SWEMAC CHS. Compression Hip Screw System

SWEMAC CHS Compression Hip Screw System

Swemac CHS Compression Hip Screw System This system provides a simple and easy-to-use solution for all surgeons facing hip fractures. Offering a wide choice of hip plates combined with a unique lag screw and innovative instrumentation. Implants are available sterile packaged for immediate use. All implants are made from stainless steel 316 LVM. Slimlined hip plates The Swemac Hip Plates has a smoothly curved outer profile and still maintains an extra ordinary mechanical strength. The hip plates are available with plate/barrel angles 130, 135 and 140 and in 2 to 16 holes. The most proximal hole in the hip plate will allow the use of a 6.5 mm selftapping cancellous bone screw. All plates have tracks for the Lateral Support Plate. The Swemac CHS is also available with holes that will allow the use of 5.1 mm locking screws as well as 4.5 mm cortical bone screws. The Swemac CHS Locking Plate is only available in 135 angle. Front-page X-ray by Dr. Johnard

Optimal Lag Screw fixation An adequate fixation in the femoral head is crucial for successful fixation of hip fractures. The Swemac Lag Screw has been designed to overcome the strength-reduction in the cancellous bone caused by osteoporosis. Swemac Lag Screw world patent: Patent no: 9404035-9 Patent no: 0100573-5 Strength of fixation is dependent upon both implant and bone properties. If too much bone trabeculae is removed, the interaction between bone and implant may be impared. To achieve a good fixation, it is vital to save sufficient bone trabeculae in the femoral head. The special design of the triple reamer and the Swemac Lag Screw minimize the disruption of the bone trabeculae. The Swemac Lag Screw has five unique features improving the holding power in the femoral head. l A conical core allows an increase of the total area of the thread. l Starting from the tip, a gradually decreasing distance between the threads compresses the bone and prevents forward rotation. l The threaded part has a consistent outer diameter over the whole length increasing the total area of the thread. l The Swemac Lag Screw has a blunt tip minimizing the risk of femoral head penetration. l A self-cutting compression thread does not destroy bone like traditional cutting flutes. 3

Prevents medial displacement The Swemac Lateral Support Plate prevents medial displacement of the femoral shaft relative to the neck and head fragment, while allowing dynamic axial compression to occur between the fractured lateral cortex and the femoral shaft. Adjustable l The Lateral Support Plate allows the surgeon to adjust the position of the support plate, depending on the distance between the plate barrel and the greater trochanter. This distance will vary depending on the plate angle. Low profile l The Lateral Support Plate has been designed to minimize soft tissue irritation. l The Lateral Support Plate has an anatomical curvature templating the greater trochanter. Sevenfold increase in complications if medial displacement is more than 30% Martyn Parker 1997 The Lateral Support Plate should always be used when the lateral cortex is fractured. 4

Innovative instrumentation Multi Angle guide with visualization windows l A correct placement of the Guide Wire is the most important step in the whole operative procedure. The Multi Angle Guide allows the surgeon to place the rigid 3.2 mm Guide Wire more accurately in the femoral head. The Guide Wire can be seen under image intensification in the visualisation windows in both AP and lateral views. Ensuring a correct placement of the Guide Wire. l The curvature of the handle reduces the skin incision by 20 mm. Direct length measurement Safe reading Rigid 3.2 mm Guide Wire Stainless steel instrument tray The required length of the 4.5 mm cortical bone screw can be read on the scale of the drill sleeve against the black mark on the 3.2 mm Drill. Less risk of misreading the adjusted length on the triple reamer. The rigid 3.2 mm Guide Wire ensures a quick, precise and safe lag screw placement. The threaded tip guarantees a secure seating in the subcondral bone. The instrument tray is made completely out of stainless steel wire, ensuring good penetration during steam autoclaving. 5

Indications Contraindications The physician s education, training and professional judgement must be relied upon to choose the most appropriate device and treatment. Conditions presenting an increased risk of implant failure include: l Any active or suspected latent infection, sepsis or marked local inflammation in or around the surgical area. l Severe osteoporosis, insufficient quantity or quality of bone/soft tissue. l Material sensitivity, documented or suspected. l Physical interference with other implants during implantation or use. l Compromised vascularity, inadequate skin or neurovascular status. l Compromised bone stock that cannot provide adequate support and/or fixation of the device due to disease, infection or prior implantation. l Femoral neck fractures l Stable trochanteric hip fractures. l Unstable trochanteric hip fractures. l Patients who are unwilling or incapable of following postoperative care instructions. l Other physical, medical or surgical conditions that would preclude the potential benefit of surgery. l Previously implanted or extracted osteosynthesis implants of the diaphyseal or proximal femur increases the risk of secondary fracture. l Obesity. An obese patient can produce loads on the implant that can lead to device/treatment failure. l The CHS System is not recommended for use with pediatric hip fractures. The surgeon must discuss all relevant risks, including the service life of the device and the need for postoperative protection of the implant with the patient, when necessary. 6

