GLOBAL CAP GLOBAL CAP CTAsynthes.vo.llnwd.net/o16/LLNWMB8/US Mobile/Synthes North...6 DePuy Synthes Joint Reconstruction GLOBAL® CAP® GLOBAL® CAP® CTA Surgical Technique The sizing

SURGICAL TECHNIQUE

GLOBAL® CAP®

GLOBAL® CAP® CTA™

Resurfacing Shoulder Systems

Surgical Technique GLOBAL® CAP® GLOBAL® CAP® CTA™ DePuy Synthes Joint Reconstruction 3

INTRODUCTION

The GLOBAL® CAP® Resurfacing Humeral Head Implant is well suited for osteoarthritic or rheumatoid arthritic patients in need of a bone-preserving implant.

The GLOBAL CAP Shoulder System design draws upon advanced research and philosophies of the GLOBAL® Anatomic Shoulder Solutions System. Design philosophies were derived from detailed investigations of the structure and mechanics of normal and prosthetic glenohumeral joints, conducted at the University of Texas at San Antonio, University of Washington, The Cleveland Clinic Foundation, University of Pennsylvania and DePuy Synthes Joint Reconstruction*, Warsaw, Indiana.

The GLOBAL® CAP® CTA™ Resurfacing Humeral Head is well suited for patients with substantial irreparable cuff tear in need of a bone-preserving implant.

The extended superior lateral head is designed to stabilize the joint and produce a low coefficient of friction at the interface with the acromion, potentially reducing pain and increasing the range of motion in abduction and external rotation.

DESIGN RATIONALE

SURGICAL TECHNIQUE

GLOBAL CAP SYSTEM

TABLE OF CONTENTS

GLOBAL CAP Shoulder System 6

GLOBAL CAP CTA Shoulder System 7

Advanced Bone Preservation 8

Advanced Design Features 9

Ease Of Use 10

Features and Benefits

GLOBAL® CAP+ Instrumentation 12

Key Surgical Steps 14

Pre-Operative Templating 16

Anesthesia and Patient Positioning 18

Exposure 19

Subscapularis Sparing Exposure Technique GLOBAL CAP CTA Shoulder System 20

Head Sizing 22

Identifying the Center of the Humeral Head 23

3-in-1 Humeral Head Shaping 25

Humeral Implant Trialing 26

Central Stem Preparation 27

GLOBAL CAP Soft Tissue Balancing 28

GLOBAL CAP Final Implantation 29

4 DePuy Synthes Joint Reconstruction GLOBAL® CAP® GLOBAL® CAP® CTA™ Surgical Technique


GLOBAL CAP CTA SYSTEM

ADVANCED SOLUTIONS

KEY INFORMATION

GLOBAL CAP CTA Superior Lateral Humeral Resection 30

GLOBAL CAP CTA Implant Trialing 32

GLOBAL CAP CTA Soft Tissue Balancing 33

GLOBAL CAP CTA Final Implantation 34

Closure and Aftercare 35

Extraction of the Implant 36

GLOBAL® ENABLE® Instrumentation 37

GLOBAL® Anchor Peg Glenoid 38

GLOBAL® APG+ Instrumentation 39

PREMIERON® X-Linked Polyethylene 40

GLOBAL® ADVANTAGE® Shoulder Arthroplasty System 41

GLOBAL® AP ® Shoulder Arthroplasty System 42

Ordering Information 43


The sizing of the GLOBAL CAP Implant is based upon the observed variability in humeral head size in normal shoulders.1 Normal shoulders exhibit a range of humeral head diameters and humeral head heights. The variable sizing options of the GLOBAL CAP System permit anatomic reconstruction of the humeral head.

Simple and Efficient Instrumentation

· 3-in-1 reamers accurately reshape humeral head wear typically seen in arthritic patients with flattened humeral heads.

· Cannulated instrumentation (head sizers, reamers, trials and stem punch) allows the surgeon to move from one step to the next.

· Centering technique allows the surgeon to position the implant accurately.

Stability and Fixation

· Apical flat on undersurface of implant allows for better fit and intimate contact.

· Secure implant design with cruciate stem.

· Undersurface of the head and the proximal portion of the central stem are surface-treated with DUOFIX®

Hydroxyapatite Coating on POROCOAT® Porous Coating.

Indicated for Osteoarthritis and Rheumatoid Arthritis


In addition to all of the features and design benefits offered in GLOBAL CAP Shoulder, GLOBAL CAP CTA Shoulder System also offers:

Increased Area of Superolateral Articulation

· Based on the GLOBAL ADVANTAGE and GLOBAL AP CTA System humeral head, the GLOBAL CAP CTA Implant has an increased area of superolateral articulation for less pain and joint stability.

Restored Stability and ROM

· GLOBAL CAP CTA Implant geometry compensates for superior humeral head migration to help restore joint stability and range of motion.

· Undersurface of the head and proximal portion of the central stem are surface-treated with DUOFIX Hydroxyapatite Coating on POROCOAT Porous Coating.

Indicated for Cuff Tear Arthropathy


Apical Flat

The GLOBAL CAP and GLOBAL CAP CTA Implant undersurface is designed with a flattened section that is positioned at the apex of the humeral head. This design more closely matches the humeral head wear typically seen in arthritic patients with flattened humeral heads and may minimize the amount of bone removed during humeral reaming. Designs featuring a spherical undersurface may require either humeral reaming beyond the anatomic neck of the humerus or leaving a portion of the implant unsupported.

