OPS External Fixation System Surgical Technique ILIZAROV EXTERNAL FIXATOR Document No.ST_T-D3 Ilizarov Rev. 00, Release Date: 23 SEP 2022 Approved by
OPS TRAUMA TABLE OF CONTENTS INTRODUCTION Indications and Contraindications 1 Indications 1 Product Features and Example of Indications 3 SURGICAL TECHNIQUE Preparation 4 Ring Selection and Assembly 4 Frame Construction 5 Wire Insertion 7 Wire Fixation 8 Wire Tensioning 10 Insert Schanz screw 12 Post-Operative Adjustment 13 Interface Matrix of Implants with Frame Components 14 PRODUCT INFORMATION Implants 15 Components 16 Instruments 23 Implant and Instrument Set 24 Important Product Information 27
OPS TRAUMA Page 1 of 27 Ilizarov External Fixation System - Surgical Technique Ilizarov external fixation system is intended for correcting, lengthening, and restoring skeletal deformities in pediatric patients and adults as the following indications: • Post-Traumatic joint contracture which has resulted in loss of range of motion • Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction • Open and closed fracture fixation • Pseudoarthrosis of long bones • Limb lengthening by epiphyseal or metaphyseal distraction • Correction of bone or soft tissue deformities • Correction of segmental bone or soft tissue defects • Arthrodesis • Infected fractures or nonunions Indications Ilizarov external fixation system is contraindicated for use in the following: • Uncooperative or mentally incompetent patients who are unable to follow the postoperative regimen • When there is an active infection • Known sensitivity and/or allergies to the materials in the external fixation device model to be used Contraindications INTRODUCTION Indications and Contraindications
OPS TRAUMA Page 2 to 27 Surgical Technique - Ilizarov External Fixation System Ilizarov External Fixation System Orthopeasia Ilizarov external fixator is used in conjunction that provides the surgeon a broad range of construct options to stabilize fractures or surgically created instability of limb fractures, available in a variety of options in frame construction, simplicity in frame components. Ilizarov external fixation system is composed of rings, Schanz screws, wires, threaded rods of various sizes as well as several types of assembly accessories. These elements are ssembled with a ring frame and linked by threaded rods which are available in several lengths and locked by nuts. Fig.1 OPS Tibia Fracture Stabilization System GRADUATED TELESCOPIC ROD easy to adjust the distance between rings OLIVE WIRE WITH BAYONET POINT Olive-stopper helps for correction of bone axis RING (stainless steel, ASTM F138) available for half and 5/8 ring type with various sizes diameter CANNULATED/SLOTTED WIRE FIXATION BOLT options for wire fixation
OPS TRAUMA Page 3 of 27 Ilizarov External Fixation System - Surgical Technique Proximal basic support Fig.2 Standard arrangement of Femur Fracture Fig.3 Standard arrangement of Tibia Fracture INTRODUCTION Product Features and Example of Indications Proximal transosseous module Proximal transosseous module Proximal basic transosseous elements Proximal basic transosseous elements Distal transosseous module Distal transosseous module Distal basic transosseous elements Distal basic transosseous elements Distal basic support Distal basic support Reductionally fixing (Intermediate) supports Reductionally fixing transosseous elements Proximal basic support Reductionally fixing (Intermediate) supports
