Fracture Reduction and Provisional Stabilization Large Distractor Femur Surgical Technique
Table of Contents Introduction Standard Femoral Distraction 2 Large Distractor System 4 Surgical Technique Prepare Distractor 5 Universal Joint Assembly 6 Sliding Carriage Assembly 7 Femoral Distraction Technique Overview 8 Adjustment Technique 10 References 11 Product Information Instruments 12 Set List 14 MR Information The Large Distractor System has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration or image artifact in the MR environment. The safety of the The Large Distractor System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury. Large Distractor Femur Surgical Technique DePuy Synthes 1
Standard Femoral Distraction An alternative to the fracture table In the treatment of multitrauma patients, it is frequently more advantageous to perform surgical procedures on a standard operating table. The use of a fracture table can cause a loss of mobility of the limb, and mandates the surgical approach. The distractor allows free manipulation of the affected limb without the restrictions imposed by the fracture table. Patient positioning Generally, patients with multiple injuries are placed supine on the fluoroscopy table. The entire limb is assessed with the C-arm in AP and lateral views. Direct application of force Unlike the fracture table, where force is applied to the fractured bone through adjacent joints and soft tissue structures, the distractor applies force directly to the bone, thus allowing repositioning of the fractured extremity while adjacent parts of the body remain undisturbed. This helps eliminate the risk of nerve injuries and complications caused by the fracture table, including peroneal nerve palsy and pudendal crush syndrome. When to use The Large Distractor aids in fracture reduction and holds provisional stabilization prior to definitive fixation. 2 DePuy Synthes Large Distractor Femur Surgical Technique
Standard Femoral Distraction Alternate applications The Large Distractor can be helpful for fractures involving the tibial plateau. When placing the distractor, the pins must be kept distal to the area that potentially will be plated. The distractor aids preoperative and intraoperative repositioning and also provides temporary fixation. This is particularly advantageous in treating pelvic and joint fractures where large forces are present. Knee-spanning For pelvic fractures: An anterior approach can be utilized, which requires a more lateral or longitudinal distraction. A posterior approach can be utilized. Acetabular fracture (anterior approach) Acetabular fracture (posterior approach) Large Distractor Femur Surgical Technique DePuy Synthes 3
Large Distractor System Warning: DePuy Synthes self-drilling and self-tapping Schanz screws are not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. Precautions: Select the appropriate Schanz screw (self-tapping, self-drilling) for the patient s bony anatomy. 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 of worn bone-cutting instruments in an approved sharps container. The self-drilling Schanz screw has been developed to minimize heat development. Nevertheless, slow insertion and additional cooling (for example with a Ringer solution) are recommended. The tip of the self-drilling Schanz screw should be embedded in the far cortex to effectively resist cantilever forces and to provide sufficient stability. Only when bones are osteoporotic does the self-drilling Schanz screw have to be screwed a bit further into the distant cortical bone, and it may even slightly penetrate through it since this can increase anchoring stability. The tip of the self-tapping Schanz screw should be embedded in the far cortex to effectively resist cantilever forces and to provide sufficient stability. Implant sites should be meticulously cared for to avoid pin-tract infection. Schanz screws may be surrounded with antiseptic coated foam sponges in an effort to avoid infection. An implant-site care procedure should be reviewed with the patient. To help minimize the risk of pin-tract infection the following points should be observed: a. Placement of Schanz screws taking anatomy into consideration (ligaments, nerves, arteries). b. Slow insertion and/or cooling, particularly in dense, hard bone to avoid heat necrosis. c. Release of skin tension at soft tissue entry point of implant. 4 DePuy Synthes Large Distractor Femur Surgical Technique
