Cannulated Pediatric Osteotomy System (CAPOS)

A Single System of Osteotomy Blade Plates and Cannulated Instrumentation Cannulated Pediatric Osteotomy System (CAPOS) Surgical Technique

Table of Contents Introduction Cannulated Pediatric Osteotomy System (CAPOS) 2 AO Principles 3 Indications 4 Surgical Technique Preoperative Planning 5 Place Guide Wire 6 Insert Chisel 9 Perform Osteotomy 12 Insert Plate 13 Secure Plate 14 Postoperative Care and Cleaning Tip 15 Product Information Instruments 16 Set Lists 19 MR Information The Cannulated Pediatric Osteotomy System (CAPOS) has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration or image artifact in the MR environment. The safety of the Cannulated Pediatric Osteotomy System (CAPOS) in the MR environment is unknown. Scanning a patient who has this device may result in patient injury. Image intensifier control Cannulated Pediatric Osteotomy System (CAPOS) Surgical Technique DePuy Synthes 1

Cannulated Pediatric Osteotomy System (CAPOS) The Cannulated Pediatric Osteotomy System (CAPOS) combines implants and instruments in one convenient system. This system offers the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates provide ease of reduction and good rotational stability while maintaining bone stock. Cannulated instruments work over a guide wire for precise placement and safety. Features Osteotomy plates are offered in a variety of sizes: infant, toddler, child, and adolescent Cannulated chisels and guide wires simplify surgical technique Saw guides improve the accuracy of the osteotomy and reduce surgical time Two graphic cases provide organization and storage for the complete system 2 DePuy Synthes Cannulated Pediatric Osteotomy System (CAPOS) Surgical Technique

AO Principles AO PRINCIPLES In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation. 1,2 In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation 1, 2. 4_Priciples_03.pdf 1 05.07.12 12:08 Anatomic Anatomic reduction reduction Fracture Fracture reduction reduction and and fixation fixation to to restore restore anatomical anatomical relationships. relationships. 1 2 Stable Stable fixation fixation Fracture Fracture fixation fixation providing providing absolute absolute or relative or relative stability, stability, as required as by the required patient, by the the injury, patient, and the the injury, personality and the personality of the fracture. of the fracture. Early, Early, active mobilization Early Early and and safe safe mobilization and rehabilitation of of the injured part and and the the patient as as a whole. 4 3 Preservation Preservation of of blood blood supply supply Preservation Preservation of of the the blood blood supply supply to to soft soft tissues tissues and and bone bone by by gentle reduction gentle reduction techniques techniques and and careful careful handling. handling. 1. Müller ME, Allgöwer M, Schneider R, Willenegger H. Manual of Internal Fixation. 3rd ed. Berlin, Heidelberg, New York: Springer-Verlag; 1991. 2. Rüedi TP, RE Buckley, CG Moran. AO Principles of Fracture Management. 1 Müller ME, M Allgöwer, R Schneider, H Willenegger. Manual of Internal 2nd ed. Stuttgart New York: Thieme; 2007. Fixation. 3rd ed. Berlin Heidelberg New York: Springer. 1991. 2 Rüedi TP, RE Buckley, CG Moran. AO Principles of Fracture Management. 2nd ed. Stuttgart, New York: Thieme. 2007. Cannulated Pediatric Osteotomy System (CAPOS) Surgical Technique DePuy Synthes 3

Indications The CAPOS System is intended for use in infants, toddlers, children, adolescents, and small-stature adult patients. Specific indications include: Intertrochanteric derotation and varus osteotomies (Osteotomy Plates Infant, Toddler, Child, Adolescent, and Bifurcated) Intertrochanteric valgus osteotomies (95 Condylar Plates Adolescent and Small Stature Adult) Femoral neck and pertrochanteric fractures (130 Angled Blade Plates Adolescent and Small Stature Adult) Please see the package insert for a complete list of contraindications, warnings, precautions, and adverse effects. 4 DePuy Synthes Cannulated Pediatric Osteotomy System (CAPOS) Surgical Technique

