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<p>Design Rationale & Surgical Technique Contents Product Rationale 2 Design Rationale 8 Pre-Operative Templating 10 Anesthesia and Patient Positioning 11 Incision and Exposure 12 Exposure 13 Head Sizing 15 Identifying the Center of the Humeral Head 16 3 in 1 Humeral Head Shaping 18 Humeral Implant Trialing 19 Closure and Aftercare 29 Extraction of the Implant 29 Ordering Information 30 Global® CAP® Central Stem Preparation 20 Global CAP Soft Tissue Balancing 21 Global CAP Final Implantation 22 Global® CAP® CTA™ Central Stem Preparation 23 Global CAP CTA Superior Lateral Humeral Resection 24 Global CAP CTA Implant Trialing 26 Global CAP CTA Soft Tissue Balancing 27 Global CAP CTA Final Implantation 28 3 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 design draws upon advanced research and design philosophies of the Global® Anatomic Shoulder Solutions system. Design philosophies 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 Orthopaedics, Inc., Warsaw, Indiana. 40 44 48 52 56 15 18 21 H ea d H ei gh ts (m m ) Head Diameters (mm) Indicated for Osteoarthritis or Rheumatoid Arthritis 5 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. The Global CAP CTA design draws upon the advanced research and design philosophies of the Global Anatomic Shoulder Solutions portfolio. Indicated for Cuff Tear Arthropathy 40 44 48 52 56 15 18 21 H ea d H ei gh ts (m m ) Head Diameters (mm) 6 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 superior 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. Optimal 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 in either Porocoat® Porous Coating or DuoFix™ Hydroxyapatite on Porous Coating. Indicated for Osteoarthritis or Rheumatoid Arthritis 7 In addition to all of the features and design benefits offered in Global CAP, Global CAP CTA also offers: Increased Area of Superolateral Articulation • Based on the Global® Advantage® and Global® AP® CTA humeral head, the Global CAP CTA has an increased area of superolateral articulation for less pain and optimized 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 on Porocoat Porous Coating. Indicated for Cuff Tear Arthropathy 8 Key Surgical Steps Summary Head Sizing Superior Lateral Humeral Resection Central Stem Preperation Incision and Exposure Black = Global CAP and Global CAP CTA Grey = Global CAP Red = Global CAP CTA GLOBAL CAP GLOBAL CAP CTA 9 3 in 1 Humeral Head Shaping Soft Tissue Balancing Identifying the Center of the Humeral Head Humeral Implant Trialing Implant Trialing Central Stem Preparation Final Implantation Soft Tissue Balancing Final Implantation 10 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). Pre-Operative Templating Figure 1 Figure 2 GLOBAL® CAP® GLOBAL® CAP® CTA GLOBA ® CAP® GLOBA ® CAP® CTA TYPE 1A CENTERED STABLE TYPE 1B CENTERED MEDIALIZED TYPE 2A DECENTERED LIMITED STABLE TYPE 2B CENTERED UNSTABLE • Intact Anterior Restraints • Intact Anterior Restraints • Intact 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 Femoralization Acetabularization Seebauer Classification2 of Cuff Tear Arthropathy (CA = Coracoacromial) Pr e- O pe ra tiv e Te m pl at in g 11 Figure 4 Figure 3 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 A nesthesia and Patient Positioning 12 Incision and Exposure Deltopectoral Approach Obtain exposure through a deltopectoral incision extending 10-15 cm inferolaterally from approximately the mid-shaft of the clavicle toward the deltoid insertion. Identify the cephalic vein within the deltopectoral groove. Dissect it away from the pectoralis major, and mobilize it laterally with the deltoid. The superior 1.0-1.5 cm of the pectoralis major insertion may be released from the humerus to improve exposure of the inferior aspect of the joint. Place a self retaining retractor to retract the deltoid and cephalic vein laterally and the pectoralis major medially. Deltopectoral Incision Identify the conjoined