Clinical Evaluation Surgical Technique

Transcription

1 Clinical Evaluation Surgical Technique

2 Table of Contents EMPERION Specifications 3 EMPERION Surgical Technique 9 EMPERION Catalog 18 Nota Bene: This technique description herein is made available to the healthcare professional to illustrate the author s suggested treatment for the uncomplicated procedure. In the final analysis, the preferred treatment is that which addresses the needs of the patient. 2

3 EMPERION Specifications Stems Made from Titanium Alloy (Ti-6Al-4V) Primary, standard revision and long bowed revision sizes Neck shaft angle at 131 Circulotrapezoidal neck for increased range of motion Primary in standard and high offset 15 neck anteversion on bowed stem Standard (STD) and +10 calcar revision options Distal stem fluted, slotted, with a polished bullet tip 10mm 12mm of bow offset Primary Stem Options Distal Diameter Length Standard Offset High Offset Neck Height Revision Stem Options Distal Diameter Length Offset (High Offset Only) Standard Neck Height +10 Calcar Neck Height Standard Revision Long Revision Bowed

4 EMPERION Primary Stem Specifications 4

5 EMPERION Standard Revision Stem Specifications 5

6 EMPERION Long Revision Stem (Bowed) Specifications 6

7 EMPERION Specifications Sleeves Titanium alloy (Ti-6Al-4V) with HA on porous coating on all sleeves Standard (STD) 40mm sleeve length - Three cone sizes: S, M and L - Three spout sizes: 1, 2 and 3 Tall 60mm sleeve length - Two cone sizes: M and L - One spout size: 2 The proximal sleeve geometry is the same for standard and tall sleeves. The only variable that is changed is the sleeve height. Sleeve Options Standard 1, 2, 3 1, 2, 3 1, 2, 3 Small Medium Large Tall 2 2 Note: Tall Sleeves are only available for stem sizes with medium and large cones and #2 spouts. Medium Large Stem Size Sleeve Length Cone Options Spout Options STD STD TALL STD TALL STD TALL STD TALL S,M,L S,M,L M,L S,M,L M,L S,M,L M,L S,M,L M,L 1,2,3 1,2,3 2 1,2,3 2 1,2,3 2 1,2,3 2 7

8 EMPERION Specifications Standard Sleeve Dimensions Size Small Cone Dia. Additional M/L Widths Spout 1 Spout 2 Spout Cone Dia. Size Medium Cone Dia. Additional M/L Widths Spout 1 Spout 2 Spout 3 M/L Standard Length=40mm Size Large Cone Dia. Additional M/L Widths Spout 1 Spout 2 Spout 3 Tall Length=60mm Tall Sleeve Dimensions Size Medium Cone Dia Additional M/L Widths Spout Size Large Cone Dia Additional M/L Widths Spout

9 EMPERION Emperion Surgical Technique Emperion Surgical Technique Technique Preoperative Planning The goal of preoperative planning is to help determine the correct stem and sleeve size, level of femoral neck cut, and proper head and stem offset combination. Preoperative templating requires at least an anteroposterior radiograph of the pelvis and a lateral radiograph of the affected hip. If the opposite hip is unaffected by disease, it can provide accurate sizing information for the femoral stem. To determine if a patient has a leg length discrepancy, the anteroposterior radiograph should be used. Draw a line tangential to both of the ischia or both of the obturator foramens. This line should extend out until it contacts the medial cortex of cone on both femurs. If the patient s legs are of equal length, the line that has been drawn will contact both femurs at the same level. If the patient s legs are of unequal length, the lines will contact the femurs at different levels along the femur. Select a reference point along the femur, such as the bottom of the lesser trochanter. The distance between the line that has been drawn and the reference point on both femurs is measured. The difference in these measurements indicates the patient s leg length discrepancy (Figure 1). Note: Using this method of templating for leg length discrepancy assumes the patient has a normal, symmetrical pelvis and has neutral limb positioning. Emperion Surgical Technique Figure 1 Preoperative Planning Intraoperatively, leg length restoration can be verified by measuring the distance between a pin in the iliac wing and a mark on the greater trochanter before hip dislocation. This measurement should be recorded. It is compared later in surgery to a measurement using the same reference points after the implant trials are in place. Another method of leg measurement consists of the surgeon placing the foot of the affected limb on top of the unaffected limb. The relative position of one knee to another is then analyzed. This second method is slightly less accurate than the previously mentioned technique; however, both methods provide a reasonable degree of accuracy in restoring limb length equality. When determining which size EMPERION stem and sleeve to use, the anteroposterior and lateral radiographs should be templated. Using the anteroposterior radiograph, place the femoral templates over the proximal femur of both the affected and unaffected hips (Figure 2). The junction of the lateral femoral neck and greater trochanter serves as a good reference point for placement of the X-ray templates. Place a mark at this junction and in the center of the femoral head. Align the lateral shoulder of the prosthesis with the mark at the junction. Find the appropriate stem and sleeve that fit and fill the femur and whose neck length matches the center of the femoral head. It is important to check that the stem fits properly into the femur on the lateral radiograph. Figure 2 9