Preoperative Planning 1 Preoperative planning Preoperatively evaluate and plan the surgical procedure. Determine the appropriate osteotomy plate by blade length, angle, and displacement. Note the corresponding guide wire diameter. The AO Preoperative Planner (6000) assists in selection of the appropriate osteotomy plate; it contains Müller s classic description 2 of osteotomy surgical technique. The osteotomy plates are available with various offsets. The plate offset is designed to create medialization of the distal fragment to restore the proper mechanical axis of the long bone. In a valgus or purely derotational osteotomy, a smaller offset is typically best. In a large, angled varus osteotomy, a larger offset is often best. Note: The technique described in this guide is for a varus derotational osteotomy of the proximal femur, utilizing a 90 osteotomy blade plate. Steps may differ for alternative osteotomy techniques or fracture repair. 2 Position the patient Surgery is typically performed on a radiolucent operating table. Position the patient for AP views of the hip under image intensification. Obtain lateral views of the hip by flexing and abducting the leg. 3 Surgical approach Use a standard lateral approach to the proximal femur. 3 2. Rüedi TP, RE Buckley, CG Moran. AO Principles of Fracture Management. 2nd ed. Stuttgart New York: Thieme; 2007. 3. Raymond T. Morrissy. Atlas of Pediatric Orthopaedic Surgery. Philadelphia: J. B. Lippincott Company, 1992. Cannulated Pediatric Osteotomy System (CAPOS) Surgical Technique DePuy Synthes 5

Place Guide Wire 4 Place guide wire Instruments 314.070 Small Hexagonal Screwdriver 333.683 Adjustable Wire Guide A guide wire may be held on the anterior side of the femoral neck to assist in determination of the direction that the definitive guide wire will take. Set the adjustable wire guide to the angle determined in the preoperative plan, using the small hexagonal screwdriver. For example, if a 30 varus osteotomy is planned, using a 90 osteotomy plate, then the adjustable wire guide should be set at 120 (= 30 +90 ). 6 DePuy Synthes Cannulated Pediatric Osteotomy System (CAPOS) Surgical Technique

Place Guide Wire Choose the guide wire that corresponds with the cannulated chisel and osteotomy plate selected. Direct Cannulated Saw Implant Size Guide Wire Measuring Chisel Guide Device Infant 292.722 (1.6 mm) 319.17 332.173 332.356 Toddler 292.652 (2.0 mm) 319.21 332.174 332.355 Child/Adolescent 292.652 (2.0 mm) 319.21 332.175 332.354 Load the guide wire through the adjustable wire guide. Insert the wire into the femoral neck (Figures 1, 2 and 3a). Optimal placement of the guide wire is inferior in the neck, above the calcar region as seen in the AP view. In the lateral view, the guide wire should be located centrally in the femoral neck. Verify final placement of the guide wire in both views, under image intensification (Figure 3b). Note: Be aware that marginal placement of the guide wire could cause the chisel and osteotomy plate to penetrate the medial, anterior or posterior cortex. Figure 1 Figure 2 Figure 3a Figure 3b Cannulated Pediatric Osteotomy System (CAPOS) Surgical Technique DePuy Synthes 7

Place Guide Wire 4 Place guide wire continued Instrument 319.17 Cannulated Screw (Direct) Measuring Device or 319.21 Slide the appropriate direct measuring device over the guide wire. Determine and record the insertion depth of the guide wire. This measurement is critical in determining appropriate chisel insertion in the next step. The proper blade length of the osteotomy plate will typically be the next size smaller than the measurement taken with the direct measuring device. 8 DePuy Synthes Cannulated Pediatric Osteotomy System (CAPOS) Surgical Technique

Insert Chisel 5 Insert chisel Instruments 332.09 Chisel Guide 332.173 Cannulated Chisels 332.175 Place the cannulated chisel in the chisel guide and over the guide wire. The chisel and chisel guide assembly can be rotated in the anterior or posterior direction to achieve flexion or extension, respectively. Should a neutral position be desired, the chisel guide should align with the femoral shaft. Anterior angulation = flexion at the osteotomy site Posterior angulation = extension at the osteotomy site Neutral Flexion Extension Cannulated Pediatric Osteotomy System (CAPOS) Surgical Technique DePuy Synthes 9