OPS TRAUMA Page 4 to 27 Surgical Technique - Ilizarov External Fixation System Ring Selection and Assembly Select half rings Select two half rings (of the same size) that allow at least 2 cm of clearance between the limb and ring (take care to measure at the thickest portion of the affected limb) (Fig. 4). Any anticipated swelling of the limb must also be taken into consideration. Assemble half rings Place the two half rings around the limb. Connect the half rings using two connection bolts (Fig. 5). Connect bolts through the nonthreaded holes of the rings. Tighten the bolts with the wrench. Repeat those steps, selection of half rings and assemble half rings, three more times so that there is a total of 4 assembled rings of the same diameter. Precautions: • Instruments and screws may have sharp edges or moving joints that may pinch or tear user’s glove or skin. • Handle devices with care and dispose worn bone cutting instruments in an approved sharps container. Preparation Patient positioning Position the patient supine on a radiolucent table with the affected limb elevated to provide access for the distraction osteogenesis ring system frame, wires, and Schanz screws. The preoperative planning can be performed by orthopedics surgeon from X-ray film of patient's fracture. It is essential and useful for preparing of pre-assembly ring construction. Components Code Product Name 132002803 Half Ring SST Round Ho 190 mm 132000600 Connection Bolt with Washer 132001000 Hexagonal Nut SURGICAL TECHNIQUE Fig. 4 Fig. 5
OPS TRAUMA Page 5 of 27 Ilizarov External Fixation System - Surgical Technique Frame Construction The assembled rings should be placed at the marked level related to the preoperative plan by (Fig. 6): The 1st ring (The most proximal): Position the ring near the joint, but no closer than 20 mm, tissue condition and anatomy permitting. The 2nd ring (The first intermediate): Position the second ring approximately 30 - 50 mm proximal to the affected area, tissue condition and anatomy permitting. Align the connection bolts of the half rings. Use threaded rods and nuts and the 10 mm wrench to connect the rings. Typically, only three threaded rods are necessary between each pair of rings (4 rods should be used between pairs of 210 mm rings). The 3rd ring (The second intermediate): Position the third assembled ring approximately 30 – 50 mm distal to the affected area, tissue condition and anatomy permitting. Align the connection bolts of the half rings with those of the previously connected rings and use threaded rods and nuts to connect this ring to them. For maximum stability, position these threaded rods as equally spaced as possible between the threaded rods from the previous ring. SURGICAL TECHNIQUE Fig. 6
OPS TRAUMA Page 6 to 27 Surgical Technique - Ilizarov External Fixation System The 4th ring (The most distal): Position the fourth assembled ring near the distal joint, but no closer than 20 mm, tissue condition and anatomy permitting. Align the connection bolts of the half rings with those of the previously connected rings and use threaded rods and nuts to connect this ring to them. For maximum stability, position these threaded rods as equally spaced as possible between the threaded rods from the previous ring. Note: When holes in the rings do not line up properly (such as when different diameter rings are used), Radius washer couples, Universal joint or Connecting plates may be used to connect the threaded rods to adjacent rings. Frame Construction (continue) Implant Code Product Name 132003300 Olive Wire with Bayonet Point 1.8x400 mm Components Code Product Name 132003400 Cannulated Wire Fixation Bolt 132003500 Slotted Wire Fixation Bolt 132001000 Hexagonal Nut SURGICAL TECHNIQUE
OPS TRAUMA Page 7 of 27 Ilizarov External Fixation System - Surgical Technique Prior place Cannulated Wire fixation bolt to a ring hole and hand tighten with nut to hold the wire (Fig. 7). Using power, insert the wire perpendicular to the long axis of the bone. Do not start the drill until the wire tip makes contact with the bone and stop drilling as soon as the tip protrudes from the far cortex of the bone. Care should be taken to ensure that diaphyseal wires are bicortical. A unicortical wire (that is so far anterior that it does not cross the intramedullary canal) can generate excessive heat during insertion and create stress risers in the bone. Use an alcohol-soaked sponge helps guide and cool the wire. Once the wire protrudes from the far cortex of the bone, tap it through the tissue on the far side. The flat side of the bending/ cutting pliers or a hammer may be used to tap the wire through the tissue. Once the wire is through, cut off the tip to prevent injury. Care should be taken to avoid violation of the joint space (15 - 20 mm from subchondral bone in proximal tibia). Wire Insertion Fig. 7 Implant Code Product Name 132003300 Olive Wire with Bayonet Point 1.8x400 mm Components Code Product Name 132003400 Cannulated Wire Fixation Bolt 132001000 Hexagonal Nut SURGICAL TECHNIQUE