Prepare Distractor Preparing the distractor for use The exact configuration of the Large Distractor Assembly depends on the particular details of each case, such as patient anatomy and which bone is involved, i.e., right or left tibia. The surgeon must consider these factors when assembling the device. Spring-loaded knurled nut (D) End piece with double joint (B) Spindle nut (F) Cotter pin (C) Threaded spindle (A) Holding sleeve (E) Spring-loaded knurled nut (D) Spindle nut (F) Sliding carriage (G) Spindle nut (F) Spring-loaded knurled nut (D) Holding sleeve (H) Large Distractor Femur Surgical Technique DePuy Synthes 5
Universal Joint Assembly 1 Select a 14.0 mm threaded spindle (A) of appropriate length (most likely 480 mm). A transverse hole will be in the proximal end when applied to the femur. A 2 Turn the end piece with double joint (B) onto the threaded spindle so that the rod and end piece are flush. If the end piece is positioned correctly, the transverse hole will be centered in the slot of the end piece. C B 3 To lock rotation of the end piece with double joint, push the cotter pin (C) through the hole until it snaps into place. Extend the end piece so that the reference marks align, and hand-tighten the spring-loaded knurled nut (D). C D 4 Mount the appropriate length holding sleeve (E) onto the end piece so that the serrated ends interface and the reference marks align. To secure the holding sleeve, put the spring-loaded knurled nut on the end piece and hand-tighten. E 6 DePuy Synthes Large Distractor Femur Surgical Technique
Sliding Carriage Assembly 5 Thread a spindle nut (F) partway down the 14.0 mm threaded spindle. Place the sliding carriage (G) over the threaded spindle, and secure it with a second spindle nut. F G 6 Mount the other holding sleeve (H or E) onto the sliding carriage. The serrated ends must interface and the reference marks must align. Put the spring-loaded knurled nut on the sliding carriage to secure the holding sleeve and hand-tighten. H Large Distractor Femur Surgical Technique DePuy Synthes 7
Femoral Distraction Technique Overview 1 Insert proximal Schanz screw Instruments 294.5x 5.0 mm Schanz Screws 294.6x 6.0 mm Schanz Screws 393.10 Universal Chuck The proximal Schanz screw should be placed through the calcar or lesser trochanter, perpendicular to the axis of the femur. Care must be taken to avoid the neurovascular structures surrounding the proximal femur, and to avoid obstructing the medullary canal if IM nailing of the fracture will be attempted. An alternative approach for plating applications is to place the proximal Schanz screw through the lateral cortex of the greater trochanter. The position of this Schanz screw will depend upon the fracture pattern. 2 Insert distal Schanz screw The distal Schanz screw should be placed parallel to the axis of the knee joint, in the posterior half of the condyle, approximately 2 cm to 3 cm from the articular surface and inserted laterally or anterolaterally. Note: For certain plating techniques, it may be necessary to insert the distal Schanz screw medially or anteromedially. 8 DePuy Synthes Large Distractor Femur Surgical Technique
Femoral Distraction Technique Overview 3 Attach distractor Instruments 394.35 Large Distractor 1 Handling the preassembled distractor as a unit, slide the holding sleeve over the proximal Schanz screw, through the stab incision to the bone. The threaded spindle should be parallel and anterolateral to the axis of the proximal femur. Slide the holding sleeve over the distal Schanz screw, to the bone. Temporarily loosen the spring-loaded knurled nut or the spindle nuts, as needed. 4 3 4 Tighten wing screws Instruments 2 393.10 Universal Chuck with T-Handle 4 Securely tighten the holding sleeves on the Schanz screws by tightening the wing screws using the 4.5 mm pin wrench. If the distractor is positioned properly, the threaded spindle will parallel the axis of the proximal femur. Tighten all springloaded knurled nuts in the neutral position (with reference marks aligned). Large Distractor Femur Surgical Technique DePuy Synthes 9
Adjustment Technique With all connections loose (except wing screws), obtain approximate alignment and rotation. When the position is acceptable, securely tighten all loose connections with the 4.5 mm pin wrench. 1 Distraction Instrument 2 1 Loosen the distal spindle nut (1). Under image intensification, apply distraction by moving the proximal spindle nut (2) distally. 2 Rotation Instrument 3 2 1 Loosen both spindle nuts (1 and 2) and the spring-loaded knurled nut (3) on the end piece with double joint. Correct rotation by simultaneously rotating the sliding carriage and the 14.0 mm threaded spindle. 3 Valgus-Varus Instrument 4 Loosen the spring-loaded knurled nut on the distal holding sleeve (4). Correction is achieved by manipulating the distal Schanz screw with the universal chuck with T-handle. 10 DePuy Synthes Large Distractor Femur Surgical Technique
