Opti Lock Proximal Humeral Plating Surgical Technique
2016-04-01
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Surgical Technique OptiLock Upper Extremity Plating System Proximal Humeral Plates ® Featuring SphereLock™ Technology • Anatomical plate contouring and diverging “showerhead” splay of bone screws allow plate to sit more distally on humerus to help avoid plate impingement with shoulder abduction • All screw holes accept either a 3.5mm cortical locking or non-locking bone screw which can be of benefit if trying to capture a fracture fragment in the head or closely appose the plate to the bone of the humeral head Contents Introduction.................................................................... Page 1 Indications and Contraindications................................... Page 2 Design Features............................................................. Page 2 Surgical Technique......................................................... Page 5 Proximal Humeral Plates and Screws............................. Page 14 Instruments.................................................................... Page 15 Disposables.................................................................... Page 17 Ordering Information....................................................... Page 18 Further Information......................................................... Page 20 Introduction Proximal humeral fractures account for 4% to 5% of all fractures in the United States1. These fractures typically occur in elderly osteoporotic patients and may involve the humeral head, surgical neck or proximal shaft . Proximal humeral fractures also occur in younger patients secondary to high energy mechanisms. Most of these fractures are minimally displaced or nondisplaced and can be managed conservatively with immobilization and early motion. However, 15% to 20% are displaced and represent a challenge to the orthopedic surgeon2. As part of the OptiLock Upper Extremity Plating System, OptiLock Proximal Humeral Plates are intended to address complex fractures of the proximal humerus. These plates are low profile, stainless steel and available in 2-hole (75mm), 4-hole (99mm), 6-hole (123mm) and 10-hole (171mm) lengths. Each of these plates is anatomically side-specific, e.g. left or right. 1 Lind T, Kroner K, Jensen J. The epidemiology of fractures of the proximal humerus. Arch Orthop Trauma Surg. 1989;108:285-287. 2 Tejwani N, Et Al. Functional Outcome Following One-Part Proximal Humeral Fractures; A Prospective Study. J Shoulder Elbow Surgery 2008; Volume 17, No. 2; 216-219. 1 Indications and Contraindications Design Features INDICATIONS • Anatomical plate contouring and bone screw trajectories allow plate to sit more distally on humerus to help avoid plate impingement with shoulder abduction The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies. The System is intended for fractures and fracture dislocations, osteotomies and nonunions of the proximal humerus, particularly in osteopenic bone. The System is intended for fixation of fractures, osteotomies and nonunions of the olecranon, humerus, radius, ulna, particularly in osteopenic bone. Patient selection factors to be considered include: 1. Need for alignment and stabilization of bone fractures 2. Ability and willingness of the patient to follow postoperative care instructions until healing is complete 3. A good nutritional state of the patient. CONTRAINDICATIONS 1. 2. 3. 4. • Patent pending SphereLockTM technology allows all screw holes to accept either a 3.5mm cortical locking or a non-locking bone screw which can be of benefit if trying to capture a fracture fragment in the head or closely appose the plate to the bone of the humeral head. • All SphereLock™ (locking and non-locking) bone screws are available in lengths of 10-44mm in increments of 2mm and 44-60mm in increments of 4mm • The most distal hole allows for dual trajectory placement based on surgeon preference and nature of fracture • Low profile plate and screw heads minimize soft tissue impingement Active infection. Patient conditions including blood supply limitations, and insufficient quantity or quality of bone. Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions or materials. Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation of the device. P/N 377xx (Locking Screw) P/N 367xx (Non-Locking Screw) * Although plates are pre-contoured, Bending Irons (P/N 36595) are available if needed. 2 Design Features (Continued) P/N 37102 (Proximal Humeral Plate Right, 2-Holes, 75mm) Lateral View (All Plates) P/N 37104 (Proximal Humeral Plate Right, 4-Holes, 99mm) P/N 36110 (Proximal Humeral Plate Left, 10-Holes, 171mm) P/N 37106 (Proximal Humeral Plate Right, 6-Holes, 123mm) P/N 36106 (Proximal Humeral Plate Left, 6-Holes, 123mm) P/N 37110 (Proximal Humeral Plate Right, 10-Holes, 171mm) P/N 36104 (Proximal Humeral Plate Left, 4-Holes, 99mm) P/N 36102 (Proximal Humeral Plate Left, 2-Holes, 75mm) 3 Design Features (Continued) Six suture holes with bottom profile facilitate suture access Oversized hole in head of plate facilitates delivery of osteobiologics • Threaded compression slot, which is lockable at both ends, can be used to aid in plate positioning and fracture reduction • A non-locking screw can be used for compression of plate to bone Dual trajectory screw hole Cannulated targeting jig which (90˚ perpendicular to plate or attaches via an attachment screw in 25˚ off-center distally) hole allows easier proximal K-wire insertion and drill guide insertion • Threaded screw holes in the proximal portion of plate allow for a diverging “showerhead” splay of bone screws (Figure 1) • Universal driver fits bone screws and can be used to attach/remove locking drill guides • Non-locking drill guides have detachable handles Figure 1 4 Surgical Technique Patient Positioning A beach-chair or supine position is recommended. The head and neck must be safely stabilized, and full access to the shoulder girdle will be required. The operating table must be oriented to allow positioning of the intraoperative image intensifier for proper AP and lateral views of the shoulder. This can be obtained with the aid of a radiolucent table or bringing the C-arm in from above the head of the patient. Exposure Step 1: A standard 12-14cm incision is made from the coracoid towards the deltoid insertion on the humerus. Step 4: The pectoralis is retracted inferiorly and medially. The conjoint tendon is identified and retracted medially with hand-held retractors. CAUTION: Should be used with deep self-retaining retractors to avoid injury to the musculocutaneous nerve. Step 5: Blunt dissection in the subacromial space and the subdeltoid area is carried out to allow full circumferential soft tissue release. The fracture is visualized. The bicep tendon is easily identified beneath the pectoralis, which helps to orientate the fracture pattern. Step 6: After exposure of the fracture, and limited debridement to allow identification of fracture fragments, heavy #2 nonabsorbable braided sutures are placed into the supraspinatus tendon insertion on the greater tuberosity and the subscapularis tendon insertion on the lesser tuberosity. This allows manipulation of displaced tuberosity fragments and helps facilitate reduction. In case there is severe comminution, suture repair of the rotator interval and the lesser and greater tuberosities can be done. Under image intensifier guidance, manual manipulation and reduction of the fracture can be carried out. Correction of any medial and lateral displacements of the humeral shaft as well as ensuring that correction of the typical varus and posterior angulation of the humeral head should be carried out. Step 2: The cephalic vein is isolated. This identifies the deltopectoral interval. Provisional fixation with the K-wire placed along the anterior aspect of the humeral shaft into the humeral head can be done. The K-wire should be placed to avoid interference with planned placement of the OptiLock Proximal Humeral Plate. Step 3: Blunt dissection of the deltoid is performed to release adhesions of the proximal humerus. 