Insert Chisel 5 Insert chisel continued Instrument 319.17 Cannulated Screw (Direct) Measuring Device or 319.21 399.42 Hammer Correct insertion depth can be calculated by taking the measurement obtained with the direct measuring device and subtracting the osteotomy plate blade length. This figure should correspond with the appropriate chisel insertion depth as measured by the calibrated window of the chisel. Note: Direct measuring device (DMD) measurement (see Step 4) minus implant blade length equals insertion measurement on chisel window (see example). Use the hammer to drive the cannulated chisel along the guide wire and into the femoral neck. It is often advantageous to intermittently withdraw the chisel during insertion. Example: 44 mm (DMD measurement) 38 mm (implant blade length) 6 mm Precaution: During hammering of the chisel, take care to keep the chisel properly tracking over the guide wire and avoid any bending force on the wire. 11 DePuy Synthes Cannulated Pediatric Osteotomy System (CAPOS) Surgical Technique

Insert Chisel During chisel insertion, verify proper tracking over the guide wire by periodically checking progress with image intensification. Monitor insertion depth by observing the position of the guide wire in the calibrated window of the chisel. Stop insertion once the predetermined insertion measure ment is achieved. Cannulated Pediatric Osteotomy System (CAPOS) Surgical Technique DePuy Synthes 11

Perform Osteotomy 6 Perform osteotomy Instruments 332.173 Cannulated Chisels 332.175 332.20 Slotted Hammer 332.354, Saw Guides 332.355 or 332.356 Before beginning the osteotomy, ensure that the chisel is loosened slightly, with a reverse impact with the slotted hammer. Insert rotation guide wires above and below the osteotomy site in a manner that will not interfere with plate placement. Protect the medial soft tissues with retractors. Figure 1 Slide the appropriate saw guide on the inferior side of the cannulated chisel. With image intensification, check that the superior cut will be below the level of the femoral neck. Using appropriate power equipment and saw, perform the first osteotomy cut parallel to the saw guide (Figure 1). Using the cannulated chisel as a lever, carefully tilt the proximal bone fragment to the desired position. Make the second cut starting at the same point on the lateral cortex, but directed perpendicular to the femoral shaft (Figure 2). Remove the wedge of bone from the distal segment of the femur. Note: In some cases, particularly of neuromuscular disease, the bone may be extremely soft. Alternative technique The first osteotomy cut may be made at a right angle (perpendicular) to the femoral shaft, at the level determined from the preoperative plan. The second cut is then made to the distal bone fragment and the wedge of bone is removed. 2 If this technique is chosen, the saw guide may still be used, exercising the proper degree of caution to prevent saw incursion into the femoral neck. Figure 2 Precaution: When the saw guide is used, exercise caution to prevent saw penetration into the femoral neck. 2. Rüedi TP, RE Buckley, CG Moran. AO Principles of Fracture Management. 2nd ed. Stuttgart New York: Thieme; 2007. 11 DePuy Synthes Cannulated Pediatric Osteotomy System (CAPOS) Surgical Technique

Insert Plate 7 Insert plate Instruments 321.20 Ratchet Wrench 332.21 Impactor 332.352 or Inserter/Extractors 332.353 333.060, Triangular Positioning Plates 333.070 or 333.080 398.811*, Plate Holding Forceps with swivel foot 398.812* or (size 0, 1 or 2) 398.813* Figure 3 Carefully remove the cannulated chisel, saw guide, and guide wire. Insert the selected osteotomy plate by hand, ensuring that the plate follows the path created by the chisel. It is best to avoid using a hammer during initial insertion, so that one can feel the plate tracking properly along the chisel path. Verify with image intensification that the plate is following the chisel track. After the plate has been inserted sufficiently, affix the proper inserter/extractor and tighten with the ratchet wrench. This will provide control of the proximal fragment. Continue insertion using the hammer (Figure 3). Figure 4 Reduce the proximal and distal segments. Provisionally clamp the distal segment to the plate, using plate holding forceps. Check varus, flexion, and extension alignment. Remove the inserter/extractor. Use the impactor to completely insert the plate into the femoral neck (Figure 4). Use the previously placed guide wires to adjust rotation. Normal anteversion is approx imately 20, but other anteversion values may be appropriate. The triangular positioning plates can be used to measure rotation. Examine osteotomy alignment with image intensification. *Also available Cannulated Pediatric Osteotomy System (CAPOS) Surgical Technique DePuy Synthes 11

