“A PROSPECTIVE STUDY ON CLINICAL, FUNCTIONAL AND

RADIOLOGICAL OUTCOME OF COMPOUND BOTH BONE

LEG FRACTURES MANAGED WITH VERSATILE

ANTIBIOTIC INTRAMEDULLARY INTER LOCKING

NAILING”

Dissertation Submitted to
THE TAMILNADU DR.M.G.R MEDICAL UNIVERSITY,
CHENNAI- 600032.
In partial fulfillment of the regulations for the
Award of the Degree of
M.S. (ORTHOPAEDIC SURGERY)
BRANCH –II
Reg no : 221712151

GOVERNMENT KILPAUK MEDICAL COLLEGE

THE TAMILNADU DR.M.G.R MEDICAL UNIVERSITY,
CHENNAI -TAMILNADU
MAY 2020
 CERTIFICATE-I
This is to certify that the dissertation entitled “A PROSPECTIVE STUDY ON

CLINICAL, FUNCTIONAL AND RADIOLOGICAL OUTCOME OF

COMPOUND BOTH BONE LEG FRACTURES MANAGED WITH

VERSATILE ANTIBIOTIC INTRAMEDULLARY INTER LOCKING

NAILING” is a bonafide work done by Dr. R. ANAND KUMAR, Post graduate in

M.S.ORTHOPAEDIC SURGERY., BRANCH-II at Government Kilpauk Medical

College, Chennai-600010, to be submitted to The Tamil Nadu Dr.M.G.R Medical

University, Chennai in partial fulfillment of the university rules and regulations for

the award of M.S.Degree Branch-II Orthopaedic Surgery, under my supervision and

guidance during the period from May 2017 to May 2020.

Prof.DR.S.VEERA KUMAR, Prof.Dr.P.VASANTHA MANI,

M.S.Ortho., MD, DGO. MNAMS. DCPSY, MBA,

Professor and HOD , DEAN,

Department of Orthopaedics, Govt. Kilpauk Medical College,

Chennai – 600 010.
Govt.Kilpauk Medical College,
Chennai-10
 CERTIFICATE - II

This is to certify that this dissertation work titled “A PROSPECTIVE

STUDY ON CLINICAL, FUNCTIONAL AND RADIOLOGICAL

OUTCOME OF COMPOUND BOTH BONE LEG FRACTURES

MANAGED WITH VERSATILE ANTIBIOTIC INTRAMEDULLARY

INTER LOCKING NAILING” of the candidate Dr. R. ANAND KUMAR

with Registration number 221712151 for the award of M.S degree in the branch

of ORTHOPAEDIC SURGERY. I personally verified the urkund.com website

for the purpose of plagiarism check. I found that the uploaded thesis file contains

from introduction to conclusion pages and result shows 1 percentage of

plagiarism in this dissertation.

Guide & Supervisor sign with Seal.

 DECLARATION

I solemnly declare that this dissertation “A PROSPECTIVE STUDY ON

CLINICAL, FUNCTIONAL AND RADIOLOGICAL OUTCOME OF

COMPOUND BOTH BONE LEG FRACTURES MANAGED WITH

VERSATILE ANTIBIOTIC INTRAMEDULLARY INTER LOCKING

NAILING” is a bonafide work done by me at Govt. Kilpauk Medical College and

Hospital, Chennai-10 during the period from May 2017 to May 2020 under the

guidance and supervision of my guide Prof.Dr.S.VeeraKumar, M.S.Ortho.,

Professor and HOD of Orthopaedics, Govt. Kilpauk Medical College and Hospital,

Chennai.

This dissertation is submitted to “THE TAMILNADU DR MGR MEDICAL

UNIVERSITY”, Chennai in partial fulfillment of the University regulations for the

award of degree of M.S. BRANCH II ORTHOPAEDIC SURGERY.

Date :
Place : Chennai Dr. R. ANAND KUMAR
 ACKNOWLEDGEMENT

I express my utmost gratitude to Prof.Dr.P.VASANTHA MANI,MD, DGO.

MNAMS, DCPSY, MBA, Dean, Government Kilpauk Medical College, Chennai, for

providing me an opportunity to conduct this study and for permitting me to use the

college and hospital facilities for my study to the fullest extent.

I would like to express my sincere thanks and gratitude to my beloved Chief

and Head of the Department, Prof. Dr. S.VEERA KUMAR, M.S.Ortho, Professor,

Department of Orthopaedics, Government Kilpauk Medical College, Chennai-10, for

allowing me to choose this topic and his valuable guidance to make this study a

successful one.

I would like to express my gratitude and reverence to my beloved Chief,

Prof.Dr.M.ANTONYVIMAL RAJ, M.S.Ortho., Professor of Orthopaedics,

Government Kilpauk Medical College, for his guidance and constant encouragement

during this study.

I wish to express my sincere gratitude and heartfelt thanks to Prof. Dr. S.

SENTHIL KUMAR, M.S. Ortho., D.Ortho., Prof. R. BALACHANDRAN, M.S.

Ortho., D.Ortho., DNB Ortho., Prof. Dr. R. PRABHAKAR, M.S. Ortho for their

encouragement.

I wish to express my sincere gratitude and heartfelt thanks to

Prof.Dr.R.Balachandran,M.S.Ortho.,D.Ortho.,Prof.Dr.R.Prabhakar,M.S.Ortho.,

Prof.Dr.V.Thirunarayanan, M.S.Ortho., for the encouragement.

 I am deeply indebted to my beloved Assistant Professors

Dr.M.ArunMozhiRajan, M.S.Ortho,

Dr.R.Prabhakar Singh, M.S.Ortho,

Dr.S.Prabhakar, M.S.Ortho., D.Ortho. DNB Ortho,

Dr.A.Anand, M.S.Ortho.,

Dr.V.Abhishek Venkataramani, M.S.Ortho,

Dr.S.Makesh Ram, M.S. Ortho, D.Ortho, DNB.Ortho,

Dr.G.Mohan, M.S.Ortho, Mch Ortho., DNB. Ortho, MNAMS,

Dr.R.KaruShanmugaKarthikeyan, M.S.Ortho, Mch Ortho,

Dr.R.Manoj Kumar, M.S.Ortho, for their valuable advice and support.

I wish to express my thanks to postgraduate colleagues, radiologist,

pathologist, blood bank medical officers, staff members, and theatre staff for the help

they have rendered.

I thank the Lord, All Mighty and I am eternally grateful to my

parents,brother and my wife for their unfaltering support.

I thank all the patients who wholeheartedly consented for the study for the

betterment of science without whom this study would not have been possible.
 ABBREVIATIONS

BP – Breaking Point
CT – Computed Tomography
AP – Antero Posterior
MIC – Minimum Inhibitory Concentration
RIA – Reamer Irrigated Aspirate
RTA – Road Traffic Accident
EDM – Electrical Discharge Machining
ROM – Range Of Motion
PMMA – Poly Methyl Meth Acrylate
VAIL – Versatile Antibiotic Inter Locking nailing
RUST – Radiological Union Score for Tibia
IMIL – Intra Medullary Inter Locking
ATLS – Advanced Trauma Life Support
DMPT – N,N-dimethyl-P-toluidine
S.NO CONTENTS PAGE NO

1. INTRODUCTION 1

2. AIM OF THE STUDY 2

3. REVIEW OF LITERATURE 3

4. REVIEW OF ANATOMY 6

5. 16
EFFECT OF ANTIBIOTIC MIXTURE AND BONE CEMENT

6. CLASSIFICATION OF COMPOUND FRACTURES 30

7. VARIOUS METHODS OF MANAGEMENT OF COMPOUND 42

FRACTURES

8. MATERIALS AND METHODS 54

9. 57
TREATMENT PROTOCOL

10. OBSERVATION AND RESULTS 66

11. COMPLICATIONS 78

12. DISCUSSION 79

13. CONCLUSION 81

14. BIBLIOGRAPHY

15. MASTER CHART

 INTRODUCTION

The incidence of compound fractures are on the rise in recent days due to

increase in motor vehicular accidents along with other high velocity injuries.