10 EMPERION Surgical Technique 1.Femoral Neck Osteotomy An osteotomy guide is available for proximal bone resection. The osteotomy guide has a vertical scale in 5mm increments to help gauge neck height. Using the greater trochanter or other anatomical landmark as a reference, align the osteotomy guide and determine the location of the appropriate resection (Figure 3). The chart below indicates the distance from the neutral head center to the top of the sleeve. When a +10 calcar neck is selected, move the osteotomy guide down the femur to ensure that sufficient bone will be removed to achieve the proper leg length. Once the appropriate vertical position of the osteotomy guide has been verified, the proposed horizontal osteotomy level is marked with a marking pen or electrocautery. The femoral osteotomy can then be made obliquely to the desired level along the medial aspect of the femoral neck, taking care to protect the greater trochanter during the osteotomy (Figure 4). The additional bone left above the osteotomy level can subsequently be resected with a ronguer or can be left until final seating of the trial sleeve has been accomplished, at which time a clean-up cut can be made flush with the top of the sleeve trial. Figure 3 Size Distance from +0mm Head Center to Top of Sleeve 11 28mm mm mm Figure 4 10

11 EMPERION Surgical Technique 2. Acetabular Preparation The acetabulum should be prepared in the recommended fashion for the acetablular component to be utilized according to preoperative planning and templating. 3. Femoral Canal Preparation For Primary: Open the medullary canal with the box osteotome (Figure 5). Sound the femoral canal using the canal finder and the reamer T-handle (Figure 6). Figure 5 For Revision: Begin with a distal reamer that is 4-6mm smaller than the templated size or a reamer that has little or no resistance. NOTE: It is important to stay lateral with both the box osteotome and canal finder. This helps ensure that femoral reaming will be in alignment with the femoral axis. The trochanteric reamer can be used to remove lateral bone (Figure 7). Removing lateral bone is important for maintaining neutral stem placement. Figure 6 Figure 7 11

12 EMPERION Surgical Technique 4. Femoral Distal Reaming Primary and Standard Revision Stems Rigid distal reamers in 0.5mm increments from 9-20mm are available for primary and standard revision stems. Continue to enlarge femoral canal sequentially using the proximal reamers. Ream the canal in 0.5mm increments until the last reamer matches the selected implant size. The actual size of flutes is 0.5mm greater than the equivalent reamer. For example, if you are using a 13mm stem, the distal diameter is actually 13.5mm, providing an automatic 0.5mm of press-fit. The final reamer size may need to be adjusted based on bone quality, anatomy and surgeon preference. Revision length reference mark Primary length reference mark Figure 8 Use the depth marks on the reamers, which correspond to the neutral head center of the prosthesis, to gauge the appropriate reaming depth (Figure 8). Long Revision Bowed Stems Thin shaft reamers are available for the long revision bowed stems. Ream the canal in 0.5mm increments until the reamer size matches the selected implant size. The final reamer size may need to be adjusted based on bone quality, anatomy and surgeon preference. Use the depth marks on the reamers, which correspond to the neutral head center of the prosthesis, to gauge the appropriate reaming depth (Figure 9). NOTE: This technique is different than traditional bowed stem techniques. Usually one will over ream by mm to ensure that the stem will be able to pass the femoral bow without fracturing the femur. This bowed stem is different because it transitions into a diameter 1mm smaller just prior to the bow (Figure 10). Therefore, when reaming line-to-line, the canal will be over reamed by 0.5mm, with respect to the outer diameter of the flutes, for the distal, bowed portion of the stem. This feature will minimize the risk of fracture during insertion. Figure mm 12.5mm Figure 10 12