Surgical technique 1. Patient positioning 2. Reduction Place the patient in supine position on the fracture operating table. Position the leg on the healthy side with the hip in flexion and adequate abduction so that the C-arm can be adjusted intraoperatively for both the anterior/posterior view, and the axial view which is necessary to obtain a true axial view of the femoral neck and head. Reduction should be obtained by gentle manipulation according to the normal procedure for unstable fractures. The fracture position should be anatomical or with a slight valgus tilt and held by immobilization on a fracture operating table. The proximal femur should be positioned so that the head and neck are parallel to the floor. The foot should be rotated inwards and fixed between 15 and 30 of internal rotation. The patella should have an either horizontal or slightly inward position. The patient should then be prepared and draped. 7

3. Locate the optimal point for skin incision 2. 2. 1. B. 3. How to locate the optimal point for skin incision and entry point for the Guide Wire. A Guide Wire (1) and the Multi Angle Guide, are held under AP-view of the image intensifier, above the skin anterior to the hip joint and in line with the medial cortex of the femoral neck. A third Guide Wire, (3) (the first Guide Wire can be used), is held under lateral view of the image intensifier. It is placed along the midline of the axis of the femoral shaft. The point where the second and the third Guide Wires cross, (B), is the optimal starting point for the incision. B. A. A second Guide Wire, (2), is held in a vertical position to the femoral shaft and directed against the point where the Multi Angle Guide and the skin meet. (A). It is important to make the incision in the same angle as the chosen plate angle. 8

4. Make incision 5. Introduce the Multi Angle Guide A longitudinal incision is made, distal from this point through the skin. The deep fascia is divided in the direction of the fibres. The lateral cortex of the femur may be approached either directly or posterior-laterally by lifting the vastus lateralis muscle. The area of the femur where the plate is to be positioned is cleared with a raspatorium. Orientation and placement of the Guide Wire is the most critical step in the whole surgical procedure. In the frontal view the Guide Wire should run centrally in relation to the femoral neck and head. Length The length of the incision is determined by the length of the chosen plate. In the lateral view, the Guide Wire should be centered in relation to the femoral head and neck. NOTE: Introduce the Guide Wire through the Multi Angle Guide before starting to drill. The threaded tip of the Guide Wire may otherwise harm the Multi Angle Guide. 9

6. Guide Wire insertion The Multi Angle Guide is placed on the lateral cortex and the 3.2 mm Guide Wire is inserted in the desired angle (130, 135 or 140 ). Using image intensification, once the alignment of the Guide Wire is satisfactory, it is advanced to subchondral bone of the femoral head. The rigid 3,2 mm Guide Wire will allow the surgeon to adjust the position of the Guide Wire slightly while drilling. If the bone quality is good or if the fracture is a femoral neck fracture, a stabilizing Guide Wire should be used to prevent rotation of the femoral head during reaming, tapping and Lag Screw placement. NOTE: The Guide Wire is single use and shall not be re-used. 10

7. Length determination 8. Assemble the Step Reamer Reamer Locking Nut Reamer + Locking Nut Place the Measuring Guage over the Guide Wire and read the length at the end of the Guide Wire. The Locking Nut is pushed forward onto the Reamer and turned clockwise as far as it will go. The pre-assembled Reamer and Locking Nut is now ready to be slid onto the rear end of the Drill. Drill Reamer + Locking Nut Step Reamer Unlocked Step Reamer Locked Make sure that the Measuring Guage is in contact with the lateral cortex before reading the length. The measured value determines the length of the Lag Screw and the settings for the Step Reamer and the Tap. The correct depth for reaming, tapping and Lag Screw length will be 10 mm less than the measurement obtained from the measuring device. The Locking Nut of the Step Reamer is turned counterclockwise when the correct measurement is seen in the measurement window. The Reamer depth is adjustable in 5 mm increments. Example l Measuring device measurement: 115 mm l Step Reamer depth setting: 105 mm l Tap depth setting (if required): 105 mm l Lag Screw length selected: 105 mm 11

