Surgical Technique - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/US Mobile/Synthes North...

For Unstable Elbow Fractures

Elbow Hinge FixatorSurgical Technique

Introduction

Surgical Technique

Product Information

Table of Contents

Elbow Hinge Fixator 2

MRI Information 4

Large Fixation System 5

AO Principles 6

Indications 7

Preparation 8

Insert Schanz Screws 9

Determine Anatomical Joint Axis 12

Connect Elbow Hinge Fixator 13

Distract Joint (Optional) 16

Check Mobility of Joint 17

Immobilize Joint (Optional) 18

Alternative Construct 19

Implants 20

Fixation Material 21

Fixation Material 22

Bibliography 25

Image intensifier control

Elbow Hinge Fixator Surgical Technique DePuy Synthes 1

2 DePuy Synthes Elbow Hinge Fixator Surgical Technique

Elbow Hinge Fixator

The modular frame construction offers the Elbow Hinge Fixator a high degree of fl exibility. The independent pin placement allows greater adaptation to the particular circumstances of each injury.

The Elbow Hinge Fixator is a single component and is compatible with the Large and Medium External Fixation Systems. This increases the fl exibility in selecting a patient-specifi c, optimum form of therapy. Minimal effort is required to switch from rigid to movable external fi xation.

The radiolucency of the Elbow Hinge Fixator facilitates fi nding the anatomical joint axis and positioning the mechanical axis of the elbow.

Independent pin placement – Patient-specifi c assembly of the fi xation frame

– Independent pin placement in the humerus and ulna

– Compatible with 8.0 mm and 11.0 mm carbon fi ber rods

– Can supplement internal fi xation


Elbow Hinge Fixator

Monitored axis determination – Axis determined with 2.5 mm guide wire

– Cannulated center sleeve allows the coaxiality to be determined at all times with the image intensifi er

– Radiolucent materials facilitate easier visualization of the affected anatomy

Early mobilization – Active and passive postoperative mobilization of

the elbow joint

– Spares the joint surface due to the guided hinge movement

– Can be locked into position by bridging with an additional rod


MRI Information

DePuy Synthes Elbow Hinge Fixator System devices are labeled MR Conditional according to the terminology specified in ASTM F2503-05, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.

Nonclinical testing demonstrated that, when used in the specific configurations stated in DePuy Synthes labeling, DePuy Synthes Elbow Hinge Fixator devices are MR Conditional. Representative DePuy Synthes Elbow Hinge Fixator devices used in a typical construct include clamps, rods and various attachments. A patient with a DePuy Synthes Elbow Hinge Fixator frame may be scanned safely after placement of the frame under the following conditions.

Static magnetic field of 1.5 Tesla when the fixation frame is positioned: – 7 cm or less from within the outside edge of the bore of

the MRI at Normal Operating Mode or;

– Completely outside of the MRI bore in First Level Controlled Mode

Static magnetic field of 3.0 Tesla when the fixation frame is positioned: – 7 cm or less from within the outside edge of the bore of

the MRI at Normal Operating Mode or;

– Completely outside of the MRI bore in First Level Controlled Mode

Highest spatial gradient magnetic field of 900 Gauss/cm or less

Maximum MR system reported whole body averaged specific absorption rate (SAR) of 2 W/kg for the Normal Operating Mode and 4 W/kg for the First Level Controlled Mode for 15 minutes of scanning

Use only whole body RF transmit coil, no other transmit coils are allowed, local receive only coils are allowed

Note: In nonclinical testing, the DePuy Synthes external fixation frame was tested in several different configurations. This testing was conducted with the construct positioned 7 cm from within the outside edge of the MRI bore. – The results showed a maximum observed heating for the

elbow hinge fixator frame of 6ºC for the 1.5 T and less than 1ºC for 3.0 T with a machine reported whole body averaged SAR of 2 W/kg.

Patients may be safely scanned in the MRI chamber at the above conditions. Under such conditions, the maximal expected temperature rise is less than 6ºC. Because higher in vivo heating cannot be excluded, close patient monitoring and communication with the patient during the scan is required. Immediately abort the scan if the patient reports burning sensation or pain. To minimize heating, the scan time should be as short as possible, the SAR as low as possible, and the device should be as far as possible from the edge of the bore. Temperature rise values obtained were based upon a scan time of 15 minutes.

The above field conditions should be compared with those of the user’s MR system, to determine if the item can safely be brought into the user’s MR environment. If placed in the bore of the MR scanner during scanning, DePuy Synthes MR Conditional external fixation devices may have the potential to cause artifact in the diagnostic imaging.

All components of DePuy Synthes external fixation frames must be identified as MR Conditional prior to being placed in or near an MR environment.