Secure Plate 8 Secure plate Instrument 332.352 or Inserter/Extractors 332.353 Secure the plate to the femoral shaft using standard DCP System screw insertion technique, selecting the appropriate size cortex screws. The final result should be verified with AP and lateral views. 332.352 and plate 332.353 and plate 11 DePuy Synthes Cannulated Pediatric Osteotomy System (CAPOS) Surgical Technique

Postoperative Care and Cleaning Tip Postoperative care Postoperative care depends on many factors and needs to be individualized by the surgeon. Bed rest, spica casting, or mobilization with partial weight bearing is dependent upon patient age, compliance, and diagnosis. Cleaning tip Instruments 319.26 or Cleaning Brushes (1.75 mm or 2.1 mm) 319.27 319.35 or Cleaning Stylets (1.6 mm or 2.0 mm) 319.36 Cleaning the cannulation of the chisels is imperative to prevent accumulation of debris. Instruments can be cleaned intraoperatively using the cleaning stylets and postoperatively using the cleaning brushes. Cannulated Pediatric Osteotomy System (CAPOS) Surgical Technique DePuy Synthes 11

Selected Instruments from CAPOS Instrument Set (105.364) 319.26 1.75 mm Cleaning Brush 319.27 2.1 mm Cleaning Brush 319.35 1.6 mm Cleaning Stylet 319.36 2.0 mm Cleaning Stylet 332.09 Chisel Guide, with adjustable angle 332.173 Cannulated Chisel, for use with Infant Osteotomy Plates 332.174 Cannulated Chisel, for use with Toddler Osteotomy Plates 332.175 Cannulated Chisel, for use with Child and Adolescent Osteotomy Plates 11 DePuy Synthes Cannulated Pediatric Osteotomy System (CAPOS) Surgical Technique

Selected Instruments from CAPOS Instrument Set (105.364) 332.21 Impactor 332.352 Inserter/Extractor, for bifurcated, infant, and toddler osteotomy plates 332.353 Inserter/Extractor, for Child and Adolescent Osteotomy Plates 332.354 Saw Guide, for Child/Adolescent Osteotomy Plates Bottom Side 332.355 Saw Guide, for Toddler Osteotomy Plates Bottom Side 332.356 Saw Guide, for Infant Osteotomy Plates Bottom Side Cannulated Pediatric Osteotomy System (CAPOS) Surgical Technique DePuy Synthes 11

Selected Instruments from CAPOS Instrument Set (105.364) 333.060 90 / 50 / 40 Triangular Positioning Plate 333.070 80 / 70 / 30 Triangular Positioning Plate 333.080 100 / 60 / 20 Triangular Positioning Plate 333.683 Adjustable Wire Guide, for 1.6 mm to 2.0 mm Guide Wires 11 DePuy Synthes Cannulated Pediatric Osteotomy System (CAPOS) Surgical Technique