Tibial fractures are the most common long bone fractures in the body of which

25- 40% are compound tibia fractures. Because of the high prevalence of

complications associated with compound tibia fractures, management is often

difficult. Insufficient blood flow and lack of soft tissues in antero-medial aspect

of tibia predisposes compound fracture tibia to non-union and development of

infection. In compound fractures, where there is no significant bone loss and the

grade of wounds is borderline there is a considerable debate whether to go for

definitive primary internal fixation or staged procedures. External fixators in

compound fractures are only for soft tissue management, requiring secondary

definitive procedure for bony union and carries high risk for infection.31 External

fixator has many practical difficulties in terms of cumbersome surgical

techniques, poor patient compliance, Inability to weight bear with heavy fixators

and prolonged requirement of intravenous antibiotics which exert significant

negative effects due to their systemic toxicity. To overcome all these difficulties,

we attempted a novel way in preventing infection, antibiotic delivery and

definitive fixation in a single staged procedure.

1
 AIM OF THE STUDY

To study the clinical, functional and radiological outcome of compound

both bone leg fractures managed with Versatile Antibiotic Intramedullary

Interlocking Nailing system.

2
 REVIEW OF LITERATURE

In 1800 BC, Edwin Smith Papyrus from Egypt,reported that in an

compound fracture ‘‘Whenever there is a gaping wound(open fracture), such as

that inflicted by the mouth of a crocodile it should be covered with raw meat.’’32

Hippocrates (460-335 BC) used iron and steel in treating the wound that

did not progress.32

In 1500 BC, idea of removal of nonvital tissue from wounds was stated

by Brunschwig and Botello.

In 18th Century Pierre Joseph De Sault,3 coined the term Debridement,

rules of debridement and irrigation of open fractures.

During first world war, Alexander fleming observed that locally applied

antiseptics failed to sterilize chronically infected wounds, but they did reduce the

burden of bacteria.

Stader popularized external fixation in domestic animals external fixation

gained considerable popularity in the military during world war II.31

Roger Anderson in early 1960 used their external fixators for managing

open fractures.30

In 1970, Buchholz and Engelbrecht reported that penicillin,

erythromycin, and gentamicin incorporated into the cement used to attach total

hip joint prosthesis diffused out into the surrounding tissues over a period of

months, thereby providing prolonged concentrations of local antibiotic.36

3
 In 1972, Gustilo and Anderson observed reduction in infection rate in

internal fixation of open fractures and recommended delayed primary closure

for open wounds.

In 1979, Klemm formed gentamicin impregnated cement into beads and

used them to temporarily fill in the dead space created after the debridement of

infected bone.24

In 1980, Fisher and AO groups modified and popularized external

fixation.39

In 1996,Wininger DA, Fass RJ,used antibiotic impregnated cement and

beads for orthopedic infections.

In 1997, Lottes And Baubigne , managed open fractures with closed tibial

nailing.

In 1997, Pedro Antich-Adrover et al, did secondary intramedullary

nailing after external fixation in compound fractures.31

In 2000, J. F. Keatings et al. reported that reamed intramedullary nailing

is a satisfactory treatment for Gustilo grade-III tibial fractures.22

In 2000, Gopal et al , stated that IMIL nailing is preferable to external

fixation in compound tibial fracture and showed good results with primary flap

cover for grade III compound fracture.17

In 2004, Sudhakar G Madanagopal, David Seligson, Craig S Roberts,

used antibiotic loaded Kuntshner nail for infection after tibia nailing.37

4
 In 2014, Younis Kamal, Hayat Ahmad Khan, Naseem Ul Gani, Snobar

Gul, Ansar Ahmad Lone, Dara Singh, did Primary IMIL nailing upto Gustilo 3

A fractures.42

In 2016, Chandan Gupta, Dharam Singh, Sohal HS, Garg RS, Dipesh

Kumar managed compound fractures with external fixators.7

In 2016, Dr.Laishram Birendro Singh, Dr.I. Deven Singh , Dr. Ch.

Arunkumar Singh, managed open fractures of tibia by Ilizarov Technique.26

In 2016, John McMurtry and Varatharaj Mounasamy, used custom made

antibiotic tibia nail management of infected ununited tibial fractures.29

In 2016, Nuno Craveiro Lopes used SAFE dual core universal antibiotic

Nailing for management of open fractures.8

In 2017, C Bhatia,AK Tiwari, SB Sharma, S Thalanki, and A Rai, used

antibiotic loaded K nail for infective non union tibia.5

In 2019 Alberto Jorge-Mora, used commercially available antibiotic–

laden PMMA-covered IMIL tibia nails for the treatment of fracture-related

infection.2

5
 REVIEW OF ANATOMY

Tibia38

The Tibia lies medial to the fibula and is exceeded in length only by the

femur. Its shaft is triangular in section and has expanded ends, a strong medial

malleolus projects distally from the smaller distal end. The anterior border of the

shaft is sharp and curves medially towards the medial malleolus. Together with

the medial and lateral borders it defines the three surfaces of the bone. The exact

shape and orientation of these surfaces show individual and racial variations. The

expanded proximal end is a bearing surface for body weight, which is transmitted

through the femur. It consists of medial and lateral condyles, an intercondylar

area and the tibial tuberosity.

6
 The tibial condyles overhang the proximal part of the posterior surface of the

shaft. Both condyles have articular facets on their superior surfaces that are

separated by an irregular, non-articular intercondylar area. The condyles are

visible and palpable at the sides of the patellar tendon, the lateral being more

prominent. In the passively flexed knee the anterior margins of the condyles are

palpable in fossae that flank the patellar tendon. The fibular facet on the

posteroinferior aspect of the lateral condyle faces distally and posterolaterally.

The angle of inclination of the superior tibiofibular joint varies between

individuals, and may be horizontal or oblique. Superomedial to it the condyle is

grooved on its posterolateral aspect by the tendon of popliteus; a synovial recess

intervenes between the tendon and bone. The anterolateral aspect of the condyle

is separated from the lateral surface of the shaft by a sharp margin for the

attachment of deep fascia. The distal attachment of the iliotibial tract makes a

flat but definite marking, Gerdy’s tubercle, on its anterior aspect. This tubercle,

which is triangular and facet-like, is usually palpable. The anterior condylar

surfaces are continuous with a large triangular area whose apex is distal and

formed by the tibial tuberosity. The lateral edge is a sharp ridge between the

lateral condyle and lateral surface of the shaft.

