQUALIS™ REVERSED Fracture Trial Insert Lateralized Standard

Ø36 mm x 6 mm


Ø36 mm x 9 mm


Ø36 mm x 12 mm

H


Ø42 mm x 6 mm


Ø42 mm x 9 mm


Ø42 mm x 12 mm

23

Components

Distal Humeral Stems

Diameter Length 90 mm

Ø9 mm 6130990PØ11 mm 6131190PØ13 mm 6131390PØ15 mm 6131590PØ17 mm 6131790P

Securitization SystemCatalog #

6404300

Assembly Screws

Size Catalog #

0 (No Spacer) 640100015 mm 640101520 mm 640102025 mm 640102530 mm 640103035 mm 640103540 mm 640104045 mm 640104550 mm 640105055 mm 640105560 mm 640106065 mm 640106570 mm 640107075 mm 640107580 mm 640108085 mm 640108590 mm 640109095 mm 6401095

100 mm 6401100115 mm 6401115*130 mm 6401130*145 mm 6401145*165 mm 6401165*

Lateralized Humeral Inserts

Size Thickness Catalog #

36 mm + 6 mm DWD86036 mm + 9 mm DWD86136 mm + 12 mm DWD862

42 mm + 6 mm DWD866 or DWD966



Metaphysis

Size Catalog #

Ø9 mm 6603609Ø11 mm 6603611Ø13 mm 6603613Ø15 mm 6603615Ø17 mm 6603617

Spacers

Size Ø9 mm Ø11 mm Ø13 mm Ø15 mm Ø17 mm

15 mm 6500915 6501115 6501315 6501515 650171520 mm 6500920 6501120 6501320 6501520 650172025 mm 6500925 6501125 6501325 6501525 650172550 mm 6500950 6501150 6501350 6501550 6501750

100 mm 6500900 6501100 6501300 6501500 6501700

* Special Order

Proper surgical procedures and techniques are the responsibility of the medical professional. This material is furnished for information purposes only. Each surgeon must evaluate the appropriateness of the material based on his or her personal medical training and experience. Prior to use of any Tornier implant system, the surgeon should refer to the product package insert for complete warnings, precautions, indications, contraindications and adverse effects. Package inserts are also available by contacting Wright. Contact information can be found in this document and the package insert.

™ and ® denote Trademarks and Registered Trademarks of Wright Medical Group N.V., or its affiliates.©2016 Wright Medical Group N.V. or its affiliates. All Rights Reserved.

CAW-5072 REV D ECN 160631 16-May-2016

10801 Nesbitt Avenue SouthBloomington, MN 55437888 867 6437952 426 7600www.tornier.com

1023 Cherry RoadMemphis, TN 38117800 238 7117901 867 9971www.wright.com

TORNIER AEQUALIS ADJUSTABLE REVERSEDexternal border of the coraco-brachialis, and the axillary nerve...

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