Kuhn 2014 Injury

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The Retrograde Tibial Nail: Presentation and biomechanical evaluationof a new concept in the treatment of distal tibia fractures

Sebastian Kuhn *, Philipp Appelmann, Philip Pairon, Dorothea Mehler, Pol M. Rommens

Department of Orthopaedics and Traumatology, University Medical Centre of the Johannes Gutenberg University, Mainz, Germany

Introduction

Fractures to the distal tibial metaphysis and pilon are oftenhigh-energy injuries combined with extensive soft-tissue dam-age. Treatment may be complicated by soft tissue and boneinfection, delayed-union and non-union, all pointing to secondaryor revision surgeries. Displaced fractures need stable fixationwhile minimizing secondary damage to the soft tissues by thesurgical approach and implants. The optimal method of fixationremains debatable. Intramedullary nailing is an alternative toplate osteosynthesis [1–3].

Open reduction and internal fixation has the drawbacks ofdevascularizing fracture fragments and damaging the soft tissuemantle. Minimal invasive percutaneous plate osteosynthesis(MIPPO) reduces these risks. Nevertheless, precontoured andangular stable plates may be prominent under the skin of themedial malleolus and may cause secondary skin necrosis. This isespecially dangerous in older patients with a compromised andvery thin soft tissue mantle [4,5].

Intramedullary nailing offers stable fixation while preserving thevascularity of the fracture site and the integrity of the surroundingsoft-tissue [6–9]. However, antegrade intramedullary nailing is atechnically challenging procedure, comprising the specific risk ofprimary and secondary malalignment. Additionally, anterior kneepain is a common complaint after antegrade tibial nailing, withvariable incidence rates from 10 to 86% reported [10–14].

The latest generation tibial intramedullary implants withmultiple locking options near the ends of the nail have extended

Injury, Int. J. Care Injured 45S (2014) S81–S86

A R T I C L E I N F O

Keywords:

Distal tibia

Metaphyseal fractures

Intramedullary nailing

Retrograde nailing

A B S T R A C T

Displaced distal tibia fractures require stable fixation while minimizing secondary damage to the soft

tissues by the surgical approach and implants. Antegrade intramedullary nailing has become an

alternative to plate osteosynthesis for the treatment of distal metaphyseal fractures over the past two

decades. While retrograde intramedullary nailing is a standard procedure in other long bone fractures,

only few attempts have been made on retrograde nailing of tibial fractures. The main reasons are

difficulties of finding an ideal entry portal and the lack of an ideal implant for retrograde insertion.

The Retrograde Tibial Nail (RTN) is a prototype intramedullary implant developed by our group. The

implant offers double proximal and triple distal interlocking with an end cap leading to an angle-stable

screw-nail construct of the most distal interlocking screw. Its design meets the requirements of a

minimally invasive surgical approach, with a stable fracture fixation by multiple locking options. The

8 mm diameter curved nail, with a length of 120 mm, is introduced through an entry portal at the medial

malleolus. We see possible indications for the RTN in far distal tibial shaft fractures, distal extraarticular

metaphyseal tibial fractures and in distal tibia fractures with simple extension into the ankle joint when

the nail is combined lag screw fixation.

A biomechanical comparison of the current RTN prototype against antegrade nailing (Expert Tibial

Nail, Synthes1, ETN) was performed. Both implants were fixed with double proximal and triple distal

interlocking. Seven biomechanical composite tibiae were treated with either osteosynthesis techniques.

A 10 mm defect osteotomy 40 mm proximal to the joint line served as an AO 43-A3 type distal tibial

fracture model. The stiffness of the implant-bone constructs was measured under low and high extra-

axial compression (350 and 600 N) and under torsional load (8 Nm). Results show a comparable stability

during axial loading for the two implant types with slightly higher stability in the RTN group. Rotational

stability was superior for the RTN. Statistical analysis proved a significant difference (p < 0.05) between

the ETN and RTN for rotational stability. This study suggests that retrograde tibia nailing with the RTN is

a promising new concept for the treatment of distal tibia fractures.

* Corresponding author at: Department of Orthopaedics and Traumatology,

University Medical Center, Johannes Gutenberg University, Langenbeckstrasse 1,

55131 Mainz, Germany. Tel.: +49 6131 177292.

E-mail address: sebastian.kuhn@unimedizin-mainz.de (S. Kuhn).