7
Tibial tuberosity:

The tibial tuberosity is the truncated apex of a triangular area

where the anterior condylar surfaces merge. It projects only a little, and is divided

into a distal rough and a proximal smooth region. The distal region is palpable

and is separated from skin by the subcutaneous infrapatellar bursa. A line across

the tibial tuberosity marks the distal limit of the proximal tibial growth plate. The

patellar tendon is attached to the smooth bone proximal to this,its superficial

fibres reaching a rough area distal to the line. The deep infrapatellar bursa and

fibroadipose tissue intervene between the bone and tendon proximal to its site of

attachment.

8
Tibial Shaft:

The shaft is triangular in section and has anteromedial, lateral and

posterior surfaces separated by anterior, lateral (interosseous) and medial

borders. It is narrowest at the junction of the middle and distal thirds, and

expands gradually towards both ends. The anterior border descends from the

tuberosity to the anterior margin of the medial malleolus and is subcutaneous

throughout. The interosseous border begins distal and anterior to the fibular facet

and descends to the anterior border of the fibular notch; it is indistinct

proximally. The interosseous membrane is attached to most of its length,

9
connecting tibia to fibula. The medial border descends from the anterior end of

the groove on the medial condyle to the posterior margin of the medial malleolus.

Its proximal and distal fourths are ill defined but its central region is sharp and

distinct.

The anteromedial surface, between the anterior and medial borders, is

broad, smooth and almost entirely subcutaneous.

Distal end :

The slightly expanded distal end of the tibia has anterior, medial,

posterior, lateral and distal surfaces. It projects inferomedially as the medial

malleolus. The distal end of the tibia, when compared to the proximal end, is

laterally rotated. The torsion begins to develop in utero and progresses

throughout childhood and adolescence till skeletal maturity is attained.

Compartments

Anterior compartment:

The anterior compartment of the leg contains the tibialis anterior, extensor

digitorum longus, extensor hallucis longus, and peroneus tertius muscles. These

muscles are enclosed in a relatively unyielding compartment. The anterior tibial

10
artery and the deep peroneal nerve run deep to the muscles. Near the ankle, the

tendons of the tibialis anterior and extensor hallucis longus and extersor

digitorum longus are close to the tibia and may be injured by an open fracture of

entrapped by callus formed during fracture healing.

Lateral Compartment:
The lateral compartment contains two muscles, the peroneus brevis

and peroneus longus. Because of their origin from the proximal and middle of

fibula, they protect the fibula from direct injury. The superficial peroneal nerve

runs the between the peroneal muscles and the extensor digitorum longus.

11
Superficial Posterior Compartment:

The superficial posterior compartment contains the gastrocnemius, the

soleus, the popliteus, and the plantaris muscles. Sural nerve and the short and

long saphenous veins are also within this compartment, but there are no arterial

structures of significance. This compartment also serves as a source of local

muscle flaps for coverage of soft-tissue defects in the proximal and middle third

of the tibia.

12
Deep Posterior Compartment:

The deep posterior compartment contains the tibialis posterior, flexor

digitorum longus, and flexor hallucis longus muscles. The major neurologic

structure is the posterior tibial nerve. Two major arteries, are present in this

compartment. The posterior tibial artery, because of its protected nature,

frequently is the major arterial supply after a significant open fracture and is a

potential source for anastomosis with free flaps for soft-tissue reconstruction of

the leg.

13
Blood Supply

The proximal end of the tibia is supplied by metaphysial vessels from the

genicular arterial anastomosis. The nutrient foramen usually lies near the soleal

line and transmits a branch of the posterior tibial artery, the nutrient vessel may

also arise at the level of the popliteal bifurcation or as a branch from the anterior

tibial artery. On entering the bone the nutrient artery divides into ascending and

descending branches. The periosteal supply to the shaft arises from the anterior

tibial artery and from muscular branches. The distal metaphysis is supplied by

branches from the anastomosis around the ankle.

14
Innervation

The proximal and distal ends of the tibia are innervated by branches from

the nerves that supply the knee joint and ankle joint respectively. The periosteum

of the shaft is supplied by branches from the nerves that innervate the muscles

attached to the tibia.

Ossification

The tibia ossifies from three centres, one in the shaft and one in each

epiphysis. Ossification begins in midshaft at about the seventh intrauterine week.

The proximal epiphysial centre is usually present at birth at approximately 10

15
years, a thin anterior process from the centre descends to form the smooth part

of the tibial tuberosity. A separate centre for the tuberosity may appear at about

the 12th year and soon fuses with the epiphysis. Distal strata of the epiphysial

plate are composed of dense collagenous tissue in which the fibres are aligned

with the patellar tendon.

Effect of Antibiotic mixture and bone cement

Vancomycin:21

Vancomycin possesses activity against a broad spectrum of gram-positive

bacteria. Strains are considered susceptible at MICs of ≤2 µg/mL for S. aureus,

≤4 µg/mL for S. epidermidis, and ≤1 µg/mL for streptococci. Excreted

unchanged in kidney. Vancomycin was undetectable in urine after the tenth day

in local antibiotic delivery .

16
 Glycopeptides (vancomycin,teicoplanin) inhibit the synthesis of the cell

wall in sensitive bacteria by binding with high affinity to the d-alanyl-d-alanine

terminus of cell wall. It act by inhibiting bacterial cell wall synthesis. It is not

absorbed orally. After I.V administration it is widely distributed , penetrates

serous cavities, inflamed meninges and excreted by glomerular filtration with t

1/2 of 6 hours .

Adverse reactions :

• Skin allergy, thrombophlebitis and anaphylaxis

• Chills, rash, and fever may occur

• The extreme flushing that can occur is sometimes called “red-man”

syndrome. This is not an allergic reaction but a direct toxic effect

of vancomycin on mast cells, causing them to release histamine.

This reaction is generally not observed with teicoplanin.

• Ototoxicity is associated with excessively high concentrations of

these drugs in plasma (60-100 µg/mL of vancomycin in serum ), in

local vancomycin serum concentration will not rise above 20 µ/ml.

Evans et al,16 used 4 gms vancomycin with bone cement for 54

17
 periprosthetic joint infections. At 2 years follow up there were no renal,

vestibular or hearing changes. In report by Springer et al,35 vancomycin load of

10.5 gms and 12.5 gms of gentamycin was clinically safe , with no evidence of

acute renal efficiency or other systemic side effects.

VANCOMYCIN WITH BONE CEMENT

Y-Values

30

25

20
Vancomycin in Bone - µg/kg

15

10

0
0 5 10 15 20 25 30

Time in Months
In 1998, M. Chohfi et al,28 in his study mentioned that local

antibiotics vancomycin and gentamycin with PMMA cement, elution may last

upto to 18 months Vancomycin and Gentamycin have synergistic effect and

both does not affect osteoblastic activity and callus formation.Elution of

18
 Gentamycin is increased by vancomycin.Vancomycin upto 4 g and gentamycin

upto 80 mg per 20 gm bone cement will not affect property of bone cement

VANCOMYCIN WITH BONE CEMENT

Y-Values
20

18

16
Vancomycin In Blood µg/L

14

12

10

0
0 1 2 3 4 5 6 7 8 9 10

No of Days of Vancomycin In Blood

Chohfi M et al,28 in his study reported that, vancomycin levels in blood did not

exceed 2.9 mg/l (toxic level of vancomycin = 90 mg/l). Since vancomycin levels

in blood were below the toxic level ,there is no risk for systemic toxicity as

compared to intravenous vancomycin therapy.