OPS TRAUMA Page 8 to 27 Surgical Technique - Ilizarov External Fixation System Use wire bolts to connect the wire to the ring. Choose a wire fixation bolt to connect another end of the wire to the ring, surgeon preference determines whether Wire fixation bolt - cannulated or slotted is used to fix the wire end (Fig. 8 - 9), depending on the position of the wire in relation to the holes in the ring. Select the wire bolt that results in the least amount of wire deformation. Wire can be placed above or below ring. Type of wire fixation bolt utilized is dependent upon the position of the wire in relationship to the ring hole. Select the wire bolt that results in the least amount of wire deformation. Do not bend wires to attach them to the ring. Precaution: The wire should be straight through the skin along the desired axis of the wire. Fluoroscopy may be used to confirm proper orientation of the ring and the wire to the limb (the same process shall be apply with screw insertion). Do not bend wires to attach them to the ring as this could increase the risk of wire breakage. See the "Additional Fixation Options (next page)" for offset fixation options. Use one wrench to stabilize the wire bolt head while using a second to tighten the nut at the location opposite from where tension will be applied. When reduction wires (olive wires) are used, tighten the nut and the bolt on the same side as the stopper. Take care to keep the wire bolt head aligned, Wire Fixation Fig. 8 Fig. 9 Implant Code Product Name 132003300 Olive Wire with Bayonet Point 1.8x400 mm Components Code Product Name 132003400 Cannulated Wire Fixation Bolt 132003500 Slotted Wire Fixation Bolt 132001000 Hexagonal Nut SURGICAL TECHNIQUE
OPS TRAUMA Page 9 of 27 Ilizarov External Fixation System - Surgical Technique Wire Fixation (continue) Additional Fixation Options There are a variety of items that can be used in conjunction with Schanz screws and wires when there is a need to position them in locations offset from the ring’s surface. For example: • Spacer washer (Fig. 10) • Posts male (Fig. 11) • Posts female (Fig. 12) • Masculine low profile hinge (Fig. 13) • Feminine low profile hinge (Fig. 14) • Rancho cube (Fig. 15) • Spring washer (Fig. 16) Components Code Product Name 132002500 Spacer Washer 132002600 Spring Washer 132002001 Posts male 132001901 Posts female 132001300 Masculine low profile hinge 132001200 Feminine low profile hinge 132002102 Rancho cube Fig. 10 Fig. 16 Fig. 11 Fig. 12 Fig. 13 Fig. 14 Fig. 15 SURGICAL TECHNIQUE
OPS TRAUMA Page 10 to 27 Surgical Technique - Ilizarov External Fixation System Position tensioner on wire From the tensioning side of the ring, opposite to the tightened nut and wire bolt, pass the wire into the cannulation of the tensioner. The tensioner should be fully open (turn the tensioner handle counterclockwise) and the jaws on the front of the device seated securely against the ring, to ensure proper tensioning of the wire. Center the wire bolt and nut between the jaws of the tensioner (Fig. 17). Note: When reduction wires are used, the tensioner should be placed on the side of the bone opposite the stopper to ensure the stopper provides compression during tensioning. Tighten offset bolt opposite the tensioner before tensioning and leave the wire bolt that is near the tensioner loose when tensioning. Turn the tensioner handle clockwise until the desired tension is attained. Typical wire tensions used are: • When attached to a ring: 130 kg • When attached to a ring on a small stature patient: 100 kg • When positioned off of a ring: 50 – 75 kg • When positioned in the hand or foot: 50 – 75 kg Use two wrenches to tighten the nut and wire bolt opposite from where tension will be applied. When reduction wires are used, tighten the side with the stopper. Take care to keep the wire bolt head aligned, to prevent bending the wire (Fig. 18 - 19). Wire Tensioning Fig. 17 Fig. 18 Fig. 19 SURGICAL TECHNIQUE