tendon of the coracobrachialis and short head of the biceps. Make an incision in the clavipectoral fascia at the lateral-most extent of the conjoined tendon. Carry this incision superiorly to the coracoacromial ligament (Figure 5). Adequate exposure is usually obtained without sacrifice of any portion of the coracoacromial ligament. Therefore, preservation of the coracoacromial ligament may be performed in all arthroplasty cases, especially those with poor quality rotator cuff tissue (i.e., rheumatoid arthritis). The axillary and musculocutaneous nerves may be injured in any deltopectoral approach. Thus, care should be taken to identify and protect them whenever possible. Routinely identify the axillary nerve at the inferior aspect of the glenohumeral joint, either by digital palpation or direct visualization. The musculocutaneous nerve has a more variable course, particularly with reference to the distance from the tip of the coracoid to its passage into the posterior surface of the conjoined tendon. Because of this variability, it may not always be easily palpable within the surgical field. However, an attempt should always be made to palpate it. This will help ensure that the nerve can be protected throughout the procedure. Figure 5 In ci si on a nd E xp os ur e 13 Exposure Deep Dissection With the conjoined tendon retracted medially and the deltoid retracted laterally, the subscapularis muscle and tendon and the anterior humeral circumflex vessels can be easily identified. Clamp and coagulate or ligate the anterior circumflex vessels to prevent excessive bleeding throughout the procedure. Identify the superior and inferior extents of the subscapularis. Superiorly, the subscapularis forms a well-defined tendon that inserts into the lesser tuberosity. Inferiorly, the subscapularis consists of laterally extending muscle fibers with a less well demarcated tendon that inserts directly into the humerus. Place stay sutures within the tendon in anticipation of its later release (Figure 6). There are different methods of taking down the subscapularis. Some surgeons prefer to perform a tenotomy while others prefer a lesser tuberosity osteotomy. Typically, a z-plasty is only performed in the event that the subscapularis was shortened by prior surgery. When performing a lesser tuberosity osteotomy, first move the arm into internal rotation to improve access to the lesser tuberosity. Introduce the sawblade or a sharp curved 1/2 inch osteotome at the interval created at the insertion side of the subscapularis and resect approximately 4-5 cm of the lesser tuberosity. When performing a release of the subscapularis tendon without an osteotomy, the tendon is removed from its insertion with a cautery or scalpel. Using a blunt dissection (Cobb) separate the capsule from the subscapularis, inferiorly and medially, using a scalpel. Release the rest of the anterior capsule from the subscapularis to the glenoid rim. Release the coracohumeral ligament from the base of the corocoid. After the subscapularis and capsule have been released by the method that is appropriate for the degree of contracture present, deliver the humerus out of the wound using simultaneous adduction, external rotation and extension of the arm. This requires a complete inferior capsular release from the humeral neck to its posterior inferior attachment (Figure 7). Figure 6 Release Limited External Rotation Figure 7 Exposure 14 Exposure Mark Superior Aspect Humeral Head Figure 8 Figure 9 Ex po su re With the humeral head delivered out of the wound, remove all humeral osteophytes (Figure 8). This is a particularly important step, since the anatomic neck must be visualized to guide humeral preparation. Place a curved Crego or reverse Hohmann retractor along the anatomic neck superiorly to protect and retract the long head of the biceps and postero- superior rotator cuff. Mark the most superior point of the articular margin or anatomic neck with electrocautery or marking pen (Figure 9). 