13 Standard/ High Offset +10mm Calcar Neck EMPERION Surgical Technique 5. Femoral Proximal Reaming Use the proximal reamers to prepare the femur for the modular sleeve implant. There are standard reamers available for the standard length sleeves and tall reamers for the tall sleeves. These reamers are sized according to cone size and distal diameter (Figure 11). First select the reamer with the smallest cone size that corresponds with the distal diameter of the stem. (For example, for a size 13, select a 13S proximal reamer.) Choose a pilot that matches the stem diameter and assemble it to the proximal reamer. In the case that the greater trochanter does not exist, you can reference the top of the proximal reamer which is equivalent to the top of the sleeve, once seated. Increase the reamer size until cortical contact is achieved. Keep in mind that you have S, M and L options per stem diameter. Pilot extenders may be utilized in combination with the pilot to reach the approximate length of the revision stems. Standard Proximal Reamers Reamer Sizes Figure S 13S-11M 15S-13M-11L 17S-15M-13L 19S-17M-15L 19M-17L 19L Tall Proximal Reamers Reamer 4T 5T 6T 7T 8T Sizes 13M 15M-13L 17M-15L 19M-17L 19L 13

14 EMPERION Surgical Technique 6. Milling of Spout for Proximal Sleeve First select the spout cutter that corresponds to the size of the stem you are implanting. Attach this to the miller handle assembly. Then select the milling frame that corresponds with the last proximal reamer that was used. The frames are labeled with both the corresponding frame numbers and the sizes. The top of the frame will have holes that correspond with the size of spout you are planning to use (Figure 12). Assemble the milling body to a pilot that matches the pilot utilized in the proximal reamer step. Assemble the milling frame onto the milling handle assembly and select the hole that matches the spout size of the sleeve implant by pulling back on the gold anodized quick connect of the T-handle. Figure 12 Note: Tall sleeves are available for Medium and Large Cones with only the #2 spouts. Milling Frames Frame No Sizes 11S 13S-11M 15S-13M-11L 17S-15M-13L 19S-17M-15L 19M-17L 19L Figure 13 Note: Milling frame numbers will coincide with the number of the last proximal reamer used. Before attaching the drill, insert milling frame assembly into femur (Figure 13). Start with the no. 1 spout and progress upward until the spout cutter/reamer reaches cortical bone. Attach drill and start drilling prior to inserting spout into femur. Mill spout until the frame assembly is fully seated. You can check the seating by matching the appropriate neck height to the greater trochanter. Note: In the case that the greater trochanter does not exist, you can reference the top of the major diameter of the cone which is equivalent to the top of the sleeve, once seated (Figure 14). Figure 14 14

15 EMPERION Surgical Technique 7. Sleeve and Stem Trialing Figure 15 Primary and Standard Revision Stems First select the trial sleeve that corresponds with the correct distal diameter, cone and spout that was reamed. Then assemble the trial sleeve to the corresponding pilot. Pilot extenders can be used for the long revision stems. Make sure the colors all match. Assemble the stem inserter pommel into the threaded hole and insert the trial assembly into the femur and use a mallet to make sure that the trial is properly seated. Select the trial neck that corresponds to the correct offset or calcar adjustment for the implant. Sizes 13mm and 15mm, and sizes 17mm and 19mm femoral stems share trial necks. Using the quick connect mechanism; snap the neck into the properly sized trial stem (Figure 15). The version of the neck can be adjusted by pushing the button on the side of the trial neck (Figure 16). Place the desired trial femoral head on the trial neck and reduce the hip to assess stability and range of motion. To remove trial assembly, screw the trial removal hook onto the trial removal handle. The hook then inserts into the hole in the trial neck. Using the slotted mallet, remove the trial assembly. Figure 16 Long Revision Bowed Stems The size of the bow must be evaluated to ensure the stem will fit properly. Bowed sounds are provided for this reason. Screw the sound insertion handle into the threaded hole at the proximal end of the appropriate sized bowed sound. Then insert this into the femur to assess the bowed stem fit (Figure 17). To remove the bowed sound, screw the sound removal handle directly into the sound. Then carefully use a slotted mallet to remove the sound. Figure 17 15