Cannulated Pediatric Osteotomy System (CAPOS) Instrument Set (105.364) Graphic Case 690.364 Cannulated Pediatric Osteotomy System Instrument Set Graphic Case Instruments 292.20 2.0 mm Kirschner Wire, 150 mm, trocar point, 1 pkg. of 10 292.652 2.0 mm Non-Colored Threaded Guide Wire, 230 mm, spade point, 4 ea. 292.722 1.6 mm Non-Colored Threaded Guide Wire, 150 mm, spade point, 4 ea. 310.25 2.5 mm Drill Bit, quick coupling, gold, 110 mm, 2 ea. 310.31 3.2 mm Drill Bit, quick coupling, 145 mm, 2 ea. 311.32 Tap for 3.5 mm Cortex Screws, gold, 110 mm 311.44 T-Handle, with quick coupling 311.46 Tap for 4.5 mm Cortex and 4.5 mm Shaft Screws, 130 mm, 57 mm tap depth 312.20 2.0 mm Parallel Drill Guide and Drill Sleeve 314.03 Small Hexagonal Screwdriver Shaft, quick coupling 314.070 Small Hexagonal Screwdriver, 2.5 mm width across flats 314.09 Holding Sleeve (for small hexagonal screwdrivers) 314.11 Holding Sleeve (for large hexagonal screwdrivers) 314.15 Large Hexagonal Screwdriver Shaft, quick coupling 314.27 Large Hexagonal Screwdriver 319.04 Depth Gauge, for 2.7 mm and small screws 319.10 Depth Gauge, for large screws 319.17 Cannulated Screw (Direct) Measuring Device, for use with 4.5 mm Cannulated Screws 319.21 Cannulated Screw (Direct) Measuring Device, for use with 7.0 mm Cannulated Screws Note: For additional information, please refer to package insert. For detailed cleaning and sterilization instructions, please refer to www.synthes.com/cleaning-sterilization or sterilization instructions, if provided. Cannulated Pediatric Osteotomy System (CAPOS) Surgical Technique DePuy Synthes 11

Cannulated Pediatric Osteotomy System (CAPOS) Instrument Set (105.364) 319.26 1.75 mm Cleaning Brush 319.27 2.1 mm Cleaning Brush 319.35 1.6 mm Cleaning Stylet 319.36 2.0 mm Cleaning Stylet 321.12 Articulated Tension Device, with gauge, span 20 mm 321.20 Ratchet Wrench, 11 mm width across flats 323.36 3.5 mm Universal Drill Guide 323.46 4.5 mm Universal Drill Guide 332.09 Chisel Guide, with adjustable angle 332.173 Cannulated Chisel, for use with Infant Osteotomy Plates 332.174 Cannulated Chisel, for use with Toddler Osteotomy Plates 332.175 Cannulated Chisel, for use with Child and Adolescent Osteotomy Plates 332.20 Slotted Hammer 332.21 Impactor 332.352 Inserter/Extractor, for bifurcated, infant, and toddler osteotomy plates 332.353 Inserter/Extractor, for Child and Adolescent Osteotomy Plates 332.354 Saw Guide, for Child/Adolescent Osteotomy Plates 332.355 Saw Guide, for Toddler Osteotomy Plates 332.356 Saw Guide, for Infant Osteotomy Plates 333.060 90 / 50 / 40 Triangular Positioning Plate 333.070 80 / 70 / 30 Triangular Positioning Plate 333.080 100 / 60 / 20 Triangular Positioning Plate 333.683 Adjustable Wire Guide, for 1.6 mm to 2.0 mm Guide Wires 359.204 Locking Pliers 399.42 Hammer, 500 grams 22 DePuy Synthes Cannulated Pediatric Osteotomy System (CAPOS) Surgical Technique

Cannulated Pediatric Osteotomy System (CAPOS) Implant Set (105.365) Graphic Cases and Trays 60.108.010 Cannulated Pediatric Osteotomy System Implant Graphic Case Implants (in 60.108.010) 3.5 mm Cortex Screws, self-tapping, 8 ea. Length (mm) Length (mm) 204.814 14 204.824 24 204.816 16 204.826 26 204.818 18 204.828 28 204.820 20 204.830 30 204.822 22 115 Bifurcated Plates, 2 holes, 2 ea. Blade Length (mm) Displacement (mm) 236.400 30 5 236.430 35 5 90 Infant Osteotomy Plates, 2 ea. Blade Length (mm) Displacement (mm) 236.250 25 7 236.260 32 7 236.350 25 12 236.360 32 12 90 Toddler Osteotomy Plates, 2 ea. Blade Length (mm) Displacement (mm) 236.001 26 4 236.002 32 4 236.011 26 8 236.012 32 8 236.013 38 8 100 Toddler Osteotomy Plates, 2 ea. Blade Length (mm) Displacement (mm) 236.101 26 4 236.102 32 4 236.103 38 4 236.104 44 4 236.111 26 8 236.112 32 8 236.113 38 8 236.114 44 8 Cannulated Pediatric Osteotomy System (CAPOS) Surgical Technique DePuy Synthes 22