OPS TRAUMA Page 11 of 27 Ilizarov External Fixation System - Surgical Technique Wire Tensioning (continue) Tighten wire bolt and nut When the wire is fully tensioned, tighten the wire bolt near the tensioner. A 10 mm Tubular Angulated Wrench can be used to hold the wire bolt head straight while a Combination Wrench is used to tighten the nut onto the bolt. Repeat this process for the remaining wire(s). After tensioning all the wires on a ring, retension them in the same sequence to maintain appropriate tension and obtain the best frame stability, with minimal deformation of the rings. After all wires have been tensioned, all nuts and bolts should be checked for tightness. If placing additional wires, after initial tensioning, consider re-tensioning all wires on the ring in the same sequence in which they were inserted to maintain appropriate tension and obtain the best frame stability, with minimal deformation of the rings. After all wires have been tensioned, all nuts and bolts should be checked for tightness. Cut ends of wire After tensioning, cut the ends of the wire. Leave at least 60 mm (approximately 3 finger widths) of wire past the wire bolt so that there is sufficient wire to grab if the wire needs tightening. Curl the end of the wire SURGICAL TECHNIQUE Implant Code Product Name 132003300 Olive Wire with Bayonet Point 1.8x400 mm Components Instruments Code Product Name 132003400 Cannulated Wire Fixation Bolt 132001000 Hexagonal Nut Code Product Name 332001101 Combination Wrench 332001001 10 mm Tubular Angulated Wrench
OPS TRAUMA Page 12 to 27 Surgical Technique - Ilizarov External Fixation System Insertion the Schanz screw through the Schanz screw bolt and finger tighten the nut. Make a skin incision ensuring the incision is large enough to allow insertion of Schanz screw. Pre-drill for the appropriate size Schanz screw. For non-self drilling Schanz screws: use 3.5 mm drill bit for 5.0 mm of Schanz screw Precaution: Pre-drilling for self-drilling screws is recommended for dense or thick cortical bone to avoid bone necrosis. Consider cooling the drill with saline. Care should be taken to ensure that diaphyseal Schanz screws are bicortical. A unicortical Schanz screw (that is so far anterior or posterior that it does not cross the intramedullary canal) can generate excessive heat during pre-drilling and create stress risers in the bone. Ensure that the Schanz screw is properly in line with the opening in the Schanz screw bolt. Do not bend the Schanz screw to meet the Schanz screw bolt to avoid unintentional side loading (Fig. 20 - 21). Perform final tighten of the Schanz screw bolt to ring using the 10 mm wrench. Ensure the Schanz screw is properly seated within the Schanz screw bolt. Insert Schanz screw Components Code Product Name 136000717 Schancrews 132002001 Posts Male 132001000 Hexagonal Nut 132000600 Connection Bolt with Washer 132002803 Half Ring SST Round Holes 190 mm Fig. 20 Fig. 21 SURGICAL TECHNIQUE
OPS TRAUMA Page 13 of 27 Ilizarov External Fixation System - Surgical Technique Post-Operative Adjustment The actual amount of distraction required and the frequency are determined by the surgeon, based on the relationship of the hinges and angular distractor to the one, and the quality of new bone formation within the distraction gap. Once angular deformity correction is complete, the hinges and angular distractor may be removed by the surgeon and the rings connected with threaded rods or other appropriate connection components. SURGICAL TECHNIQUE
