SAMSON. Expandable Vertebral Body Replacement
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- Marylou O’Neal’
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1 SAMSON Expandable Vertebral Body Replacement
2 System SAMSON is an expandable vertebral body replacement system which is used for the anterior stabilisation of the spinal column, from the upper thoracic to the lower lumbar sections. The system is used to replace vertebral bodies in cases of cancerous, inflammatory and traumatic diseases which lead to instabilities around the anterior support or compression of the neural structures, or for diseases which require treatment of an infection. The SAMSON system has been designed for use with an additional dorsal (e.g. VENUS ) and a ventral fixation system (e.g. VENUSnano). The system offers a range of different dimensions for both implant base units and endplates, making it possible to perform adaptations which take into account the unique anatomy of each individual patient. All components of the SAMSON vertebral body replacement system are manufactured using titanium alloy Ti6AI4V, which has been a tried and tested material for many years in the field of implantology. The clear and ergonomically configured instruments have been logically designed to meet the requirements of the surgeon. With its special features, SAMSON offers outstanding product-specific advantages: Anatomical: A convex endplate profile which is identical to the patient s own sectional anatomy Endplates with a generous contact surface reduced risk of migration Stepless expansion All common access methods possible Stable: Pyramid-shaped tooth profile for primary fixation of the endplates Rotation-proof connection of the endplates on the implant base unit Stable expansion mechanism no skipping Flexible: Optimum adaptability to patient anatomy A range of different base unit heights Various freely combinable endplate widths and angulations 2
3 SAMSON Expandable Vertebral Body Replacement Product-specific advantages Five outstanding product features 1. 1 Position-stable expansion mechanism, no skipping 2. 2 Stepless expansion 3. 3 All common access methods possible 4. 4 reduced risk of migration through generous contact surface 5. 5 Fully reversible 3
4 Surgical Technique Opening, preparation of the access and removal of the vertebral body Depending on the surgical area and the clinical disease picture, the patient will be positioned and the access is chosen accordingly (also see page 9). After preparation of the access, depending on the anatomy a partial or full corpectomy is performed using appropriate surgical instruments. Careful preparation is necessary in order to ensure the fitting and correct positioning of the implant. The adjacent intervertebral discs are also removed and the endplates processed superficially. Caution: Care should be taken to maintain the integrity of the endplates. Damage to the endplates or excessive partial endplate wear can lead to sintering of the implant and to a loss of segmental stability. Determining the implant size Using the trial implants (VBR Trial), the correct implant size can be selected under x-ray control. The trial implants are screwed in using the insertion instrument (PLIF Inserter) and inserted into the space created. Note: The trial implants should not be driven in with high force. The trial implant to be selected must be smaller than the space of the defect, to allow subsequent expansion of the implant. The precise dimensional comparison between the trial implant and the final implant is explained in detail on pages If the corresponding trial implant is too large for the defect, the next size down (smaller) must be selected. Determining the endplate size Using the trial implants for the endplates (Samson Plate Trials), the correct implant size can be selected under x-ray control. The trial implants are screwed in using the insertion instrument (ALIF/PLIF Inserter B) and inserted into the space created. The required sagittal angle of the endplates is determined under x-ray control. Note: The endplates selected should be choosen sufficiently large to make use of the maximum contact surface of the vertebral body. This will ensure the greatest possible stability and counteract implant sintering. However, to avoid injury to the adjacent structures the endplates should not protrude beyond the vertebral body. 4