9. Reaming If the Guide Wire is withdrawn The Step Reamer is inserted over the Guide Wire and drilling is carried out to within 10 mm of the subchondral bone. In case the Guide Wire is accidentally withdrawn, it must be reinserted immediately. Otherwise there is a risk of placing the Lag Screw in a wrong direction, especially in osteoporotic bone. The hole which is made in one step has three different diameters: one for the Lag Screw, one for the plate barrel and one for the junction between the plate and the barrel. To reinsert the Guide Wire, push the Centering Sleeve into the hole and slide an inverted Lag Screw into the Centering Sleeve. 12

10. Assemble the implants and instruments 11. Lag Screw insertion Hip Plate Lag Screw Centering Sleeve Long Coupling Screw Wrench Assemble the Lag Screw, the Hip Plate and Insertion instruments. Insert the Long Coupling Screw into the Wrench, slide the appropriate plate onto the introducer assembly and connect the Lag Screw. The Centering Sleeve should be placed over the introducer assembly. Push the assembled instruments over the Guide Wire and slide the Centering Sleeve into the pre-drilled hole. Insert the Lag Screw until it reaches the desired position. The Lag Screw, the Hip Plate and Insertion instruments are assembled. 0 on the Centering Sleeve indicates that the end of the Lag Screw is positioned flush with the end of the plate. 5-15 on the Centering Sleeve indicates that the Lag Screw is positioned 5-15 mm within the end of the plate barrel. This will allow the surgeon to compress the fracture by turning a Compression Screw clockwise. The Lag Screw position should be 10 mm short from the joint. In osteoporotic bone, advance the Lag Screw 5 mm deeper. 13

If tapping is required If the lateral cortex is fractured In the case of hard cortical and cancellous bone, the reamed channel is tapped to prepare it for the Lag Screw threads. The Lateral Support Plate should always be used when the lateral cortex is fractured. The Lateral Support Plate is introduced together with the Hip Plate. The distal part of the Hip Plate can be used as a periost elevator in order to separate the muscles from the bone, creating a pocket proximal to the entrance hole of the plate barrel. The Centering Sleeve is placed over the Tap to ensure that the cutting flutes remain centered in the reamed hole. The Tap is usually not required in osteoporotic bone. The Lateral Support Plate allows the surgeon to adjust the position of the Lateral Support Plate depending on the distance between the plate barrel and the greater trochanter. The holes in the Lateral Support Plate will accept either 4.5 mm cortical bone screws or 6.5 mm cancellous bone screws. The Lateral Support Plate can be inserted without screw fixation. 14

12. Plate alignment 13. Plate Impaction The T-handle of the Wrench should be parallel to the femoral shaft at the end of the Lag Screw insertion. If not, the plate can not be placed in alignment with the femoral shaft and correctly onto the Lag Screw. Impaction of the plate and the fracture may be accomplished by using the Plate Impactor and a hammer. Remove the Centering Sleeve and push the plate over the introducer assembly onto the femoral shaft. Loosen the Long Coupling Screw and remove the introducer assembly. The Guide Wire is then removed, with the power drill in reverse. The Plate Impactor is inserted in the most proximal screw hole. 15

14. Drill for Cortical Bone Screw 15. Measure screw length For 4.5 mm screw placement, a pilot hole is drilled with a 3.2 mm Drill. Before any drilling is carried out, the surgeon may reduce traction from the fracture table. Care should be taken, not losing the fracture reduction. The screw length is read against the projecting part of the Drill. In this case, the selected cortical screw length is 40 mm. If the projecting part of the Drill is positioned between two screw sizes, always choose the longer one. Always start with the most distal screw hole in order to get the correct alignment along the femoral shaft. Compression may be accomplished by placing the screws distally in the oval slots, using the 3.2 mm Drill Sleeve. The most proximal slot will accommodate a 6.5 mm Self-tapping Cancellous Screw. For the 6.5 mm screw placement, a pilot hole is drilled with a 4.5 mm Drill through a 4.5 mm Drill Sleeve. NOTE: If the Swemac CHS Locking Plate is used, a Protective Measuring Sleeve and a 4.5 mm Drill should be used to drill and measure the drill depth of the 5.1 mm Locking Screws. This is the only difference in the surgical technique. Image intensification is used to determine the position of the Drill. 16

