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cannulated screws for foot
surgical technique
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AGOCAN & CBS SCREWS
FOREFOOT HINDFOOT
Ø 7.5 Ø 4.5 Ø 4.5 Ø 4.5 Ø 3.5 Ø 3.5 Ø 2.7 Ø 3.2/3.9 Ø 2.3 Ø 1.8 Ø 1.5/2.0
MIDFOOT
MAKEYOUR
CHOICE!
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INDEX
INDICATIONS, CONTRA INDICATIONS, WARNINGS
SCREW DESIGN AND FEATURES AGOCAN AND CBS SCREWS
HEADED & HEADLESS SCREWS
DESIGN AND FEATURES AGOCAN AND CBS SCREWS
SURGICAL TECHNIQUE AND PROCEDURE WITH THE CORRECT SCREWS
CBS SCREW SELECTION
AGOCAN SCREW SELECTION
HEADED CBS SURGICAL THECHNIQUE PROCEDURE
AGOCAN SCREWS SURGICAL PROCEDURE AND INSTRUMENTATION
GENERAL INFORMATION
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Patient Positioning
• Patient positioning per surgeon’s technique and preference.
Osteotomies / Bone Tissue Preparation
• Joint preparation: Decorticate involved joint surfaces completely by means of appropriate burrs, curettes and osteotomes (e.g. AGOMED Charcot chisel or special osteotomes for joint surface preparation) until the subchondral bone surface is fully exposed on each side.
• Only use appropriate saw blades designed for small bone surgery.
Handling of Implants
• Use the provided forceps as to remove plates and screws from the tray.
• Implants that have been removed from the tray intraoperatively, but were not used in situ, need to be cleaned separately with a validated procedure before being put back into the tray. Afterwards they can be sterilized.
• The removable screw tray allows a handy use during the operation and optimizes the sterilization of the cannulated fixation screw
Screw Application
• Only the appropriate instruments must be used to manipulate and handle the screws. AO system screwdrivers as well as screwdriver handles are provided. Manipulating the screws with inappropriate instruments may result in damage of the threads. The screws may become unusable. Damaged screws must no longer be used and be replaced.
• Attach the screwdriver blade to the handle by pulling the coupling piece backwards while introducing the blade into the shaft. Once the blade reaches the end of the shaft, release the coupling piece to lock the blade in the handle.
• Ensure the proper mounting of all components prior to passing the instrument to the surgeon.
• Warning: The screwdriver blade has to be removed from the screwdriver handle before the instruments are passed on to sterilization.
Tip: For removing the screws from the tray, the screwdriver blade needs to be pushed firmly in vertical direction into the screw head in order to achieve a good grip of the screw.
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Wound Closure and Dressing; Post-op positioning
• The incision is closed per the surgeon’s preferred technique. Sterile wound dressing and post-op positioning are carried out according to the surgeon’s instruction.
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INDICATIONS, CONTRA INDICATIONS, WARNINGS
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Reliable and easy use:
• AGOMED has designed a verity of foot and ankle screws which are specificly made for an easy, fast and reliable procedure for the surgen. All of our screws where developed by some of the best surgens and ingniers, creating a high quality product with a remarkable versatility.
• AGOMED offers flexibility to the surgens to change the type of screw used intraoperatively between headless and headed as well as partially threaded and fully threaded screws.
• AGOMED canulated screws are made with a strong screw bite and high compression, as to mantaining a low cost and a high quality product.
• AGOMED provides an individual set for each screw diameter including all K-wires and instruments needed for a correct operation procedure.
CBS 7.5 set
AGOCAN 4.5 set
AGOCAN 3.5 set
SCREW DESIGN AND FEATURES AGOCAN AND CBS SCREWS HEADED SCREW
HEADLESS SCREW
Screw heaad: headed screw
• Rounded for decreassed soft tissue irritation when the screw is inserted at an angle, leaving a portion of the screw head proud. The head diameter was optimized to prevent plunging of the screw head into softer bone.
Screw neck: headed screw
• Reinforced neck geometry helps to prevent stress risers at a traditional weak point of the screw.
Screw neck: headless screw
• Studies have demonstrated that with traditional headless screws, maximum compression is achieved too early. This results in distal thread stripping when the screw reaches final placement. The Agomed headless screw design provides a tapered neck which enables controlled pre-compression before proximal thread engagement. The pitch ratio and taper were engineered to not exceed (for a given size) the distal thread purchase while achieving maximum compression.
Dual pitch threads: headless screw
• German studies show that the larger pitch differential (between proximal and distal threads) is what contributes to early compression and resultant stripping of the distal threads during final screw insertion to make the screw head flush with bone. The larger the differential between proximal and distal pitch, the more exaggerated this phenomenon.