5 Surgical Technique (Continued) Attach Targeting Jig to the Plate Attach the low profile Targeting Jig Head [P/N 36118 or 37118] (Figure 2) to the appropriate plate, left or right sided, and lock it into place by tightening the jig’s attachment screw with the Hex Screwdriver [P/N 36505] (Figure 3). (Top) (Side) Left Jig Head (P/N 36118) shown Figure 2 Figure 3 6 Final Application of the Plate to the Bone Positioning from AP view 15mm This low profile locking plate is designed to be placed approximately 10-15mm distal to the rotator cuff attachment on the greater tuberosity (Figure 5). Figure 5 Provisional plate positioning can be achieved by passing two 1.6 mm K-wires [P/N 14-4014401] through the targeting jig. (Figure 6). Figure 6 7 Surgical Technique (Continued) Positioning from a lateral view The plate should be positioned against the greater tuberosity (Figure 7), placed just lateral to bicipital groove. NOTE: To check the placement of the plate, before inserting screws, 1.6mm K-wires can be used through the proximal K-wire holes.* *K-wires and suture have been omitted for better visual. Check plate and K-wire placement on multiple C-Arm views including AP, axillary and lateral views. Figure 7 8 Insert Screws* The placement of the initial screw will depend on the fracture type and the reduction achieved. OPTION 1: Insertion of proximal screws first • This will permit fixation of proximal fragments initially. • Verify the correct placement of the plate in the proximal-distal dimensions with image intensifier, and proper reduction of the fracture. • Locking screw guides [P/N 36526] are then utilized to place locking screws into the humeral head. *IMPORTANT: 1) Placement of distal screws first can compromise the proximal screw trajectories. Special care must be taken at this point to ensure the fracture is properly reduced and the plate is aligned correctly on the greater tuberosity. 2) Only place ONE screw in the slotted hole. 3) Use of the Torque Limiting Coupler (p/n 36510) is strongly recommended if inserting the bone screws under power. Final turns of the bone screws are then to be done by hand. 4) Do not use the Torque Limiting Coupler with the A/O Driver Handles (p/n 22875, 22880). 9 Surgical Technique (Continued) Proximal locking screw insertion • Insert a 1.6mm K-Wire, 150mm [P/N 14-4014401] through the hole designation in the jig assembly to hold plate to bone. • Insert the appropriate locking drill guide [P/N 36526] into the Targeting Jig Head [P/N 36118 or 37118] (Figure 8). • Drill the near cortex with the 2.7mm Drill Bit [P/N 36550] (Figure 9). Screw length can then be read directly off the Figure 8 calibrated drill bit while in the drill guide, or measured using the Depth Gauge [P/N 36515] (Figure 10). IMPORTANT: Selection of screw length for the proximal screws must take into account possible fracture collapse. Make sure the screws are 4mm shorter than measured so that they do not protrude through the joint surface if collapse does occur. NOTE: Inserting strong, non-absorbable sutures through the provided suture holes on the outer perimeter can help control, anatomically Figure 9 reduce the fragments and also increase construct stability postoperatively. The suture can be inserted/passed through the suture holes before or after plate placement due to scalloping of plate. Figure 10 10 Insert Screws (Continued) Insert the appropriate length locking screw using the Hex Screwdriver, [P/N 36505] (Figure 11). Use of the Torque Limiting Coupler [P/N 36510] is recommended. NOTE: This depth gauge will give a measurement for the proximal screws when used through the Insertion Guide and will give a measurement for the distal screws when seated in hole of plate. To ensure that the screw tip is a sufficient distance from Figure 11 the joint surface, 5mm should be deducted from depth gauge readings for the proximal screw. Check K-wire and screw placement on multiple C-Arm views including AP, axillary and lateral views to avoid articular penetration. 