Reduced fluoroscopic radiation, reduced time, increased ... · Introduction Nowadays the...

Reduced fluoroscopic radiation, reduced time, increased accuracy

Clinical summaryRadiation-free distal locking of intramedullary nails: Evaluation of a newelectromagnetic computer-assisted guidance system

Stathopoulos Ioannis*, Karampinas Panagiotis, Evangelopoulos Dimitrios-Stergios,Lampropoulou-Adamidou Kalliopi, Vlamis John

Third Orthopaedic Department, University of Athens, KAT Hospital, Athens, Greece

Introduction

Nowadays intramedullary nailing (IMN) is the gold standard forthe treatment of long bone diaphyseal fractures. However, distallocking still remains a difficult and sometimes frustrating part ofIMN, since it can be time-consuming and expose the surgeon, thesurgery personnel and the patient to a considerable amount ofradiation as fluoroscopy is usually guiding the procedure.1 In somecases the radiation time needed for distal locking approaches halfof the total radiation time for IMN.2 Fluoroscopy is of greatimportance for the whole operation and also facilitates thereduction of the fracture, the identification of the nail’s entrypoint and its insertion.

Concerns about the safety of IMN regarding radiation exposure,as well as the need to ease and lessen the duration of the procedurehave led to various alternative distal locking methods for IMNs.1

These include modified freehand techniques with or without use ofradiolucent drills and jigs,3–5 mechanical guiding systems that areattached either to the proximal part of the nail6–13 or to the image

intensifier14,15 or even to the surgical table16 and computer-assisted navigation systems with or without application ofrobotics.17–22 Accurate targeting of the distal holes is problematicdue to the inevitable deformation of the nail after its insertion tothe tibia or the femur23–26 and that is the main cause of failure formany of the aforementioned targeting systems, especially for thosethat are mounted to the proximal section of the nail. Computer-assisted methods provide satisfactory accuracy, but imposes time-consuming set up and still depend on fluoroscopy for the initialmapping of the surgical field.18 Application of electromagneticfields offers an attractive solution.

The SURESHOTTM Distal Targeting System (Smith & Nephew,Inc., Memphis, TN, USA) is a novel commercially availableradiation-free aiming system utilizing computerized electromag-netic field tracking technology for distal IMN locking. In acomparative study with standard fluoroscopic freehand techniqueon cadaveric limbs, the new technique was found to be equallyeffective (100% vs. 94% for the tibial nail, 96% for both techniquesfor the femoral nail), faster (by 32% for the femoral nail and 47.5%for the tibial nail) to traditional distal locking, while the averageradiation time saved was 36 � 13 sec (tibial nail) and 49 � 25 sec(femoral nail) accounting for 785 � 285 mRad and 2362 � 1232 mRadradiation exposure to the limb, respectively.27

To evaluate the efficacy of the system we conducted thepresent study.

Injury, Int. J. Care Injured xxx (2012) xxx–xxx

* Corresponding author at: Third Orthopaedic Department, University of Athens,

KAT Hospital, 10, Athinas str., Kifissia, Athens PC 14561, Greece.

Tel.: +30 2108018123; fax: +30 2108018122.

E-mail address: [email protected] (I. Stathopoulos).

A R T I C L E I N F O

Article history:

Accepted 29 August 2012

Keywords:

Intramedullary nail

Distal locking

Radiation exposure

Electromagnetic fields

A B S T R A C T

Distal locking of intramedullary nails (IMNs) is a difficult part of intramedullary nailing (IMN) that could

be time-consuming and expose the surgeon, the surgery personnel and the patient to a considerable

amount of radiation as fluoroscopy is usually guiding the procedure. Utilization of electromagnetic fields

for that purpose offers an attractive alternative. The SURESHOTTM Distal Targeting System (Smith &

Nephew, Inc., Memphis, TN, USA) is a novel commercially available radiation-free aiming system that

utilizes computerized electromagnetic field tracking technology for the distal locking of IMNs. In order to

evaluate the efficacy of the system we conducted the present study. Nineteen patients (six females–

thirteen males, mean age 39.5 years, range 17–85 years) with closed diaphyseal fracture of the femur

(eight patients) or the tibia (eleven patients) were treated with IMN using the SURESHOTTM Distal

Targeting System for the distal interlocking. All targeting attempts were successful at first try and

followed by correct positioning of the screws. Mean time for distal locking of tibial IMNs (two screws)

was 219 sec (range 200–250 sec). Mean time for distal locking of femoral IMNs (two screws) was 249

(range 220–330 sec). In the current study the SURESHOTTM Distal Targeting System proved to be

accurate, fast and easy to learn.