ADVANCED BONE PRESERVATION

3-in-1 Humeral Head Shapers

The GLOBAL CAP+ System humeral head shapers accurately reshape the humeral head and prepare a flattened section at the apex of the humerus. Additionally, the 3-in-1 humeral head shapers prepare the humerus for the cruciate stem streamlining the surgical procedure.

CTA Resection Guide

The GLOBAL CAP CTA Shoulder instrument set features a humeral resection guide that creates a continuous surface to support GLOBAL CAP CTA Shoulder superior lateral flange. Combined with a precison marked resection blade, the GLOBAL CAP CTA Shoulder superior resection guide is engineered to preserve bone.


Anatomic Sizing

Variable sizing options allow the proper restoration of patient anatomy.

ADVANCED DESIGN FEATURES

40 x 15 44 x 15

48 x 18 52 x 18 56 x 18

40 x 18 44 x 18

48 x 21 52 x 21 56 x 21

Coating

The undersurface of the resurfacing implant and the proximal portion of the central stem are coated with DUOFIX Hydroxyapatite Coating on POROCOAT Porous Coating.

CTA Humeral Head

With an increased area of superior lateral articulation for less pain and optimized joint stability, the GLOBAL CAP CTA Implant geometry compensates for superior humeral head migration to help restore joint stability and range of motion. The extended head design provides a smooth surface across a greater area of articulation, which preserves acromial bone and may reduce pain.

Additionally, the GLOBAL CAP+ Instrument System offers guidance on performing a subscapularis sparing GLOBAL CAP CTA Shoulder System surgical technique. By taking advantage of the failed supraspinatus to perform the resurfacing procedure, the subscapularis can be protected, potentially leading to faster recovery times for patients, when compared with a procedure performed utilizing a traditional deltopectoral approach.


EASE OF USE

Versatility

Versatility in an instrument set allows a surgeon to tailor their approach to the needs of the patient, as well as their own individual preferences. The GLOBAL CAP+ Instrument Set allows the surgeon to select and implant either the GLOBAL CAP or GLOBAL CAP CTA Humeral Resurfacing Implants.

GLOBAL CAP+ Instruments are an updated version of the GLOBAL CAP and GLOBAL CAP CTA Instrument Set. The instruments were designed for ease of use and heightened efficiency in the operating room by incorporating features that enhance versatility, simplicity and precision through a streamlined approach.


Simplicity

Total shoulder arthroplasty requires many complex instruments that need to interact with one another. Making the instrument connections, additions, and modifications less laborious increases user-friendliness and improves functionality. These innovations may lessen the time lapse during and between surgical steps.

Precision

A major design feature that provides an advanced level of precision while enhancing speed and efficiency at the same time is cannulation. The GLOBAL CAP+ System delivers enhanced precision through a streamlined cannulated approach that also allows the procedure to flow quickly from step to step.


FEATURES AND BENEFITS GLOBAL CAP+ INSTRUMENTATION

3-IN-1 HUMERAL HEAD SHAPERS

Versatility

The GLOBAL CAP+ System humeral head shapers accurately reshape the humeral head and prepare a flattened section at the apex of the humerus. Additionally, the 3-in-1 humeral head shapers prepare the humerus for the cruciate stem streamlining the surgical procedure.

QUICK CONNECT DRIVER SHAFTS

Simplicity

The quick connect end enables fast and easy connections between instruments. Cannulation allows for fast insertion over guide pin.

HUMERAL HEAD TRIALS

Versatility

The humeral head trials are designed with large open windows that allow the prepared humeral surface to be checked. The trials can also be used to verify joint tensioning when reduced into the glenohumeral joint.


CANNULATED PIN

Precision

The cannulated pin heightens precision and allows the procedure to flow quickly from one step to the next.

CAP CTA CUTTING BLOCK

Precision

The superior humeral resection guide guides the reshaping of the greater tuberosity for the superior lateral flange of the GLOBAL CAP CTA Implant.

HUMERAL HEAD SIZER / DRILL GUIDE

Versatility

The humeral head sizer verifies the size of the humeral head and acts as a pin guide for the precise placement of the cannulated pin.


GLOBAL CAP SHOULDER

KEY SURGICAL STEPS

Head Sizing

Superior Lateral Humeral Resection

GLOBAL CAP CTA SHOULDER

Incision and Exposure

Central Stem Preparation


Soft Tissue Balancing Final Implantation

Soft Tissue BalancingImplant Trialing Final Implantation

3-in-1 Humeral Head ShapingIdentifying the Center of the Humeral Head

Humeral Implant Trialing


PRE-OPERATIVE TEMPLATING

TYPE IA CENTERED

STABLE

TYPE IB CENTERED

MEDIALIZED

TYPE IIA DECENTERED

LIMITED STABLE

TYPE IIB DECENTERED

UNSTABLE

• Intact Anterior Restraints • Lack of Anterior Restraints • Lack of Anterior Restraints• Intact Anterior Restraints

• Minimal Superior Migration • Superior Translation • Anterior Superior Escape• Minimal Superior Migration

• Compromised Dynamic Joint Stabilization

• Insufficient Dynamic Joint Stabilization

• Absent Dynamic Joint Stabilization

• Dynamic Joint Stabilization

• Medial Erosion of the Glenoid, Acetabularization of CA Arch, and Femoralization of Humeral Head

