Surgical Technique Guide
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- Maximillian McDonald
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1 Guide CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician.
2 INDICATIONS FOR USE The Align Anterior Ankle Fusion Plate is intended to facilitate arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints. Plate Selection and Preparation The Align Ankle Fusion System s Plates are right and left specific and are offered in standard (dual tab) and slim (single tab) configurations. The standard plate incorporates a lateral tab design that enhances construct stability and can assist in the distribution of compressive forces when combined with the Homerun Screw. Pre-operative assessment and templating is recommended to assess the most appropriate plate selection for each patient. Incision, Joint Preparation and Plate Reduction Guidelines Incision Identify the anterior tibia ridge and the lateral aspect of the talonavicular joint. Make an incision just lateral to the tibial ridge and approximately 1cm medial to the lateral edge of the talonavicular joint (care should be taken to avoid injury to the superficial peroneal nerve). Dissection is carried down to the deep fascia keeping the incision in the interval between the tibialis anterior and the extensor hallucis longus (caution should be taken to avoid the neurovascular bundle). Dissection is taken directly down to the tibia and developed distally to the talar neck. Elevate the soft tissue off the distal tibia to expose medial and lateral gutters. The extensor retinaculum should be mobilized off the tibial ridge to allow for closure of the plate over the shoulders of the plate. The dorsomedial and lateral aspects of the talus should be exposed. Anterior osteophytes should be removed as required to allow proper positioning of the tibiotalar joint and placement of the plate. Joint Preparation The tibiotalar joint should be prepared for arthrodesis in the standard fashion. Utilize the Parallel Compressor/ Distractor to help gain exposure of the joint as required. All remaining articular cartilage should be removed with a curette, osteotome, and/or rongeur. The subchondral bone should be perforated with multiple small holes or a burr to a recommended depth of 2-4 mm. Joint Reduction The tibiotalar joint should be reduced to neutral dorsi/plantarflexion and inversion/eversion. A 2.0mm Guidewire can be placed across the joint to help maintain the reduction. Soft tissue release/mobilization and/or bone resection may be required if an anterior extrusion of the talus is present. An Achilles tendon lengthening procedure may be required to obtain proper position. Note: Incision, joint preparation, and plate reduction techniques are left to the surgeon s discretion
3 STEP 1 - Plate Placement Place the Align Anterior Fusion Plate so that the lateral tab rests lateral to the talar neck and the proximal end of the plate rests on the anterolateral aspect of the tibia. Provisionally pin the plate with an Olive Wire in the most dorsal hole on the medial tab. Subsequently add a second Olive Wire in the tibia in either the slotted fixation hole or the axial compression slot. Note: If the neck component of the plate does not fit flush on the talus remove osteophytes from the dorsal and lateral surface of the talar neck. STEP 2 - Screw Placement - 1st Medial Tab Hole In order to ensure the proper trajectory of the converging screws in the medial tab, it is recommended to use the Locking Drill Guide for both of the medial tab screws. Choice of screw type is left up to the surgeon s discretion. It is recommended to place a Non-Locking 4.0mm Screw in the first hole, and a 4.0mm Locking Screw in the second. Place the 2.9mm Non-Locking Drill Guide into the most medial hole on the medial tab. Measure and drill for screw length. Insert the appropriate 4.0mm Screw. Screw Drill Size Drill Guide Color 4.0 mm Non-Locking 2.9mm Gray 4.0 mm Locking 2.9mm Green Note: Drills are calibrated to Drill Guides and thus screw lengths can be determined directly off of the drill. Alternatively, a standard hook-style Depth Gauge is available and can be used to directly measure screw length. Drill and measure for each subsequent screw in preferred manner.
4 STEP 3 - Screw Placement - 2nd Medial Tab Hole Place the 2.9mm Locking Drill Guide into the most dorsal hole of the medial tab. Drill and measure for screw length. Insert the appropriate 4.0mm Locking Screw. Screw Drill Size Drill Guide Color 4.0 mm Non-Locking 2.9mm Gray 4.0 mm Locking 2.9mm Green Optional Step: Plate Reduction It is recommended to reduce the Plate to the tibia prior to the placement of any tibial screws. The Compression Pin/Compression Sleeve device can be utilized to reduce the plate to the tibia. Place the Compression Pin in the most proximal hole of the plate. Advance the Compression Sleeve over the Compression Pin. Turn the compression sleeve clockwise to reduce the plate.
5 STEP 4 - Screw Placement - Lateral Tab Hole: Standard Plate Care should be taken to assess proper alignment of the plate with relation to the tibia prior to placing the lateral tab screw. Place the 3.5mm Locking Drill Guide into the lateral tab hole. Drill and measure for screw length. Insert the appropriate length 5.0mm Screw. Note: A 5.0mm Non-Locking Screw can be used to reduce the lateral tab down to bone. Utilize the 2.9mm Drill Guide & 2.9mm Drill to prepare for this non-locking screw. Screw Drill Size Drill Guide Color 5.0 mm Non-Locking 3.5mm Gray 5.0 mm Locking 3.5mm Blue
6 STEP 5 - Parallel Compression The Parallel Compressor/Distractor can be utilized to generate compression across the tibiotalar joint. The anatomic location for placement of the 2.0mm Guidewires utilized with this device is left up to the surgeon s preference. Lateral placement (illustrated in this guide) can be helpful to assist in the reduction and maintenance of a varus deformity. Medial placement can be helpful to assist in the reduction and maintenance of a valgus deformity. Place a 2.0mm Guidewire in both the talus (anterior to the fibula) and tibia at a maximum distance of 60mm apart. Set the Parallel Compression Device to the COMP setting. Squeeze the handle fully. The device is now set to compress. Slide the device over the 2.0 Guidewires and squeeze the handle to apply compression as desired. STEP 6 - Homerun Screw Placement A Homerun Screw (6.5mm Partially Threaded Screw) can be placed through the Align Plate. The trajectory of the placement of this screw is left up to the surgeon s discretion. The plate and Polyaxial Cone Drill Guide allows for up to 30 of angulation which allows for screw placement across the tibiotalar or subtalar joint for a TTC Fusion. Place a 2.0mm Guidewire through the Polyaxial Cone Guide in the desired screw trajectory and depth. Note: Homerun Screw Guidewire placement recommendations: Tibiotalar Fusion: Place the guidewire in the center most portion of the posterior talar body and advance it ~8mm from the posterior cortex of the talus. Tibiotalocalcaneal Fusion: Place the guidewire in the Calcaneal body just lateral to the medial wall.