Artifact informationMR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the DePuy Synthes Elbow Hinge Fixator construct, and it may be necessary to optimize MR imaging parameters, to compensate for the presence of the fixation frame.

Representative devices used to assemble a typical DePuy Synthes Elbow Hinge Fixator frame have been evaluated in the MRI chamber and worst-case artifact information is provided below. Overall, artifacts created by DePuy Synthes Elbow Hinge Fixator devices may present issues if the MR imaging area of interest is in or near the area where the fixation frame is located. – For FFE sequence: Scan duration: 3 min, TR 100 ms,

TE 15 ms, flip angle 15º and SE sequence: Scan duration: 4 min, TR 500 ms, TE 20 ms, flip angle 70º radio echo sequence, worst-case artifact will extend approximately 10 cm from the device.

Warning – Do not place any radio frequency (RF) transmit coils

over the external fixation frame.


Large Fixation System

Warnings:– 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:– To keep from damaging the femoral cutaneous nerve,

avoid pin insertion up to 15 mm in a dorsal direction from the superior anterior iliac spine.

– When dealing with the humerus, primary consideration should be given to the radial and axillary nerves. Distally, a dorsal approach to the humerus is appropriate. Proximally, it is recommendable to introduce the Schanz screws from a ventrolateral direction, caudal to the path of the axillary nerve.

– Select the appropriate Schanz screw (self-tapping, self-drilling), or Steinmann pin 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 and Steinmann pins 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 and Steinmann pins 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.


AO Principles

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4_Priciples_03.pdf 1 05.07.12 12:08

4 DePuy Synthes Expert Lateral Femoral Nail Surgical Technique

AO PRINCIPLES

In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation1, 2.

1 Müller ME, M Allgöwer, R Schneider, H Willenegger. Manual of Internal Fixation. 3rd ed. Berlin Heidelberg New York: Springer. 1991.

2 Rüedi TP, RE Buckley, CG Moran. AO Principles of Fracture Management. 2nd ed. Stuttgart, New York: Thieme. 2007.

Anatomic reductionFracture reduction and fixation to restore anatomical relationships.

Early, active mobilizationEarly and safe mobilization and rehabilitation of the injured part and the patient as a whole.

Stable fixationFracture fixation providing abso-lute or relative stability, as required by the patient, the injury, and the personality of the fracture.

Preservation of blood supplyPreservation of the blood supply to soft tissues and bone by gentle reduction techniques and careful handling.

In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation.1,2

Anatomic reductionFracture reduction and fixation to restore anatomical relationships.

Early, active mobilizationEarly and safe mobilization and rehabilitation of the injured part and the patient as a whole.

Stable fixationFracture fixation providing absolute or relative stability, as required by the patient, the injury, and the personality of the fracture.

Preservation of blood supplyPreservation of the blood supply to soft tissues and bone by gentle reduction techniques and careful handling.

1. Müller ME, Allgöwer M, Schneider R, Willenegger H. Manual of Internal Fixation. 3rd ed. Berlin, Heidelberg, New York: Springer-Verlag; 1991.

2. Rüedi TP, RE Buckley, CG Moran. AO Principles of Fracture Management. 2nd ed. Stuttgart New York: Thieme; 2007.


Indications

The Elbow Hinge Fixator is intended for supplementary treatment of complex, unstable elbow injuries when early functional stress must be limited due to persistent ligament instability.

The indications for guided joint bridging with external fixators are:

– Delayed treatment of dislocated and stiff elbows

– Chronic, persistent joint instability

– Acute joint instability after complex ligament injuries

– Unstable elbow fractures

– Additional stabilization of postoperative unstable internal fixation

The Elbow Hinge Fixator is compatible with the components of the Synthes Large External Fixation System for adults (11 mm rod diameter), and with components of the Synthes Medium External Fixation System (8 mm rod diameter) for children and small stature adults.


Preparation

Required sets

115.720 or Large External Fixation System 115.740 or 01.302.602 or Medium External Fixation System 01.302.604

The following steps are explained with reference to the DePuy Synthes large external fixator components and self-drilling Schanz screws. Optionally, this technique can be performed with the corresponding DePuy Synthes medium external fixator components. An additional complete construct option using the medium external fixator components is featured on page 19 of this technique guide.

Conventional self-tapping Schanz screws can also be used. For a detailed description of the handling of the Schanz screws, please refer to the surgical technique for DePuy Synthes large and medium external fixators.

The joint bridging construct for the elbow is assembled in modules and is oriented around the pivot of the condyles. Therefore, for correct application, it is necessary to accurately align the upper arm segment before connecting the frame to the Schanz screws in the ulna.