� 2012 Elsevier Ltd. All rights reserved.

G Model

JINJ-5122; No. of Pages 4

Please cite this article in press as: Stathopoulos I, et al. Radiation-free distal locking of intramedullary nails: Evaluation of a newelectromagnetic computer-assisted guidance system. Injury (2012), http://dx.doi.org/10.1016/j.injury.2012.08.051

Contents lists available at SciVerse ScienceDirect

Injury

jo ur n al ho m epag e: ww w.els evier . c om / lo cat e/ in ju r y

0020–1383/$ – see front matter � 2012 Elsevier Ltd. All rights reserved.

http://dx.doi.org/10.1016/j.injury.2012.08.051

Injury, Int.

locking of intramedullarycomputer-assisted

Karampinas Panagiotis,Kalliopi, Vlamis John

Hospital, Athens,

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have led to various alternative distal locking methods forThese includemodified freehand techniqueswith orwithoutradiolucent drills and jigs,3–5 mechanical guiding systemsattached either to the proximal part of the nail6–13 or to the

B S T R A C T

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ORIGINAL ARTICLE

The Insertion of Intramedullary Nail Locking ScrewsWithout Fluoroscopy: A Faster and Safer Technique

Daniel S. Chan, MD,* Richard B. Burris, MD,† Murat Erdogan, MD,‡ and H. Claude Sagi, MD*

Objective: This study was designed to compare the accuracy, time,and radiation exposure during the insertion of intramedullary naillocking screws using either standard fluoroscopic assistance or anelectromagnetic (EM)-based navigational system without fluoroscopy.

Design: Prospective.

Setting: Level I academic trauma center.

Methods: Patients were divided into 2 groups: group 1 (fluoro-scopic assistance), consisted of standard freehand fluoroscopicallyassisted insertion of locking screws (OEC 9900; G.E. HealthCare,Waukesha, WI), whereas group 2 (EM), consisted of EM naviga-tionally assisted insertion without fluoroscopy (SureShot; Smith &Nephew, Memphis, TN). Technician arrival time, setup (SU) time,screw insertion (SI) time (seconds), fluoroscopy time (seconds), radi-ation exposure (mrads), and accuracy (hit or miss) were recorded foreach screw. For group 1, the SU time was recorded as the time andradiation required to obtain “perfect circles” before insertion, and forgroup 2, the SU time was recorded as the time required to set up thenavigational EM unit. Data collected regarding SI were then com-pared using standard analysis of variance.

Results: Forty-one locking screws were inserted in group 1, whereas60 screws were inserted in group 2. Accuracy was 100% for bothgroups. For group 1, mean technician wait time was 77 seconds plus amean perfect circle SU time of 105 seconds (9.2 mrads and 10 secondsof fluoroscopy). Mean SU time for group 2 was 94 seconds (nofluoroscopy). Mean insertion time was 342 seconds per screw for group1 (32.9 mrads and 18 seconds of fluoroscopy) compared with234 seconds per screw for group 2 (no fluoroscopy). These differenceswere statistically significant (P = 0.006).

Conclusions: The use of EM navigation (SureShot; Smith &Nephew) for the insertion of intramedullary nail locking screwsdemonstrated accuracy similar to conventional fluoroscopic-guided

insertion. However, EM-guided locking SI resulted in a significantlyshorter total procedural time and completely eliminated radiationexposure.

Key Words: IMN, fluoroscopy, radiation, locking screw, electro-magnetic, SureShot

Level of Evidence: Therapeutic Level III. See Instructions forAuthors for a complete description of levels of evidence.

(J Orthop Trauma 2013;27:363–366)

INTRODUCTIONCurrently, locking screws for intramedullary nails

(IMN) are placed either with a jig attached to the nail orwith fluoroscopic assistance (FA) using the “perfect circle”technique. Whether the surgeon is a novice or an expert withthis technique, the patient, operating surgeon, and operatingroom personnel are exposed to additional radiation. Previousstudies have reported that the use of fluoroscopy for all lock-ing screw placement can add an additional 1.1–6.9 minutes offluoroscopy time and an additional 12 mrems of radiation tothe dominant hand of the surgeon.1–5