Contents lists available at ScienceDirect

Injury

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http://dx.doi.org/10.1016/j.injury.2013.10.025

the spectrum of fractures amenable to intramedullary nailing [15–18]. Favourable clinical results support the extending indicationsfor intramedullary nailing in distal tibial fractures. These nailsallow the placement of up to 4 distal interlocking screws in threedifferent planes within 40 mm of the nail end [17]. This designmakes the implants suitable for distal metaphyseal fractures andspecific intraarticular Pilon fractures. Following the AO classifica-tion, multiple locking tibial nails can be used as a sole implant in43-A1/A2/A3 fractures and in case of simple extension of thesefracture types into the joint (43-C1/C2) in combination withprimary lag screw fixation [19]. Intramedullary nails are regularlyused in secondary procedures or revision surgery such as non-unions and mal-unions of the distal tibia.

While retrograde intramedullary nailing is a standard proce-dure in other long bone fractures, only few attempts have beenmade on retrograde nailing of tibia fractures. A few case series ofretrograde tibia nailing were published addressing proximal tibialpathologies ranging from proximal tibial fractures to allogenicvascularized knee transplantations and callus distraction [20,21].But retrograde nailing did not find application in common practice.With the IP-XS-Nail1 system (Smith & Nephew1), Gehr and Friedlperformed nail osteosynthesis of distal tibia, pilon and medialmalleolus as well as olecranon and patella fractures. Locking isachieved by threaded K-wires, which are shortened after insertion.The outcome showed mixed results in a limited patient collective[22,23].

The Retrograde Tibial Nail (RTN) is a prototype intramedullaryimplant that has been under design by our group since 2008. Wedeveloped the new implant through multiple prototype stages andconducted anatomical insertion studies and preliminary bio-mechanical testing. The concept of minimal invasive percutaneousplate osteosynthesis is transferred to a minimal invasive localintramedullary osteosynthesis. Its goal is to offer stable fracturefixation with minimal additional soft-tissue injury distally andwithout additional damage of the structures around the knee joint.In this paper we present the prototype implant and the results ofthe biomechanical testing comparing the Retrograde Tibial Nail(RTN) against a standard antegrade intramedullary nail (ETN1,Synthes).

Materials and methods

Implant design

The RTN is an experimental intramedullary implant made ofstainless steel (Fig. 1a and b). The current prototype has a length of120 mm and a diameter of 8 mm. The geometry, which is based onanatomical CT morphometric studies, displays a straight proximaland a curved distal section with an angulated tip. The implantoffers double proximal and triple distal locking. The three distallocking options for locking screws are at 9, 17, and 25 mm from thenail tip. The distal locking screws converge and reach the samelevel 45 mm medially from the nail in the AP view. They diverge by258 in the lateral view to each other. The distal locking screwsfeature a dual core design for optimized purchase in the cancellousbone (Fig. 2). Proximally the RTN features two locking optionswhich deviate 158 from each other, so that each screw is insertedperpendicular to the medial tibia shaft. The proximal lockingscrews are standard 4.0 mm cortical screws.

The nail is introduced through the medial cortex near the tip ofthe medial malleolous. A 9 mm opening and cavern through themedial malleolus is created by an awl. The nail is introduced byhand force and slight rotatory movements with the aiming device.The angulated tip allows for easy introduction, while the nailslides along the lateral cortex of the distal tibia. Secure proximaland distal locking is possible through the aiming device (Fig. 3). An

end cap leads to an angle-stable distal screw to nail construct(Fig. 4a–c).

Biomechanical testing

Biomechanical testing was conducted to investigate whetherthe RTN provides enough stability to allow functional after-treatment. The null hypothesis was that there is no difference inthe biomechanical properties after RTN osteosynthesis comparedto conventional antegrade tibial nailing (Expert Tibial Nail1) in anextraarticular distal tibial fracture (AO 43 A3) model. Biomechani-cal composite bone tibiae (Sawbones Europe, Malmo, Sweden) areused for biomechanical testing. A total of 14 composite tibiae, 7 ineach group, are tested in the comparative investigation. Implanta-tions of the 8 mm diameter Expert Tibial Nails are performedaccording to the manufacturer’s instructions. RTN is implantedaccording to the description above.

