Surgical Technique Table of contents Introduction ................................................................................................................. 2 TRIGEN™ META-TAN™ Nail specifications ................................................................... 3 Surgical technique ..................................................................................................... 4 Patient positioning ..................................................................................................... 4 Opening the proximal femur ..................................................................................... 5 Incision and entry point ................................................................................................ 5 Entry portal acquisition ................................................................................................. 6 Intramedullary reaming .............................................................................................. 8 Fracture reduction ........................................................................................................ 8 Implant measurement .................................................................................................. 9 Preparing the canal ...................................................................................................... 9 Nail assembly ............................................................................................................... 10 Verifying targeting accuracy ......................................................................................... 11 Insertion ....................................................................................................................... 11 Nail anteversion ........................................................................................................... 11 Insertion depth .............................................................................................................. 12 Proximal locking ......................................................................................................... 13 Standard femoral locking ............................................................................................. 13 Proximal (integrated screw mode) ................................................................................ 14 Integrated Screw insertion ......................................................................................... 16 Integrated Screw insertion: no compression ............................................................... 18 Integrated Screw insertion: with compression ............................................................ 19 Locking the Cannulated Set Screw (optional) ............................................................... 20 Nail Cap Insertion without set screw (optional) ............................................................ 20 Distal locking .............................................................................................................. 21 Implant removal: optional .......................................................................................... 22 Catalog information ................................................................................................... 25 Nota Bene The 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 specific patient. 1 Introduction The following technique is for informational and educational purposes only. It is not intended to serve as medical advice. It is the responsibility of treating physicians to determine and utilize the appropriate products and techniques, according to their own clinical judgment, for each of their patients. For more information on the TRIGEN™ META-TAN™ Trochanteric Antegrade Nail System, including its indications for use, contraindications, and product safety information, please refer to the product’s label and the Instructions for Use packaged with the product. The TRIGEN META-TAN Trochanteric Antegrade Nail is indicated for fractures of the femur including simple long bone fractures, severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; and for fixation of fractures that occur in and between the proximal third and distal fourth of the femur. In addition, TRIGEN META-TAN Nails contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability and are indicated for the following: subtrochanteric fractures; intertrochanteric fractures; ipsilateral femoral shaft/neck fractures; and intracapsular fractures. 2 TRIGEN™ META-TAN™ Nail Specifications Nail diameter 9mm 10mm 11.5mm 13 mm Nail diameter 9mm 10mm 11.5mm 13 mm 27mm 12.7mm 12.7mm 12.7mm 14mm 12.7mm 12.7mm 12.7mm 14mm 14.1mm 14.1mm 14.4mm 14.6mm 14.1mm 14.1mm 14.4mm 14.6mm Entry mm mm 14 mm mm reamer size 14 14 15 Entry mm mm 14 mm mm reamer size 14 14 15 Nail length 30 – 34 cm 36 – 40 cm 42 – 50 cm Nail length 30 – 34 cm 36 – 40 cm 42 – 50 cm AP Bow 1.4m 1.5m 1.6m AP Bow 1.4m 1.5m 1.6m 30 – 50cm 5° 15° Screw is inserted from posterolateral to anteromedial 35 – 40mm 25mm 15mm Proximal screw options Recon mode Femoral mode 8.6mm 27mm 23mm 44mm 146° 37mm 32mm 7mm 127° 6.2mm 12º 13.5mm 3 Surgical technique Patient positioning Place the patient in the supine or lateral decubitus position on a fracture table. The foot of the affected limb is placed in a foot holder or a pin is inserted through the calcaneus for traction purposes. The unaffected limb is extended below and away from the affected limb or flexed and placed in a leg holder. Check the affected limb for length and rotation by comparison to the unaffected limb. Abduct the torso 10°-15° to allow clear access to the intramedullary canal. Rotate the C-Arm to ensure optimal AP and lateral visualization of the entire femur. Note If using a radiolucent table, a distraction device may be helpful in reducing the fracture. 4 Opening the proximal femur Incision and entry point Assemble the Honeycomb (7167-4075, Figure A), Entry Portal Handle (7167-4092, Figure B) and Entry Portal Tube (7167-4060, Figure C). Figure c Figure A The pieces will lock in place securely at either 0 or 180. Figure B A longitudinal incision is made proximal to the greater trochanter. Carry the incision through to the fascia and palpate the tip of the greater trochanter. The optimal entry point for the TRIGEN™ META-TAN™ nail is located on the medial face of the greater trochanter, 5º from the anatomical axis in the AP and in-line with the intramedullary canal in the lateral view. 5 Entry portal acquisition Insert the Entry Portal Instrumentation through the incision down to bone. Attach a 3.2mm Guide Pin (7163-1436) to power via the Mini Connector (7163-1186) and insert 2 – 3cm into the trochanteric region. Avoid over-insertion of the Guide Pin as this can establish a false trajectory and lead to fracture malalignment. Confirm Guide Pin placement in the AP and lateral planes. Note In the instance of suboptimal Guide Pin placement, rotate the Honeycomb within the Entry Portal Tube to the desired location and insert another 3.2mm Guide Pin. Following Guide Pin placement, remove the Honeycomb from the Entry Portal Tube along with any additionally inserted Guide Pins. Insert the 12.5mm Entry Reamer (7163-1116) into the 14mm or 15mm Channel Reamer (7163-1039 or 7163-1445) until it clicks and attach to power. Advance the assembly through the Entry Portal Instrumentation 2 – 3cm into the trochanteric region. Evaluate reamer position before proceeding. Note The 14mm Channel Reamer is used with the 9mm, 10mm and 11.5mm META-TAN™ Nail. The 15mm Channel Reamer is used with the 13mm META-TAN Nail. 6 Adjust the trajectory of the reamer assembly if desired and advance to the positive stop on the Entry Portal Tube. The reamer will stop just below the level of the lesser trochanter. If the Entry Portal Instrumentation is not used, the Channel Reamer must still be advanced to the same point. Confirm the reamer assembly’s final position in both the AP and lateral planes. Detach and remove the 12.5mm Entry Reamer from the 14mm or 15mm Channel Reamer. Note The Channel Reamer and Entry Portal Instrumentation will serve as a soft tissue protector. Alternative Technique: Entry Portal Acquisition Attach the T-Handle (7167-4076 or 7167-4576) to the Cannulated Awl (7167-4000) and insert the 3.2mm Trocar (7167-4074) into the back of the assembly. Introduce the awl into the proximal femur at the designated entry point until it is below the level of the lesser trochanter. Remove the 3.2mm Trocar and pass a 3.0mm Ball Tip Guide Rod (7163-1626) into the back of the T-Handle. Remove the awl from the proximal femur. The region of the proximal femur extending to the lesser trochanter must be enlarged to 14mm in order to accommodate the proximal geometry of a 9mm, 10mm, and 11.5mm META-TAN™ Nail. The 13mm nail requires the proximal femur to be enlarged to 15mm. Note Intramedullary reamers should be used to prepare the proximal femur if the 14mm or 15mm Channel Reamer is not used*. *The largest Reamer Head that the TRIGEN™ Base Instrument Tray can hold