Measure with the Measuring Gauge 16. Place Cortical Bone Screw Measuring can also be done by using the traditional Measuring Gauge. The Drill is removed and the hook of the measuring gauge is introduced through the drill hole in the lateral cortex. The Hip Plate is attached to the femoral shaft with 4.5 mm self-tapping cortical screws. All screws are inserted with a 3.5 mm hexagonal Screw Driver. Capture the medial cortex with the hook and push the outer part of the Measuring Gauge forward against the lateral cortex. The length is read off the hook in the measurement window. The cutting flutes of the Cortical Bone Screw shall penetrate the medial cortex for maximal bone purchase. When all cortical bone screws have been inserted, the wound is closed in layers. According to the normal procedures for wound closure. 17

Self-drilling/self-tapping Unicortical Bone Screw 17. Compression of the fracture In order to minimize the risk of losing the alignment of the plate or the pre-drilled bone channel, a 28 mm self-drilling/selftapping Unicortical Bone Screw is available as an option to the insertion of the first bicortical bone screw. A Compression Screw can be used to compress the fracture. The Unicortical Bone Screw is attached to the quick coupling hex Screwdriver and inserted with the surgical power drill in the most distal hole of the plate. The Hip Plate is secured to the lateral cortex and the surgeon can move forward with the insertion of the bicortical bone screws. The risk of loosing the alignment of the plate or the pre-drilled bone channel have been minimized. This is only possible if the surgeon left the end of the Lag Screw inside (5-15 mm) the end of the plate barrel. NOTE: Too much compression might strip the bone thread. 18

18. Check implant position Implant extraction It is important to ensure that the Lag Screw is placed within the femoral head. This can be done by removing traction and rotating the hip under image intensification in both AP and lateral view. Should the need arise for implant removal, the Lag Screw is extracted after removal of the plate through the use of the introducer assembly. Post operative care The wound is closed in layers, according to the normal procedures for wound closure. Full weight-bearing as tolerated by the patient may be allowed in elderly patients. In younger patients, partial weight-bearing is preferable. 19

Product information CAT. NR. IMPLANTS SWEMAC HIP PLATES, 130 250.02.130S Swemac Hip Plate, 130 2 holes 250.04.130S Swemac Hip Plate, 130 4 holes 250.06.130S Swemac Hip Plate, 130 6 holes 250.08.130S Swemac Hip Plate, 130 8 holes 250.10.130S Swemac Hip Plate, 130 10 holes 250.12.130S Swemac Hip Plate, 130 12 holes 250.14.130S Swemac Hip Plate, 130 14 holes 250.16.130S Swemac Hip Plate, 130 16 holes SWEMAC HIP PLATES, 135 250.02.135S Swemac Hip Plate, 135 2 holes 250.04.135S Swemac Hip Plate, 135 4 holes 250.06.135S Swemac Hip Plate, 135 6 holes 250.08.135S Swemac Hip Plate, 135 8 holes 250.10.135S Swemac Hip Plate, 135 10 holes 250.12.135S Swemac Hip Plate, 135 12 holes 250.14.135S Swemac Hip Plate, 135 14 holes 250.16.135S Swemac Hip Plate, 135 16 holes SWEMAC HIP PLATES, 140 250.02.140S Swemac Hip Plate, 140 2 holes 250.04.140S Swemac Hip Plate, 140 4 holes 250.06.140S Swemac Hip Plate, 140 6 holes 250.08.140S Swemac Hip Plate, 140 8 holes 250.10.140S Swemac Hip Plate, 140 10 holes 250.12.140S Swemac Hip Plate, 140 12 holes 250.14.140S Swemac Hip Plate, 140 14 holes 250.16.140S Swemac Hip Plate, 140 16 holes 20

SWEMAC CHS LOCKING PLATES 350.02.135S CHS Locking Plate 2 holes 135 350.04.135S CHS Locking Plate 4 holes 135 350.06.135S CHS Locking Plate 6 holes 135 350.08.135S CHS Locking Plate 8 holes 135 SWEMAC LATERAL SUPPORT PLATES 250.01.005S Lateral Support Plate, short 250.01.010S Lateral Support Plate, standard SWEMAC LAG SCREWS 250.00.070S Lag Screw, 70 mm 250.00.075S Lag Screw, 75 mm 250.00.080S Lag Screw, 80 mm 250.00.085S Lag Screw, 85 mm 250.00.090S Lag Screw, 90 mm 250.00.095S Lag Screw, 95 mm 250.00.100S Lag Screw, 100 mm 250.00.105S Lag Screw, 105 mm 250.00.110S Lag Screw, 110 mm 250.00.115S Lag Screw, 115 mm 250.00.120S Lag Screw, 120 mm 250.00.125S Lag Screw, 125 mm 250.00.130S Lag Screw, 130 mm 250.00.135S Lag Screw, 135 mm COMPRESSION SCREW 250.01.000 Compression Screw SELFTAPPING CORTICAL SCREWS 202.45.028 Cortical Screw, 4,5 x 28 mm 202.45.030 Cortical Screw, 4,5 x 30 mm 202.45.032 Cortical Screw, 4,5 x 32 mm 202.45.034 Cortical Screw, 4,5 x 34 mm 202.45.036 Cortical Screw, 4,5 x 36 mm 21