16 EMPERION Surgical Technique 8. Sleeve and Stem Implant Insertion Primary and Standard Revision Stems When implanting a stem, the sleeve should be implanted first. The sleeve implant should be loosely inserted into the femur in the correct position. Then insert the sleeve insertion tool into the cone of the sleeve and use a mallet to properly seat the sleeve (Figure 18). To insert the stem implant, engage the tip of the stem inserter frame and pommel assembly into the stem driver slot on the implant and turn the pommel to thread the inserter onto the implant (Figure 19). Fully tighten the pommel before impaction. Figure 18 Insert the implant through the sleeve into the canal with hand pressure and verify proper implant version. Use firm mallet blows to seat the implant to the desired level. NOTE: Once the implant flutes have engaged the bone, the implant version cannot be changed without removing the implant. The implant can be removed by using the separation tool to separate the sleeve from the stem and then striking the underside of the threaded stem driver with a slotted mallet. Long Revision Bowed Stems When implanting bowed stems, first loosely place the sleeve implant onto the stem implant. Then advance the stem as far as possible down the femur (Figure 20). Attach the stem inserter frame and pommel assembly to the stem as shown for the straight stem. Making sure the neck version and sleeve position are correct, use firm mallet blows to seat the implant. Figure 19 If the bowed stem stops progressing during insertion, remove the implant and enlarge the canal with a larger size thin shaft reamer. NOTE: A fully seated bowed stem will be extremely difficult to remove from the femur and may require an osteotomy to remove. Figure 20 16

17 EMPERION Surgical Technique 9. Implant Trialing Once the implant is fully seated, perform a final trial reduction to determine appropriate neck length. Place the desired trial femoral head on the implant and reduce the hip to assess stability and range of motion. 10. Femoral Head Assembly Clean and dry the taper with a sterile cloth, place the prosthetic femoral head on the neck and firmly impact several times with a femoral head impactor and a mallet. 17

18 EMPERION Catalog HA Coated Sleeves Sm Cone 1 Spout Sm Cone 2 Spout Sm Cone 3 Spout Md Cone 1 Spout Md Cone 2 Spout Md Cone 3 Spout Lg Cone 1 Spout Lg Cone 2 Spout Lg Cone 3 Spout Sm Cone 1 Spout Sm Cone 2 Spout Sm Cone 3 Spout Md Cone 1 Spout Md Cone 2 Spout Md Cone 2 Spout Tall Md Cone 3 Spout Lg Cone 1 Spout Lg Cone 2 Spout Lg Cone 2 Spout Tall Lg Cone 3 Spout Sm Cone 1 Spout Sm Cone 2 Spout Sm Cone 3 Spout Md Cone 1 Spout Md Cone 2 Spout Md Cone 2 Spout Tall Md Cone 3 Spout Lg Cone 1 Spout Lg Cone 2 Spout Lg Cone 2 Spout Tall Lg Cone 3 Spout Sm Cone 1 Spout Sm Cone 2 Spout Sm Cone 3 Spout Md Cone 1 Spout Md Cone 2 Spout Md Cone 2 Spout Tall Md Cone 3 Spout Lg Cone 1 Spout Lg Cone 2 Spout Lg Cone 2 Spout Tall Lg Cone 3 Spout Sm Cone 1 Spout Sm Cone 2 Spout Sm Cone 3 Spout Md Cone 1 Spout Md Cone 2 Spout Md Cone 2 Spout Tall Md Cone 3 Spout Lg Cone 1 Spout Lg Cone 2 Spout Lg Cone 2 Spout Tall Lg Cone 3 Spout Polished Primary Stems Primary SO Primary HO Primary SO Primary HO Primary SO Primary HO Primary SO Primary HO Primary SO Primary HO Polished Standard Revision Stems Std Rev Pol Std Rev Pol Std Rev Pol Std Rev Pol Std Rev Pol Std Rev Pol Std Rev Pol Std Rev Pol +10 Polished Long Revision Stems (Bowed) Lng Rev Pol +0 L Lng Rev Pol +0 R Lng Rev Pol +10 L Lng Rev Pol +10 R Lng Rev Pol +0 L Lng Rev Pol +0 R Lng Rev Pol +10 L Lng Rev Pol +10 R Lng Rev Pol +0 L Lng Rev Pol +0 R Lng Rev Pol +10 L Lng Rev Pol +10 R Lng Rev Pol +0 L Lng Rev Pol +0 R Lng Rev Pol +10 L Lng Rev Pol +10 R 18