• At AGOMED, we have engineered a “Pre-Compression“ taper at the neck of the screw to help provide controlled compression. The proximal threads are designed to then “lock“ in that compression rather than acting as the source of compression, thereby intending not to exceed what the distal thread purchase can tolerate.
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REVERSE CUTTING FLUTES
• Self-tapping reverse threads help facilitate screw removal.
SHARP TIP
• The 4 sharp tips are self-drilling and self-tapping. They allow bone to easily escape along the backside of the tip, which requires less torque upon insertion.
FORWARD CUTTING FLUTES
Forward cutting flutes
Designed so that bone can easily escape along the backside of the tip, allowing for less torque and fatigue on insertation
Three sharp tips are sellf-drilling
Extremly sharp thread
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DESIGN AND FEATURES AGOCAN AND CBS SCREWS SURGICAL TECHNIQUE AND PROCEDURE WITH THE CORRECT SCREWS
CBS SCREW SELECTION
• Chevron osteotomy with lateral release with CBS 1.5 / 2.0 cannulated screws
• Metatarsal osteotomies
• Malleolar fractures
• Patellar fractures
• For foot osteotomies
- Scarf, Akin, Austin/Cheveron, Younswick, Reverdin Green, etc.
• Chevron osteotomy with lateral release with CBS 3.2 / 3.9 cannulated screws
• Universal usage
• Cannulated double-threaded screws for forefoot surgery
- Scarf, Austin/Cheveron, Closing Wedge, Ludloff, Akin, Youngswick, Reverdin Green, etc.
• Ankle arthrodesis with 7.5 CBS cannulated screws
• Calcaneus displacement osteotomy procedure with 7.5 CBS cannulated screws
• Arthrodesis of the subtalar joint
• Revision of pseudo arthrosis
• Compression arthrodesis of the Talo-naviculare joint
• Correction of wrong positioned arthrodesis
• Compression arthrodesis of the Calcaneo-cuboidal joint
• Surgical combination procedures with osteosynthesis
• Arthrodesis of the Charcot arthropathics titanium plates
• Fixation of mid-sized intra-articular bone fragments in foot surgery.
CBS 1.5 / 2.0
CBS 4.5
CBS 7.5
CBS 3.2 / 3.9
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1.5-2.0 mm8-30 mm, step 1 mm
30-34 mm, step 2 mm
Diameters Screw Lengths
4.5 mm18-40 mm, step 2 mm
40-70 mm, step 5 mm
1.5-2.0 mm Purple 1.7 mm 1.9 mm TX6 0.9 mm
3.2-3.9 mm Silver 2.0 mm 3.7 mm TX10 0.9 mm
4.5 mm Green 2.8 mm 4.0 mm TX10 1.3 mm
7.5 mm Purple 4.0 mm 7.0 mm TX25 1.6 mm
Diameters
Screw Ø
Table 1
Screw Lengths
Color Pilot drill Countersink Driver K-Wire
3.2-3.9 mm10-30 mm, step 1 mm
30-36 mm, step 2 mm
Diameters Screw Lengths
7.5 mm 40-120 mm, step 5 mm
Diameters Screw Lengths
AGOCAN SCREW SELECTION
• Indication for tension banding in orthopaedic and traumatological surgeries.
• Indication for tension banding in orthopaedic and traumatological surgeries.
• Indication for tension banding in orthopaedic and traumatological surgeries.
• Foot surgery:
- Small bone fractures, bony ligaments ruptures, arthrodesis.
AGOCAN 1.8 / 2.3
AGOCAN 2.7
AGOCAN 3.5
AGOCAN 4.5
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1.8 mm 6-30 mm, step 2 mm
2.3 mm 6-40 mm, step 2 mm
Diameters Screw Lengths
2.7 mm10-40 mm, step 2 mm
40-60 mm, step 5 mm
Diameters Screw Lengths
3.5 mm
12-24 mm, step 2 mm
24-26 mm, step 1 mm
26-34 mm, step 2 mm
34-36 mm, step 1 mm
36-40 mm, step 2 mm
40-60 mm, step 5 mm
Diameters Screw Lengths
3.5 mm
12-24 mm, step 2 mm
24-26 mm, step 1 mm
26-40 mm, step 2 mm
40-90 mm, step 5 mm
Diameters Screw Lengths
4.5 mm18-40 mm, step 2 mm
40-90 mm, step 5 mm
Diameters Screw Lengths
4.5 mm18-40 mm, step 2 mm
40-90 mm, step 5 mm
Diameters Screw Lengths
1.8 mm Purple - 1.7 mm TX6 0.7 mm
2.3 mm Gold - 2.2 mm TX8 0.9 mm
2.7 mm Blue 2.0 mm 2.5 mm TX8 0.9 mm
3.5 mm Gold 2.5 mm 3.3 mm TX8 0.9 mm
4.5 mm Green 2.5 mm 4.2 mm TX10 0.9 mm
Screw Ø Color Pilot drill Countersink Driver K-Wire
Table 2
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HEADED CBSSURGICAL THECHNIQUE
PROCEDURE
• All CBS screws follow the same surgical procedure in continuation an example for a CBS 4.5 Diameter screw
CBS 4.5
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1 - Temporary fixation with K-wires and image intensification check
2 - Insertion of guide wire and control with image intensifier
• K-wire Placement The appropriate K-wire (TABLE 1 page 8) is advanced across the fusion or osteotomy site. Verify the desired positioning of the wire fluoroscopically.