Various techniques have been developed in an effort todecrease or eliminate the need for fluoroscopy during lockingscrew placement6–11; however, none of these methods haveconsistently demonstrated sufficient efficacy or accuracy.Recently, a navigational system using electromagnetic (EM)field–based tracking technology (Trigen Sureshot; Smith andNephew, Memphis, TN) has been developed to assist in theplacement of locking screws in IMNs with out the need forfluoroscopy. Tornetta et al reported on a decrease in screwinsertion (SI) time while maintaining accuracy without theneed for fluoroscopy when this system was tested in a cadav-eric model against the standard freehand technique.12

The purpose of this study was to compare setup (SU)time, fluoroscopic time, radiation exposure, insertion time, andaccuracy for intramedullary rod locking screw placementin vivo when using standard fluoroscopically assisted techniqueand EM navigation without fluoroscopy. Our hypothesis wasthat the EM technique would require less time and eliminateradiation while maintaining similar or improved accuracy.

METHODS

Study DesignThis was a prospective Institutional Review Board

approved study. Patients that underwent femoral or tibial

Accepted for publication December 11, 2012.From the *Orthopaedic Trauma Service, Florida Orthopaedic Institute, Tampa,

FL; †University of South Florida, Tampa, FL; and ‡Ondokuz Mayis Uni-versity, Samsun, Turkey.

Presented at the Annual Meeting of the Orthopaedic Trauma Association,2011, San Antonio, TX.

H. Claude Sagi is a consultant for Smith & Nephew, Synthes, and Stryker.The other authors report no conflicts of interest.

There was no external funding source for this study. The SureShot device wasprovided for use at our institution by Smith & Nephew, Memphis, TN.

The current study was approved by the IRB.Reprints: Daniel S. Chan, MD, Orthopaedic Trauma Service, Florida Ortho-

paedic Institute, 5 Tampa General Circle, Suite 710, Tampa, FL 33606(e-mail: [email protected]).

Copyright © 2013 by Lippincott Williams & Wilkins

J Orthop Trauma � Volume 27, Number 7, July 2013 www.jorthotrauma.com | 363

Daniel S. Chan, MD, Richard B. Burris, MD,

This study was designed to compare the accuracy, time,and radiation exposure during the insertion of intramedullary nail

uoroscopic assistance or anelectromagnetic (EM)-based navigational system without fluoroscopy.

Patients were divided into 2 groups: group 1 (scopic assistance), consisted of standard freehand fluoroscopicallyassisted insertion of locking screws (OEC 9900; G.E. HealthCare,Waukesha, WI), whereas group 2 (EM), consisted of EM naviga-

uoroscopy (SureShot; Smith &Nephew, Memphis, TN). Technician arrival time, setup (SU) time,

uoroscopy time (seconds), radi-ation exposure (mrads), and accuracy (hit or miss) were recorded foreach screw. For group 1, the SU time was recorded as the time and

before insertion, and forgroup 2, the SU time was recorded as the time required to set up thenavigational EM unit. Data collected regarding SI were then com-

Forty-one locking screws were inserted in group 1, whereas60 screws were inserted in group 2. Accuracy was 100% for bothgroups. For group 1, mean technician wait time was 77 seconds plus amean perfect circle SU time of 105 seconds (9.2 mrads and 10 seconds

uoroscopy). Mean SU time for group 2 was 94 seconds (nouoroscopy). Mean insertion time was 342 seconds per screw for group

uoroscopy) compared withuoroscopy). These differences

The use of EM navigation (SureShot; Smith &Nephew) for the insertion of intramedullary nail locking screwsdemonstrated accuracy similar to conventional fluoroscopic-guided

From the *Orthopaedic Trauma Service, Florida Orthopaedic Institute, Tampa,University of South Florida, Tampa, FL; and ‡Ondokuz Mayis Uni-

Presented at the Annual Meeting of the Orthopaedic Trauma Association,

H. Claude Sagi is a consultant for Smith & Nephew, Synthes, and Stryker.icts of interest.


Reprints: Daniel S. Chan, MD, Orthopaedic Trauma Service, Florida Ortho-paedic Institute, 5 Tampa General Circle, Suite 710, Tampa, FL 33606


Volume 27, Number 7, July 2013

This study was designed to compare the accuracy, time,and radiation exposure during the insertion of intramedullary nail

uoroscopic assistance or anelectromagnetic (EM)-based navigational system without