A 10-mm wide transverse defect osteotomy serves as an AO 43A3 fracture model. After implant insertion into the intact bone, theosteotomy parameters are established. Removing 10 mm of bonebetween 40 and 50 mm from the plafond with a parallel sawcreates the defect. The tibial ends are potted in poly-methylmethacrylate (PMMA). Before testing, X-ray control in 2 planes are

Fig. 1. (a and b) CAD drawing of the Retrograde Tibial Nail in AP and lateral view.

Fig. 2. The distal locking screws feature a dual core design.

S. Kuhn et al. / Injury, Int. J. Care Injured 45S (2014) S81–S86S82

performed to document the exact position of the implants and toexclude any possible damage, which might have occurred duringimplantation.

Biomechanical testing was performed with a pneumaticuniversal testing machine (SincoTec; Clausthal-Zellerfeld,Germany) and the basic setup is based on Hansen et al. [24]. Allconstructs underwent the same sequence of biomechanicaltesting. All settings of the testing machine were controlled byPneuSys software (SincoTec, Clausthal-Zellerfeld, Germany). First,a non-destructive test for extra-axial force with 350 and 600 N wasperformed. Afterwards a bi-directional rotational test with 8 Nmwas done.

For extra-axial compression the load transmission point at theknee joint was in accordance to Horwitz et al. [25]. The force wasintroduced with a 10 mm offset posteromedial from the tibialeminentia into the tibial plateau through a steel ball in a trough. Aforce-transmitting bar was located above the steel ball. Distally acardanic joint was used to position the samples in the testingmachine. The kinematics of the upper and lower ankle joint arebest simulated by this technical joint.

Force-controlled axial loading was started under a preload of18 N and increased up to 350 N respective 600 N and then backto 18 N with 0.05 Hz. One pre-cycle and 3 measurement cycleswere recorded. Axial movements were recorded by the actuator

of the testing machine being connected to a force-transmittingbar.

For torsional testing the bone constructs were fixed proximallyand distally. Angle-controlled testing was performed under aconstant preload of 10 N. Bi-directional torque was applied from0 Nm to 8 Nm clockwise and back to 8 Nm counter-clockwise. Thisled to a sinus wave pattern load with a maximum torsion of 8 Nmand duration of 20 s. One pre-cycle and 3 measurement cycleswere recorded. A rotational transducer being connected to theactuator of the testing machine registered the difference inrotation of the proximal versus the distal segment. An overview ofthe testing sequence is given in Table 1.

The stiffness of the constructs was measured during axial loadingtests, by the load to deformation curve, by the testing machine. Forrotational test, the stiffness of the constructs was measured by thetorsion to rotation curve. The biomechanical comparisons of theconstructs in the linear–elastic area of the force–displacement andforce–rotation diagram provided the basis for the evaluation of thenon-destructive tests. The load–displacement and force–rotationvalues were used for statistical data analysis.

Additionally interfragmentary movement was recorded by anopto-electric measurement system (Simo-motion, Simi RealityMotion Systems, Unterschleißheim, Germany) with markers at thefracture proximal and distal defect line.

Methods for data management and analysis

SPSS software (SPSS 21.0, IBM, Ehningen, Germany) was usedfor the statistical analysis. The load–displacement and force–rotation values of the different implant groups were comparedwith the two tailed non-parametric Wilcoxon signed-rank test.Statistical significance was defined as an error level of less than 5%(p-value, 0.05).

Results

Axial compression

Results show a comparable axial construct stability of the twoimplants with slightly higher stability in the RTN group during the

Fig. 3. CAD drawing of the Retrograde Tibial Nail and aiming device with allows for

X-ray free proximal and distal interlocking.

Fig. 4. (a–c) Fluoroscopy image of RTN implanted in an intact biomechanical composite tibiae in a.p., lateral and oblique view. The images demonstrate the deviation of the

locking screws in the plafond.

Table 1Test sequence of the biomechanical evaluation. All constructs underwent the test

sequence 1, a–b and 2.