OPS TRAUMA Page 14 to 27 Surgical Technique - Ilizarov External Fixation System Implants SCHANZ SCREW 5.0 MM K-WIRE WITH TROCAR TIP 0.8 - 2.2 MM CORTICAL WIRE 1.5, 1.8 MM CANCELLOUS WIRE 1.5, 1.8 MM ILLIZAROV WIRE BAYONET POINT 1.8 OLIVE WIRE WITH BAYONET POINT Frame Components HALF RING 5/8 RING THREADED ROD 6 MM GRADUATED TELESCOPIC ROD CONNECTION BOLT CONNECTION BOLT WITH WASHER CONNECTION PLATE CONNECTION PLATE, THREADED END POSTS FEMALE POSTS MALE FEMININE LOW PROFILE HINGE MASCULINE LOW PROFILE HINGE 90 DEGREE HINGE UNIVERSAL JOINT RANCHO CUBE CANNULATED WIRE FIXATION BOLT SLOTTED WIRE FIXATION BOLT SINGLE PIN FIXATION BOLT SPRING WASHER CONICAL WASHER COUPLE HEXAGONAL NUT NYLON INSERTER NUT WITH WASHER TTHREADED SOCKET HEX. 9.5 MM Interface Matrix of Implants with Frame Components PRODUCT INFORMATION Indicate as the recommended combination of implants but can be further considered as appropriate by the surgeon's discretion. Indicate as the combination of implants and components that cannot be used together
OPS TRAUMA Page 15 of 27 Ilizarov External Fixation System - Surgical Technique Implants Schanz Screws Threaded Length Length Ø Code Length (mm) Threaded Length (mm) Ø 5.0 mm 136000715 100 50 136000717 150 50 136000719 175 50 Code Length (mm) Threaded Length (mm) Ø 5.0 mm 136000720 200 50 136000721 225 50 136000722 250 50 Code Product Name 125010221 Kirschner Wire with Trocar Tip 1.8x310 mm Code Product Name 132003300 Olive Wire with Bayonet Point 1.8x400 mm Wires PRODUCT INFORMATION Code Product Name 132003301 Wire Bayonet Tip 1.8x400 mm
OPS TRAUMA Page 16 to 27 Surgical Technique - Ilizarov External Fixation System 5/8 Ring Stainless Steel Slotted Holes Half Ring Stainless Steel Slotted Holes Half Ring Stainless Steel Round Holes Components PRODUCT INFORMATION Code Size (mm) 132002800* 130 132002801 150 132002802 170 132002803 190 132002804 210 132002805* 230 Code Size (mm) 132002806* 130 132002807* 150 132002808 170 132002809 190 132002810 210 132002811* 230 5/8 Ring Stainless Steel Round Holes Code Size (mm) 132002705* 130 132002706 150 132002707 170 132002708 190 132002709 210 132002710* 230 Code Size (mm) 132002700* 130 132002701* 150 132002702* 170 132002703* 190 132002704* 210 *Special Request
OPS TRAUMA Page 17 of 27 Ilizarov External Fixation System - Surgical Technique Components Italian Femoral Arch 90 Deg Italian Femoral Arch 120 Deg Code Size (mm) 132001500* 120 132001501* 140 132001502 160 132001503* 180 132001504* 200 132001505* 220 Code Size (mm) 132001506* 120 132001507* 140 132001508 160 132001509* 180 132001510* 200 132001511* 220 Short Connection Plates Long Connection Plates Code Holes Length (mm) 132002300 2 35 132002301 3 45 132002302 4 55 132002303 5 65 132002304 6 75 132002305 7 85 132002306 8 95 132002307* 9 105 132002308* 10 115 Code Holes Length (mm) 132001602* 8 155 132001601* 12 235 132001600* 17 335 PRODUCT INFORMATION *Special Request
OPS TRAUMA Page 18 to 27 Surgical Technique - Ilizarov External Fixation System Twisted Plates Connection Plates with Threaded Ends Components PRODUCT INFORMATION Code Holes Length (mm) 132000700* 5 135 132000701* 7 175 132000702* 9 215 132000703* 11 255 Code Holes Length (mm) 132003100 1+1 48 132003101 1+2 68 132003102 1+3 88 132003103* 2+2 88 132003104* 2+3 108 Curved Plate Code Holes Length (mm) 132000800 3 120 *Special Request
OPS TRAUMA Page 19 of 27 Ilizarov External Fixation System - Surgical Technique Graduated Telescopic Rods Code Length (mm) 132000902 60 132000903 100 132000904* 150 Components PRODUCT INFORMATION Threaded Sockets Code Length (mm) 132003000 20 132003001 30 132003002 40 132003003 60 Code Length (mm) 132002902 60 132002903 80 132002904 100 132002905 120 132002906 150 132002907 200 132002908 250 132002909 300 132002910 350 132002911* 400 132002912* 450 Threaded Rods 6.0 mm Code Product Name 132001800 Oblique Support with Thread Code Product Name 132000300 Centering Sleeve 5 mm Masculine Hinges Feminine Hinges Code Description 132001301* High Profile 132001300 Low Profile Code Description 132001201* High Profile 132001200 Low Profile *Special Request