5 Inserting the holder shaft The handle (Samson Inserter Handle) can be secured to the insertion instrument (Samson Inserter) in different positions, depending on the specific application, via a threaded connection. The holder shaft (Samson Inserter Holder) can then be guided into the channel of the inserter on the right-hand side (viewed from the rear). Turn the holder shaft clockwise into the final position on the insertion instrument over the safety thread. The holder shaft is protected from accidental loss by the safety thread. Connecting the implant to insertion instrument I First the locking screw located in the implant should be loosened with the Samson Locking Screw Driver T10 by turning it counterclockwise maximal 1,5 (minimal 0,5) turns. The preassembled insertion instrument can be connected directly to the implant base unit in the implant tray. To do so, the lugs on the insertion instrument must latch into the cut-outs on the implant base unit provided for this purpose. The exact axial orientation of the insertion instrument to the implant should be considered. Attention: It has to be considered, that the locking screw is not loosend to far, because this may negatively affect the mobility of the expansion mechanism. Connecting the implant to insertion instrument II After the insertion instrument has been attached to the implant base unit, it is securely connected to the implant base unit via a threaded connection by turning the handle of the holder shaft clockwise. Note: To prevent damage to the implant or instrument, the correct placement of the implant on the insertion instrument needs to be checked. The holder shaft has to be tightened without any resistance. It can be pulled at the insertion instrument to check the correct mounting. If the fixation of the implant is difficult or if the connection to the instrument is not correct, the insertion instrument must be attached to the implant again. Therefore the exact axial orientation of the insertion instrument to the implant should be considered. 5
6 Surgical Technique Assembling the endplate I The selected endplates are placed on the multiprofile form of the base unit. Care must be taken to ensure that the endplates are correctly positioned for the cranial and caudal ends of the base unit of the implant. The endplate is fixed to the implant base unit by using the Plate Screw. The Plate Screw is secured by hand using the LP Setscrew Driver with Handle. Take care that when using angled endplates, the Plate Screw is not placed parallel to the surface of the endplate but aligned axially relative to the base unit. To prevent cross-threading while screwing in the Plate Screw, first screw about half a turn in a counterclockwise direction until you feel the thread click into the base unit. Then continue to screw in the Plate Screw. Assembling the endplate II Note: The endplates can be placed individually on the implant base unit every 15. Care must be taken that both endplates are mounted in the same angular position. The connection of the endplates to the base unit must be free from play. Assembling the caudal endplate (optional) The endplate previously determined for the caudal end is inserted into the Assembling Aid (marked CAUDAL). The unmarked end of the implant base unit is then assembled in the desired position on the endplate. This endplate is then also screwed from below using the Plate Screw. The Plate Screw is secured by hand using the LP Setscrew Driver with Handle. Note: The possible angulations for assembling the endplates to the implant base units are marked on the Assembling Aid. 6
7 Assembling the cranial endplate (optional) The endplate envisaged for the cranial end is inserted into the Assembling Aid (marked CRANIAL). The preassembled implant base unit is attached to the cranial endplate with the end marked CRANIAL in the same position as the previously assembled caudal endplate. This endplate is then also screwed from below using the plate holding screw. The Plate Screw is tightened by hand using the LP Setscrew Driver with Handle. Caution: Ensure that both endplates are assembled with the same angularity. This can be checked using the marking on the Assembling Aid. Inserting the expansion shaft After the implant base unit has been secured, the expansion shaft (Samson Expander) can then be guided into the channel of the inserter on the lefthand side (viewed from the rear). Press the button on the insertion instrument to move the expansion shaft into the final position on the insertion instrument. The torx geometry of the expansion shaft must be connected to the torx of the drive mechanism. Note: The expansion shaft is secured against accidental loss by the mechanics of the button device located on the insertion instrument. Insertion of the implant The preassembled implant secured on the insertion instrument is inserted and the implant position is checked using x-rays. It is important to ensure that the endplates lie as flat as possible against the vertebral body endplates. 7