• Minimum Stabilization by CA Arch, Superior-medial Erosion and Extensive Acetabularization of CA Arch and Femoralization of Humeral Head

• No Stabilization by CA Arch

• Deficient Anterior Structures

• Acetabularization of CA Arch and Femoralization of Humeral Head

femoralisationFemoralization

acetabularisationAcetabularization

Seebauer Classification2 of Cuff Tear Arthropathy (CA = Coracoacromial)


Pre-operative templating of radiographs is important for predicting the humeral head size that will be needed during surgery. The head size can be further verified intraoperatively by measuring the head after osteophyte removal. Begin preparation of the humerus by approximating the template (appropriate head size) over the pre-operative radiograph (Figures 1 and 2).

GLOBAL® CAP® Shoulder GLOBAL® CAP® CTA™ Shoulder

GLOBAL® CAP® Shoulder GLOBAL® CAP® CTA™ Shoulder

Figure 1

Figure 2


Proximal humeral replacement using the GLOBAL CAP or GLOBAL CAP CTA Implant can be performed using general anesthesia, regional anesthesia (i.e. interscalene block), or a combination of general anesthesia and regional anesthesia. Place the patient in a supine position, with the hips flexed approximately 30 degrees, knees bent approximately 30 degrees and back elevated approximately 30 degrees (i.e. the beach chair position) (Figure 3).

Complete access to the top and back of the shoulder can be achieved through the use of specialized headrests or operating tables with break-away side panels (Figure 4).

ANESTHESIA AND PATIENT POSITIONING

Figure 4

Figure 3


Figure 5

Initial Incision

The initial incision line runs from the mid-clavicle, over the top of the coracoid and extends in a straight line down the anterior aspect of the arm (Figure 5).

It should follow the path of the cephalic vein along the interval between the deltoid and the pectoralis major. The length of the initial incision along this line can be varied, depending on the exposure needed to provide adequate access and visualization of the joint, and is determined by patient body habitus.

EXPOSURE

ENABLEGLENOID EXPOSURE SIMPLIFIED

Please refer to the GLOBAL ENABLE Glenoid Exposure System surgical technique (0612-44-510 Rev. 1) for detailed information regarding exposure.

Glenoid Exposure Simplified


Figure 6

Figure 7

SUBSCAPULARIS SPARING EXPOSURE TECHNIQUE GLOBAL CAP CTA SHOULDER SYSTEM

An alternative method of exposing the humeral head for shoulder resurfacing is through a subscapularis sparing technique. Specific for the GLOBAL CAP CTA Shoulder, the interval created by a previously failed supraspinatus tendon provides an opportunity to expose the humeral head without releasing the subscapularis tendon. The approach potentially limits the complications involved with subscapularis repair and healing while allowing adequate access to the glenohumeral joint. An additional benefit is that a more rapid postoperative protocol may be possible.

The biceps tendon is tenodesed to the pectoral sling if it is intact with the proximal portion being excised.

Using blunt dissection, release any adhesions between the deltoid and the humeral head. This mobilizes the humeral head during later dislocation steps (Figure 6).

Release the anterior capsule. Internally rotate the humerus and insert a darrach retractor (medium acromial 2810-03-000) or some other blunt retractor between the subscapularis and the anterior capsule through the superior rotator interval (Figure 7). The internal rotation of the arm creates a space between the tissues that allow dissection. Dissect the anterior capsule from the 12 o’clock position to the six o’clock position on the neck of the glenoid. This will allow greater excursion of the subscapularis.


SUBSCAPULARIS SPARING EXPOSURE TECHNIQUE GLOBAL CAP CTA SHOULDER SYSTEM

Dislocate the humeral head out of the capsule by internally rotating and extending the arm. This motion lessens the tension placed on the humerus by the subscapularis and allows the humeral head to be delivered through the large rotator interval (Figure 8).

If necessary, the subscapularis can be taken down in a step-wise fashion to help mobilize the arm. Release the upper portion of the subscapularis and attempt to dislocate the humeral head. If the desired humeral head mobilization is not achieved, release an additional portion of the subscapularis.

Exposure of the humeral head is complete when the surgeon is able to visualize the anatomic neck of the humerus circumferentially and the surgeon can identify the center of the humeral head. Once humeral head exposure is complete, head sizing can commence (Figure 9).

A surgical video of this procedure is available from DePuy Synthes Joint Reconstruction. Please work with your local sales associate to order the GLOBAL CAP CTA System surgical video, part number 0612-19-511.

Figure 8

Figure 9


Head Diameter Larger than 48mm

52mm x 18mm

Figure 10

A B

52mm Humeral Sizer

Use 52mm x 18mm Reamer, Trial and Implant

Use 52mm x 21mm Reamer, Trial and Implant

Articular Margin Gap

Figure 11

HEAD SIZING

Head sizing is confirmed intraoperatively using the humeral head sizers or humeral head gauge (Figure 10). For reference, locate and mark the most superior aspect of the humeral head.

Assemble the appropriate humeral head sizer to the sizer/drill guide handle. Place the sizer over the humeral articular surface, such that its superior mark is aligned with the previously placed mark on the humeral head and the plane of the head sizer rim is parallel with the plane of the anatomic neck of the native humerus. Measure the humeral head size in both the Superior / Inferior and the Anterior / Posterior directions. The humeral head size selected should seat at the articular margin of the humeral head and transition smoothly with the insertion site of the rotator cuff.