7 STEP 6 - Homerun Screw Placement (continued) There are two sides to the Guidewire Depth Gauge. Utilize the 6.5mm + Plate side to measure for the Homerun Screw. Utilize the 6.5mm Direct Depth side for screws placed outside of the Align Plate. -Measure over the Guidewire for screw length. -Drill over the Guidewire with the 4.5mm Cannulated Drill. -Insert the appropriate length Partially Threaded 6.5mm Screw over the Guidewire.
8 Optional- Axial Compression Slot The Compression Slot in the Align Plate can be utilized to generate additional axial compression. Place the Non-Locking Drill Guide and drill in the proximal portion of the plate s Compression Slot. Drill, measure and place a Non-Locking Screw in the most proximal portion of the slot.
9 STEP 7 - Screw Placement: Proximal Holes Insert remaining proximal screws as desired. Anterior Lateral Posterior TTC IMPLANT REMOVAL Clear tissue in-growth from the screws. Insert the T25 Star Driver into the screw head and remove the screw from the plate by turning the Star Driver counter-clockwise. Remove all screws and then the plate.
10 Implant # Description Plate Anterior Ankle Fusion Plate, Slim, Left Anterior Ankle Fusion Plate, Slim, Right Anterior Ankle Fusion Plate, Standard, Left Anterior Ankle Fusion Plate, Standard, Right Implant # Description 4.0 Non-Locking Screws (solid) Non-Locking Screw x 22mm Non-Locking Screw x 24mm Non-Locking Screw x 26mm Non-Locking Screw x 28mm Non-Locking Screw x 30mm Non-Locking Screw x 32mm Non-Locking Screw x 34mm Non-Locking Screw x 36mm Non-Locking Screw x 38mm Non-Locking Screw x 40mm Non-Locking Screw x 45mm 4.0 Locking Screws (solid) Locking Screw x 22mm Locking Screw x 24mm Locking Screw x 26mm Locking Screw x 28mm Locking Screw x 30mm Locking Screw x 32mm Locking Screw x 34mm Locking Screw x 36mm Locking Screw x 38mm Locking Screw x 40mm Locking Screw x 45mm STANDARD Left Right SLIM Left Right Implant # Description 5.0 Non-Locking Screws (solid) Non-Locking Screw x 30mm Non-Locking Screw x 32mm Non-Locking Screw x 34mm Non-Locking Screw x 36mm Non-Locking Screw x 38mm Non-Locking Screw x 40mm Non-Locking Screw x 42mm Non-Locking Screw x 44mm Non-Locking Screw x 46mm Non-Locking Screw x 48mm Non-Locking Screw x 50mm 5.0 Locking Screws (solid) Locking Screw x 30mm Locking Screw x 32mm Locking Screw x 34mm Locking Screw x 36mm Locking Screw x 38mm Locking Screw x 40mm Locking Screw x 42mm Locking Screw x 44mm Locking Screw x 46mm Locking Screw x 48mm Locking Screw x 50mm Homerun Screws Partially Threaded Screw (Cannulated) x 50mm Partially Threaded Screw (Cannulated) x 55mm Partially Threaded Screw (Cannulated) x 60mm Partially Threaded Screw (Cannulated) x 65mm Partially Threaded Screw (Cannulated) x 70mm Partially Threaded Screw (Cannulated) x 75mm Partially Threaded Screw (Cannulated) x 80mm Partially Threaded Screw (Cannulated) x 85mm Partially Threaded Screw (Cannulated) x 90mm Partially Threaded Screw (Cannulated) x 95mm Partially Threaded Screw (Cannulated) x 100mm Partially Threaded Screw (Cannulated) x 105mm Partially Threaded Screw (Cannulated) x 110mm Non-Locking Screws 4.0 mm Locking Screws 4.0 mm 5.0 mm 5.0 mm 6.5 mm Partially Threaded Screw
11 Align Screw Placement Sequence Quick Reference 6. Locking/Non-Locking Screw Options mm Partially Threaded Screw 6. Non-Locking Screw Only
12 Reusable Instruments Screw Retaining Sleeve Slotted Bending Iron Screw Holding Forceps AO Depth Gauge Parallel Compressor/Distractor Compression Pin Compression Sleeve T25 Star Driver Locking Drill Guide - 2.9mm Locking Drill Guide - 3.5mm Non-Locking Drill Guide - 2.9mm Polyaxial Cone Drill Guide - 4.5mm Solid Drill - 2.9mm Solid Drill - 3.5mm Guide Wire Depth Gauge Disposable Instruments Guidewire - 2.0mm Threaded Olive Wire - 2.5mm Cannulated Drill - 4.5mm Align Plate X-ray Template 300 Interpace Parkway Suite 410 Parsippany, NJ Phone: Fax: LBL EN Rev A 04/2016
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