15 A 52 mm Humeral Sizer Use 52 mm x 18 mm Reamer, Trial and Implant Use 52 mm x 21 mm Reamer, Trial and Implant Articular Margin Gap Head Sizing Head sizing is confirmed intraoperatively using the humeral head sizers or humeral head gauge (Figure 10). 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 3 mm 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 Larger than 48 mm Humeral Head Size (mm) 40 15 18 Laser Etch Bottom Edge 44 15 18 48 18 21 56 18 21 52 18 21 H u m er al H ea d H ei g h t R ea d in g (m m ) 52 mm x 18 mm Figure 10 H ead Sizing Figure 11 16 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 Id en tif yi ng t he C en te r of t he H um er al H ea d 17 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. Identifying the C enter of the H um eral H ead 3 in 1 H um er al H ea d Sh ap in g 3 in 1 H um er al H ea d Sh ap in g 18 Insert Insert Remove 1. Assemble the Global CAP Humeral Head Shaper Inserter onto the Humeral Head Shaper 2. Engage the J-slot of the Humeral Head Shaper with the Shaper Handle 3. Lock the Shaper Handle to the Humeral Head Shaper and remove the Shaper Inserter Lock Lock Unlock Humeral Head Shaper Shaper Handle Shaper Ready on Handle J-Slot 3 in 1 Humeral Head Shaping Assemble the appropriate reamer to the shaper / drill guide handle and tighten using the assembling tool (Figure 16). Note: When inserting the reamer to the humeral head shaper handle, the J-slot of the reamer must be engaged with the shaper handle before the neck can be locked. Turn the neck counterclockwise to lock handle. Based on previously determined head size, perform humeral shaping with the appropriate size reamer (Figure 17). Connect the reamer to power. Pass the assembled reamer over the guide wire onto the humeral head. Ream until bone chips are seen to exit from the most superior holes in the peripheral surface of the reamer (Figure 18). Reaming depth can also be checked by observing the distance between the advancing reamer and the rotator cuff attachment site. Note: Reaming should cease before the sharp-toothed edge of the reamer damages the rotator cuff attachment. 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 excized with a rongeur. Remove all remaining osteophytes so that the implant forms a smooth transition to the peripheral rim of the humeral head. Figure 17 Figure 16 Figure 18 H um eral Im plant Trialing 19 Slide Trial Over Guide Wire Confirm Trial is Fully Seated Figure 19 Figure 20 Use the trial to assess final implant size and fit (Figure 19). 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 20). 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, please proceed to page 23. Humeral Implant Trialing G lo ba l C A P C en tr al S te m P un ch 20 Hole Matches Cruciate Stem If performing a Global CAP CTA, please proceed to page 23. 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 enable correct stem seating of the implant (Figure 21). 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 22). Use the stem punch to confirm 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 23 to illustrate that the cruciform shaped hole matches the shape of the stem on the implant. Figure 22 Figure 21 Figure 23 Global CAP Central Stem Punch G lobal C A P Soft Tissue Balancing 21 Global CAP 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 24). 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 24 Global CAP Final Implantation Figure 25 Figure 26 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 25). 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. After joint reduction, verify that the shoulder has the desired amount of laxity (Figure 26). For information on Closure and Aftercare proceed to page 29. G lo ba l C A P Fi na l I m pl an ta tio n 22 G lobal C A P C TA C enral Stem Preparation 23 Hole Matches Cruciate Stem 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 27). 