19 Thin Shaft Reamers mm Thin Shaft Reamer mm Thin Shaft Reamer mm Thin Shaft Reamer mm Thin Shaft Reamer mm Thin Shaft Reamer mm Thin Shaft Reamer mm Thin Shaft Reamer mm Thin Shaft Reamer mm Thin Shaft Reamer mm Thin Shaft Reamer mm Thin Shaft Reamer mm Thin Shaft Reamer mm Thin Shaft Reamer mm Thin Shaft Reamer mm Thin Shaft Reamer mm Thin Shaft Reamer mm Thin Shaft Reamer mm Thin Shaft Reamer mm Thin Shaft Reamer mm Thin Shaft Reamer mm Thin Shaft Reamer Milling Frames S-9M Milling Frame S-11M-9L Milling Frame S-13M-11L-9XL Milling Frame S-15M-13L-11XL Milling Frame S-17M-15L-13XL Milling Frame S-19M-17L-15XL Milling Frame S-21M-19L-17XL Milling Frame Spout Cutters Spout Cutter Spout Cutter Spout Cutter Spout Cutter Spout Cutter Milling Handle Assembly Milling Handle Assembly Trial Necks SO HO/Std Revision SO HO/Std Revision SO HO/Std Revision Calcar Calcar Trial Sleeves Sm Cone 1 Spout Sm Cone 2 Spout Sm Cone 3 Spout Md Cone 1 Spout Md Cone 2 Spout Md Cone 3 Spout Lg Cone 1 Spout Lg Cone 2 Spout Lg Cone 3 Spout Sm Cone 1 Spout Sm Cone 2 Spout Sm Cone 3 Spout Md Cone 1 Spout Md Cone 2 Spout Md Cone 3 Spout Lg Cone 1 Spout Lg Cone 2 Spout Lg Cone 3 Spout Sm Cone 1 Spout Sm Cone 2 Spout Sm Cone 3 Spout Md Cone 1 Spout Md Cone 2 Spout Md Cone 3 Spout Lg Cone 1 Spout Lg Cone 2 Spout Lg Cone 3 Spout Sm Cone 1 Spout Sm Cone 2 Spout Sm Cone 3 Spout Md Cone 1 Spout Md Cone 2 Spout Md Cone 3 Spout Lg Cone 1 Spout Lg Cone 2 Spout Lg Cone 3 Spout Sm Cone 1 Spout Sm Cone 2 Spout Sm Cone 3 Spout Md Cone 1 Spout Md Cone 2 Spout 19

20 EMPERION Catalog Trial Sleeves (continued) Md Cone 3 Spout Lg Cone 1 Spout Lg Cone 2 Spout Lg Cone 3 Spout 28mm Trial Femoral Heads mm mm mm mm mm mm Pilots mm Pilot mm Pilot mm Pilot mm Pilot mm Pilot Pilot Extenders mm Extender mm Extender mm Extender mm Extender Miscellaneous Instruments Reamer T-Handle Osteotomy Guide Pilot Removal Tool Trial Removal Hook Sleeve Insertion Tool Sleeve/Stem separator mm Bowed Stem Sound mm Bowed Stem Sound mm Bowed Stem Sound mm Bowed Stem Sound Trial Removal Handle Box Osteotome - Small \ Machined Box Osteotome - Small \ Casting Stem Inserter Pommel Stem Inserter Frame Slotted Hammer Starter Reamer Femoral Head Impactor Trochanteric Reamer Distal Reamers mm Distal Reamer mm Distal Reamer mm Distal Reamer mm Distal Reamer mm Distal Reamer mm Distal Reamer mm Distal Reamer mm Distal Reamer mm Distal Reamer mm Distal Reamer mm Distal Reamer mm Distal Reamer mm Distal Reamer mm Distal Reamer mm Distal Reamer mm Distal Reamer mm Distal Reamer mm Distal Reamer mm Distal Reamer mm Distal Reamer mm Distal Reamer mm Distal Reamer mm Distal Reamer Standard Proximal Reamers Reamer 1, 9S Reamer 2, 11S-9M Reamer 3, 13S-11M-9L Reamer 4, 15S-13M-11L-9XL Reamer 5, 17S-15M-13L-11XL Reamer 6, 19S-17M-15L-13XL Reamer 7, 21S-19M-17L-15XL Reamer 8, 23S-21M-19L-17XL 20

21 Tall Proximal Reamers Tall Reamer 1, 13M Tall Reamer 2, 15M-13L Tall Reamer 3, 17M-15L Tall Reamer 4, 19M-17L Tall Reamer 5, 19L Trays Milling Frame Tray Instrument Tray Starter Tray Distal Reamer Tray Proximal Reamer Tray Trial Trial Trial Thin Shaft Reamers Bowed Trials Double Height Case Single Height Case Case Lid 21

22 Orthopaedics Smith & Nephew, Inc Brooks Road Memphis, TN USA Telephone: Information: Orders/Inquiries: Trademark of Smith & Nephew. 04/05