S3 Prox Humerus Surgical Technique
2016-04-01
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Proximal Humerus Plating System Surgical Technique One Surgeon. One Patient. Over 1 million times per year, Biomet helps one surgeon provide personalized care to one patient. The science and art of medical care is to provide the right solution for each individual patient. This requires clinical mastery, a human connection between the surgeon and the patient, and the right tools for each situation. At Biomet, we strive to view our work through the eyes of one surgeon and one patient. We treat every solution we provide as if it’s meant for a family member. Our approach to innovation creates real solutions that assist each surgeon in the delivery of durable personalized care to each patient, whether that solution requires a minimally invasive surgical technique, advanced biomaterials or a patient-matched implant. When one surgeon connects with one patient to provide personalized care, the promise of medicine is fulfilled. S 3 Proximal Humerus Plating System Contents Introduction................................................................................................................................................................... 3 S3 Proximal Humerus Plating System........................................................................................................................... 4 Deltopectoral Approach................................................................................................................................................ 6 Surgical Technique........................................................................................................................................................ 8 Ordering Information................................................................................................................................................... 14 1 S 3 Proximal Humerus Plating System Introduction The S3 pegs and screws utilize blunt smooth ends so that fixation can be provided directly below the hard articular shell. Engaging the subchondral bone with blunt fixation and the use of a manually inserted blunt-tipped drill bit reduces the risk for articular surface penetration. Biomet’s experience in developing implants for fracture fixation through locked plating technology has been used to design the S3 plate for the management of proximal humerus fractures. The S3 Proximal Humerus Plate takes full advantage of the principle of spatial subchondral support successfully applied in the design of its sister product, the DVR Crosslock distal volar radiuwws plate. Indications The S3 Proximal Humerus Plate is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus. The S3 system is designed around the natural anatomy of the proximal humerus to address varus collapse. Convergent and divergent fixed angle pegs are centered around the natural 135° neck-shaft angle of the proximal humerus. The central guiding k-wire provides visual confirmation for plate positioning, ensuring that the predetermined peg trajectories will provide consistent spatial distribution within the humeral dome. This unique concept of humeral fixation helps resist varus forces throughout the full range of motion. Surgical Approach Proximal Humeral fractures are treated with the S3 Proximal Humerus Plating System through the deltopectoral approach. The S3 plate has been designed to help prevent subacromial impingement. The unique design of the S3 allows the plate to be positioned more distally, minimizing the risk of impingement. 3 S 3 Proximal Humerus Plating System Minimizes Subacromial Impingement • The S3 plate is designed to be positioned approximately 3.0 cm distal to the greater tuberosity helping to prevent subacromial impingement 3.0 cm Minimizes Varus Collapse Provides Strong and Secure Fixation • The parametric design of the pegs distribute the loads more anatomically through the full range of motion by maintaining the neck shaft angle of 135º minimizing the risk of varus collapse. • The proximal end of the S3 plate has fixed angle locking pegs/screw holes. Its parametric design of convergent and divergent screw peg trajectories ensures a consistent spatial distribution of the pegs within the entire humeral head. This particular distribution provides spatial subchondral support to resist varus forces throughout the full range of motion. • 4.0 mm blunt tipped subchondral support smooth or threaded pegs provide stability while preventing protrusion through the articular surface. • Proximal and distal locking pegs and screws provide a strong interface for a stable fixation. 