Insert Schanz Screws

1Insert Schanz screws into humerus

Instruments

393.103 Drive Adaptor with quick coupling, for 5.0 mm Schanz Screws

394.181 3.5 mm Trocar, short

395.911 Drill Sleeve Handle

395.912 5.0 mm/3.5 mm Drill Sleeve, short

395.921 6.0 mm/5.0 mm Threaded Drill Sleeve, short

Insert the fi rst two Schanz screws in the humerus. Select their positions as appropriate for the soft tissue and anatomical situation. When inserting the Schanz screws, pay special attention to the radial nerve. It is recommended to spread the tissue with a blunt clamp to the bone, and to use a protection sleeve.

The greater the distance between the Schanz screws, the greater the stability of the frame.

Alternative medium external fi xation instruments

392.955 4.0 mm/2.5 mm Drill Sleeve


394.183 2.5 mm Trocar


395.922 4.0 mm Threaded Drill Sleeve



2Insert Schanz screws into ulna

Instruments


394.181 3.5 mm Trocar, short


395.912 5.0 mm/3.5 mm Drill Sleeve, short

395.921 6.0 mm/5.0 mm Threaded Drill Sleeve, short

Insert two more Schanz screws into the ulna from a dorsal direction. To optimize the pronation/supination of the lower arm, the two screws in the ulna should lie far dorsal, at the edge of the ulna.

Alternative medium external fi xation instruments



394.183 2.5 mm Trocar




3Connect Schanz screws with carbon fi ber rods

Instrument

321.20 Ratchet Wrench, 11 mm width across fl ats

Fixation material

390.008 Large Open Adjustable Clamp

394.80– 11.0 mm Carbon Fiber Rods394.85

Connect the Schanz screws in the humerus with two open adjustable clamps and a carbon fi ber rod. Repeat this process with the Schanz screws in the ulna. The rods should protrude slightly on the side closest to the elbow joint so that, if necessary, there is ample room to connect an additional carbon fi ber rod and combination clamp.

Tighten all the clamp nuts.

Note: If the reduction needs to be secured, it is recommended to stabilize it during surgery with an additional rod.

Alternative medium external fi xation instrument and fi xation material

321.158 Combination Wrench, 8 mm width across fl ats

390.035 Medium Open Adjustable Clamp




Determine Anatomical Joint Axis

4Determine anatomical joint axis

Instrument

292.26 2.5 mm Kirschner Wire, trocar point, 285 mm

Determine the anatomical axis using the image intensifi er, and laterally insert a 2.5 mm K-wire as a guide for reference. To prevent damaging the ulnar nerve, do not drill through the medial cortex.

When it is in the correct position, the K-wire represents a point in the center of the rotational axis.

Note: It may be possible to determine the joint axis directly by the projection of the two condyles. The cannulated center of the elbow hinge fi xator must be concentric with the superimposed condyles (see Step 8).


Connect Elbow Hinge Fixator

5Position elbow hinge fi xator and connect to humerus with carbon fi ber rod

Instrument


Fixation material

390.005 Large Combination Clamp

394.055 Elbow Hinge Fixator

394.80– 11.0 mm Carbon Fiber Rods 394.85

Place the elbow hinge fi xator over the K-wire, and connect it to the partial frame of the humerus using an additional rod and a combination clamp. When connecting the elbow hinge fi xator to the humeral partial frame, it is important to not bend the K-wire since the anatomical axis would then no longer correspond to the mechanical axis of the joint.

Note: Depending on the position of the partial frame on the humerus, the elbow hinge fi xator can be connected to the rod by means of a combination clamp.



390.031 Medium Combination Clamp




6Connect elbow hinge fi xator to carbon fi ber rod on ulna partial frame

Instrument


Fixation material



After reducing the joint, connect the end of the elbow hinge that is distal from the central guide hole to the ulnar partial frame.

Note: Depending on the position of the partial frame, the elbow hinge fi xator can also be connected directly by means of a combination clamp.




390.037 8.0 mm/11.0 mm Combination Clamp




7Remove K-wire

Remove the K-wire after all clamps of the construct have been tightened.

8Check axis

The elbow hinge position is checked by visualizing the elbow joint in lateral position. When positioned correctly, the centers of the fi xator and the radial and ulnar condyles will align in one visual plane. The center of the elbow hinge fi xator will appear as a small circle in the center of the superimposed images of the radial and ulnar condyles.


Distract Joint (Optional)

9Distract joint (optional)

Instruments

321.158 Combination Wrench, 8 mm width across flats

321.20 Ratchet Wrench, 11 mm width across flats

393.76 Open Compressor

Distract the joint either manually or using the open compressor.

After tightening the combination clamps, release the pin side of the open adjustable clamps on the carbon fiber rod on the humerus. Distract manually or attach the open compressor to just distal to either open adjustable clamp. After distraction is achieved, retighten open adjustable clamps and remove the open compressor.