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 28). Use the stem punch to verify that the axes of the punch and the eventual implant stem are collinear (Figure 29). If these two axes are divergent, the implant may not be completely seated. Note: The pin has been removed in Figure 29 to illustrate that the cruciform shaped hole matches the shape of the stem on the implant. Figure 29 also demonstrates the correct orientation of the cruciate stem punch to allow the Global CAP CTA to be properly positioned on the humerus. Figure 28 Figure 27 Figure 29 Global CAP CTA Central Stem Punch G lo ba l C A P Fi na l I m pl an ta tio n G lo ba l C A P C TA S up er io r La te ra l H um er al R es ec tio n 24 Global CAP CTA Superior Lateral Humeral Resection Small Bone Power Saw Requirements The Global CAP CTA superior lateral humeral 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. Stryker, Linvatech and De Soutter all distribute small bone power systems in the US that can be used with the sawblades listed in this 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 30). 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 31). Secure the cutting block with two fixator pins (Figure 32). Figure 30 Figure 32 Figure 31 Mark the Most Superior Point Align Laser Line With Most Superior Point G lobal C A P C TA Superior Lateral H um eral Resection 25 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: 2235-00-120: Linvatec Small Bone Power 2235-01-120: Stryker Global CAP CTA Blade 2235-02-120: DeSoutter Small Bone Power The distance from the Laser Etch Mark to the tip of the sawblade measures 30mm. The sawblade is 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 cutting guide has a laser etching (Figure 33) 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 34). 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 35). Figure 33 Figure 35 Figure 34 Laser Etch on Saw Blade 26 Global CAP CTA Implant Trialing Use the trial to assess final implant size and fit (Figure 36). 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 36 Confirm Trial is Fully Seated G lo ba l C A P C TA Im pl an t Tr ia lin g 27 G lobal C A P C TA Soft Tissue Balancing Global CAP CTA Soft Tissue Balancing Figure 37 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 37). 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. 28 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 38). 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 39). Reduce the humerus into the glenoid fossa. After joint reduction, verify that the shoulder has the desired amount of laxity. Figure 38 Figure 39 G lo ba l C A P C TA F in al Im pl an ta tio n Global CAP CTA Final Implantation 29 C losure and A ftercare Extraction of the Implant 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. Begin pendulum exercises and passive range of motion within 24 hours of surgery. There are no limits to the passive range of motion performed, except that external rotation should not exceed the safe zone of rotation observed at surgery after subscapularis closure. A sling may be used for comfort and protection. An overhead pulley is added at four to six weeks. Passive stretching and strengthening exercises of the rotator cuff, deltoid and scapular muscles should commence at six weeks postoperatively. These exercises are progressed as tolerated over the next three to six months. Indications for revision may include infection, glenoid wear, implant loosening or dislocation. Additionally, in rare cases, 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 40). 