19
 VANCOMYCIN WITHOUT BONE CEMENT

Y-Values
700

600
Vancomycin concentration in bone µg/g

500

400

300

200

100

0
0 1 2 3 4 5 6 7

Time in days

When vancomycin alone used without combining with bone cement elution

of antibiotic in intramedullary canal(bone vancomycin concentration ) last upto

6- 7 days only .6

20
 VANCOMYCIN WITHOUT BONE CEMENT

Y-Values

1400

1200

1000
Vancomycin level in muscle

800

600

400

200

0
0 20 40 60 80 100 120 140

Time in hrs
When vancomycin alone used without combining with bone cement elution

of antibiotic in muscle last upto 100 to 120 hrs only .6

21
Gentamycin:21

Gentamycin used for the treatment of many serious gram-negative

bacillary infections and active against Escherichia coli, Staphylococcus,

Klebsiella, Serratia, Proteus, Acinetobacter, Enterobacter, Pseudomonas,

Salmonella and Shigella . It binds to the prokaryotic ribosome, inhibiting protein

synthesis in susceptible bacteria. It is the aminoglycoside of choice because of

its lower cost and reliable activity against all but the most resistant gram-negative

aerobes. Gentamicin preparations are available for parenteral, ophthalmic and

topical administration.. Adverse effects are ototoxicity, nephrotoxicity and

neuromuscular blockade. Long term efficacy with persistency of antibiotic

within bone upto 2 years.

Tobramycin:21

The antimicrobial activity, pharmacokinetic properties, and toxicity

profile of tobramycin are similar to those of gentamicin. Tobramycin may be

given intramuscularly, intravenously or by inhalation. The superior activity of

tobramycin against P. aeruginosa makes it the preferred aminoglycoside for

treatment of serious infections known or suspected to be caused by this organism,

typically in combination with an antipseudomonal β-lactam antibiotic. In

contrast to gentamicin, tobramycin shows poor activity in combination with

penicillin against many strains of enterococci. Most strains of E. faecium are

highly resistant.

22
Streptomycin:

Streptomycin is a protein synthesis inhibitor. It binds to the small

16S rRNA of the 30S subunit of the bacterial ribosome, interfering with the

binding of formyl-methionyl-tRNA to the 30S subunit. Streptomycin is an

antibiotic that inhibits both Gram-positive and Gram- negative bacteria. The

dose of streptomycin is 15 mg/kg per day for patients with creatinine clearances

>80 mL/minute. Adverse reactions such as presence of pain, irritation, headache,

fever, blood pressure drop, disturbances in eighth cranial nerve, skin eruption,

albumin in urine

Teicoplanin:

Teicoplanin is a glycopeptide antibiotic.It is active against

methicillin-susceptible and methicillin-resistant staphylococci, which typically

have MICs of <4 µg/mL. The MICs for Listeria monocytogenes,

Corynebacterium spp., Clostridium spp., and anaerobic gram-positive cocci

range from 0.25-2 µg/mL. Nonviridans and viridans streptococci, S.

pneumoniae, and enterococci are inhibited by concentrations ranging from 0.01-

1 µg/mL. Some strains of staphylococci, coagulase positive and coagulase

negative, as well as enterococci and other organisms that are intrinsically

resistant to vancomycin (i.e., Lactobacillus spp. and Leuconostoc spp.), are

resistant to teicoplanin.

23
Colistin:

The antimicrobial activities of colistin is restricted to gram-

negative bacteria, including Enterobacter, E. coli, Klebsiella, Salmonella,

Pasteurella, Bordetella,and Shigella, which usually are sensitive to

concentrations of 0.05-2 µg/mL. Most strains of P. aeruginosa and Acinetobacter

are inhibitedby <8 µg/mL in vitro. Proteus and Serratia spp. are intrinsically

resistant. These poly-cationic regions interact with the bacterial outer membrane,

by displacing bacterial counter ions in the lipopolysaccharide.

Hydrophobic/hydrophillic regions interact with the cytoplasmic membrane just

like a detergent, solubilizing the membrane in an aqueous environment.

Other thermostable antibiotics commonly used are Cefazolin,

Cefotaxime, Clindamycin, Amphotericin B and Ticarcillin.

Antibiotic sensitivity test done before surgery in all cases.

24
 We followed systemic antibiotic therapy based on Cross ww et al.9

treatment principles in the management of open fractures. Indian J Orthop. 2008.

Clinical
Fracture
Infection Antibiotic Of Choice Antibiotic Duration
Type
Rates

Every 8 Hours Three

1 1.4 Cefazolin
Doses

Piptaz Or Cefazolin And Continue For 24 Hrs

2 3.6
Tobramycin after wound closure

Piptaz Or Cefazolin And

3a 22.7 Tobramycin +Penicillin For 3 Days
Anaerobes

Piptaz Or Cefazolin And

10- Continue For 3 Days
3b Tobramycin +Penicillin For
50% after wound closure
Anaerobes

Piptaz Or Cefazolin And

10- Continue For 3 Days
3c Tobramycin +Penicillin For
50% after wound closure
Anaerobes

25
Ulinastatin:12

Ulinastatin (Urinary Trypsin Inhibitor) is a kind of protease inhibitor

extracted from human blood and urine. It is cleaved from the larger inter-α-

trypsin inhibitor molecule by neutrophil elastase in the presence of

inflammation.

Ulinastatin inhibits inflammatory markers: trypsin, pancreatic elastase,

polymorphonuclear leukocyte elastase and interleukin 1, 8 and 6. It inhibits

coagulation and fibrinolysis and promotes microperfusion. It is an effective

agent for immune modulation to prevent organ dysfunction and promote

homeostasis. Dosage: 200,000 I.U. iv BD for 5 days. Administration: Its

reconstituted in 100 ml of dextrose 5% or 100 ml of 0.9% normal saline by

intravenous infusion over 1 hour each time.

Bone cement :23

Bone cements are orthopaedic acrylic sterile cements that allow

stable fixation of surgical implants into the bone. They are basically spacer used

26
to fill gap between implant and the bone .PMMA bone cements are offered as

two-component systems powder and liquid. The polymer powder component

consists of PMMA and/or methacrylate copolymers. Additionally, it contains

benzoyl peroxide (BPO) as initiator of the radical polymerization being included

in the polymer beads. The powder also contains a radiopacifier and optionally an

antibiotic. In the liquid phase, methyl methacrylate is the main ingredient and

sometimes other methacrylates such as butyl methacrylate also used. In order to

be used for bone cements the methacrylates must be polymerizable. As a pre-

condition for that they must bear a C=C double bond. As an activator for the

formation of radicals the liquid contains an aromatic amine, such as N,N-

dimethyl-p-toluidine (DmpT). Additionally, it contains an inhibitor to avoid

premature polymerization during storage and optionally a colouring agent. The

addition of antibiotics to acrylic bone cement was started as early as 1969. The

property of elution of acryclic polymers from bone cement, gave them the idea

that antibiotics agents might also be released as well. The elution of antibiotics

depends not only on the properties of the bone cement but also on the amount

incorporated in the bone cement. It is surprising that not only the amount of

antibiotics results in better elution properties but also the combination of

antibiotics. In the presence of clindamycin, the elution of gentamicin is much

better in contrast to the application of gentamicin alone

27
 Bone cements are composed of two components

1) Powder (polymer)

• Polymethyl methacrylate

• Benzyl peroxide - initiates polymerization

• Barium sulphate – Radioopacifier

• Gentamycin sulphate 2 %

2) Liquid (monomer)

• Methyl methacrylate

• Butyl methacrylate

• N, N dimethyl p-toluidine - promotes cold curing of the

finished therapeutic compound

• Hydroquinone - prevents premature polymerization. Sterilized

by beta radiation

Antibiotic agents that are heat stable can be used with bone cement and

active against suspected pathogen are appropriate choices for local therapy.