11 Surgical Technique (Continued) OPTION 2: Insertion of distal screw first. This will provide fixation of the shaft fragment (Figure 12). A non-locking screw placed into the oval hole will allow reduction of the plate to the humeral shaft. This will also allow fine adjustments of the plate proximally or distally. Proximal screws may then be placed utilizing the locking drill guides and the targeting jig. Figure 12 NOTE: It is recommended that 5mm be subtracted from the measured distance of the lateral humeral cortex to the subchondral bone. Final Construct Distal locking screw insertion • Insert the threaded portion of the Drill Guide into the threaded part of the shaft holes. • Drill with the 2.7mm Drill Bit and remove the Drill Guide. • Measure screw length with the Depth Gauge [P/N 36515]. For proper drilling, the 2.7mm Threaded Drill Guide [P/N 36526] must be used for locking screws. NOTE: For more rigid fixation, insertion of the locking screw through both cortices is recommended. Distal standard screw insertion • For non-locking screws, use the standard screw insertion technique. • Use the 2.7mm Threaded Drill Guide when drilling holes for the 3.5mm locking screws in the shaft holes of the plate. • Use the 2.5mm Drill Bit for drilling when using non-locking screws. 12 Implant Removal To remove locking screws, loosen all screws 1-2 turns, disengaging from the plate, then remove the screws completely from the bone. This will prevent rotation of the plate when removing the last locking screw. A Hex Driver can be used, but superior torque can be achieved utilizing the Torx Driver (P/N 36505). NOTE: Supplied Torx Driver can withstand more torque than hex. Osteobiologics To help facilitate healing in the resultant defect, the use of Biomet osteobiologics should be considered: • Osteobiologic material (DBM, scaffolding and osteogenic material) may be placed in the fracture gap through the oversized osteobiologics hole in the plate. • InterGro DBM Paste may be directly inserted through the hole using accessory extensions included in packaging (extensions are included in 2cc and 5cc sizes of InterGro Paste and 5cc and 10cc sizes of Biomet DBM Putty). • Scaffolding material (Pro Osteon 500R Granules) may be inserted manually through the same hole followed by a DBM to assist in holding the scaffold in place. Osteogenic material (bone marrow aspirate for example) may be injected through the hole as well. 13 Proximal Humeral Plates and Screws Proximal Humeral Plate (Left, 2 Holes, 75mm ) P/N: 36102 Proximal Humeral Plate (Right, 2 Holes, 75mm ) P/N: 37102 Proximal Humeral Plate (Left, 4 Holes, 99mm) P/N: 36104 Proximal Humeral Plate (Right, 4 Holes, 99mm) P/N: 37104 Proximal Humeral Plate (Left, 6 Holes, 123mm) P/N: 36106 Proximal Humeral Plate (Right, 6 Holes, 123mm) P/N: 37106 Proximal Humeral Plate (Left, 10 Holes, 171mm) P/N: 36110 Proximal Humeral Plate (Right, 10 Holes, 171mm) P/N: 37110 3.5mm Non-Locking Screws P/N: 36710 through 36760 3.5mm Locking Screws P/N: 37710 through 37760 14 Instruments* Drill A/O Connector Torque Limiting Coupler P/N: 22855 P/N: 36510 Fixed A/O Handle 2.0mm Depth Gauge P/N: 22875 P/N: 36515 Ratcheting A/O Handle 2.0mm Guide Wire Sleeve, 2.7mm Drill Guides (Locking) P/N: 22880 P/N: 36522, 36526 Torx A/O Driver 2.5mm, 3.5mm Drill Guides (Non-Locking) P/N: 36505 P/N: 36534, 36538 15 Instruments (Continued)* 3.5mm Non-Locking Screw Tap P/N: 36546 Large Plate Holding Forceps P/N: 36597 3.5mm Locking Screw Tap P/N: 36551 Left Humeral Jig Head P/N: 36118 Drill Guide Handle P/N: 36575 Right Humeral Jig Head P/N: 37118 * Not shown are 3.5mm Locking and Non-Locking Screw Taps (p/n 36551) and Large Bone Holding-Forceps (p/n 22896). 16 Disposables Osteobiologics 2.5mm, 2.7mm, 3.5mm A/O Drill Bit P/N: 36545, 36550, 36555 InterGro DBM Paste 1.6mm x 150mm Guide Wire P/N: 14-4014401 Pro Osteon 500R Granules 17 Ordering Information OptiLock Upper Extremity Plating System 3.5mm Non-Locking Screws (cont’d) Proximal Humeral Plates* Catalog No. Description Set Qty Catalog No. Description Set Qty 36738 3.5mm x 38mm Non-Locking Screw 2 36102 Proximal Humeral Plate, Left 2 Holes, 75mm 2 36740 3.5mm x 40mm Non-Locking Screw 2 36742 3.5mm x 42mm Non-Locking Screw 2 36104 Proximal Humeral Plate, Left 4 Holes, 99mm 2 36744 3.5mm x 44mm Non-Locking Screw 2 36748 3.5mm x 48mm Non-Locking Screw 2 36106 Proximal Humeral Plate, Left 6 Holes, 123mm 1 