Test sequence 7 RTN vs. 7 ETN1

1. Extra-axial compression a. 350 N b. 600 N

2. Bi-directional torsion 8 Nm

S. Kuhn et al. / Injury, Int. J. Care Injured 45S (2014) S81–S86 S83

low (ETN 812 � 324 N/mm vs. RTN 870 � 194 N/mm) and high (ETN797 � 219 N/mm vs. RTN 929 � 104 N/mm) axial loading tests(Figs. 5 and 6). No statistically significant difference was observedduring the low (p = 0.39) and high (p = 0.063) axial loading tests.

The interfragmentary movement recorded by optico-electricmarker movement at the fracture line was reduced for the RTN groupduring the low (ETN 0.28 � 0.10 mm vs. RTN 0.14 � 0.03 mm) andhigh (ETN 0.47 � 0.17 mm vs. RTN 0.26 � 0.05 mm) axial loading tests.

Torsion

Rotational stability testing resulted in superior performance forthe RTN in comparison to the ETN. The average force–rotationvalue was 0.66 � 0.07 Nm/8 in the ETN vs. 1.91 � 0.21 Nm/8 for theRTN group (Fig. 7). Statistical analysis proved a significant difference(p < 0.05) between the ETN and RTN group for rotational stability(p = 0.018).

The interfragmentary movement recorded by optico-electricmarker movement at the fracture line was reduced for the RTNcompared to the ETN group (ETN 5.91 � 0.95 mm vs. RTN1.91 � 0.24 mm).

Discussion

The distal tibia is one of the most common fractured bones.Court-Brown and McBirnie provide very detailed epidemiologicaldata for tibial fractures in a patient collective from Edinburgh,Scotland [26]. They found that 37.8% of these fractures were locatedin the distal third of the tibia. Incidence rates of metaphysealfractures (including ankle fractures) vary considerably by age andgender [27]. Incidence ranged from a low of 3 per 10,000 per yearamong 30–34-year-old women to a high of 28 per 10,000 per yearamong 15–19-year-old boys. Metaphyseal fractures are morecommon than shaft fractures in the tibia in all age groups afterthe age of 35 years [28]. Cowie and Court-Brown report that distaltibial fractures have shown an increase by almost 30% in westernsocieties in the past 10 years. The average age of patients sustainingdistal tibial fractures rose from 37 years to 44 years. Tibial fracturesin general show a bimodal distribution with peaks for young malesand elderly females. This trend will continue and surgeons are goingto treat an increasing number of osteopenic and osteoporotic distaltibial fractures [29]. Tibial fractures are also often associated withhigh-energy trauma and up to 30% of the tibial fractures occur inpatients with multiple injuries [26,30].

The nail provides stable fixation of tibial fractures in the distal6 cm to the tibial plafond. Possible indications for the Retrograde

Tibial Nail are therefore far distal tibial shaft fractures (AO 42 A–C),distal extraarticular metaphyseal tibial fractures (AO 43 A1–3) andin combination with additional screw fixation, simple Pilonfractures (AO 43 C1).

Key requirements for the management of distal tibia fracturesare a minimally invasive surgical approach and the ability of asecure fracture fixation. Optimal treatment should take pre-existing and posttraumatic soft tissue condition, the medicalhistory of the patient and the fracture morphology into account.Choosing an appropriate treatment is difficult especially in elderlypatients, who can present with a combination of thin skin,compromised soft tissues, compromised peripheral vascular bloodsupply, peripheral neuropathy and other comorbidities. Histori-cally, non-surgical treatment with plaster cast immobilization hasbeen unsuccessful in axially unstable fractures and mal- and non-union were very common in addition to joint stiffness [31–33].External fixation as a definitive treatment is not optimal, asks forcontinuous care and additionally is associated with mal- and non-union as well as pin tract infections [34]. Percutaneous plating is areasonable option but risky in patients with poor soft tissues,diabetes or peripheral arterial disease. In our opinion there is aneed for a specific intramedullary implant for distal tibial fractures.Some surgeons advocate using a hindfood nail in the treatment ofdistal metaphyseal tibial fractures with problematic soft tissues[35,36]. However, this surgical treatment cannot be routinely

Fig. 5. Axial construct stability for extra-axial force with 350 N for the ETN (dark)

and RTN (light). Results show a comparable axial construct stability of the two

implants.

Fig. 6. Axial construct stability for extra-axial force with 600 N for the ETN (dark)

and RTN (light). Results demonstrate a comparable axial construct stability of the

two implants with slightly higher, however, not statistically significant, stability in

the RTN group.