Amino glycosides and vancomycin satisfy these criteria.

28
 Fluroquinolones, tetracycline and polymyxin B, are broken down during

the exothermic process of cement hardening, hence cannot be used with bone

cement.

Ideal quality of antibiotic in bone cement:14,23

• Heat stable

• Broad spectrum of activity

• Less side effects

• Low frequency of emerging resistances

• Cost effective

• Low protein binding

• No interaction with the soft tissues

• No interaction with PMMA or during polymerisation

• No effect on the mechanical property of the bone cement

• Good release from polymerised bone cement.

29
 METHODS OF CLASSIFICATION

A) Grading system – focus on severity of limb injury only

• Gustilo and Anderson

• Tscherne and Gotzen,

• Byrd and Spicer

B) Scoring System – focuses on limb injury and general health, also give

‘Amputation score’.

• Mangled Extremity Severity Score (MESS),

• The Nerve Injury, Ischemia, Soft-Tissue Injury, Skeletal Injury, Shock,

and Age of Patient Score (NISSA),

• Limb salvage index score,

• Predictive salvage index score.

C) Comprehensive System – combines the above two systems

• AO system ,

• Ganga hospital score

30
 CLASSIFICATION OF COMPOUND FRACTURES

In History of orthopaedics, first compound fracture classification was

proposed by Veliskakis. He treated 80 patients with open fractures in the

Derbyshire Royal Infirmary (Derby, England) and published his work in 1959 in

New York. He divided the fractures in 3 categories depending on the:

• Size of the injury

• Skin involvement

• Muscle involvement

Veliskakis classification of open fractures(1959):

Puncture wound about one inch in length

Grade I
with no loss of skin.

Larger wounds over an inch in length with

Grade II contusion of the adjacent skin of variable
degree.

Severe crush injury with extensive damage

Grade III
to the skin and muscles.

Based On Veliskakis classification,40 Gustilo and Anderson proposed his first

classification on 1976 based on:

• Wound size

• Soft tissue involvement

• Osseous involvement

31
Gustilo and Anderson Classification (1976)

Grade 1 : Clean wound <1 cm in diameter, minimal soft

Tissue injury.

Grade 2 : laceration >1 cm, moderate soft tissue injury, moderate

contamination.

Grade 3 : laceration > 10 cm , extensive soft tissue injury ,high

contamination

Special categories gun shot injuries ,farm yard injuries

Gustilo and Anderson Modified his classification in 198418 and subdivided into

grade 3 A,B,C

32
 1984 Modification is Based on

• Wound Size

• Soft Tissue Injury

• Periosteal Stripping

• Vascular Injury

Grade 3 is further subdivided into:18

Grade 3 A: open fracture with extensive soft tissue laceration or

flaps(7%) risk of infection, but maintain adequate soft tissue cover /high energy

wound irrespective of their size.

Grade 3 B : open fractures with extensive soft tissue damage(10- 50 %)

risk of infection, periosteal damage and bone exposed,massiveley

contaminated.

Grade 3 C: open fractures with arterial injury (25-50% infection),

regardless size of wound.

33
Advantages:

• Easy to interpret

• Can able to determine prognosis

• Used to categorize patients in emergency room fastly

Limitations of Gustilo Anderson classification:33

• Interobserver variability

• Surface injury does not always reflect the amount of deeper tissue

damage

• Limb salvage not able to decide

• All long-bone open fractures were included despite different bones

inherently having different risks of infection owing to their particular

34
 soft tissue envelope.

• Type III B injuries imposes inherent difficulty in using this classification

to predict which injuries need a muscle flap for coverage

• Lacks the ability to comprehensively measure prognostic patient

outcome.

• Because open fractures may be under classified on initial evaluation in

the emergency department accurate assessment of an open fracture is

best accomplished in the operating room after surgical exploration and

debridement

35
TSCHERNE CLASSIFICATION OF OPEN FRACTURES 19

Typical fracture
Grade Typical soft tissue damage
patterns/injuries

Fractures resulting from Skin laceration, none to

1
indirect trauma minimal

Skinlaceration,circumferential
Fractures resulting from
2 contusions,moderate
direct trauma
contamination

Comminuted fractures, Extensive, major vascular

3 farming injuries high- and/or nerve damage;
velocity gunshot wounds compartment syndrome

Subtotal and complete Extensive, major vascular

4
amputations and/or nerve damage

This system includes compartment syndrome which is not included in other

grading systems

THE AO-ASIF GROUP

This added to their extensive fracture classification and a soft-tissue

classification that closely follows that of Tscherne system.This classification

includes

• Closed injuries (C),

• Open (O) injuries,

• Muscle tendon injury (MT),

• Neurovascular injury (NV).

36
Scale AO-ASIF Soft-Tissue Injury Classification

1 Normal (except open fractures)

2-4 Increasing severity of lesion

5 special situation

Skin Lesions (Closed Fractures)

IC 1
No skin lesion

IC 2 No skin laceration, but contusion

IC 3 Circumferential degloving

IC 4 Extensive, closed degloving

IC 5 Necrosis from contusion

Skin Lesions (Open Fractures)

IO 1
Skin breakage from inside out

IO 2 Skin breakage <5 cm, edges contused

IO 3 Skin breakage >5 cm, devitalized edges

Full-thickness contusion, avulsion, soft-tissue

IO 4 defect, muscletendon
Injury

37
Muscle Tendon injury:

T1 No muscle injury

MT2 Circumferential injury, one compartment only

MT3 Considerable injury, two compartments

MT4 Muscle defect, tendon laceration, extensive contusion

MT5 Compartment syndrome/crush injury

Neurovascular Injury:

NV11 No Nerve Injury NEUROVASCULAR INJURY

NV2 Isolated nerve injury

NV3 Localized vascular injury

NV4 Extensive segmental vascular injury

Combined neurovascular injury, including subtotal or

NV5
complete Amputation

38
Ganga hospital open injury severity score:34

A score to prognosticate limb salvage and outcome measures in Type III B open

tibial fractures:

Components:

1. Covering Structures : Skin and Fascia (1-5)

2. Skeletal Structures : Bone and Joints(1-5 )

3. Functional Tissues : Musculotendinuous and nerve units (1-5)

4. Co-morbid Conditions : 0-14

1 .Covering structures skin and fascia:

Not over the fracture

Wounds with out skin 1

loss

exposing the fracture 2

Not over the fracture 3

Wounds with skin loss

Over the fracture 4

Circumferential wound with skin loss 5

39
2. Skeletal Structures:

Transverse /oblique fracture /butterfly fragment 50%

1
circumference

Large butterfly fragmment > 50 % circumference 2

Communition /segmental fractures without bone loss 3

Bone loss <4 cm 4

Bone loss >4 cm 5

3. Functional Tissues: Musculotendinuous & Nerve Units:

Partial Injury to musculotendinous unit 1

complete but repairable injury to musculotendinous unit 2

Irrepairable injury to musculotendinous unit /partial loss

3
of compartment of musculotendinuous unit

Loss of one compartment of musculotendinous unit 4

Loss of two or more compartment /subtotal amputation 5

40
4. co-morbid condition 2 points for each:

Injury Debridement interval > 12 hrs

Sewage or organic contamination /Farmyard injuries

Age > 65 yrs

Drug dependent diabetes /cardio respiratory diseases leading to

increased anaesthetic risk

Polytrauma involving chest or abdomen with ISIS>25/embolism

Hypotension with systolic blood pressure <90 mm hg at

presentation

Another major injury to same limb/Compartment

Total score 14 used to predict salvage and high specificity and sensitivity for

Amputation .