The appropriate head sizer is determined by identifying the articular margin of the humerus in relation to the inferior edge of the sizer. If the inferior margin is 3mm below the inferior edge of the sizer, a deeper head height is necessary (Figure 11). Also, note that the interior of the sizer represents the outermost diameter of the definitive implant. If the sizer looks too small or too large, a smaller or larger head sizer can be used.

Head Diameter (mm)

Hum

eral

Hea

d H

eigh

t Re

adin

g (m

m)

40 44 48 52 56

Laser Etch 15 15 18 18 18

Bottom Edge 18 18 21 21 21


IDENTIFYING THE CENTER OF THE HUMERAL HEAD

Further mark the humerus at the most anterior, posterior and inferior aspects of the sizer (Figure 12).

Next, mark the surface of the humeral head along the determined superior-inferior and anterior-posterior axes using electrocautery or marking pen through the round fenestrations in the sizer (Figure 13).

Figure 12

Figure 13

Align Humeral Sizer to the Superior Mark

Mark Inferior and Posterior

Mark Anterior


IDENTIFYING THE CENTER OF THE HUMERAL HEAD

Remove the sizer and visualize the marked surface of the humeral head.

Note: It is important that the intersecting marks identify the center of the humeral head for proper guide pin and definitive implant placement.

Complete the interrupted superior-inferior and anterior-posterior lines using the humeral head gauge as a template (Figure 14). If the lines do not intersect at what appears to be the center of the humeral head, repeat the previous steps until the center of the humeral head has correctly been identified.

Figure 15

Figure 14

Engage Lateral Cortex

Using the head gauge, confirm the humeral head diameter and thickness.

Replace the humeral sizer over the humeral head in the previously determined center position. Drill the threaded guide pin through the center of the cannulated sizer, the center of the humeral articular surface and into the humeral head (Figure 15). The tip of the guide wire should penetrate the lateral cortex of the humerus.

Note: Full penetration of lateral cortex will prevent guide pin from migrating in cancellous bone.

Remove the humeral sizer.


3-IN-1 HUMERAL HEAD SHAPING

Assemble the appropriate reamer to the quick connect reamer shaft.

Note: If humeral head size measurements are between head diameters, ream with the larger diameter reamer first. The reamer prepares the proximal humerus for the inner diameter of the implant. Selecting the larger of the two sizes provides the opportunity to go back and ream to the smaller size. If the humeral head height is between the available options, select the shorter of the two options. If additional head height is needed, then the proximal humerus can again be reamed to meet the desired head height.

Connect the reamer to power. Pass the assembled reamer over the guide wire onto the humeral head (Figure 16). Ream until bone chips are seen to exit from the most superior holes in the peripheral surface of the reamer. Reaming depth can also be checked by observing the distance between the advancing reamer and the rotator cuff attachment site (Figure 17).

Note: Reaming should cease before the sharp-toothed edge of the reamer damages the rotator cuff attachment.

Figure 16

Figure 17


HUMERAL IMPLANT TRIALING

Slide Trial Over Guide Wire

Confirm Trial is Fully Seated

Figure 18

Figure 19

There may be some apparent cancellous bone at the superior shelf of the reamed humeral head. The humeral bone fragments generated from the reaming process can be saved for bone graft between the implant and humerus if needed. The reaming process creates a shelf, equal in width to the thickness of the eventual implant at the base of the humeral head in the anatomic neck region. Any attached fragments of bone that might interfere with complete seating of the trial or implant should be excised with a rongeur. Remove all remaining osteophytes so that the implant forms a smooth transition to the peripheral rim of the humeral head.

Use the trial to assess final implant size and fit (Figure18). Pass the appropriate cannulated trial implant over the guide wire onto the reamed humeral surface. If the trial is the appropriate size and reaming has been adequately performed, the trial should seat completely so that the edge of the trial rests on the shelf created at the anatomic neck region.

Note: Check to confirm that there is uniform contact between the undersurface of the trial and the bone (Figure 19).

The trials have large viewing windows to aid in this visualization. Remove the trial using the trial grasping tool.

If performing a GLOBAL CAP CTA Shoulder, please proceed to page 29.


Hole Matches Cruciate Stem

Figure 21

Figure 20

Figure 22

The shape of the definitive implant’s stem is cruciform. This shape improves implant rotational stability. The cannulated cruciform stem punch is used to create a path for the implant stem in the unreamed cancellous bone in the base of the central hole and confirm correct stem seating of the implant (Figure 20).

Pass the stem punch over the guide pin and into the central hole in the humeral head. Place the centering sleeve into the locked position by turning it clockwise one-quarter turn. Advance the stem punch shaft into the reamed central hole. Rotate the centering sleeve one counterclockwise turn to unlock the punch and then impact the stem punch with a mallet into the cancellous bone of the humerus. The depth of penetration is controlled by the centering sleeve. Remove the central guide pin.

Note: When impacting the stem punch, avoid impacting the mallet over drill pin hole to avoid striking the pin (Figure 21).

Use the stem punch to verify that the axes of the punch and the eventual implant stem are collinear (Figure 21). If these two axes are divergent, the implant may not be completely seated.