135˚ 4 Ease of Use F.A.S.T. Guide Technology The S3 plate comes preloaded with Fixed Angle Screw Targeting Guides – F.A.S.T. Guide Technology – facilitating accurate drilling and easy plate identification (left vs right). Central K-wire Central K-wire hole provides a guide for initial plate positioning through the use of fluoroscopy and temporary fixation. Suture Holes Suture holes allow for simplified tuberosity repairs after humeral head fixation through frontal and lateral access. User Friendly System Design Intuitive set layout and simple instrumentation allow for convenience in surgery. 5 S 3 Proximal Humerus Plating System Figure 1 Figure 3 Cephalic vein Figure 2 Deltopectoral Approach Patient positioning and approach Exposure The procedure can be performed in the beach-chair position or supine position (Figure 1) as per the surgeon’s discretion. If necessary, a sterile mayo stand can be used to assist during dissection. Make an incision approximately 12–14 cm over the coracoid process, extending down to the deltoid insertion in an oblique fashion. Identify and retract the cephalic vein (Figure 3). Assess the fracture fluoroscopically. Note: Taking the cephalic vein medially provides additional protection against perforation during drilling. Examine the fracture based on intraoperative fluoroscopy. Internal rotation, external rotation and sometimes axillary views are necessary (Figure 2). 6 Figure 4 Figure 6 Figure 5 Identify the Biceps Tendon Fracture Debridement and Reduction Gently retract the coracobrachialis medially. Find the pectoralis insertion at the floor of the deltoid pectoralis interval (Figure 4). If necessary, release the proximal third of the pectoralis tendon to expose the biceps. Reduce the humeral head fragments using traction and manipulation and check the reduction under fluoroscopy (Figure 6). Note: In the case of severe comminution, suturing the rotator cuff together will help reduce the tuberosities. To facilitate healing, bone graft should be considered. Complete Exposure Develop the subacromial space and mobilize the proximal deltoid (Figure 5). Note: Use of a large, blunt humeral head depressor can facilitate exposure. 7 S 3 Proximal Humerus Plating System Figure 9 Figure 7 Figure 8 Surgical Technique Plate Positioning Drill Central K-Wire Select the appropriate side plate (lime=left; rose=right) and length (3, 4, 6, 8, 11 or 14 hole) (Figure 7). Drill the 2.0 mm K-wire (KW20SS) through the central K-wire hole on the proximal portion of the plate aiming the center of the humeral head (Figure 9). Position the plate 2.5–3.0 cm distal to the greater tuberosity. The anterior border of the plate (straight border) should be immediately lateral to the bicepital groove (Figure 8). 8 135˚ Figure 10 Figure 12 Figure 11 Verify Central K-Wire Distal Plate Provisional Fixation Check the trajectory of the central K-wire under fluoroscopy. If there’s a deviation from the center of the humeral head remove the K-wire and redrill until the center is reached (Figure 10). Drill through the oblong hole of the plate shaft with the 2.8 mm Drill Bit (DB28) using the Soft Tissue Protector (SSTG) (Figure 11). Determine the required screw depth using the Depth Gauge (SBDG) (Figure 12). Note: Verify the positioning of the central k-wire, it should be in the center/ center position and centered on Anterior Posterior and Laterial views. Note: Other distal K-wire holes can be used to aid in fracture reduction and provisionally fix the plate to the bone. 9 S 3 Proximal Humerus Plating System Figure 13 Figure 15 3 6 5 2 1 4 Figure 14 Fix the plate into place with a 3.8 mm Multidirectional Cortical Screw (MD20-MD38) using the Hex Driver (FHDS) (Figure 13). and posterior inferior peg