OPS TRAUMA Page 20 to 27 Surgical Technique - Ilizarov External Fixation System Components PRODUCT INFORMATION Posts Male Code Holes 132002000 2 132002001 3 132002002* 4 Posts Female Code Holes 132001900 2 132001901 3 132001902 4 90 Degree Hinges Code Description 132001100* - 132001101* High Profile 132001102* Low Profile Rancho Cubes Code Holes 132002100 1 132002101 2 132002102 3 132002103 4 132002104* 5 132002105* 6 Code Product Name 132003200 Universal Joint Code Product Name 132002200 Set Screw *Special Request
OPS TRAUMA Page 21 of 27 Ilizarov External Fixation System - Surgical Technique Components PRODUCT INFORMATION Code Product Name 132001000 Hexagonal Nut Code Product Name 132001700 Nylon Inserter Nut with Washer Code Product Name 132000000 4 Point D/C Counter Code Product Name 132003400 Cannulated Wire Fixation Bolt Code Product Name 132003500 Slotted Wire Fixation Bolt Code Product Name 132002400 Pin Fixation Bolt Connection Bolts Code Length (mm) 132000501 10 132000502 15 132000500* 16 132000503 20 Connection Bolt with Washers Code Length (mm) 132000600 15 132000601 20 *Special Request
OPS TRAUMA Page 22 to 27 Surgical Technique - Ilizarov External Fixation System Components PRODUCT INFORMATION Code Product Name 132002600 Sping Washer Code Product Name 132000401 Inside Radius Washer Code Product Name 132000402 Outside Radius Washer Spacer Washers Code Size (mm) 132002500 13.0 x 1.0 132002501 13.0 x 2.5
OPS TRAUMA Page 23 of 27 Ilizarov External Fixation System - Surgical Technique Instruments PRODUCT INFORMATION Standard Set Code Product Name 332000901 Wire Tensioner-Dynamometer Code Product Name 332001101 Combination Wrench Code Product Name 332001001 10 mm Tubular Angulated Wrench Code Product Name 343110901 3.0 mm Hexagonal Wrench Code Product Name 332000900 T-Universal Box Wrench 10 mm Code Product Name 333000500 Ruler 300.0 mm
OPS TRAUMA Page 24 to 27 Surgical Technique - Ilizarov External Fixation System Code Product Name Qty in Set 125010221 KIRSCHNER WIRE WITH TROCAR TIP 1.8x310 MM 20 132003301 WIRE BAYONET TIP 1.8x400 MM 10 132003300 OLIVE WIRE WITH BAYONET POINT 1.8x400 MM 6 136000722 SCHANZ SCREW 5.0x250 MM (THREAD LENGTH 50 MM) 5 136000721 SCHANZ SCREW 5.0x225 MM (THREAD LENGTH 50 MM) 5 136000720 SCHANZ SCREW 5.0x200 MM (THREAD LENGTH 50 MM) 5 136000719 SCHANZ SCREW 5.0x175 MM (THREAD LENGTH 50 MM) 5 136000717 SCHANZ SCREW 5.0x150 MM (THREAD LENGTH 50 MM) 4 136000715 SCHANZ SCREW 5.0x100 MM (THREAD LENGTH 50 MM) 4 132002000 POSTS MALE 2 HO 3 132002001 POSTS MALE 3 HO 3 132002002 POSTS MALE 4 HO 3 132001800 OBLIQUE SUPPORT WITH THREAD 2 132001300 MASCULINE LOW PROFILE HINGE 6 132000300 CENTERING SLEEVE 5 MM 6 132003200 UNIVERSAL JOINT 4 132001902 POSTS FEMALE 4 HO 2 132001901 POSTS FEMALE 3 HO 2 132001900 POSTS FEMALE 2 HO 2 132002500 SPACER WASHER 13x1 MM 15 132002501 SPACER WASHER 13.0x2.5 MM 14 132001200 FEMININE LOW PROFILE HINGE 6 132000000 4 POINT D/C COUNTER 4 IMPLANT AND INSTRUMENT SET Ilizarov External Fixator Implant Set
OPS TRAUMA Page 25 of 27 Ilizarov External Fixation System - Surgical Technique IMPLANT AND INSTRUMENT SET Code Product Name Qty in Set 132003003 THREADED SOCKET SIZE 60.0 MM 4 132003002 THREADED SOCKET SIZE 40 MM 4 132003001 THREADED SOCKET SIZE 30 MM 4 132003000 THREADED SOCKET SIZE 20 MM 4 132000800 CURVED PLATE 3 HO 2 132002103 RANCHO CUBE 4 HO 3 132002102 RANCHO CUBE 3 HO 2 132002101 RANCHO CUBE 2 HO 3 132002100 RANCHO CUBE 1 HO 2 132002801 HALF RING SST ROUND HO SIZE 150 MM 8 132002802 HALF RING SST ROUND HO SIZE 170 MM 6 132002803 HALF RING SST ROUND HO SIZE 190 MM 6 132002804 HALF RING SST ROUND HO SIZE 210 MM 6 132002709 5/8 RING SST ROUND HO SIZE 210 MM 1 132002707 5/8 RING SST ROUND HO SIZE 170 MM 1 132002801 HALF RING SST SLOTTED SIZE 210 MM 2 132002808 HALF RING SST SLOTTED SIZE 170 MM 2 132002708 5/8 RING SST ROUND HO SIZE 190 MM 1 132001508 ITALIAN FEMORAL ARCH 120 DEG 160 MM 1 132002809 HALF RING SS SLOTTED SIZE 190 MM 2 132001502 ITALIAN FEMORAL ARCH 90 DEG 160 MM 1 132002902 THREADED ROD 6.0x60.0 MM 6 132002903 THREADED ROD 6.0x80.0 MM 8 132002904 THREADED ROD 6.0x100.0 MM 8 132002905 THREADED ROD 6.0x120.0 MM 8 132002906 THREADED ROD 6.0x150.0 MM 8 132002907 THREADED ROD 6.0x200.0 MM 8 132002908 THREADED ROD 6.0x250.0 MM 8 132002909 THREADED ROD 6.0x300.0 MM 6 132002910 THREADED ROD 6.0x350.0 MM 6 132002911 THREADED ROD 6.0x400.0 MM 6 132003100 TWISTED PLATE 1/1H L48 MM 1 132003101 TWISTED PLATE 1/2H L68 MM 1 132003102 TWISTED PLATE 1/3H L88 MM 1 132000401 INSIDE RADIUS WASHER 30 132000402 OUTSIDE RADIUS WASHER 30 132002600 SPRING WASHER 90 132001700 NYLON INSERTER NUT WITH WASHER 12 132001000 HEXAGONAL NUT 90 Ilizarov External Fixator Implant Set