Patients were divided into 2 groups: group 1 (scopic assistance), consisted of standard freehandassisted insertion of locking screws (OEC 9900; G.E. HealthCare,Waukesha, WI), whereas group 2 (EM), consisted of EM naviga-

uoroscopy (SureShot; Smith &Nephew, Memphis, TN). Technician arrival time, setup (SU) time,

uoroscopy time (seconds), radi-ation exposure (mrads), and accuracy (hit or miss) were recorded foreach screw. For group 1, the SU time was recorded as the time and

before insertion, and forgroup 2, the SU time was recorded as the time required to set up thenavigational EM unit. Data collected regarding SI were then com-

Forty-one locking screws were inserted in group 1, whereas60 screws were inserted in group 2. Accuracy was 100% for bothgroups. For group 1, mean technician wait time was 77 seconds plus amean perfect circle SU time of 105 seconds (9.2 mrads and 10 seconds

uoroscopy). Mean SU time for group 2 was 94 seconds (nouoroscopy). Mean insertion time was 342 seconds per screw for group

uoroscopy) compared withuoroscopy). These differences

The use of EM navigation (SureShot; Smith &Nephew) for the insertion of intramedullary nail locking screwsdemonstrated accuracy similar to conventional

From the *Orthopaedic Trauma Service, Florida Orthopaedic Institute, Tampa,University of South Florida, Tampa, FL; and

Presented at the Annual Meeting of the Orthopaedic Trauma Association,

H. Claude Sagi is a consultant for Smith & Nephew, Synthes, and Stryker.icts of interest.


Reprints: Daniel S. Chan, MD, Orthopaedic Trauma Service, Florida Ortho-paedic Institute, 5 Tampa General Circle, Suite 710, Tampa, FL 33606


Volume 27, Number 7, July 2013

Next generation distal locking for intramedullary nails using anelectromagnetic X-ray-radiation-free real-time navigation system

Michael Hoffmann, MD, MBA, Malte Schroder, MD, Wolfgang Lehmann, MD, PhD,Michael Kammal, MD, Johannes Maria Rueger, MD, PhD, and Andreas Herrman Ruecker, MD,

Hamburg, Germany

BACKGROUND: Distal locking marks one challenging step during intramedullary nailing that can lead to an increased irradiation and pro-longed operation times. The aim of this study was to evaluate the reliability and efficacy of an X-ray-radiation-free real-timenavigation system for distal locking procedures.

METHODS: A prospective randomized cadaver study with 50 standard free-hand fluoroscopic-guided and 50 electromagnetic-guided distallocking procedures was performed. All procedures were timed using a stopwatch. Intraoperative fluoroscopy exposure timeand absorbed radiation dose (mGy) readings were documented. All tibial nails were locked with two mediolateral and oneanteroposterior screw. Successful distal locking was accomplished once correct placement of all three screws was confirmed.

RESULTS: Successful distal locking was achieved in 98 cases. No complications were encountered using the electromagnetic navigationsystem. Eight complications arose during free-hand fluoroscopic distal locking. Undetected secondary drill slippage on theipsilateral cortex accounted for most problems followed by undetected intradrilling misdirection causing a fissural fractureof the contralateral cortex while screw insertion in one case. Compared with the free-hand fluoroscopic technique, electro-magnetically navigated distal locking provides a median time benefit of 244 seconds without using ionizing radiation.

CONCLUSION: Compared with the standard free-hand fluoroscopic technique, the electromagnetic guidance system used in this study showedhigh reliability and was associated with less complications, took significantly less time, and used no radiation exposure fordistal locking procedures. (J Trauma Acute Care Surg. 2012;73: 243Y248. Copyright * 2012 by Lippincott Williams &Wilkins)

LEVEL OF EVIDENCE: Therapeutic study, level II.KEY WORDS: Intramedullary nailing; distal locking; radiation exposure; targeting devices; time.

C losed intramedullary nailing has proven its efficacy in thetreatment of diaphyseal fractures of long bones.1,2 Despite

the advances made over the years in nail design and instrumen-tation, distal locking remains a demanding step of the pro-cedure resulting in potential vast theater time consumption3,4

and increased radiation exposure for both the patient and thesurgeon.5,6 Great efforts have been made over the years to findan enduring solution for this problem. These include hand-heldtargeting devices and radiolucent drill guides,7 laser-guidedsystems,8 computer-assisted systems,9 self-locking nailing sys-tems,3 image-intensifier-mounted targeting devices,10,11 andproximally mounted distal locking devices.12 Each of thesedevices features its own privileges pitfalls, and limitations, andsuccessful use requires a certain learning curve.3 However,proximally mounted targeting devices seem to fail due to lack-ing compensation for insertionrelated deformation of the im-

plant.3,12 Therefore, the freehand fluoroscopic technique remainsthe most common method for distal locking.12 The purpose ofthis study was to compare the efficacy of the standard free-handfluoroscopic technique with a new electromagnetic navigationsystem for distal locking in terms of reliability, operation time,and radiation exposure.