Note: The pin has been removed in Figure 22 to illustrate that the cruciform shaped hole matches the shape of the stem on the implant.

Figure 22 also demonstrates the correct orientation of the cruciate stem punch to allow the GLOBAL CAP CTA Shoulder to be properly positioned on the humerus.

If performing a GLOBAL CAP CTA Shoulder, please proceed to page 27.

CENTRAL STEM PREPERATION


GLOBAL CAP SHOULDER SYSTEM SOFT TISSUE BALANCING

Soft tissue releases are required to maximize postoperative range of motion. The humeral head trial may be re-inserted to aid in protection of the reamed bone (Figure 23).

Circumferential release of the glenohumeral joint capsule may then be accomplished. In cases where the anteroinferior capsule is pathologically thickened, it can be excised.

After appropriate soft-tissue releases have been performed, evaluate soft-tissue tension. Re-insert the humeral head trial and reduce the humerus into the glenoid fossa. As a general rule, with the humerus in neutral rotation and the arm in 0-20 degrees of scapular plane abduction, a posteriorly directed subluxating force should cause posterior translation of 50 percent of the humeral head. In addition, the subscapularis should be long enough to reattach to its insertion site, allowing the arm to go to at least 30 degrees of external rotation.

Figure 23


GLOBAL CAP SHOULDER SYSTEM FINAL IMPLANTATION

Figure 25

Figure 24

Expose the humeral head so that the entire prepared surface of the humerus can be seen. Remove the humeral trial. Place the stem of the humeral head implant into the central hole with the cruciform flanges aligned in the appropriate cruciate path. Use the head impactor tool to completely seat the implant with a mallet (Figure 24).

Verify that the implant has been fully seated. There should be no gap from the periphery of the implant and reamed margin of the humerus. Reduce the humerus into the glenoid fossa (Figure 25). After joint reduction, verify that the shoulder has the desired amount of laxity.

For information on Closure and Aftercare proceed to page 35.

Cruciate Stem Length (mm)

Head Diameter (mm)

Head Height (mm) 40 44 48 52 56

15 30mm 30mm X X X

18 35mm 35mm 35mm 35mm 35mm

21 X X 40mm 40mm 40mm


GLOBAL CAP CTA SHOULDER SYSTEM SUPERIOR LATERAL HUMERAL RESECTION

Small Bone Power Saw Requirements

The GLOBAL CAP CTA Superior Lateral Humeral Shoulder resection guide is designed to be used with a small bone power system and the saw blades listed in the back of the surgical technique. Failure to use a small bone power system to make the superior lateral humeral resection may compromise the final fit between the implant and the prepared humeral surface.

Verify that the most superior point of the greater tuberosity has been identified using electrocautery or marking pen (Figure 26).

Based on previously determined head size, perform the humeral resection with the appropriate size cutting block. The diameter of the determined head size will identify the correct superior lateral resection guide.

Slide the cutting block over the guide wire onto the prepared humeral surface aligning the mark on the greater tuberosity with the black line on the cutting block (Figure 27).

Secure the cutting block with two fixator pins (Figure 28).

Figure 26

Figure 28

Figure 27

Mark the Most Superior Point

Align Laser Line With Most Superior Point


GLOBAL CAP CTA SYSTEM SUPERIOR LATERAL HUMERAL RESECTION

To allow greater saw blade access remove the guide wire.

Resect the greater tubercle using one of the three sawblades made specifically for the GLOBAL CAP CTA System:

2235-00-120: GLOBAL CAP CTA Sawblade - Linvatec®

2235-01-120: GLOBAL CAP CTA Sawblade - Stryker®

2235-02-120: GLOBAL CAP CTA Sawblade - DeSoutter®

These sawblades are 30mm long, 6mm wide and 0.64mm thick. The sawblade capture for the GLOBAL CAP CTA cutting block is 1.5mm wide.

Note: The sawblade intended for use with the GLOBAL CAP CTA System cutting guide has a laser etching (Figure 29) to mark the deepest resection that should be made to properly seat the GLOBAL CAP CTA Implant. The laser etching on the blade is designed to trace the implant profile by following the top edge of the humeral resection guide. Further resection may lead to excess bone being removed.

Remove the fixator pins and cutting block (Figure 30).

Any attached fragments of bone that might interfere with complete seating of the trial or implant should be excised with a rongeur. Remove all remaining osteophytes (Figure 31).

Figure 29

Figure 31

Figure 30

Laser Etch on Saw Blade


GLOBAL CAP CTA SHOULDER SYSTEM IMPLANT TRIALING

Use the trial to assess final implant size and fit (Figure 32). Place the appropriate trial implant onto the resected humeral surface. If the trial is the appropriate size and the resection has been adequately performed, the trial should seat completely on the shelves created at both the anatomic neck and the greater tubercle regions.

Note: Check to confirm that there is uniform contact between the undersurface of the trial and the bone.

The trials have large viewing windows to aid in this visualization. Remove the trial using the trial grasping tool.

Figure 32

Confirm Trial is Fully Seated


GLOBAL CAP CTA SHOULDER SYSTEM SOFT TISSUE BALANCING

Figure 33

Soft tissue releases are required to maximize postoperative range of motion. The humeral head trial may be re-inserted to aid in protection of the reamed bone (Figure 33).