Adjustment Technique 4 Anterior-posterior angulation Instrument Loosen the spring-loaded knurled nut that secures the proximal holding sleeve in the end piece with double joint (5), and correct the angulation. 5 Compression Instrument Loosen the proximal spindle nut (2). Under image intensification, apply compression by moving the distal spindle nut (1) proximally. After reduction, secure distractor joints by tightening all connections. Notes: To aid with manipulation of the distractor, attach the universal chuck with T-handle to the distal Schanz screw. These steps need not be performed in the order given, except for Step 5 (compression), which should be performed last. To avoid loss of correction, retighten all loosened nuts after each step. References 1. Baumgaertel, Fred et al. Technique of Using the AO Femoral Distractor for Femoral Intramedullary Nailing. Journal of Orthopaedic Trauma. 8;4. 315 321. 2. Berton R. et al. Unreamed Retrograde Intramedullary Nailing of Fractures of the Femoral Shaft. Journal of Orthopaedic Trauma. 12;5. 334 342. 3. Duwelius, Paul J., M.D., Knute Buehler, M.D., and Jim Green, The Universal Distractor: The Evaluation of a Technique to Reduce Tibia Fractures. Techniques in Orthopaedics. 12;4. 280 288. 4. Mast J., R. Jakob and R. Ganz. Planning and Reduction Technique in Fracture Surgery. Springer & Verlag. 1989. 195 197. Large Distractor Femur Surgical Technique DePuy Synthes 11
Instruments 310.37 3.5 mm Drill Bit, 195 mm, quick coupling 393.10 Universal Chuck with T-Handle 394.182 3.5 mm Trocar, 118 mm (long) 394.35 Large Distractor, complete 394.40 14.0 mm Threaded Spindle, 480 mm 394.41 14.0 mm Threaded Spindle, 330 mm 12 DePuy Synthes Large Distractor Femur Surgical Technique
Instruments 394.42 Spindle Nut 394.43 Sliding Carriage 394.44 End Piece with double joint 394.45 Holding Sleeve, 55 mm length 394.46 Holding Sleeve, 105 mm length 395.913 5.0 mm/3.5 mm Drill Sleeve, 107 mm (long) 395.923 6.0 mm/5.0 mm Threaded Drill Sleeve, 98 mm (long) Large Distractor Femur Surgical Technique DePuy Synthes 13
Large Distractor Set (115.700) Graphic Case 305.78 Large Distractor Set Graphic Case Contents 294.55 5.0 mm Schanz Screw, blunted trocar point, 170 mm, 4 ea. 294.56 5.0 mm Schanz Screw, blunted trocar point, 200 mm, 4 ea. 294.67 6.0 mm Schanz Screw, spade point, 160 mm, 4 ea. 294.68 6.0 mm Schanz Screw, spade point, 190 mm, 4 ea. 310.37 3.5 mm Drill Bit, 195 mm, quick coupling, 2 ea. 393.10 Universal Chuck with T-Handle 394.182 3.5 mm Trocar, 118 mm (long) 394.40 14.0 mm Threaded Spindle, 480 mm 394.41 14.0 mm Threaded Spindle, 330 mm 394.42 Spindle Nut, 3 ea. 394.43 Sliding Carriage 394.44 End Piece with double joint 394.45 Holding Sleeve, 55 mm length, 2 ea. 394.46 Holding Sleeve, 105 mm length, 2 ea. 395.913 5.0 mm/3.5 mm Drill Sleeve, 107 mm (long) 395.923 6.0 mm/5.0 mm Threaded Drill Sleeve, 98 mm (long) Also Available 105.731 Medium Distractor Set 03.100.048 6.0 mm LCP Attachment Pin 305.79 Medium Distractor Set Graphic Case 394.35 Large Distractor, complete 395.49 Medium Distractor, complete Note: Additional sets are needed for nailing applications. Contact your DePuy Synthes sales representative for a list of replacement parts that are available for the Large and Medium Distractors. Note: For additional information, please refer to package insert. 14 DePuy Synthes Large Distractor Femur Surgical Technique
Limited Warranty and Disclaimer: DePuy Synthes products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed. Please also refer to the package insert(s) or other labeling associated with the devices identified in this surgical technique for additional information. CAUTION: Federal Law restricts these devices to sale by or on the order of a physician. Some devices listed in this surgical technique may not have been licensed in accordance with Canadian law and may not be for sale in Canada. Please contact your sales consultant for items approved for sale in Canada. Not all products may currently be available in all markets. Manufactured or distributed by: Synthes USA Products, LLC 1302 Wrights Lane East West Chester, PA 19380 Synthes USA, LLC 1101 Synthes Avenue Monument, CO 80132 To order (USA): 800-523-0322 To order (Canada): 855-946-8999 Note: For recognized manufacturer, refer to the product label. www.depuysynthes.com DePuy Synthes 2006 2017. All rights reserved. DSUS/TRM/0916/1052 6/17 DV