MATERIALS AND METHODS

Tibial intramedullary nailing was performed in a pro-spective study on 20 nonfractured cadaveric limbs (10 bodies)using the semi-extended approach with the torso supine. Distallocking was performed randomized using either the standardfluoroscopic free-hand technique or the new electromagneticnavigation system. Both techniqueswere performed randomizedby two senior surgeons locking with one technique and thenbacking the nail up and rotating it slightly for further lockingprocedures.

For the standard free-hand fluoroscopic technique, theimage intensifier was aligned with the two distal nail holes untilthe passage for each screw appeared as a perfect circle in thecenter of the image, indicating coaxial alignment of the hole. Afollowing skin incision was made through the fascia, down tothe bone cortex. The drill was mounted on a radiolucent drillguide. Targeting was performed using pulsed fluoroscopyaiming for a circle in circle alignment of both the drill guide andthe distal locking hole of the nail. Once the hole was palpated

ORIGINAL ARTICLE

J Trauma Acute Care SurgVolume 73, Number 1 243

Submitted: June 30, 2011, Revised: January 9, 2012, Accepted: January 12, 2012,Published online: May 2, 2012From the Department of Trauma (M.H., M.S., W.L., J.M.R., A.H.R.), University

Medical Centre Hamburg-Eppendorf, Hand and Reconstructive Surgery, Mar-tinistrasse, Hamburg, Germany; and Department of Forensic Medicine (M.K.),University Medical Centre Hamburg-Eppendorf, Martinistrasse, Hamburg,Germany.

Address for reprints: Michael Hoffmann, MD, MBA, Department of Trauma, Uni-versity Medical Centre Hamburg-Eppendorf, Hand and Reconstructive Surgery,Martinistrasse 52, D-20246 Hamburg, Germany; email: [email protected].

DOI: 10.1097/TA.0b013e31824b0088

Copyright © 2012 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

Next generation distal locking for intramedullary nails using anelectromagnetic X-ray-radiation-free real-time navigation system

Michael Hoffmann, MD, MBA, Malte SchroMichael Kammal, MD, Johannes Maria Rueger, MD, PhD,

Hamburg, Germany

BACKGROUND: Distal locking marks one challenging step during intramedullary nailing that can lead to an increased irradiation and pro-longed operation times. The aim of this study was to evaluate the reliability and efficacy of an X-ray-radiation-free real-timenavigation system for distal locking procedures.

METHODS: A prospective randomized cadaver study with 50 standard free-hand fluoroscopic-guided and 50 electromagnetic-guided distallocking procedures was performed. All procedures were timed using a stopwatch. Intraoperative fluoroscopy exposure timeand absorbed radiation dose (mGy) readings were documented. All tibial nails were locked with two mediolateral and oneanteroposterior screw. Successful distal locking was accomplished once correct placement of all three screws was confirmed.

RESULTS: Successful distal locking was achieved in 98 cases. No complications were encountered using the electromagnetic navigationsystem. Eight complications arose during free-hand fluoroscopic distal locking. Undetected secondary drill slippage on theipsilateral cortex accounted for most problems followed by undetected intradrilling misdirection causing a fissural fractureof the contralateral cortex while screw insertion in one case. Compared with the free-hand fluoroscopic technique, electro-magnetically navigated distal locking provides a median time benefit of 244 seconds without using ionizing radiation.

CONCLUSION: Compared with the standard free-hand fluoroscopic technique, the electromagnetic guidance system used in this study showedhigh reliability and was associated with less complications, took significantly less time, and used no radiation exposure fordistal locking procedures. (J Trauma Acute Care Surgdistal locking procedures. (J Trauma Acute Care Surgdistal locking procedures. (Wilkins)

LEVEL OF EVIDENCE: Therapeutic study, level II.KEY WORDS: Intramedullary nailing; distal locking; radiation exposure; targeting devices; time.