• Minimum score : 0

• Maximum score :29

Limitations :

• Interpretation is tough

• Because of complexity of interpretation introduced new application in

Android /IOS

41
Various methods of management of compound fractures :

1. External fixator

i. Uniplanar

ii. Biplanar (V.fix)

iii. Multiplanar

2. Ilizarov external fixator

3. Intramedullary nailing

4. Antibiotic nailing

Antibiotic V or K nail

VAIL Nail

1) External Fixator :

External fixator is a device used for “stabilization and immobilization of long

bone open fractures

Types of Frames:

Type 1: Unilateral

1a: unilateral uniplanar

1b: unilateral biplanar

Type 2: Bilateral

2a: bilateral uniplanar

2b:bilateral biplanar

Type 3: Modular external fixator

42
 Advantages:

• shorter operating time

• less blood loss

• good stability

Disadvantages:7

• infections

• malunion

• pin site infections

• shortening /non union

• will require secondary definitive procedure for bone healing.

V- Fix: (Versatile External Fixator):13

Bilateral biplanar external fixator.

Can correct rotational deformity in three planes

43
Advantages :

• Can be converted to uniplanar also if needed

• Has property of interfragmentary compression

• Provide axial compression healing can be achieved

Versatile External Fixator

Ilizarov Fixator:26

Invented by Prof Gabriel Abramovitich Ilizarov, gold standard in

managing wounds with bone loss, deformity correction.

Principles of Ilizarov:26

• Law of tension stress

• Distraction osteogenesis

• Mechanical induction of new bone formation

• Neovascularization

• Activation of recruitment of progenitor cells

44
 • Intramembranous ossification

Advantage

• Faster bone union

• Fractures with bone loss also can be managed

• Early mobilisation

• Cylindrical shape of the fixator allows correction of deformities in three

dimension.

• Minimally invasive as the wires fix the frames

• Patient remains mobile throughout the course

Disadvantages

• Poor patient compliance

• Cumbersome procedure

• Pintract infections

• Muscle contracture

• Joint stiffness

45
 • Long learning curve

• Depressive status

• Suicidal tendency

Intramedullary Nailing:1,42
Usage of intramedullary nailing in management of compound fractures is

still contentious .

Reamed intramedullary nailing is associated with high chances of

infection/non union. Unreamed nailing may compromise stability in fracture site.

Intravenous antibiotics concentration is low at fracture site because of

compromised vascularity.

Antibiotic Loaded V or K Nail:

• Only control of local infection.

• No fracture healing due to rotational instability.

46
 • Requires a secondary definitive interlocking nailing for union after

infection control.

Advantage :5

• Cost effective

• Less operative time

• Same portal of entry as regular tibia nail

Disadvantage:5

• No interlocking screws, so rotational stability compromised

• High incidence of non union and Implant failure

• Chance of nail migration of nail into joints

• Non weight beraing till evidences of bony union

• May require secondary definitive procedure after infection control for

bony union.

• Risk of instability due to overeaming.

47
VAIL Nail (Versatile Antibiotic Interlocking Nail):

Holes are made in VAIL Nail by method known as Electrical discharge

machining (EDM) or spark machining, In this method desired shape is obtained

by using electrical discharges.

Moreover, while EDM is technically a stress-free machining process

since no direct mechanical force is applied to the workpiece. The principle

advantages of EDM are that the process is very predictable, accurate and

repeatable

There’s no cutting pressure on adjacent sides of nail while preparing VAIL

Nail in this method.main advantage of EDM over other method of preparation

is less chance of nail breakage and nail bending.

48
 VAIL nail preparation by EDM method.

We use stainless 316 L nail for VAIL nail preparation.

VAIL Nail stability test report

There is no significant difference in stability of VAIL Nail ,in terms of tensile

strength and yield strength as compared to regular 316 L IMIL Nail.11

49
Advantages of VAIL Nail:

• Small learning curve

• High local concentrations of antibiotic 200 times greater than systemic

drug delivery.14

• Antibiotics level above the minimal inhibitory concentration of sensitive

organisms.

• Post operative morbidity is less and early weight bearing due to its

inherent stability.

• Long stay in hospital is avoided hence less chances of hospital acquired

infections.

• Antibiotic concentration at source of infection is not dependent on the

pharmacokinetics of the antibiotic.28

• No chance of nail migration into joints

• Soft tissue procedure like SSG/flap cover are made easy by this method.

• Greater surface area of elution of antibiotics allows for higher local

antibiotic concentration along entire length of the bone treated.

• Good local concentration of antibiotic even in compromised vascularity

are the advantages over intravenous antibiotic therapy.

• Painful inflammatory response subsides rapidly.daily dressing not

required, as wound is closed.

• Has all the comforts that we have in regular intramedullary nailing.

50
RADIOLOGICAL ASSESSMENT

RUST SCORE25(The radiographic union score for tibia)

It was developed by Whelan et al,to assess the healing of tibial fractures

following intramedullary nailing. Managing tibial fractures by IMIL nailing has

been shown to have good results ,but no predictable criteria for assessment of

radiological bony union . RUST Score, was developed to standardise the

radiological assessment of tibia fractures .RUST Score calculated after taking

Antero posterior and Lateral radiographs during follow up of patient.

Fracture line visible,no callus, Fracture line visible,callus

RUST score =1 present,RUST score=2

Fracture line still visible,bridging Fractutre line not visible with

callus present,RUST score:3 bridging callus,RUST score:3

51
 score interpretation

4 Fracture not Healed

7 or above Fracture Healing

12 Fully united

Score per cortex Fracture line

Callus

1 Absent Visible

2 Present Visible

3 Present Invisible

X ray Knee with leg (AP view )

52
X ray knee with leg (Lateral view)

RUST SCORE 25

Cortex Visible Visible No fracture Total score

fracture line fracture line line with Minimum=4

without with Visible Maximum:12

callus(1) callus(2) callus(3)

Lateral

Medial

Anterior

Posterior

53
 MATERIALS AND METHODS

Study topic : A Prospective study on clinical, functional and radiological

outcome of Compound Both Bone leg fractures managed with Versatile

Antibiotic Intramedullary Interlocking Nailing

Study Venue :

Department of Orthopaedics,

Govt.Kilpauk Medical College and Hospital,

Chennai

Sample Size : Twenty four

Data Collection : Data collected as per proforma with consent from the patients

admitted in Orthopaedic ward, Govt.Kilpauk Medical College and Hospital.

Duration of study: 1 year

Type of study : Prospective study

54
IMPLANTS

• Versatile Antibiotic interlocking tibia nail,

• Interlocking nail instrumentation set.

• Others

• Bone cement 20 grams,

• Vancomycin 4 grams,

• Gentamycin 80 mg.