36752 3.5mm x 52mm Non-Locking Screw 2 36756 3.5mm x 56mm Non-Locking Screw 2 36110 Proximal Humeral Plate, Left 10 Holes, 171mm 1 36760 3.5mm x 60mm Non-Locking Screw 2 37102 Proximal Humeral Plate, Right 2 Holes 75mm 2 37104 Proximal Humeral Plate, Right 4 Holes, 99mm 2 37106 Proximal Humeral Plate, Right 6 Holes, 123mm 1 37110 Proximal Humeral Plate, Right 10 Holes, 171mm 1 3.5mm Locking Screws Catalog No. Description 37710 3.5mm x 10mm Locking Screw 5 37712 3.5mm x 12mm Locking Screw 5 37714 3.5mm x 14mm Locking Screw 5 37716 3.5mm x 16mm Locking Screw 5 37718 3.5mm x 18mm Locking Screw 5 37720 3.5mm x 20mm Locking Screw 5 37722 3.5mm x 20mm Locking Screw 5 37724 3.5mm x 24mm Locking Screw 5 37726 3.5mm x 26mm Locking Screw 5 Set Qty 37728 3.5mm x 28mm Locking Screw 5 3.5mm x 30mm Locking Screw 5 3.5mm Non-Locking Screws Catalog No. Description Set Qty 36710 3.5mm x 10mm Non-Locking Screw 2 37730 36712 3.5mm x 12mm Non-Locking Screw 2 37732 3.5mm x 32mm Locking Screw 5 3.5mm x 34mm Locking Screw 5 36714 3.5mm x 14mm Non-Locking Screw 2 37734 36716 3.5mm x 16mm Non-Locking Screw 2 37736 3.5mm x 36mm Locking Screw 5 3.5mm x 38mm Locking Screw 5 36718 3.5mm x 18mm Non-Locking Screw 2 37738 36720 3.5mm x 20mm Non-Locking Screw 2 37740 3.5mm x 40mm Locking Screw 5 3.5mm x 42mm Locking Screw 5 36722 3.5mm x 22mm Non-Locking Screw 2 37742 36724 3.5mm x 24mm Non-Locking Screw 2 37744 3.5mm x 44mm Locking Screw 5 3.5mm x 48mm Locking Screw 5 36726 3.5mm x 26mm Non-Locking Screw 2 37748 36728 3.5mm x 28mm Non-Locking Screw 2 37752 3.5mm x 52mm Locking Screw 5 3.5mm x 56mm Locking Screw 5 3.5mm x 60mm Locking Screw 5 36730 3.5mm x 30mm Non-Locking Screw 2 37756 36732 3.5mm x 32mm Non-Locking Screw 2 37760 36734 3.5mm x 34mm Non-Locking Screw 2 36736 3.5mm x 36mm Non-Locking Screw 2 *Description includes total length of plate, e.g. 75mm. 18 Instruments Disposables Catalog No. Description Set Qty Catalog No. Description Set Qty 22855 Drill A/O Connector 1 36545 2.5mm A/O Drill Bit 2 22875 Fixed A/O Handle 1 36546 3.5mm Non-Locking Screw Tap 1 22880 Ratcheting A/O Handle 1 36550 2.7mm A/O Drill Bit 2 36118 Left Low Profile Humeral Jig Head 1 36551 3.5mm Locking Screw Tap 1 36505 Torx A/O Driver 2 36555 3.5mm A/O Drill Bit 2 36510 Torque Limiting Coupler 1 14-4014401 1.6mm x 150mm Guide Wire 5 36515 2.0mm Depth Gauge 1 (Non-threaded) 36522 Guide Wire Sleeve 2 36534 2.5mm Drill Guide (Non-Locking) 2 36526 2.7mm Drill Guide (Locking) 3 36538 3.5mm Drill Guide (Non-Locking) 2 36546 3.5mm Non-Locking Screw Tap 1 36551 3.5mm Locking Screw Tap 1 36575 Drill Guide Handle 2 36594 Plate Holding Forceps 1 36595 Plate Bender 2 36597 Large Plate Holding Forceps 1 37118 Right Low Profile Humeral Jig Head 1 19 Further Information This brochure describes the surgical technique used by Brian Notes: Chalkin, D.O., Kumar Kadiyala, M.D. and Nirmal Tejwani, M.D. Biomet Trauma, as the manufacturer of this device, does not practice medicine and does not recommend this product or any surgical technique for use on any individual patient. The surgeon who performs any implant procedure is responsible for determining the appropriate product(s) and utilizing the appropriate technique(s) for said implantation in each individual patient. For further information, please contact the Customer Service Department at: Biomet Trauma 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587 800.348.9500 x 1501 www.biomet.com 20 All trademarks herein are the property of Biomet, Inc. or its subsidiaries unless otherwise indicated. This material is intended for the sole use and benefit of the Biomet sales force and health care professionals. It is not to be redistributed, duplicated or disclosed without the express written consent of Biomet. For product information, including indications, contraindications, warnings, precautions and potential adverse effects, see the package insert and Biomet’s website. Responsible Manufacturer Biomet, Inc. P.O. Box 587 56 E. Bell Drive Warsaw, Indiana 46581-0587 USA ©2013 Biomet Orthopedics • Form No. BMET0339.0 • REV011513 www.biomet.com Rx only.
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