3 - Overdrilling of K-wire using cannulated drill bit:
• CBS have been designed to be self-drilling and selftapping. However, in some situations such as hard cortical bone, bicortical fixation, or when an oblique approach is desired, drilling may be necessary. Additionally, it is recommended to pre-drill the near cortex when using headless screws to prevent the proximal threaded portion from splitting or cracking the cortical shell. Slide the appropriate color-banded drill bit over the K-wire. Under power, drill just past the osteotomy or fusion site.
Ref. 1101055 K-Wire 150 x 1.3 mm, trocar/round, pack/6
Ref. 1300970 - Soft tissue protector CBS 4.5, 35 mm cannulated 5,0 mm
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• Diferent options available
* If required, the provided soft tissue protector can be used for minimally invasive surgery
Ref. 1201086 - Twist drill 2,8 x 120 mm f. CBS 4,5 cannulation 1,4 mm, AO-shaft
Ref. 1201087 - Twist drill 2,8 x 150 mm f. cbs 4,5 cannulation 1,4 mm, AO-shaft
4 - Checking of drill depth with image intensifier
5 - Manual thread tapping, also over guide wire! Thread tapping will only take place with 4.5 and 7.5 systems!! (Screwdriver handle not provided in set):
Ref. 1300958 - 4.5 mm tap cannulated AO-shaft
7 - Determination of the appropriate screw length, using the depth gauge or scale on the drill or tap.
• To measure the length of the screw, apply the depth gauge over the K-Wire. To allow for a precise measurement, the depth gauge and the bone surface need to be in direct contact. Determine the appropriate screw length from the scale on the gauge.
• To ensure complete seating of the headed screws, the appropriate countersink may be used. Load the appropriate color-banded countersink onto the Cannulated AO Driver Handle, and turn the countersink in a clockwise motion to penetrate the cortex of the bone
* If is recommended to recheck the depth of the K-Wire, using the image intensifier
Ref. 1006034 - Depth gauge 100 mm f. K-Wires up to 1,4 mm, shaft 3 mm diam.
6 - Thread depth determination with the image intensifier, with the tap still introduced.
• Slide the tip of the Cannulated Depth Gauge over the K-wire and down to the surface of the bone, ensuring that the gauge is seated flush to the bone. The gauge measurement indicates the depth from the surface of the bone to the tip of the K-wire; adjust accordingly for countersinking or lagging.
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8 - Countersinking over K-Wire
• We recommend countersinking over the K-Wire with the cannulated countersink. Therefor attach the countersink to the screwdriver handle.
• Manual application of the countersink is required, as mechanical application involves the risk of destroying small fragments. Apply the cannulated countersink over the guide wire and prepare the bone for the head of the AGOCAN screw, countersinking with slight pressure
Ref. 1203080 - CBS 4,5 countersink, 80 mm round- shaft, cannulated 1,4 mm
ATTENTION: The countersinks should not be confused with the screwdriver blade • Load the appropriate Driver into the Cannulated AO Driver Handle. Place the screw over the
K-wire and use the Driver to advance the screw into the bone, until the head is completely countersunk within the bone.Depending on the stability of the first screw, procedure type, and patient related factors (obesity, postoperative compliance issues), multiple screws may be used for additional fixation. In the case of soft bone, a washer may be used under the head (for headed screws only) to limit excursion of the screw into the bone. Slide the screw through the washer until it contacts the head and insert the screw over the K-wire as detailed above. Remove the K-wire and perform surgical closure.
9 - Manual insertion of the screw (screwdriver blade and screwdriver handle) over guide wire. The head of the screw is to be screwd flush to the cortical bone in order to avoid limitations of the surrounding soft tissue.
Ref. 1004032 - Silicone screwdriverhandle, green cannulated, 12 cm, AO-shaft
Ref. 1001009 - CBS 4.5 blade TX 10, cannulated interchangeable, AO-shaft
AGOCAN SCREWSSURGICAL PROCEDURE
AND INSTRUMENTATION
* All AGOCAN screws follow the same surgical procedure, with exception that the 1.8 and 2.3 screws are not provided with washers as they are not needed. In continuation the example with the AGOCAN 3.5 mm Diameter screws
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11 - Removal of guide wire and perform surgical closure.