Cannulated Pediatric Osteotomy System (CAPOS) Implant Set (105.365) Implants (in 60.108.010) 4.5 mm Cortex Screw, self-tapping, 8 ea. Length (mm) Length (mm) 214.816 16 214.826 26 214.818 18 214.828 28 214.820 20 214.830 30 214.822 22 214.832 32 214.824 24 80 Child Osteotomy Plates, 2 ea. Blade Length (mm) Displacement (mm) 235.170 35 8 235.190 45 8 90 Child Osteotomy Plates, 2 ea. Blade Length (mm) Displacement (mm) 235.270 35 8 235.290 45 8 100 Child Osteotomy Plates, 2 ea. Blade Length (mm) Displacement (mm) 235.370 35 8 235.390 45 8 90 Adolescent Osteotomy Plates, 2 ea. Blade Length (mm) Displacement (mm) 235.600 50 10 235.680 40 10 235.700 50 15 235.720 60 15 235.780 40 15 100 Adolescent Osteotomy Plates, 2 ea. Blade Length (mm) Displacement (mm) 235.601 50 10 235.681 40 10 235.701 50 15 235.721 60 15 235.781 40 15 Instrument 319.97 Screw Forceps 22 DePuy Synthes Cannulated Pediatric Osteotomy System (CAPOS) Surgical Technique

Also Available 90 Infant Osteotomy Plates Blade Length (mm) Displacement (mm) 236.352 37 12 236.354 42 12 90 Toddler Osteotomy Plate Blade Length (mm) Displacement (mm) 236.003 38 4 95 Condylar Plates, 5 holes Blade Length (mm) Shaft Length (mm) 282.50 50 92 282.52 60 92 282.54 70 92 282.58 40 92 95 Condylar Plates, 7 holes Blade Length (mm) Shaft Length (mm) 282.70 50 124 282.72 60 124 282.74 70 124 282.78 40 124 95 Condylar Plates, 9 holes Blade Length (mm) Shaft Length (mm) 282.90 50 156 282.92 60 156 282.94 70 156 282.98 40 156 130 Angled Blade Plates, 4 holes* Blade Length (mm) Shaft Length (mm) 283.40 50 60 283.42 60 60 283.44 70 60 283.46 80 60 130 Angled Blade Plates, 6 holes* Blade Length (mm) Shaft Length (mm) 283.60 50 104 283.62 60 104 283.64 70 104 283.66 80 104 130 Angled Blade Plates, 9 holes* Blade Length (mm) Shaft Length (mm) 283.90 50 152 283.92 60 152 283.94 70 152 283.96 80 152 332.19 Seating Chisel 398.811 Plate Holding Forceps with swivel foot, size 0 398.812 Plate Holding Forceps with swivel foot, size 1 398.813 Plate Holding Forceps with swivel foot, size 2 *Note: Seating Chisel (332.19) is needed for use with these plates. Cannulated Pediatric Osteotomy System (CAPOS) Surgical Technique DePuy Synthes 22

Limited Warranty and Disclaimer: DePuy Synthes 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. Please also refer to the package insert(s) or other labeling associated with the devices identified in this surgical technique for additional information. CAUTION: Federal Law restricts these devices to sale by or on the order of a physician. Some devices listed in this surgical technique may not have been licensed in accordance with Canadian law and may not be for sale in Canada. Please contact your sales consultant for items approved for sale in Canada. Not all products may currently be available in all markets. Manufactured or distributed by: Synthes USA Products, LLC 1302 Wrights Lane East West Chester, PA 19380 Synthes USA, LLC 1101 Synthes Avenue Monument, CO 80132 To order (USA): 800-523-0322 To order (Canada): 855-946-8999 Note: For recognized manufacturer, refer to the product label. www.depuysynthes.com DePuy Synthes 2010 2017. All rights reserved. DSUS/TRM/0916/1041 6/17 DV