202.45.038 Cortical Screw, 4,5 x 38 mm 202.45.040 Cortical Screw, 4,5 x 40 mm 202.45.042 Cortical Screw, 4,5 x 42 mm 202.45.044 Cortical Screw, 4,5 x 44 mm 202.45.046 Cortical Screw, 4,5 x 46 mm 202.45.048 Cortical Screw, 4,5 x 48 mm 202.45.050 Cortical Screw, 4,5 x 50 mm 202.45.052 Cortical Screw, 4,5 x 52 mm LOCKING CORTICAL SCREW 302.51.028 Locking cortical screw 5,1 x 28 mm 302.51.030 Locking cortical screw 5,1 x 30 mm 302.51.032 Locking cortical screw 5,1 x 32 mm 302.51.034 Locking cortical screw 5,1 x 34 mm 302.51.036 Locking cortical screw 5,1 x 36 mm 302.51.038 Locking cortical screw 5,1 x 38 mm 302.51.040 Locking cortical screw 5,1 x 40 mm 302.51.042 Locking cortical screw 5,1 x 42 mm 302.51.044 Locking cortical screw 5,1 x 44 mm 302.51.046 Locking cortical screw 5,1 x 46 mm 302.51.048 Locking cortical screw 5,1 x 48 mm 302.51.050 Locking cortical screw 5,1 x 50 mm 302.51.052 Locking cortical screw 5,1 x 52 mm SELFDRILLING / SELFTAPPING UNICORTICAL SCREW 203.45.028 Unicortical Screw, 4,5 x 28 mm CAT. NR. INSTRUMENTS 200.00.000 Sterilizing Tray 200.00.016 Reamer 200.00.031 Cannulated Drill for Lag Screw 200.00.035 Cannulated Screw tap for Lag Screw 200.00.050 Centering Sleeve for Lag Screw 22

200.00.055 Introducer for Lag Screw 200.00.060 Inner Introducer for Lag Screw 200.00.065 Impactor 200.00.070 Impactor Tip 200.00.075 Screwdriver, hex 3,5 mm 200.00.080 Screwdriver, quick coupling, hex 3,5 mm 200.00.085 Drill Guide & Tap Guide 200.00.095 Depth Gauge, length 110 mm 200.00.100 Measuring Gauge for Guide Wire 200.00.105 Screw Forceps 200.00.115 Drill 4,5 x 145 mm 200.00.120 Threaded Guide Wire, 3,2 x 230 mm 200.00.175 Multi Angle Guide 130-140 200.00.201 Locking Nut 200.00.205 Drill Guide with scale 200.00.210 Drill, quick coupling, 3,2 x 195 mm 300.00.025 Protective Measuring Sleeve Ø4.5 (For Locking Cortical Screw Ø5.1 mm) 300.00.125 Drill Ø4.5 Length 195 mm (For Locking Cortical Screw Ø5.1 mm) COMPATIBILITY The Swemac CHS Hip Plate can be used in combination with a Swemac Lateral Support Plate The Swemac CHS Hip Plate can be used in combination with a Swemac Twin Hook. The Swemac CHS Lag Screw can be used in combination with a Medoff Sliding Plate The Swemac CHS Hip plate can be used in combination with Swemacs cortical and cancellous screws NOTE: The Guide Wire is single use and shall not be reused. IFU For the latest version of this Instruction For Use. Please visit: http://download.swemac.com/swemac-chs-compression-hip-screw-system 23

Swemac develops and promotes innovative solutions for fracture treatment and joint replacement. We create outstanding value for our clients and their patients by being a very competent and reliable partner. Swemac CHS Compression Hip Screw System Manufacturer: Swemac Innovation AB 0413 Cobolgatan 1 SE-583 35 Linköping Sweden Sales and distribution: Swemac Orthopaedics AB Cobolgatan 1 SE-583 35 Linköping Sweden Phone +46 13 37 40 30 Fax +46 13 14 00 26 E-mail info@swemac.com www.swemac.com P110-28-20170503 Print date: 2017-05-03