55
INCLUSION CRITERIA

1. Compound fractures(Grade 1,2,3 A,3 B )

2. Both sex

3. Age:18 yrs -60 yrs

EXCLUSION CRITERIA

1. Age less than 18 years & >60 years

2. Pathologic fractures

3. Previous trauma to same limb with existing deformity

4. Segmental fractures

56
 TREATMENT PROTOCOL

On receiving the patients in Trauma casualty, we resuscitated them

according to ATLS guide lines. After haemodynamic stabilization patient were

examined for associated injuries, injection Tetanus Toxoid , anti gas gangrene

serum 25000 i.u,40 intra muscularly 3 doses 4 to 6 hourly interval and

immunoglobin was given to all of the patients. All the patients were given 2gm

of cefotaxime (After test dose) at admission. Inj.diclofenac and Inj. tramadol

were used for pain relief.

After temporary stabilization with Thomas splint /AK splint / Kramer

wire splint wound was inspected and grading done according to Gustilo and

Anderson classification. Plastic surgeon opinion was obtained for all patients

initially.

If the wound is clean, saline and betadine wash is given .Then sterile dressing,

above knee slab applied.

If the wound is contaminated with external dirt, preliminary wound debridement

was done.

57
 Type of Irrigation methods
wound

Type 1 3 Litre Normal Saline With Liquid Castle Soap Additive Only

Type 2 6 Litre Normal Saline With Liquid Castle Soap Additive Only

9 Litre Normal Saline With Liquid Castle Soap Additive Only .

Type 3 A to C Highly Contaminated Wound Benefit From Antibiotic In Irrigation
Solution

After resuscitation, patient were subjected to blood investigation. Antero-

posterior (AP) and lateral x-rays including knee and ankle were taken for the

involved limb . screening x-rays were taken to rule out associated injuries . CT-

brain and ultra-sound was taken if necessary .

Patients were shifted to operation theatre after anesthesiological

assessment. Second dose of Inj. cefotaxime was given to all of the patients in

operation theatre. Dressing was opened and limb was prepared for surgery.

Thorough wound debridement was done layer by layer after adequate extension

of the wound. Fracture ends were debrided, thorough wound wash given with

Reamer Irrigation Aspiration system (RIA).

58
 Fracture reduced and edges freshened. Loose fragments which were

smaller and without soft tissue attachments were removed. Fragments with soft

tissue attachments were retained as much as possible. After thorough

debridement the wound grading was done as per Gustilo and Anderson method.

Plastic Surgeon’s opinion was sought for five cases during surgery. After

ensuring thorough debridement, fracture was stabilized with Primary Versatile

Antibiotic interlocking Nailing System.

All Grade II wounds were closed primarily after adequate wound debridement.

All Grade III wounds were closed primarily or split skin grafting/Flap cover

based on the nature and extent of wound.

59
 SURGICAL METHOD

Position: Supine Position

Anaesthesia: Spinal anaesthesia

Approach: Anterior Patellar Tendon Splitting Approach

Definitive surgical fixation includes 3 steps:

1. Preparation of Intramedullary Canal

2. Preparation of Antibiotic Bone Cement

3. Preparation of VAIL Nail

Skin incision is extended about 3cm proximal to the tibial plateau at the

anterior aspect of the left knee

Patella tendon is incised longitudinally in line with the medullary cavity

Entry Point:

60
 In the frontal plane: in line with the medullary canal (3 mm medial of the

tibial crest)

In the sagittal plane: just distal to the angle between tibial plateau and

anterior tibial metaphysis

Solid curved awl is used to create an entry point for nail.

Fracture is reduced and ball-tipped guide wire is inserted

Medullary cavity is reamed starting from smaller size reamer. Medullary

cavity should be reamed 1 size larger than the intended nail.

Tissue protector is used during reaming procedure

61
Preparation of antibiotic bone cement:

20 gram standard viscosity bone cement is taken in a bowel, liquid

monomer and powder polymer are mixed up in separate container .

Vancomycin 4 g and 80 mg gentamycin are mixed in seperate bowl and

10 to 15 gms of bone cement is added to the antibiotic bowl and stirred up .

62
 The mixing and manipulation process should be at least 4 minutes. The

completion of polymerisation occurs with an exothermic reaction with

considerable liberation of heat. once the bone cement reaches its doughy

consistency,it is ready to incorporate into VAIL Nail.

Preparation of VAIL Nail:

Appropriate size VAIL Nail, chosen, after trial nailing , because once

VAIL Nail incorporated with bone cement,nail cannot be changed .

63
 Incorporation of antibiotic bone cement into VAIL Nail can be done by 2

methods

1) Hand mixing cement and placing antibiotic cement inside VAIL Nail

manually with hand

2) Incorporating antibiotic bone cement with cement gun

After incorporation of bone cement into VAIL Nail, it is allowed to set

for 15 minutes before insertion for the monomer to evaporate and to prevent

cement nail debonding.

VAIL Nail, is inserted with help of jig, distal two screws are fixed by free

hand technique and Proximal dynamic/static screws or both decided based on the

level of fracture and fixed through jig.

Post Operative Protocol:

• Inj.Cefotaxime 2g iv bd and inj.metronidazole 500 mg is

administered during the first 24 to 48 hours after surgery until the

results of culture and sensitivity obtained.

• Inj Ulinostatin 2 lakh I.U 11 IV bd for 5 days used .

• Periodic dressings as by primary wound status or post coverage

status.

• All patients were discharged after suture removal

• On case to case basis , If there is good reduction ,fracture stability

patient encouraged to do full weight bearing.

• The patients were followed until there were no evidence of further

infection.

64
 • In patients with knee stiffness knee mobilisation exercises was

encouraged earlier .

Follow-Up

All patients are advised

• Static/Dynamic quadriceps strengthening exercise & knee mobililsation

exercise started immediately in post operative period.

• Suture removal on 12th day.

• Monthly follow-up for first 3 months and 6 ,9 months

Each follow-up patient were examined for

• Knee / Ankle pain

• Tenderness at the fracture site

• Signs of infection, range of joint motion

• Radiological assessment of union by RUST criteria

For cases with no signs of union

Alternative Methods :

1. Dynamisation

2. Exchange Nailing

3. Bone Grafting

65
 OBSERVATION AND RESULTS

Table 1 :Distribution of study participants based on age

Frequency Frequency Percent

11 11 45.8

11 11 45.8

2 2 8.3

24 24 100.0

Majority of population are between the age group of 20 to 60 yrs .

50
45.8 45.8
45

40

35

30

25

20

15

10 8.3

0
20-40 41-60 >60

age distribution

66
Table 2 : Distribution of study participants based on gender

Frequency Percent

Female 2 8.3

Male 22 91.7

Total 24 100.0

Majority of patients in our study with compound tibia fractures are belonged to
male sex.