8 Surgical Technique Expansion of the implant The implant can be expanded by turning the expansion shaft (Samson Expander) on the insertion instrument clockwise. 7 turns on the expansion shaft correspond to a height change at the implant of 1mm. The implant can be retracted again by turning the expansion shaft anti-clockwise. Caution: The implant must be implanted under prestress in order to avoid dislocation. Expansion of the implant must be performed under continuous x-ray control in order to avoid over-distraction or damage of the endplates. The implant has a fixed mechanical stop that limits the maximum expansion way of the implant. If this clearly noticeable stop is reached during the expansion, it may not be further expanded, as this may lead to excessive stress of individual components of the expansion mechanism. Locking of the expansion mechanism Once the implant is expanded, the mechanism has to be locked. For this purpose, the locking screwdriver (Samson Locking Screw Driver T10) is inserted into the torque wrench (Torque Driver - 2,3). The assembled instruments are then guided over the insertion instrument into the torx of the locking screw. Tighten the locking screw clockwise until the torque wrench releases. Removal of the locking screwdriver after the final fixing of the locking screw. Note: The full torque of 2.3Nm is reached when you hear a clicking sound in the torque wrench. Loosening the insertion instrument If the implant is expanded to its final position, the screw connection with the implant can be loosened by turning the holder shaft (Samson Inserter Holder) on the insertion instrument anticlockwise and the insertion instrument can be removed. If it is difficult to loosen the holder shaft, the LP Setscrew Driver with Handle can be used. 8
9 System Subsequent placement of the insertion instrument The insertion instrument can be relocated on the implant for possible position corrections. To do this, the expansion shaft must be removed from the insertion instrument. The exact alignment of the insertion instrument to the implant must be observed. The lugs at the insertion instrument must engage in the provided notches for on the implant base unit. The holder shaft has to be tightened without any resistance. If the fixation of the implant is difficult or if the connection to the instrument is not correct, the insertion instrument must be attached to the implant again. To check the correct attachment it can be pulled at the instrument. A positional correction by a blow of hammer may only be carried out with a completely fixed shaft, in order to avoid possible damage to the implant or instrument. Final construction Finally, the Samson vertebral body replacement is placed in the corpectomy gap. An additional dorsal fixation (e.g. with the VENUS screw and rod system) including transverse connector elements and additional ventral treatment (e.g. with the VENUSnano screw and rod system) is recommended. SAMSON - expansion mechanism The expansion mechanism used by the Samson vertebral body replacement is based on a worm drive. This offers the following advantages: Stepless, extremely fine height adjustment possible No undesirable turning back of the expansion mechanism No springing back of the expansion mechanism and thus no loss of height Extremely low force needed for expansion Fully reversible 9
10 Functional test before use System To guarantee the function of the implant, a short functional test must be performed. First the locking screw located in the implant should be loosened with the Samson Locking Screw Driver T10 by turning it counterclockwise maximal 1,5 turns (minimal 0,5 turns). Then the insertion instrument (Samson Inserter), as described in the surgical steps, is fitted to the implant body and fixed with the holder shaft (Samson Inserter Holder). The expansion shaft (Samson Expander) is then, as described, inserted into the insertion instrument until it engages with the torx geometry of the gear mechanism on the implant base unit (marked in red). The implant is expanded by rotating the expansion shaft in a clockwise direction. Once function is ensured, the implant is turned back to the start by turning the expansion shaft anti-clockwise. The insertion instrument can then be completely removed. 10