Circumferential release of the glenohumeral joint capsule may then be accomplished. In cases where the anteroinferior capsule is pathologically thickened, it can be excised.

Evaluate soft-tissue tension. Re-insert the humeral head trial and reduce the humerus into the glenoid fossa. As a general rule, with the humerus in neutral rotation and the arm in 0-20 degrees of scapular plane abduction, a posteriorly directed subluxating force should cause posterior translation of 50 percent of the humeral head. In addition, the subscapularis should be long enough to reattach to its insertion site, allowing the arm to go to at least 30 degrees of external rotation.


Figure 34

Figure 35

GLOBAL CAP CTA SHOULDER SYSTEM FINAL IMPLANTATION

Expose the humeral head so that the entire prepared surface of the humerus can be seen. Remove the humeral trial. Place the stem of the humeral head implant into the central hole with the cruciform flanges aligned in the appropriate cruciate path. Use the head impactor tool to completely seat the implant with a mallet (Figure 34).

Note: Verify that the superior lateral head is rotated as superiorly as possible. The implant should be inserted with the cruciate stem aligned to the stem punch pattern previously created.

Verify that the implant has been fully seated. There should be no gap from the periphery of the implant and reamed margin of the humerus (Figure 35). Reduce the humerus into the glenoid fossa. After joint reduction, verify that the shoulder has the desired amount of laxity.

Cruciate Stem Length (mm)

Head Diameter (mm)

Head Height (mm) 40 44 48 52 56

15 30mm 30mm X X X

18 35mm 35mm 35mm 35mm 35mm

21 X X 40mm 40mm 40mm


CLOSURE AND AFTERCARE

Repair the subscapularis according to the method of detachment. If the subscapularis was released intratendinously, repair it anatomically, tendon to tendon.

If it was released from the lesser tuberosity with maximum length, it is most often advanced medially to the implant-bone junction and repaired to bone. On rare occasions, a z-lengthening is performed using the medially based subscapularis tendon and the laterally based anterior capsule.

Following subscapularis closure, passive external rotation with the arm at the side should be at least 30 degrees. Close the deltopectoral interval. In a routine fashion, close the subcutaneous tissue and skin. Radiographs should be taken to verify implant positioning and seating.


EXTRACTION OF THE IMPLANT

Indications for revision may include infection, glenoid wear, implant loosening or dislocation. Additionally, removal of the implant may be required during revision surgery. Attain exposure as described above. Attach the extractor tool to the implant that is to be removed (Figure 36).

This may require removal of a small amount of bone at the edge of the implant to allow the extraction tool to be attached to the edge of the implant. Extract the implant using a slotted mallet. If the implant is well-fixed, a saw can be used to cut the periphery of the humerus at the bone-implant junction. The implant and the contained humeral bone can then be removed together. The surface of the remaining humerus can then be prepared for conversion to a stemmed prosthesis.

Note: When removing the GLOBAL CAP CTA Implant, the jaws of the extraction tool are placed over the implant at the three and nine o’clock position.

Figure 36


ACCESSSoft Tissue Release

GLOBAL ENABLE System retractors are designed to aid the surgeon during recommended soft tissue releases while helping to protect other soft tissue and neurovascular bundles. Proper and adequate soft tissue releases enhance access to the glenoid fossa.

PROTECTIONRetractor Placement

GLOBAL ENABLE System retractors have been designed to simplify glenoid exposure. When placed in the recommended positions, GLOBAL ENABLE System retractors protect key tissues in the shoulder and allow for optimal displacement of soft tissue and bone to better expose the glenoid.

CONTROLArm Positioning

GLOBAL ENABLE System retractors are designed to be used in conjunction with arm position to control soft tissue and bone for a simplified glenoid exposure technique. The surgeon needs to be able to fully adduct and extend the arm to maintain control during glenoid exposure.

The GLOBAL ENABLE Glenoid Exposure System is designed to simplify glenoid exposure during primary and reverse shoulder arthroplasty. The GLOBAL ENABLE System provides a step-by-step methodology for glenoid exposure with consideration for challenging exposure situations. The retractor set includes eight retractors designed for Access, Protection, and Control.

Throughout the glenoid exposure process, three functions are highlighted for their contribution to Access, Protection, and Control. Used together with the GLOBAL ENABLE Glenoid Exposure System, these three steps will improve the ability to gain consistent glenoid exposure.

GLOBAL ENABLE INSTRUMENTATION


GLOBAL ANCHOR PEG GLENOID SYSTEM

Advanced Fixation

The patented GLOBAL Anchor Peg Glenoid System achieves immediate stability with the three cemented peripheral pegs, and provides a proven method of fixation through an interference fit of the central peg, which:

· Addresses long-term fixation and stability concerns

Advanced Biomechanics

DePuy Synthes Joint Reconstruction glenoid products have been designed with a constant 6mm diametric mismatch between the glenoid and the humeral head component, which:

· Emulates anatomic biomechanics of a healthy shoulder

· Optimizes load transfer

Advanced Wear Reduction

DePuy Synthes Joint Reconstruction polyethylene solutions optimized for the unique demands of each joint. PREMIERON® X-Linked Polyethylene for the shoulder balances wear reduction and mechanical integrity, which:

· Reduces wear by 85% when compared with standard polyethylene3

· Maintains oxidative stability4

HEAD52

52


GLOBAL APG+ INSTRUMENTATION

GLOBAL APG+ Instrument System is an advanced cannulated instrumentation system that helps accurate placement, orientation, and precise bone preparation for optimal implantation of the GLOBAL Anchor Peg Glenoid Implant. The instruments were designed for ease of use and heightened efficiency in the operating room by incorporating features that enhance Versatility, Simplicity, and Precision through a streamlined surgical approach. GLOBAL APG+ Instrument System is designed to be used with the GLOBAL UNITE, GLOBAL ADVANTAGE, or GLOBAL AP Shoulder Arthroplasty Systems.