C losed intramedullary nailing has proven its efficacy in thetreatment of diaphyseal fractures of long bones.1,2

the advances made over the years in nail design and instrumen-tation, distal locking remains a demanding step of the pro-cedure resulting in potential vast theater time consumptionand increased radiation exposure for both the patient and thesurgeon.5,6 Great efforts have been made over the years to findan enduring solution for this problem. These include hand-heldtargeting devices and radiolucent drill guides,7 laser-guidedsystems,8 computer-assisted systems,9 self-locking nailing sys-tems,3 image-intensifier-mounted targeting devices,10,11

proximally mounted distal locking devices.12 Each of thesedevices features its own privileges pitfalls, and limitations, andsuccessful use requires a certain learning curve.3 However,proximally mounted targeting devices seem to fail due to lack-ing compensation for insertionrelated deformation of the im-

ORIGINAL

Submitted: June 30, 2011, Revised: January 9, 2012, Accepted: January 12, 2012,Published online: May 2, 2012From the Department of Trauma (M.H., M.S., W.L., J.M.R., A.H.R.), University

Medical Centre Hamburg-Eppendorf, Hand and Reconstructive Surgery, Mar-tinistrasse, Hamburg, Germany; and Department of Forensic Medicine (M.K.),University Medical Centre Hamburg-Eppendorf, Martinistrasse, Hamburg,Germany.

Address for reprints: Michael Hoffmann, MD, MBA, Department of Trauma, Uni-versity Medical Centre Hamburg-Eppendorf, Hand and Reconstructive Surgery,

ORIGINAL ARTICLE

Distal Locking Using an Electromagnetic Field–GuidedComputer-Based Real-Time System for Orthopaedic

Trauma Patients

Maxwell K. Langfitt, MD,* Jason J. Halvorson, MD,* Aaron T. Scott, MD,* Beth P. Smith, PhD,*Gregory B. Russell, MS,† Riyaz H. Jinnah, MD, FRCS,* Anna N. Miller, MD,* and Eben A. Carroll, MD*

Objectives: To compare the efficacy of distal interlocking duringintramedullary nailing using a freehand technique versus anelectromagnetic field real-time system (EFRTS).

Design: A prospective, randomized controlled trial.

Setting: Level I academic trauma center.

Patients/Participants: Patients older than 18 years who sus-tained a femoral or tibial shaft fracture amenable to antegradeintramedullary nailing were prospectively enrolled betweenAugust 2010 and November 2011. Exclusion criteria includedinjuries requiring retrograde nailing and open wounds near thelocation of the distal interlocks (distal third of the femur, knee, ordistal tibia).

Intervention: Each patient had 2 distal interlocking screws placed:one using the freehand method and the other using EFRTS.

Main Outcome Measurement: Techniques were compared onprocedural time and number of interlocking screw misses. Two timepoints were measured: time 1 (time to find perfect circles/time fromwand placement to drill initiation) and time 2 (drill initiation untilcompletion of interlocking placement).

Results: Twenty-four tibia and 24 femur fractures were studied.EFRTS proved faster at times 1 and 2 (P , 0.0001 and P , 0.0002)

and total time (P , 0.0001). This difference was larger for juniorresidents, though reached statistical significance for senior residents.Senior residents were faster with the freehand technique comparedwith junior residents (P , 0.004), but the 2 were similar usingEFRTS (P = 0.41). The number of misses was higher with free handcompared with EFRTS (P = 0.02).

Conclusion: These results suggest that EFRTS is faster than thetraditional freehand technique and results in fewer screw misses.

Key Words: distal locking, intramedullary nailing, femur/tibia frac-ture, electromagnetic, fluoroscopy, orthopaedic trauma

Level of Evidence: Therapeutic Level II. See Instructions forAuthors for a complete description of levels of evidence.

(J Orthop Trauma 2013;27:367–372)

INTRODUCTIONIntramedullary nails are the gold standard for the

treatment of lower extremity long bone fractures.1–4 The tech-nique for both femoral and tibial antegrade nails has been welldescribed.1–3 Many surgeons use a freehand or "perfect circle"technique for placement of the distal locking screws, whichinvolves intraoperative fluoroscopy to guide freehand drillingthrough the bone and intramedullary nail followed by place-ment of the locking screw. Although effective, potential pit-falls of this technique include increased operative time andradiation exposure, as well as the potential to "miss" the nailwith the drill or locking screw. For surgeons who do not oftenperform intramedullary nailing, distal locking can be difficultand time consuming. To improve the method of distal lockingscrew placement, an ideal system would decrease radiationexposure, improve accuracy of drill/screw placement, be easyand accessible to the community surgeon, and decrease oper-ating room time while also being cost effective. Numeroussystems and techniques have been proposed and are welldescribed.5–15 However, many of these systems continue toexpose the patient and surgeon to radiation, are cumbersome,and may have a steep learning curve for the surgeon.