Fig. 7. Rotational stability testing for the ETN (dark) and RTN (light). Results show a

statistically significant superior performance of the RTN in comparison to the ETN.

suggested since it sacrifices the tibiotalar and subtalar joint andleads to gait disturbances.

An intramedullary device is biomechanically favourable since itis based on the concept of load sharing. The RTN offers distinctadvantages due to its concept and design over antegrade nails. Thedistal introduction portal spares the knee joint and patella tendon.Anterior knee pain, which is the most common complaint ofpatients treated by antegrade tibial nailing is prevented [10–14].Injury to the patellar tendon and the retropatellar fat are relevantfactors [37]. Knee pain often does not subside after implantremoval and is associated with deficient quadriceps strength[37,38].

Fat emboli occur during intramedullary nailing. The mainemboli occur in reamed nailing during the first two reaming stepsand in unreamed nailing during nail insertion and when the nail isadvanced through the tibial shaft [39–41]. The short RTN implantleaves most of the medullary canal, and especially the isthmusuninvolved, which minimized the risk of fat emboli. This advantagecould represent a relevant clinical factor especially in patients withpulmonary injuries and polytraumatised patients. However, this isa conceptional assumption, which will have to be proven throughfurther studies.

Additionally retrograde intramedullary nailing might be anattractive option in patients with a tibia fracture and ipsilateraltotal knee arthroplasty, who are not candidates for antegradenailing. In these patients, retrograde calcaneotalotibial nails havebeen used in selected cases, sacrificing the upper and lower anklejoint [36].

Antegrade intramedullary nailing of distal metaphyseal frac-ture is generally associated with a high radiation exposureespecially for distal locking [42,43]. Using the RTN, proximaland distal locking is achieved through the aiming device, whichmight lessen the duration of surgery and radiation exposure.

Critical factors of the Retrograde Tibial Nailing concept are therisk of creating a fracture at the medial malleolus while creatingthe entry portal and primary malalignment, since the nail does notaid fracture reduction. As in other nailing procedures ofmetaphyseal lesions, the fracture must be reduced before nailinsertion.

Appropriate stability is essential to bone healing. Kuntscher’swork from the 1940s demonstrated that intramedullary nailingoffers adequate stability to prevent pseudarthrosis formation butallows micro-motion, which induces callus formation. Optimalfracture healing has been reported with bone strains ranging from7 to 33% [44,45]. Operative fracture fixation must keep theinterfragmentary strain within optimal limits and avoid excessivemovement and strain. In distal tibia defect fractures, unreamednailing with small calibre nails can lead to shear movements due tolimited guidance of the implant to bone construct [44,46]. In ourbiomechanical testing, results show a comparable axial constructstability of the two implants with slightly higher stability in theRetrograde Tibial Nail group during the low and high axial loadingtests. Torsional stiffness tests resulted in far superior performancefor the RTN with absolute movement reduced to approximately athird of unreamed antegrade nailing. In literature, biomechanicalstudies investigating reamed vs. unreamed nailing in distal tibiafractures have shown torsional stiffness to be the greatestdifference between the two methods [47]. Our data suggests thattorsional stiffness of the RTN is comparable to reamed antegradetibial nailing [47].

There are some limitations to this biomechanical study.Artificial composite bones are not completely comparable tohuman bones. Their stiff mechanical properties most closelyresemble bones of young healthy adults. In elderly, osteoporoticpatients failure will most likely occur at lower values. However,biomechanical composite bones have also advantages and were

therefore chosen as a surrogate, since no biological variations exist,which might influence the comparability between samples.Additionally, the tests were performed on isolated tibiae. In aclinical setting, the fibula, which might be broken or be intact, willinfluence the stability of the construct and reduce interfragmen-tary movement. The mentioned assumptions on fat emboli andradiation exposure are currently based on conceptional ideas andwill have to be examined in detail in separate studies.

Conclusions

Until now no retrograde intramedullary implant has beenintroduced into daily clinical practice. The experimental RTNmeets the requirements of a minimally invasive surgical approach,with the ability of a secure fracture fixation pointing to advantagesover antegrade nailing. The outcome of this study suggests the RTNto be a promising new concept for the treatment of distal tibialfractures.

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