EASE OF USE


PREMIERON X-LINKED POLYETHYLENE

X-traordinary Wear Reduction

PREMIERON X-Linked Polyethylene creates a technologically advanced shoulder implant. When assessed for gravimetric wear using a shoulder model simulator with kinematic considerations PREMIERON X-Linked Polyethylene showed an 85% wear reduction (7.0 + 0.4 versus 46.7 + 2.6 mg/Mc) over conventionally manufactured and sterilized components.3 This process results in optimum crosslinking providing increased resistance to the multidirectional wear generated by shoulder implants.

Gra

vim

etric

Wea

r (m

g/M

c)

Conventional

10

20

30

40

50

Crosslinked

85% Reduction

X-traordinary Biomechanical Criteria

The significant wear resistance of PREMIERON X-Linked Polyethylene, coupled with the nonconforming design of DePuy Synthes Joint Reconstruction glenoid implants, addresses the biomechanical concerns associated with glenoid loosening. A constant 6mm diametrical mismatch in the glenoid-humeral head articulation replicates the biomechanics of a healthy shoulder, and is designed to provide patients with a more natural range of motion.1

X-traordinary Mechanical Integrity

Shoulder patients of the 21st century demand more from their replacements than ever before. Their active lifestyles can benefit from the significant advances in wear reduction offered by moderately crosslinked polyethylene. PREMIERON X-Linked Polyethylene balances wear reduction and mechanical integrity while maintaining oxidative stability4 through an exclusive scientific formulation that has been proven to provide improved resistance to the multidirectional wear typically seen in shoulder implants.3

WearResistance

ManufacturingProcess

MechanicalIntegrity

OxidativeStability

Key attributes of PREMIERON X-Linked Polyethylene include:

· GUR 1020 polyethylene resin

· 5 Mrad of irradiation

· Thermally treated to 155º F to eliminate free radicals for an oxidatively stable material

· Maintains mechanical integrity


ADVANCED SOLUTIONS

THE NEXT GENERATION PLATFORM SHOULDER SYSTEM FEATURING:

Principled Adaptability

The GLOBAL UNITE Platform Shoulder System provides conversion at the height and version to optimize deltoid function.

· “Stack-on” adapters can overstretch the deltoid which can lead to complications and diminished elevation.5,6

· Version adjustability allows the surgeon to place the epiphysis in the version that suits the patient’s range of motion requirements.7

Simplicity

· Instrumentation is designed to offer surgical process efficiency with innovative concepts like Brosteotomes.

· The GLOBAL UNITE Platform Shoulder System offers surgeons a streamlined approach to treat Anatomic and Fracture shoulder indications, with the ability to convert to a Reverse Shoulder.

Outcomes-Based Design

The GLOBAL UNITE Platform Shoulder System has been designed on the GLOBAL Shoulder philosophy, which has demonstrated clinical success on both the humerus and the glenoid.

· GLOBAL Shoulder System—98.4% Survivorship at 8 Years.8

· GLOBAL APG —100% Survivorship at 34 Months.9

UNITEPLATFORM SHOULDER SYSTEM


The GLOBAL AP Shoulder Arthroplasty System is a proximal press-fit DePuy Synthes Joint Reconstruction Shoulder Arthroplasty System that combines advanced engineering and over 20 years of GLOBAL Shoulder clinical success.10

· Collarless design allows for anatomic reconstruction of the proximal humerus with two neck options using a single surgical technique:

· Fixed 135 degree neck angle for simplicity in uncomplicated arthroplasty

· Adjustable (120-150 degree neck angle and +/– 15 degrees version) for enhanced joint stability