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, the jaws of the extraction tool are placed over the implant at the 3 and 9 o’clock position. Figure 40 30 Ordering Information Global CAP Implants - Porocoat Porous Coated Order Code Description 1230-40-000 Global CAP Head Porocoat Porous Coated 40 mm x 15 mm 1230-40-010 Global CAP Head Porocoat Porous Coated 40 mm x 18 mm 1230-44-000 Global CAP Head Porocoat Porous Coated 44 mm x 15 mm 1230-44-010 Global CAP Head Porocoat Porous Coated 44 mm x 18 mm 1230-48-010 Global CAP Head Porocoat Porous Coated 48 mm x 18 mm 1230-48-020 Global CAP Head Porocoat Porous Coated 48 mm x 21 mm 1230-52-010 Global CAP Head Porocoat Porous Coated 52 mm x 18 mm 1230-52-020 Global CAP Head Porocoat Porous Coated 52 mm x 21 mm 1230-56-010 Global CAP Head Porocoat Porous Coated 56 mm x 18 mm 1230-56-020 Global CAP Head Porocoat Porous Coated 56 mm x 21 mm Global CAP Implants - DuoFix HA on Porocoat Porous Coating Order Code Description 1230-40-005 Global CAP Head DuoFix HA 40 mm x 15 mm 1230-40-015 Global CAP Head DuoFix HA 40 mm x 18 mm 1230-44-005 Global CAP Head DuoFix HA 44 mm x 15 mm 1230-44-015 Global CAP Head DuoFix HA 44 mm x 18 mm 1230-48-015 Global CAP Head DuoFix HA 48 mm x 18 mm 1230-48-025 Global CAP Head DuoFix HA 48 mm x 21 mm 1230-52-015 Global CAP Head DuoFix HA 52 mm x 18 mm 1230-52-025 Global CAP Head DuoFix HA 52 mm x 21 mm 1230-56-015 Global CAP Head DuoFix HA 56 mm x 18 mm 1230-56-025 Global CAP Head DuoFix HA 56 mm x 21 mm Global CAP CTA Implants - DuoFix HA on Porous Coating Order Code Description 1235-40-005 Global CAP CTA Head DuoFix HA 40 mm x 15 mm 1235-40-015 Global CAP CTA Head DuoFix HA 40 mm x 18 mm 1235-44-005 Global CAP CTA Head DuoFix HA 44 mm x 15 mm 1235-44-015 Global CAP CTA Head DuoFix HA 44 mm x 18 mm 1235-48-015 Global CAP CTA Head DuoFix HA 48 mm x 18 mm 1235-48-025 Global CAP CTA Head DuoFix HA 48 mm x 21 mm 1235-52-015 Global CAP CTA Head DuoFix HA 52 mm x 18 mm 1235-52-025 Global CAP CTA Head DuoFix HA 52 mm x 21 mm 1235-56-015 Global CAP CTA Head DuoFix HA 56 mm x 18 mm 1235-56-025 Global CAP CTA Head DuoFix HA 56 mm x 21 mm 31 Ordering Information Instrumentation Order Code Description 14012-9 Threaded Guide Pin 2001-65-000 Head Impactor 2001-66-000 Impactor Tip 2128-61-017 Glenoid Graspers 2230-40-000 Global CAP Humeral Head Trial 40 mm x 15 mm 2230-40-010 Global CAP Humeral Head Trial 40 mm x 18 mm 2230-44-000 Global CAP Humeral Head Trial 44 mm x 15 mm 2230-44-010 Global CAP Humeral Head Trial 44 mm x 18 mm 2230-48-010 Global CAP Humeral Head Trial 48 mm x 18 mm 2230-48-020 Global CAP Humeral Head Trial 48 mm x 21 mm 2230-52-010 Global CAP Humeral Head Trial 52 mm x 18 mm 2230-52-020 Global CAP Humeral Head Trial 52 mm x 21 mm 2230-56-010 Global CAP Humeral Head Trial 56 mm x 18 mm 2230-56-020 Global CAP Humeral Head Trial 56 mm x 21 mm 2230-80-010 Global CAP Humeral Head Sizer / Drill Guide 40 mm 2230-80-020 Global CAP Humeral Head Sizer / Drill Guide 44 mm 2230-80-030 Global CAP Humeral Head Sizer / Drill Guide 48 mm 2230-80-040 Global CAP Humeral Head Sizer / Drill Guide 52 mm 2230-80-050 Global CAP Humeral Head Sizer / Drill Guide 56 mm 2230-80-060 Global CAP Humeral Head Sizer / Drill Guide Handle 2230-81-010 Global CAP Humeral Head Shaper 40 mm x 15 mm 2230-81-020 Global CAP Humeral Head Shaper 40 mm x 18 mm 2230-81-030 Global CAP Humeral Head Shaper 44 mm x 15 mm 2230-81-040 Global CAP Humeral Head Shaper 44 mm x 18 mm 2230-81-050 Global CAP Humeral Head Shaper 48 mm x 18 mm 2230-81-060 Global CAP Humeral Head Shaper 48 mm x 21 mm 2230-81-070 Global CAP Humeral Head Shaper 52 mm x 18 mm 2230-81-080 Global CAP Humeral Head Shaper 52 mm x 21 mm 2230-81-090 Global CAP Humeral Head Shaper 56 mm x 18 mm 2230-81-100 Global CAP Humeral Head Shaper 56 mm x 21 mm 2230-81-110 Global CAP Humeral Head Shaper Handle 2230-81-120 Global CAP Humeral Head Shaper Inserter 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 40 mm, 56 mm 2230-84-020 Humeral Head Gauge 44 mm, 48 mm, 52 mm 2230-90-000 Global CAP Instrument Case 32 Ordering Information Global CAP CTA Instruments Order Code Description 2235-40-005 Global CAP CTA Head Trial 40 mm x 15 mm 2235-40-015 Global CAP CTA Head Trial 40 mm x 18 mm 2235-44-005 Global CAP CTA Head Trial 44 mm x 15 mm 2235-44-015 Global CAP CTA Head Trial 44 mm x 18 mm 2235-48-015 Global CAP CTA Head Trial 48 mm x 18 mm 2235-48-025 Global CAP CTA Head Trial 48 mm x 21 