OPS TRAUMA Page 26 to 27 Surgical Technique - Ilizarov External Fixation System IMPLANT AND INSTRUMENT SET Ilizarov External Fixator Instrument Set Code Product Name Qty in Set 332000901 WIRE TENSIONER-DYNAMOMETER 2 343110901 3.0 MM HEXAGONAL WRENCH 2 332001001 10 MM TUBULAR ANGULATED WRENCH 2 332000900 T-UNIVERSAL BOX WRENCH 10 MM 1 333000500 RULER 300.0 MM 1 332001101 COMBINATION WRENCH 10 MM 4 Code Product Name Qty in Set 132002300 35.0 MM SHORT CONNECTION PLATES 2 132002301 45.0 MM SHORT CONNECTION PLATES 2 132002302 55.0 MM SHORT CONNECTION PLATES 2 132002303 65.0 MM SHORT CONNECTION PLATES 2 132002304 75.0 MM SHORT CONNECTION PLATES 2 132002305 85.0 MM SHORT CONNECTION PLATES 2 132002306 95.0 MM SHORT CONNECTION PLATES 2 132000903 GRADUATED TELESCOPIC ROD 100 MM 4 132000902 GRADUATED TELESCOPIC ROD 60 MM 4 132000501 CONNECTION BOLT SIZE 10.0 MM 20 132000502 CONNECTION BOLT SIZE 15 MM 40 132000503 CONNECTION BOLT SIZE 20 MM 20 132000600 CONNECTION BOLT WITH WASHER SIZE 15 MM 15 132000601 CONNECTION BOLT WITH WASHER SIZE 20 MM 15 132002400 SINGLE PIN FIXATION BOLT M6x16 MM 20 132003400 CANNULATED WIRE FIXATION BOLT 20 132003500 SLOTTED WIRE FIXATION BOLT 25 Ilizarov External Fixator Implant Set
OPS TRAUMA Page 27 of 27 Ilizarov External Fixation System - Surgical Technique DESCRIPTION Orthopeasia Ilizarov external fixation system is a technique based on the use of transfixion wires and external fixation attached to rings that encircle the affected limb. The frame construction design requires expertise to appropriately arrange the assembly without any complications. Ilizarov external fixation system is composed of rings, Schanz screws, wires, threaded rods of various sizes as well as several types of assembly accessories. These elements are assembled with a ring frame and linked by threaded rods which are available in several lengths and locked by nuts. Note: Orthopeasia external fixation system is designed for limb fixation. To achieve the best results, Orthopeasia external fixation system should not be used with components from other systems or manufacturers. INTENDED USE Ilizarov external fixator is intended for fixation and intra- and postoperative treatment of open and closed fractures and elective orthopedic interventions. INDICATIONS FOR USE Ilizarov external fixation system is intended for correcting, lengthening, and restoring skeletal deformities in pediatric patients and adults as the following indications: 1. Post-Traumatic joint contracture which has resulted in loss of range of motion 2. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction 3. Open and closed fracture fixation 4. Pseudoarthrosis of long bones 5. Limb lengthening by epiphyseal or metaphyseal distraction 6. Correction of bone or soft tissue deformities 7. Correction of segmental bone or soft tissue defects 8. Arthrodesis 9. Infected fractures or nonunions CONDITIONS FOR USE Ilizarov external fixation system should only be implanted by certified orthopedic surgeons who have in-depth knowledge of human limb anatomy and a specific patient’s anatomical variation as well as experiences in Ilizarov surgery with specific training in the use of Ilizarov external fixation system. CONTRAINDICATIONS Ilizarov external fixation system is contraindicated for use in the following: 1. Uncooperative or mentally incompetent patients who are unable to follow the postoperative regimen 2. When there is an active infection 3. Known sensitivity and/or allergies to the materials in the external fixation device model to be used WARNINGS AND PRECAUTIONS The surgeon should be aware of use and selection of this fixation system as follow: 1. Projectiles from wire cutting could cause injury to patient or medical personnel during surgery. 