holes first, and then finish by drilling the remaining proximal holes in a crisscross, opposing fashion (Figure 14). Note: Do not fully tighten the screw to allow for later plate adjustments. Manual Drill for Subchondral Support Pegs To prevent the drill from protruding through the rear cortex the following step should be made by manual drilling (Figure 15). Note: Insert the second kickstand k-wire and/or the screw in the oblong hole, to reduce the possibility of the plate and fragments moving. With the 4.0 mm Long Drill Bit (FDB40L or FDS40) attached to the Driver Handle (QCH), advance through the proximal plate hole F.A.S.T. Guide inserts until resistance from subchondral bone is felt. This will ensure the peg engages subchondral bone for optimal fixation. Proximal Plate Fixation Drill through the inferior anterior F.A.S.T. Guide inserts with the 4.0 mm Short Drill Bit (FDB40S), and perforate the cortex. The drill bit has a stop that will only allow it to penetrate the near cortex. Note: Do not use powered drilling for inserting the subchondral pegs. When manual drilling for smooth pegs use the Long Drill Bit (FDB40L). When manual drilling for partially threaded pegs use the Step Drill Bit (FDS40). Note: The K-wire can be bent to avoid drill bit obstruction. Note: Fully seat the FDB40S (Short drill bit) into the F.A.S.T Guide before turning on power Note: Make multiple passes with the hand drill (FDB40L) to remove all material before inserting pegs. Note: To aid with peg engagement, start with the anterior 10 Figure 16 Figure 18 Figure 17 Determine Peg Length Peg Insertion Once resistance is felt, fluoroscopy imaging should verify that the tip of the manual drill is close to the subchondral bone (Figure 16). Care should be taken not to penetrate the subchondral bone. Use the appropriate side of the dual scale drill bit to determine the correct peg size. Remove and discard the respective F.A.S.T. Guide inserts (Figure 17) and insert the appropriate size peg using the Hex Driver (FHDS) (Figure 18). Note: If the pegs do not engage initially, re-insert the F.A.S.T. Guide insert or drill guide (DRGSH) and drill again using the hand drill (FDB40L) Note: If a F.A.S.T. Guide insert was removed before the screw length was recorded, insert the 4.0 mm Drill Guide (DRGSH) and measure using the appropriate side of the dual scale stepped Depth Gauge (FSDGS). 11 S 3 Proximal Humerus Plating System Figure 19 Figure 21 Figure 20 Attach Tuberosities to Plate Insert Distal Screws Secure the tuberosities to the plate by passing the needles close to the insertion of the tendon and then through to side, front or top loading wire attachment points found on the proximal end of the plate (Figure 19). Use the appropriate end of the Soft Tissue Protector (SSTG) and drill to the far cortex with the 2.8 mm Drill Bit (DB28) (Figure 20). Measure with the Barrel Depth Gauge (SBDG). Note: An alternate approach is to apply the sutures to the plate prior to placing the subchondral support pegs. This may aid in reduction. Fix the remaining Shaft Cortical Screws with either 90º Locking Screws (NL20-NL38; NLSS) or Multidirectional Screws (MD20-MD38) (Figure 21). Use a Set Screw (NLSS) to lock each 90º Screw to the plate. Do not use a set screw when using Multidirectional Screws. 12 Figure 22 Figure 23 Final Verification Evaluate the humerus under fluoroscopy to assess the reduction and to confirm proper plate positioning (Figure 22 & 23). 13 S 3 Proximal Humerus Plating System Ordering Information Pegs and Screws Smooth Peg, Locking Provide spatial subchondral support. Threaded Pegs, Locking Help to capture and lag the humeral head. Cat No: STP20 STP25 STP30 STP325 STP35 STP375 STP40 STP425 STP45 STP475 STP50 STP525 STP55 STP575 STP60 STP625 STP65 Cat No: STPT20 STPT25 STPT30 STPT325 STPT35 STPT375 STPT40 STPT425 STPT45 STPT475 STPT50 STPT525 STPT55 STPT575 STPT60 STP625 STP65 Size: 20 mm 25 mm 30 mm 32.5 mm 35.5 mm 37.5 mm 40 mm 42.5 mm 45 mm 47.5 mm 50 mm 52.5 mm 55 mm 57.5 mm 60 mm 62.5 mm 65 mm 90˚ Cortical Screws, Non-locking Provide bi-cortical fixation while locking to the plate using the NLSS set screws. Cat No: NL20 NL22 NL24 NL26 NL28 NL30 NL32 NL34 NL36 NL38 