10 - 2 Dimensional image intensification.
Agocan 3.5
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1 - Cartilage removal of the joint surfaces or removal of scar tissue and fibroses in case of pseudo arthrosis and / or osteotomy.
2 - Axial adjustment of joints or osteotomy surfices.
3 - Temporary fxatio with K-Wires and image intensification check.
4 - Insertion of guide wire (K-Wire) and control with image instensifire.
• K-wire Placement The appropriate K-wire (TABLE 2 page 11 ) is advanced across the fusion or osteotomy site. FIGURE 4 Verify the desired positioning of the wire fluoroscopically.
5 - Over drilling of K-Wire with the cannulated drill
• It is recommended to pre-drill the near cortex when using headless screws to prevent the proximal threaded portion from splitting or cracking the cortical shell. Slide the appropriate color-banded drill bit over the K-wire. Under power, drill just past the osteotomy or fusion site.
Ref. 1101021 - Kirschner wire 100 x 0,9 mm, trocar/round, pack/6
Ref. 1019105 - Twist drill 2,5 x 95 mm, cannulated 1,2 mm, thread 30 mm, AO-shaft
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6 - Drill depth determination with the image intensiffier.
7 - If required, manual thread tapping with the provided tap, also over guide wire!
Ref. 1019113 - Agocan 3.5 tap, cannulated, AO-shaft, 60 mm
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10 - Countersinking over K-Wire, if required:
• We recommend countersinking over the K-Wire with the cannulated countersink. Therefor attach the countersink to the screwdriver handle.
• Manual application of the countersink is required, as mechanical application involves the risk of destroying small fragments. Apply the cannulated countersink over the guide wire and prepare the bone foe the head of the AGOCAN screw, countersinking with slight pressure.
Ref. 1203075 - Agocan 3.5 countersink 90 mm, cannulated AO-shaft
ATTENTION: The countersinks should not be confused with the screwdriver blade
* It is recommended to recheck the depth of the K-Wire, using the image intensifier
Ref. 1006034 - Depth gauge 100 mm f. K-Wires up to 1,4 mm, shaft 3 mm diam.
8 - Thread depth determination with the image intensifier while the tap is still introduced.
9 - Measuring of the appropriate screw length, using the depth gauge over the guide wire.
• To measure the length of the screw, apply the depth gauge over the K-Wire. To allow for a precise measurement, the depth gauge and the bone surface need to be in direct con-tact. Determine the appropriate screw length from the scale on the gauge.
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Ø 3.5 mm
Ø 4.9 mm
Ø 4.9 mm
Ø 3.5 mm
5038035Titanium washer for
3.5 mm screws, pack/5
1.0 mm
Ø 6.9 mmPartial thread
Full thread
12 - Manual insertion of the screw (screwdriver blade and screwdriver handle) over guide wire. The head of the screw is to be screwd flush to the cortical bone in order to avoid limitations of the surrounding soft tissue.
• Attach the screwdriver blade to the handle by pulling the coupling piece backwards while introducing the blade into the shaft. Once the blade reaches the end of the shaft, release the coupling piece to lock the blade in the handle. Ensure the proper mounting of all components prior to passing the instrument to the surgeon.
11 - Washer application
• If required, Application of the screw with a washer. Each set comes with it’s complete set of washers, except for 1.8 and 2.3 Agocan screws as they are not required in any case)
• In the case of soft bone, a washer may be used under the head (for headed screws only) to limit excursion of the screw into the bone. Slide the screw through the washer until it contacts the head and insert the screw over the K-wire.
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14 - Removal of guide wire.
13 - 2 Diamensional image intensification. GENERAL INFORMATION
• The decision regarding the use of our implants and instruments rests with the responsible operating surgeon.
• We cannot provide a risk evaluation for indications that deviate from the recommended use.
• Our implants, if not otherwise mentioned, are manufactured of titanium as per ASTM F67 – 95 and therefore are chemically passive and non-magnetic. Our instruments are manufactured of different sorts of steel.
• Our implants are made and supplied in support of the healing of bone tissue after osteotomies, fractures and reconstructive surgery, but neither to replace normal body structures nor to carry the body weight in case of incomplete healing.
• Instruments and implants included in this system must only be utilized through medical personnel, who have obtained qualification for said in accordance with the local / national laws and requirements.
• The implants are made for single use only!
• Prior to the surgical procedure the system and the implants require cleaning and sterilisation by means of a validated procedure in accordance with the local / national applied laws.
Tip: Please ensure that there is sufficient space to place all sterile system components, to prevent dropping of implants or instruments into the unsterile area during the operation.
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NOTESNOTES
AGOMED Medizin-Technik GmbHÖschweg 29 - D-78567 Fridingen - Germany
(+49) 7463 / 267 06 16
http://www.agomed.com