2. Preoperative frame assembly and adequate supply of components is recommended. 3. Anatomical considerations are importance during wire and Schanz screw placement to avoid damage to nerves, muscles, tendons, and vessels. 4. Avoid heat necrosis of surrounding tissue and bone by drilling wires slowly through the bone. 5. Hold wire tips when clipping and wear eye protection. Handle the sharp tips of wires with caution. 6. Schanz screw/ wire site care is crucial in reducing infections. 7. Use periodic postoperative follow-ups and radiographs to monitor the distraction phase. 8. The correct selection of device components is of the importance. The type, size, shape, and frame construction design should be appropriate and selected based on orthopedic problems, existing device complications and patient’s anatomical conditions in order to increase the potential for satisfactory treatment outcomes. 9. Advise the patient of the importance of complying with: a. The limitations in weight bearing as compared to that of a normal, healthy bone, b. The limitations of activity levels and the medical follow-up required. 10. Advise the patient to report unanticipated reactions or problems without delay. 11. Visualize and reevaluate the bone healing progress and arrange for adjustments accordingly. 12. When applicable, touch down weight bearing may be allowed after surgery and gradually increased as the callus thickens and matures. 13. Weekly to biweekly follow-up and radiographs are recommended during the distraction phase. 14. Do not use the device if any damage is noted. POSSIBLE ADVERSE EFFECTS The possible adverse effects may necessitate reoperation or revision. The surgeon should warn the patient about the possibility of adverse effects occurrence. Possible adverse effects include but are not limit to: 1. Nonunion or delayed union, malunion 2. Superficial infection 3. Deep infection 4. Loss of fixation 5. Bending, breakage or migration of the device 6. Bone fracture during or after treatment 7. Bone loss or reduced bone density 8. Damage to surrounding tissues due to surgical trauma 9. Wound healing complications 10. Tissue necrosis 11. Joint contracture, dislocation, instability, or loss of range of motion 12. Arthritic changes 13. Compartment syndrome STORAGE CONDITION Ilizarov external fixator components are intended to be stored at room temperature. STERILIZATION Steam sterilization according to EN ISO 17665 and ANSI/ AMMI ST79 is recommended. Use a validated, properly maintained and calibrated steam sterilizer. The steam quality must be appropriate for the process to be effective. Sterilize by steam autoclaving, utilizing conditions according to the table below: REMOVAL AND DISPOSAL OF IMPLANTS Once the treatment with external fixation is complete, implant must be removed by certified orthopedic surgeons. Orthopedic surgeons should consider premature removal in case of adverse events. Used implant should be discarded in the hospital according to the medical procedures from hospital infection control. The adulteration of the product is the sole responsibility of the hospital institution as well as methods and procedures for disposing. MATERIAL Ilizarov external fixation system is made of biocompatible medical grade Stainless Steel. IMPORTANT PRODUCT INFORMATION Method Temperature Duration of exposure Pressure Steam Pre-vacuum 134 °C (273.2 °F) 5 minutes 2 bars
Orthopeasia Co., Ltd. Manufacturer 32/6 Moo 11, Rattanakosin 200 Pi Rd., Khlong Preng, Mueang Chachoengsao, Chachoengsao 24000 Thailand Tel: +66 3359 9412 Email: [email protected] Website: www.orthope.com Head Office 33/15 Moo 10, Theparak Rd., Bangpla, Bangplee, Samutprakan 10540 Thailand Tel: +66 2730 1791 Fax: +66 2312 3310