· Titanium alloy in POROCOAT Porous Coating for cementless application11

· Low profile standard and eccentric humeral heads

· Revision long stem lengths up to 220mm

ADVANCED SOLUTIONS


ORDERING INFORMATION

GLOBAL CAP CTA Implants - DUOFIX HA on POROCOAT Porous Coating

1235-40-005 GLOBAL CAP CTA HEAD DUOFIX HA 40MM X 15MM










GLOBAL CAP Implants - DUOFIX HA on POROCOAT Porous Coating

1230-40-005 GLOBAL CAP HEAD DUOFIX HA 40MM X 15MM












Instruments2235-97-001 THREADED 6 INCH GUIDE PIN

2001-65-000 HEAD IMPACTOR

2001-66-000 IMPACTOR TIP

2128-61-017 HUMERAL TRIAL GRASPERS

2230-40-000 GLOBAL CAP HUMERAL HEAD TRIAL 40MM X 15MM










2230-80-010 GLOBAL CAP HUMERAL HEAD SIZER / DRILL GUIDE 40MM





2230-80-060 GLOBAL CAP HUMERAL HEAD SIZER / DRILL GUIDE HANDLE

2230-81-500 GLOBAL CAP QC HH SHAPER 40X15










2230-81-600 GLOBAL QC DRIVER SHAFT

2230-82-000 GLOBAL CAP IMPLANT STEM PUNCH

2230-83-000 HEAD EXTRACTOR

2235-60-000 GLOBAL SHOULDER RETRACTOR STRAIGHT

2230-84-000 GLOBAL CAP TEMPLATE

2230-84-010 HUMERAL HEAD GAUGE 40MM, 56MM

2230-84-020 HUMERAL HEAD GAUGE 44MM, 48MM, 52MM

2230-90-000 GLOBAL CAP INSTRUMENT CASE



GLOBAL CAP CTA Instruments2235-40-005 GLOBAL CAP CTA HEAD TRIAL 40MM X 15MM

2235-40-015 GLOBAL CAP CTA HEAD TRIAL 40MM X 18MM









2235-40-110 GLOBAL CAP CTA CUTTING BLOCK SIZE 40MM





2235-90-005 GLOBAL CAP CTA PIN 2.4MM DIAMETER X 42MM LENGTH

2235-99-001 GLOBAL CAP CTA INSTRUMENT TRAY

2490-91-000 PIN EXTRACTOR 0.125 INCH

2235-99-005 GLOBAL CAP CTA X-RAY TEMPLATE

DNI2235-99-999 GLOBAL CAP CTA DNI 52X18

Disposables2235-00-120 GLOBAL CAP CTA SAWBLADE - LINVATEC

2235-01-120 GLOBAL CAP CTA SAWBLADE - STRYKER

2235-02-120 GLOBAL CAP CTA SAWBLADE - DESOUTTER

DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, IN 46582T. +1 (800) 366-8143

www.depuysynthes.com

© DePuy Synthes Joint Reconstruction, a division of DOI 2014. All rights reserved. DSUS/JRC/0514/0149(1) 10/14

References:1. Iannotti, J.P.; Gabriel, J.P.; Schneck, S.L.; Evans, B.G.; and Misra, S. “The normal

glenohumeral relationships. An anatomical study of one hundred and forty shoulders.” Journal of Bone and Joint Surgery April 1992: 491-500.

2. Jeffrey L. Visotsky, Carl Basamania, Ludwig Seebauer, Charles A. Rockwood and Kirk L. Jensen. Cuff Tear Arthropathy: Pathogenesis, Classification, and Algorithm for Treatment. J Bone Joint Surg Am. 2004; 86:35-40.

3. Wirth, M., Klotz, C., Deffenbaugh, D., McNulty, D., et. al. “Cross-Linked Glenoid Prosthesis: A Wear Comparison to Conventional Glenoid Prosthesis with Wear Particulate Analysis.” Journal of Shoulder and Elbow Surgery, Vol. 18, 2009.

4. Greer, K. A Prospective Study of the Effects of Five Years Shelf Aging on the Properties of UHMWPE Following Gamma Sterilization in Air or in a Vacuum Foil Pouch. Society for Biomaterials, 2003, 378.

5. Whatley A, Fowler L, Warner J.P. “Postoperative rupture of the anterolateral deltoid muscle following reverse total shoulder arthroplasty in patients who have undergone open rotator cuff repair”. Journal of Shoulder and Elbow Surgery, 2011; 20, 114-122.

6. Wiater, B.P., et al. “The evaluation of the failed shoulder arthroplasty”. Journal of Shoulder and Elbow Surgery, 2014; 1-14.

7. Gulotta, L, et al. “Humeral component retroversion in reverse total shoulder arthroplasty: a biomechanical study”. Journal of Shoulder and Elbow Surgery, 2012;21(1) 1121-1127.

8. Wirth, M, Tapscott R., et al, “Treatment of Glenohumeral Arthritis with a Hemiarthroplasty: A minimum five-year follow-up outcome study.” Journal of Bone and Joint Surgery. Am.88:964-973, 2006. 79, 1997.

9. Groh, GI. Survival and Radiographic Analysis of a Glenoid Component with a Cementless Fluted Central Peg. Journal of Shoulder and Elbow Surgery, 2010;19(8) 1265-1268.

10. Jeong, J., Bryan, J., Iannotti, J.P., “Effect of a Variable Prosthetic Neck-Shaft Angle and the Surgical Technique on Replication of Normal Humeral Anatomy.” Journal of Bone and Joint Surgery, Vol. 91, 2009.

11. Matsen III, F.A., Iannotti, J.P., Rockwood Jr., C.A. “Humeral Fixation by Press-Fitting of a Tapered Metaphyseal Stem: A Prospective Radiographic Study.” Journal of Bone and Joint Surgery, Vol. 85, 2003.

*DePuy Synthes Joint Reconstruction is a division of DePuy Orthopaedics, Inc.

The third party trademarks used herein are the trademarks of their respective owners.

Limited Warranty and Disclaimer: DePuy Synthes Joint Reconstruction products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed.

WARNING: In the USA, this product has labeling limitations. See package insert for complete information.

CAUTION: USA Law restricts these devices to sale by or on the order of a physician.

Not all products are currently available in all markets.

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GLOBAL CAP GLOBAL CAP CTAsynthes.vo.llnwd.net/o16/LLNWMB8/US Mobile/Synthes North...6 DePuy Synthes Joint Reconstruction GLOBAL® CAP® GLOBAL® CAP® CTA Surgical Technique The sizing