A new system, an electromagnetic field real-timesystem (EFRTS) (Trigen Sureshot, Smith & Nephew, Mem-phis, TN), aims to provide surgeons with a fast, reliable, andaccurate technique for distal locking screw placement withoutradiation exposure. The EFRTS uses an electromagnetic field

Accepted for publication February 7, 2013.From the *Department of Orthopaedic Surgery, Wake Forest Baptist Medical

Center, Winston-Salem, NC; and †Department of Biostatistical Sciences,Wake Forest Baptist Medical Center, Winston-Salem, NC.

This study was supported by research grant provided by Smith andNephew.

Dr. Anna Miller receives research support from Synthes and Smith andNephew not related to this study.

Drs M. K. Langfitt, J. J. Halvorson, B. P. Smith, E. A. Carroll, and Mr G. B.Russell have nothing to disclose that relates to this study and no conflictsof interest that relate to this study.

Dr A. T. Scott has provided expert testimony and given lectures in an activityunrelated to this study.

Presented as a podium presentation at the Eastern Orthopaedic AssociationConference, Bolton Landing, NY, June 21, 2012, and at the SouthernOrthopaedic Association Conference, White Sulphur Springs, WV, July19 2012.

Reprints: Eben A. Carroll, MD, Department of Orthopaedic Surgery, WakeForest Baptist Medical Center, Medical Center Boulevard, Winston-Salem, NC 27157 (e-mail: [email protected]).


J Orthop Trauma � Volume 27, Number 7, July 2013 www.jorthotrauma.com | 367

2

Study designs included:• Prospective comparative studies• Cadaveric investigations

Follow-up range: Intraoperative

Study designs included:• Prospective comparative studies• Cadaveric investigations

TRIGEN™ SURESHOT™ Distal Targeting System clinical study characteristics


Procedures:Femoral and tibial shaft fracture fixationRetrograde knee drilling for osteochondritis dissecans (OCD)

Sample size range:16-60 fractures treated with the TRIGEN SURESHOT Distal Targeting System

Number of total fractures treated:273

3

TRIGEN™ SURESHOT™ Distal Targeting System clinical study characteristics


Procedures:Femoral and tibial shaft fracture fixationRetrograde knee drilling for osteochondritis dissecans (OCD)

Sample size range:16-60 fractures treated with the TRIGEN SURESHOT Distal Targeting System

Number of total fractures treated:273

1. Langfitt Maxwell K., Halvorson Jason J., Scott Aaron T., Smith Beth P., Russell Gregory B., Jinnah Riyaz H., Miller Anna N., Carroll Eben A. Distal

Locking Using an Electromagnetic Field-Guided Computer-Based Real-Time System for Orthopaedic Trauma Patients. Journal of Orthopaedic Trauma 2013; 27:367-372.

2. Chan Daniel S., Burris Richard B., Erdogan Murat., Sagi H Claude. The Insertion of Intramedullary Nail Locking Screws Without Fluoroscopy: A Faster and Safer Technique. Journal of Orthopaedic Trauma. 2013;27:363-366.

3. Hoffmann Michael, Schröder Malte, Lehmann Wolfgang, Kammal Michael, Rueger Johannes Maria, Ruecker Andreas Herrman. Next Generation Distal Locking for Intramedullary Nails Using an Electromagnetic X-Ray-Radiation-Free Real-Time Navigation System. The Journal Of Trauma And Acute Care Surgery. 2012;73:243-248.

4. Ioannis Stathopoulos, Panagiotis Karampinas, Dimitrios-Stergios Evagelopoulos, Kalliopi Lampropoulou-Adamidou, John Vlamis. Radiation-Free Distal Locking of Intramedullary Nails: Evaluation of a New Electromagnetic Computer-Assisted Guidance System. Injury. 2012;08:51-54.