Check Mobility of Joint

10Check mobility of joint

Check the mobility and position of the joint. When the position is correct, the central, cannulated metal sleeve of the elbow hinge fi xator projects exactly in the center of the concentric condyles in the form of a circle in a lateral visualization. In the AP plane, the central metal sleeve must be parallel to the joint surface to ensure proper alignment and joint function.


Immobilize Joint (Optional)

11Immobilize joint (optional)

Instrument


Fixation material



If necessary, the elbow joint can be temporarily immobilized directly after surgery with an additional rod connecting the two partial frames proximal and distal to the joint. The duration of the immobilization depends on the patient’s situation and surgeon preference.






Alternative Construct

Alternative construct—elbow hinge fixator with medium external fixator components

Fixation material

390.031 Medium Combination Clamps

390.035 Medium Open Adjustable Clamps



395.779– 8.0 mm Carbon Fiber Rods 395.792


Implants

Self-Drilling Schanz Screws– Reinforced bone anchoring due to radial preloading

and symmetrical thread profile

– Reduced heat generation and insertion torque due to optimized drill tip geometry

Stainless Steel Titanium Diameter (mm) Length (mm)

294.774 494.774 4.0 60294.775 494.775 4.0 80294.776 494.776 4.0 100294.777 494.777 4.0 125294.778 494.778 4.0 150294.779 494.779 4.0 175294.782 494.782 5.0 100294.783 494.783 5.0 125294.784 494.784 5.0 150294.785 494.785 5.0 175294.786 494.786 5.0 200294.788 494.788 5.0 250

Protective Caps394.97 For 11.0 mm Carbon Fiber Rods (10/pkg.)394.991 For 4.0 mm Fixation Pins (10/pkg.)394.993 For 5.0 mm Fixation Pins (10/pkg.)395.781 For 8.0 mm Carbon Fiber Rods (2/pkg.)


Fixation Material

For Large External Fixation


390.008 Large Open Adjustable Clamp


11.0 mm Carbon Fiber Rods, (for Large External Fixation)

394.80 100 mm394.81 125 mm394.82 150 mm394.83 200 mm394.84 250 mm394.85 300 mm


Fixation Material

For Medium External Fixation


390.035 Medium Open Adjustable Clamp


8.0 mm Carbon Fiber Rods (for Medium External Fixation)

395.780 120 mm 395.779 160 mm 395.782 200 mm 395.784 220 mm 395.786 240 mm 395.788 280 mm 395.792 320 mm


Instruments

For Large External Fixation


393.103 Drive Adaptor with quick coupling, for 5.0 mm Schanz screws

292.26 2.5 mm Kirschner Wire, trocar point, 285 mm

393.76 Open Compressor, for Large External Fixator


394.181 3.5 mm Trocar, 88 mm (short)

395.912 5.0 mm/3.5 mm Drill Sleeve, 77 mm (short)

395.921 6.0 mm/5.0 mm Threaded Drill Sleeve, 68 mm (short)



394.183 2.5 mm Trocar

For Medium External Fixation

321.158 Combination Wrench, 8 mm width across flats


393.101 Drive Adaptor with quick coupling, for 4.0 mm Schanz screws

Instruments


Bibliography

Jupiter JB, and Ring D., (2002). “Treatment of Unreduced Elbow Dislocations with Hinged External Fixation”, J Bone Joint Surg Am, 84-A: 1630–1635.

Schmickal T, Heppert V, Wentzensen A. (2002). “Einsatzmˆglichkeiten des Fixateur externe bei Oberarm- und Ellbogenverletzungen”. Trauma Berufskrankheiten, 4: 337–382.

Schmickal T, Wentzensen A. (2000). “Die Behandlung komplexer Ellbogenverletzungen mit einem gelenks¸berbr¸ckenden Fixateur mit Bewegungsachse”. Unfallchirurg, 103: 191–196.

Tan V, Daluiski A, Capo J and Hotchkiss R. (2005). “Hinged Elbow External Fixators: Indications and Uses”. J Am Acad of Orthop Surg, 13: 503–514.

© DePuy Synthes 2007–2017. All rights reserved.DSUS/TRM/0916/1050 6/17 DV

Synthes USA, LLC 1101 Synthes AvenueMonument, CO 80132

Manufactured or distributed by:Synthes USA Products, LLC 1302 Wrights Lane EastWest Chester, PA 19380

To order (USA): 800-523-0322 To order (Canada): 855-946-8999

Note: For recognized manufacturer, refer to the product label.

www.depuysynthes.com

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.

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Surgical Technique - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/US Mobile/Synthes North...

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