11 Access direction for SAMSON Thanks to the flexible connection geometry between implant base unit and endplate, all common access directions can be covered using the Samson vertebral body replacement. The endplates can be attached individually to the implant base unit every 15. The assembly aid included in the set can be used to ensure that the desired assembling position of the endplates is achieved. ventrolateral left ventral ventrolateral right The slim construction of the base unit ensures that it does not protrude over the endplates or only protrudes slightly in selected assembly positions. lateral left lateral right dorsolateral left dorsolateral right The endplate is connected to the base unit via a multi-profile form, which is identical for the cranial and caudal endplates. This rotation-proof connection is secured using a threaded connection between the Plate Screw and the implant base unit. The primary fixation is ensured due to the pyramid-shaped toothing on the endplates. Blasting of the endplate surface using blasting media such as ceramic and aluminium oxide produces a surface structure which promotes optimum osseointegration. 11
12 System Determining the implant height The size information on the preassembled base units (VBR Size 1 to VBR Size 6) indicates the total height of the implant when compressed or expanded to its maximum, including two assembled endplates with an angulation of 0. The total height of the implant is measured without the toothing, i.e. from tooth base to tooth base. If endplates with angulation are used, the heights listed in the table below must also be added to the size information for the preassembled base unit (individually for each respective endplate). The additional height information for the individual endplate types relates to the height with or without toothing as required. Here, the height is determined at the highest point of the relevant implant. To allow subsequent expansion of the implant, the height of the entire structure (base unit with endplates) when compressed must be lower than the defect. Height Dimensions of the base units with endplates VBR Size 1 VBR Size 2 VBR Size 3 VBR Size 4 VBR Size 5 VBR Size 6 Compressed 20 mm 23 mm 27 mm 35 mm 47 mm 71 mm Max. expansion 26 mm 30 mm 38 mm 50 mm 74 mm 120 mm The size overview table is also provided on the implant tray. Calculation example: A required total angulation of 12 has been determined for the endplates. The lower endplate has an angulation of 8 and the upper endplate 4. If a vertebral body replacement VBR Size 2 is used, which is expanded to its maximum, this will produce a maximum implant height from tooth tip to tooth tip of 37.2 mm. The height from tooth base to tooth base is 34.2 mm. Height information VBR Size 1 to 6 Including toothing: 4 endplate + 8 endplate + VBR Size 2 (max. expansion) = 2.9 mm mm + 30 mm = 37.2 mm Endplate angulation Additional height per endplate Including toothing Excluding toothing Excluding toothing: 4 endplate + 8 endplate + VBR Size 2 (max. expansion) = 1.4 mm mm + 30 mm = 34.2 mm 37.2 mm 34.2 mm mm 0 mm +/ mm 1.4 mm +/ mm 2.8 mm 12
13 Plate combination with resulting implant heights Type State 0 /0 0 /4 = 4 /0 VBR Size 1 (20-26) VBR Size 2 (23-30) VBR Size 3 (27-38) VBR Size 4 (35-50) VBR Size 5 (47-74) VBR Size 6 (71-120) Compressed Max. expansion Compressed Max. expansion Compressed Max. expansion Compressed Max. expansion Compressed Max. expansion Compressed Max. expansion 0 /8 = 8 /0 4 /4 4 /8 = 8 /4 Including toothing 23mm 24.4 mm 25.8 mm 25.8 mm 27.2 mm 28.6 mm Excluding toothing 20mm 21.4 mm 22.8 mm 22.8 mm 24.2 mm 25.6 mm Including toothing 29mm 30.4 mm 31.8 mm 31.8 mm 33.2 mm 34.6 mm Excluding toothing 26mm 27.4 mm 28.8 mm 28.8 mm 30.2 mm 31.6 mm Including toothing 26mm 27.4 mm 28.8 mm 28.8 mm 30.2 mm 31.6 mm Excluding toothing 23mm 24.4 mm 25.8 mm 25.8 mm 27.2 mm 28.6 mm Including toothing 33mm 34.4 mm 35.8 mm 35.8 mm 37.2 mm 38.6 mm Excluding toothing 30mm 31.4 mm 32.8 mm 32.8 mm 34.2 mm 35.6 mm Including toothing 30mm 31.4 mm 32.8 mm 32.8 mm 34.2 mm 35.6 mm Excluding toothing 27mm 28.4 mm 29.8 mm 29.8 mm 31.2 mm 32.6 mm Including toothing 41mm 42.4 mm 43.8 mm 43.8 mm 45.2 mm 46.6 mm Excluding toothing 38mm 39.4 mm 40.8 mm 40.8 mm 42.2 mm 43.6 mm Including toothing 38mm 39.4 mm 40.8 mm 40.8 mm 42.2 mm 43.6 mm Excluding toothing 35mm 36.4 mm 37.8 mm 37.8 mm 39.2 mm 40.6 mm Including toothing 53mm 54.4 mm 55.8 mm 55.8 mm 57.2 mm 58.6 mm Excluding toothing 50mm 51.4 mm 52.8 mm 52.8 mm 54.2 mm 55.6 mm Including toothing 50mm 51.4 mm 52.8 mm 52.8 mm 54.2 mm 55.6 mm Excluding toothing 47mm 48.4 mm 49.8 mm 