Reference Pros

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Cada

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tudy

Gro

ups

Dis

tal d

rill t

ime

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es)

Dis

tal l

ocki

ng a

ccur

acy

Fluo

ro ti

me

durin

g sc

rew

in

sert

ion

(sec

onds

)

Dis

tal L

ocki

ng R

adia

tion

expo

sure

(MRA

DS)

Langfitt1

Freehand Technique 5.79 67% 26.2 Not recorded

SURESHOT™ 3.51 96% 0 Not recorded Chan2

Freehand

technique5.70 100% 18.0 42.1

SURESHOT 3.80 100% 0 0 Hoffman3 Freehand

Technique8.43 96% 30.71 66.3

SURESHOT 4.46 100% 0 Not recorded

Stathopoulos4 Freehand 5.45 95% Not recorded Not recordedSURESHOT 3.9 98% Not recorded Not recorded

4

Reduced radiation

Highlights

Flouroscopy time and radiation exposure

0

10

20

30

40

50

60

70

Langfitt Chan Hoffmann Stathopoulos

Not recorded

Not recorded

Seco

nds/

mRa

ds

Fluoroscopy time during screw insertion (seconds)


TRIGEN™ SURESHOT™ 0 0 0 N/A

Freehand technique

Distal locking radiation exposure (mRAD)

TRIGEN SURESHOT N/A 0 0 N/A

Freehand technique N/A 42.71 66.3 N/A

Fluoroscopy was not recorded for SURESHOT for NO fluoroscopy was used.

Average of six minutes to insert a single screw, and this was associated with, on average, 18 seconds of fluoroscopy time and 42.1mRads of radiation.

Mean radiation time for distal locking was 30.7 seconds with a mean dosage of 666.3mGy using freehand technique.

26.2 18 30.71 N/A


5

Reduced radiation Reduced time

Highlights

Distal drill time

Min

utes

0

2

4

6

8

10

12


Fluoroscopy time during screw insertion (seconds)


TRIGEN™ SURESHOT™ 0 0 0 N/A

Freehand technique

Distal locking radiation exposure (mRAD)

TRIGEN SURESHOT N/A 0 0 N/A

Freehand technique N/A 42.71 66.3 N/A

Mean distal drill time in clinical study


TRIGEN™ SURESHOT™ 5.07 1.32 1.16 3.44 3.45 5.15 5.02 3.8 4.46 3.65 4.15

Freehand technique 8.03 3.3 2.28 6.08 4.4 9.38 7.08 5.7 8.53 4.75 6.12

Average of six minutes to insert a single screw, and this was associated with, on average, 18 seconds of fluoroscopy time and 42.1mRads of radiation.

Overall Screw Insertion time (12 – 18 minutes) and radiation (84.2 – 126.3mrads).

26.2 18 30.71 N/A


6

Increased accuracy

1 2 3 4 5

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Perc

enta

ge

Distal locking accuracy


TRIGEN™ SURESHOT™ 96% 100% 100% 100% 96%

Freehand technique 67% 100% 96% 94% 96%67% 100% 96% 94% 96%

The number of misses was higher with Freehand compared to SURESHOT.

Drill bit missed the interlocking hole eight times with freehand technique compared to one time

with SURESHOT.

Distal locking was accomplished successfully in all 50 procedures with SURESHOT.

Six incidences defined as complications using the freehand technique encountered.

12/50 cases using Freehand technique had drill-nail contact vs. 2/50 for SURESHOT.

Accuracy of SURESHOT was 100%.

Highlights



7

Increased accuracy References



TRIGEN™ SURESHOT™ 96% 100% 100% 100% 96%

Freehand technique 67% 100% 96% 94% 96%

1. Langfitt Maxwell K., Halvorson Jason J., Scott Aaron T., Smith Beth P., Russell Gregory B., Jinnah Riyaz H., Miller Anna N., Carroll Eben A. Distal Locking Using an Electromagnetic Field-Guided Computer-Based Real-Time System for Orthopaedic Trauma Patients. Journal of Orthopaedic Trauma 2013; 27:367-372

2. Chan Daniel S., Burris Richard B., Erdogan Murat., Sagi H Claude. The Insertion of Intramedullary Nail Locking Screws Without Fluoroscopy: A Faster and Safer Technique. Journal of Orthopaedic Trauma. 2013;27:363-366

3. Hoffmann Michael, Schröder Malte, Lehmann Wolfgang, Kammal Michael, Rueger Johannes Maria, Ruecker Andreas Herrman. Next Generation Distal Locking for Intramedullary Nails Using an Electromagnetic X-Ray-Radiation-Free Real-Time Navigation System. The Journal Of Trauma And Acute Care Surgery. 2012;73:243-248

4. Ioannis Stathopoulos, Panagiotis Karampinas, Dimitrios-Stergios Evagelopoulos, Kalliopi Lampropoulou-Adamidou, John Vlamis. Radiation-Free Distal Locking of Intramedullary Nails: Evaluation of a New Electromagnetic Computer-Assisted Guidance System. Injury. 2012;08:51-54

Reduced fluoroscopic radiation, reduced time, increased accuracy

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