mm 2235-52-015 Global CAP CTA Head Trial 52 mm x 18 mm 2235-52-025 Global CAP CTA Head Trial 52 mm x 21 mm 2235-56-015 Global CAP CTA Head Trial 56 mm x 18 mm 2235-56-025 Global CAP CTA Head Trial 56 mm x 21 mm 2235-40-110 Global CAP CTA Cutting Block Size 40 mm 2235-44-110 Global CAP CTA Cutting Block Size 44 mm 2235-48-110 Global CAP CTA Cutting Block Size 48 mm 2235-52-110 Global CAP CTA Cutting Block Size 52 mm 2235-56-110 Global CAP CTA Cutting Block Size 56 mm 2235-90-005 Global CAP CTA Pin 2.4 mm diameter x 42 mm length 2235-97-001 Global CAP CTA 6 inch Threaded Pin 2235-99-001 Global CAP CTA Instrument Tray 2307-99-004 Pin Extractor 0.125 inch 2235-99-005 Global CAP CTA X-Ray Template Disposables Order Code Description 2235-00-120 Global CAP CTA Sawblade - Linvatec 2235-01-120 Global CAP CTA Sawblade - Stryker 2235-02-120 Global CAP CTA Sawblade - DeSoutter DNI Order Code Description 2235-99-999 Global CAP CTA DNI 52x18 33 Notes Important: This Essential Product Information sheet does not include all of the information necessary for selection and use of a device. Please see full labeling for all necessary information. Indications: Total shoulder or hemi-shoulder replacement is indicated for: 1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis; 2. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon’s experience indicates that alternative methods of treatment are unsatisfactory; 3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g., revision of a failed primary component). Hemi-shoulder replacement is also indicated for: 1. Ununited humeral head fractures; 2. Avascular necrosis of the humeral head; 3. Rotator cuff tear arthropathy. Global CAP® is indicated for intact or repairable rotator cuff. 4. Deformity and/or limited motion. Global CAP CTA is indicated for hemi-shoulder replacement only. Porocoat® Porous-Coated Components Porocoat porous-coated humeral stem prostheses are indicated for cemented or cementless use with fixation provided by biological tissue ingrowth into the porous coating. Global CAP and Global CAP CTA are intended for cementless use only. Cemented Components Humeral stem and Glenoid components labeled “For cemented use only” are indicated only for use with bone cement. Press-fit or Cemented Components Humeral stem prostheses without porous coating and labeled “for press fit or cemented use only” are indicated for press-fit uncemented use or for use with bone cement. Contraindications The following conditions are contraindications for total shoulder and hemi-shoulder arthroplasty. 1. Active local or systemic infection. 2. Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components. 3. Poor bone quality, such as osteoporosis, where there could be considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid. The following condition is a contraindication for total shoulder arthroplasty. 1. Absent, irreparable or nonfunctional rotator cuff or other essential muscles. Warnings and Precautions: The use of a glenoid prosthesis in patients with cuff tear arthropathy could increase the risk of glenoid component loosening due to non anatomic loading conditions. The following conditions tend to adversely affect shoulder replacement implants: excessive patient weight, high levels of patient activity, likelihood of falls, poor bone stock, metabolic disorders, disabilities of other joints. Adverse Events: The following are the most frequent adverse events after shoulder arthroplasty: change in position of the components, loosening of components, dislocation, infection, hematoma, pneumonia, and cardiovascular disorders. 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. Cuff Tear Arthropathy: Pathogenesis, Classification, and Algorithm for Treatment. Jeffrey L. Visotsky, Carl Basamania, Ludwig Seebauer, Charles A. Rockwood and Kirk L. Jensen. J Bone Joint Surg Am. 2004; 86:35-40. Printed in USA. ©2010 DePuy Orthopaedics, Inc. All rights reserved. 1M0610 0612-31-509 (Rev. 1) </p>