49.8 mm 51.2 mm 52.6 mm Including toothing 77mm 78.4 mm 79.8 mm 79.8 mm 81.2 mm 82.6 mm Excluding toothing 74mm 75.4 mm 76.8 mm 76.8 mm 79.2 mm 79.6 mm Including toothing 74mm 75.4 mm 76.8 mm 76.8 mm 78.2 mm 79.6 mm Excluding toothing 71mm 72.4 mm 73.8 mm 73.8 mm 75.2 mm 76.6 mm Including toothing 123mm mm mm mm mm mm Excluding toothing 120mm mm mm mm mm mm 8 /8 Associated trial Height of associated trial Samson Trial Size 1 Samson Trial Size 2 Samson Trial Size 3 Samson Trial Size 4 Samson Trial Size 5 Samson Trial Size 6 Samson Trial Size Max 23mm 26mm 30mm 38mm 50mm 74mm 123mm Rule for determining the necessary base unit height: 1. Trial has clearance in the prepared implant seat: -> the base unit to be selected corresponds to the size of the trial 2. Trial fits press-fit in the prepared implant seat: -> the base unit to be selected should be one size smaller than the selected trial 3. base unit does not fit in the prepared implant seat: -> the body to be selected should be at least one size smaller than the selected trial, re-check with a smaller trial 13
14 Use of trial implants Implants The size information on the preassembled base units (VBR Size 1 to VBR Size 6) indicates the total height of the implant when compressed or expanded to its maximum, including two assembled endplates with an angulation of 0. The total height of the implant is measured without the toothing, i.e. from tooth base to tooth base. The associated trial implants (Samson Trials) used to determine the required implant height each represent the height of the preassembled base unit in the fully compressed state, including the height of two assembled endplates with an angulation of 0 including toothing. If angled endplates are used, a certain height supplement must be factored in according to the lists on the previous pages. The largest trial (Samson Trial Max) is the largest implant when expanded to its maximum expanded state. The individual implant sizes overlap each other as the size increases. Thus the implant which can best fill the defect should be selected optional 49 Ø20 Ø20 optional 14
15 SAMSON Trial Implants Item no. Description Samson Trial Size Samson Trial Size 2 Trial implants Base units Samson Trial Size Samson Trial Size Samson Trial Size 5 optional Samson Trial Size Samson Trial Size Max Samson Plate Trial 25x Samson Plate Trial 30x20 optional optional Trial Implants Plates Samson Plate Trial 40x Samson Plate Trial 45x Samson Plate Trial 55x20 15
16 SAMSON Base Units Implants Item no. Name Diameter Height when compressed Height at max. expansion VBR Size 1 (20-26 mm) 20 mm 26 mm VBR Size 2 (23-30 mm) 23 mm 30 mm VBR Size 3 (27-38 mm) 27 mm 38 mm 20 mm VBR Size 4 (35-50 mm) 35 mm 50 mm VBR Size 5 (47-74 mm) 47 mm 74 mm VBR Size 6 ( mm) optional 71 mm 120 mm Note: The preassembled base units are supplied in the fully compressed position, to prevent the unintentional loosening of individual components. After washing and reprocessing, the base units should also be stored in the implant tray in the compressed position. Base units optional 16
17 SAMSON Plates Item no. Name Length Width Angle Plate 25x20 mm 0 25 mm Plate 30x20 mm 0 30 mm 0 Endplates Plate 40x20 mm 0 20 mm 40 mm Plate 45x20 mm 0 45 mm Plate 55x20 mm 0 55 mm Plate 25x20 mm 4 25 mm Plate 30x20 mm 4 30 mm Plate 40x20 mm 4 20 mm 40 mm Plate 45x20 mm 4 45 mm Plate 55x20 mm 4 55 mm Plate 25x20 mm 8 25 mm Plate 30x20 mm 8 30 mm Plate 40x20 mm 8 20 mm 40 mm Plate 45x20 mm 8 45 mm Plate 55x20 mm 8 55 mm Plate screw 8 Screw 17
18 SAMSON Instruments Instruments Item no. Description SAMSON Inserter SAMSON Inserter Holder Samson Locking Screw Driver T SAMSON Expander SAMSON Inserter Handle PLIF Inserter 18
19 Item no B Description ALIF/PLIF-Inserter B LP Setscrew Driver with Handle Torque Driver 2.3 optional 19
20 Manufacturer and Sales for Europe Marketing Middle East Sales for Latin America Other countries HumanTech Germany GmbH HumanTech Med. Sag. Tic. Ltd. HumanTech Mexico, S. DE R.L. DE C.V. HumanTech Germany GmbH Gewerbestr. 5 D Steinenbronn Germany Phone: +49 (0) 7157/ Fax: +49 (0) 7157/ sales@humantech-solutions.de İkitelli OSB Tümsan 2. Kısım C-Blok No: 47 TR Başakşehir İstanbul Turkey Phone: +90 (0) 212/ Fax: +90 (0) 212/ info@humantech.com.tr Rio Mixcoac No Acacias del Valle Del. Benito Juárez C.P Mexico, D.F. Mexico Phone: +52 (0) 55/ Fax: +52 (0) 55/ info@humantech-solutions.mx Gewerbestr. 5 D Steinenbronn Germany Phone: +49 (0) 7157/ Fax: +49 (0) 7157/ sales@humantech-solutions.de Edition 1/ Subject to change
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