Size: 20 mm 22 mm 24 mm 26 mm 28 mm 30 mm 32 mm 34 mm 36 mm 38 mm Size: 20 mm 25 mm 30 mm 32.5 mm 35 mm 37.5 mm 40 mm 42.5 mm 45 mm 47.5 mm 50 mm 52.5 mm 55 mm 57.5 mm 60 mm 62.5 mm 65 mm Multi-directional Cortical Screws, Non-Locking Provide multi-directional fixation when used through the oblong hole. Cat No: MD20 MD22 MD24 MD26 MD28 MD30 MD32 NL34 NL36 MD38 Size: 20 mm 22 mm 24 mm 26 mm 28 mm 30 mm 32 mm 34 mm 36 mm 38 mm 14 90˚ Locking Set Screw Secures the 90˚ lock distal screws to the plate. Cat No: NLSS S3 Proximal Humerus Plating System Options S3 Plate, 3 Holes: 16 mm x 71 mm SSPL3 / SSPR3 Lime=Left; Rose=Right S3 Plate, 4 Holes: 16 mm x 84 mm SSPL4 / SSPR4 S3 Plate, 6 Holes: 16 mm x 108 mm SSPL6 / SSPR6 S3 Plate, 8 Holes: 16 mm x 150 mm SSPL8 / SSPR8 S3 Plate, 11 Holes: 16 mm x 190 mm SSPL11 / SSPR11 S3 Plate, 14 Holes: 16 mm x 236 mm SSPL14 / SSPR14 The S3 plate, pegs and screws are manufactured from 316L Stainless Steel. 15 S 3 Proximal Humerus Plating System S3 Proximal Humerus Plating Modular Tray Top Tray 1 2 3 4 5 6 7 8 SSTG DB28 SBDG FHDS FDB40S DRGSH FDS40 QCH 10 11 12 13 FDB40L SDI FSDGS MQC KW20SS 9 Soft Tissue Guide Drill Bit 2.8 mm Depth Gauge Hex Driver Drill Bit 4.0 mm Short Drill Guide 4.0 mm Drill Bit 4.0 mm Step Quick Connect Handle Drill Bit Fast 4.0 mm Long Square Driver Insert 2.0mm Depth Gauge Step Shoulder Fast Mini Quick Connect Handle K-wire 2.0 mm SS 5 10 12 3 8 4 1 13 4 2 7 9 11 12 6 Bottom Tray SSPL03 SSPL04 SSPL06 3 Hole Plate, Left 4 Hole Plate, Left 15 6 Hole Plate, Left SSPL08 8 Hole Plate, Left 16 SSPL14 14 Hole Plate, Left 17 SSPL11 11 Hole Plate, Left 14 14 18 16 17 SSPR03 SSPR04 19 SSPR06 3 Hole Plate, Right 4 Hole Plate, Right 6 Hole Plate, Right SSPR08 8 Hole Plate, Right 20 SSPR11 11 Hole Plate, Right 21 SSPR14 14 Hole Plate, Right 20 21 18 15 19 SNP Shoulder Nail Plate • The SNP Anatomic Plate Module Tray contains all SNP Anatomic Plate components • All other instruments and pegs/screws are found in the S3 Proximal Humeral Tray System The SNP Proximal Humeral Plating System provides the surgeon with a less invasive option than the S3 Proximal Humerus plate for fractures of the proximal humerus. The SNP combines the proximal stability of fixed angle locking pegs and suture attachments with the minimal soft tissue disruption of an intramedullary nail. 16 S3 Proximal Humerus Plating System Indications: The S3 Shoulder FIxation System is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus. Contraindications: If any of the following are suspected, tests are to be performed prior to implantation. Active or latent infection. Sepsis. Insufficient quantity or quality of bone and/or soft tissue. Material sensitivity. Patients who are unwilling or incapable of following post operative care instructions. 17 This material is intended for health care professionals and the Biomet sales force only. Distribution to any other recipient is prohibited. All content herein is protected by copyright, trademarks and other intellectual property rights owned by or licensed to Biomet Inc. or its affiliates unless otherwise indicated. This material must not be redistributed, duplicated or disclosed, in whole or in part, without the express written consent of Biomet. Check for country product clearances and reference product specific instructions for use. For complete product information, including indications, contraindications, warnings, precautions, and potential adverse effects, see the package insert and Biomet’s website. This technique was prepared in conjunction with a licensed health care professional. Biomet does not practice medicine and does not recommend any particular orthopedic implant or surgical technique for use on a specific patient. The surgeon is responsible for determining the appropriate device(s) and technique(s) for each individual patient. Not for distribution in France. Legal Manufacturer Biomet Trauma 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581 USA ©2014 Biomet Trauma • Form No. BMET0018.0-GBL • REV0814 www.biomet.com Authorised Representative Biomet UK Ltd. Waterton Industrial Estate Bridgend, South Wales CF31 3XA UK 0086
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