Gender

male
8%

female
92%

67
Table 3: Distribution of study participants based on side of fracture

Frequency Percent

Right 9 37.5

Left 15 62.5

Total 24 100.0

In our study, left sided fractures are more than right

side of fracture

right
37%

left
63%

68
Table 4: Distribution of study participants based on site of fracture

Frequency Percent

Proximal 6 25.0

Middle 9 37.5

Distal 9 37.5

Total 24 100.0

Majority of fractures in middle and distal third of tibia.

site of fracture

proximal
distal 25%
38%

middle
37%

69
Table 5: Distribution of study participants based on Gustilo Anderson score

Frequency Percent

Grade 2 14 58.3

Grade 3A 5 20.8

Grade 3B 5 20.8

Total 24 100.0

The Gustilo Anderson score is Grade 2 in majority of the cases

Gustilo Anderson grade distribution

70

60

50

40

30

20

10

0
Grade 2 Grade 3A Grade 3B

70
Table 6: Distribution of study participants based on time delay in surgery

Frequency Percent

< 24 hrs 19 79.2

>24 hrs 5 20.8

Total 24 100

Majority of the cases were operated within 24hrs of fracture

Time delay in surgery

80

70

60

50

40

30

20

10

0
<24 hrs >24hrs

71
Table 7: Distribution of study participants based on Rust score

Frequency Percent

4 1 4.3

8 4 17.4

10 10 43.5

12 8 34.8

Total 23 100

Majority had rustic score of 10 ie 43.5% followe by 34.5 % had score 12

RUST score distribution

45

40

35

30

25

20

15

10

0
4 8 10 12

72
Table 8 :Associated Injuries / Fractures

Fractures / Injuries No. Of Patients

Head injury Nil
Pelvis injury Nil
Distal radius # 1
Metatarsal # 1
Tibial plateau # 1
Fibula #
1) Fixed 2
2) Not Fixed 22

Along with VAIL Nail,we fixed 2 cases of distal fibula fracture with plating to

prevent ankle joint instability.

Associated Injuries / Fractures

Fibula # not fixed

Fibula # fixed

Tibial plateau #

Metatarsal #

Distal radius #

Pelvis injury

Head injury

0 5 10 15 20 25

73
Table 9. Fracture Pattern

Pattern No of cases

Transverse 4
Oblique 14

Communited 6
Segmental Nil

Majority of fracture pattern observed was Oblique

Pattern of Fractures
Transverse Oblique Communited Segmental

0%
17%
25%

58%

74
Table 10. Distribution based on Follow up

Frequency Percent

Loss to follow up 1 4.2

Followed up 23 95.8

Total 24 100.0

In our study one patient lost follow up .

Follow up of participants

Lost follow up Followed up

4%

96%

75
Table 11. Distribution study population based on post op wound status

Infection rate Frequency Percent

Superficial infection 2 8.5

Deep infection 2 8.5

Nil infection 20 83

24 100.0

In our study 20 patient does not have any post operative infection

post operative infection status

90

80

70

60

50

40

30

20

10

0
no infection superficial infection deep infection

76
Table 12: Association between Post op infection and Time delay in surgery

Post op infection
Time delay in
P value
surgery
0 1 2

12 hrs 7 0 0 0.008

16 hrs 1 1 0

24 hrs 9 0 1

36 hrs 2 1 1

48 hrs 0 0 1

TOTAL 19 2 3 24

In our study, there is a significant association between the time delay of surgery

and post operative infection with p value 0.008 . lesser the time delay of surgery

better the infection control rate. In our study, average time from admission to

surgery was 20.9 hours.

77
 COMPLICATIONS

In our study, out of 24 cases only four cases developed

infection, out of four cases 2 case had superficial infection and 2 cases has deep

infection. Superficial infection settled with regular dressing and sensitive

systemic antibiotics and exchange nailing done for deep infection. Another

patient had nail breakage and subsequent exchange nailing done.

78
 DISCUSSION

In early 1960 external fixator have been used for managing compound

tibia fractures.30 It requires secondary procedure for bony union and risk of pin

site infections, joint stiffness and malunion.Reamed/unreamed intramedullary

nailing1,22 are also used in managing compound fractures .It is associated with

higher degree of infection and wound healing problems .

In 2017, C Bhatia et al,5 used antibiotic coated nailing for compound

fractures, overreaming of medullary canal and smaller size nail jeopardize the

implant stability in it .In our study we aimed for preventing infection, perennial

antibiotic delivery and bony union in a single stage.

As VAIL Nailing is a definitive single staged procedure, risk of mutilple

surgeries is avoided and prolonged duration of systemic antibiotics can be

minimized. Immediate weight bearing and early mobilisation allow the patient

to carry out their day to day activities and most of them returned to their pre

injury work earlier compared to other procedures .VAIL Nail traverses entire

medullary canal and enables a more effective delivery of antibiotics.VAIL Nail

provide more intimate contact with the medullary canal,hence more elution of

antibiotics to endosteal surface. It is inserted through same portal of entry as the

regular IMIL nail.

Local Antibiotic delivery was found to be useful and safe component in

the armamentarium of managing compound fractures and infections . In 1978,

79
the safety of local antibiotic therapy has been well documented by Wahlig H et

al,41 main advantage of local antibiotic therapy is high local antibiotic

concentration that could not be safely achieved with systemic antibiotics. In

1993, Evans RP et al,15,16 stated that by combining wound debridement with

antibiotic cement and systemic antibiotics 100 % infection may be prevented.

Irrespective of the usage of antibiotic bone cement in compound fractures

, primary extensive wound debridement always plays a vital role in reducing

the chance of infection.In our study VAIL Nail is designed in such a way that,

the mechanical strength is barely compromised when compared to fully

coated(external coating)antibiotic nail , as the size of the nail is not reduced due

to overeaming.

In our study, in 2019 duration of bony union was significantly shorter as

well as overall complication were significantly lower when compared to other

procedure like secondary nailing followed external fixation and antibiotic coated

(external coating only)nail.

80
 CONCLUSION

We have operated 24 cases of compound tibia fractures (Grade 2,3A,3B)

with VAIL Nailing. All cases showed significant improvements as evaluated by

wound healing, progressive callus formation & radiological union in monthly

follow up.

By VAIL Nailing we can mobilise the patient earlier and put the patient

on his toes as soon as possible.

In our study, patient who underwent surgery within 24 hrs of admission

had good functional outcome, wound healing and good bony union.

The final outcome in our study mainly depended on wound debridement

and thorough pulsatile lavage and early intervention (VAIL Nailing), earlier the

surgery better the outcome.

VAIL Nailing ,till now given promising solution in management of

compound fractures in our study. Further improvement and studies will

definitely bring better outcome. Prophylactic primary antibiotic nailing in all

compound fractures will decrease mortality, morbidity and economic burden to

the patient.

81
 Case Illustration :

case 1

32/F, Alleged with RTA (2W vs 4W) and sustained injury to left leg.

Procedure : VAIL Nailing with flap cover

Pre Op X ray AP/LAT

6 Months Follow Up AP/LAT

1 Year Follow Up AP/LAT

case 2

20/M, Alleged with RTA (2W vs 4W) and sustained injury to left leg.

Procedure : VAIL Nailing with split skin graft.

Pre Op X ray AP/LAT

6 Months Follow Up AP/LAT

1 Year Follow Up AP/LAT

Case 3

54/M, Alleged with RTA (2W vs 2W) and sustained injury to right leg.
Procedure : VAIL Nailing with primary wound closure.
Pre Op X ray
AP/LAT

6 Months
Follow Up
AP/LAT

1 Year Follow
Up AP/LAT
Case 4

28/F, Alleged with RTA (2W vs 2W) and sustained injury to right leg.

Procedure : VAIL Nailing with Split skin grafting.

Pre Op X ray AP/LAT

6 Months Follow Up
AP/LAT

1 Year Follow
Up AP/LAT
Case 5

58/M, Alleged with Self Fall and sustained injury to left leg.

Procedure : VAIL Nailing with primary wound closure.

Pre Op X ray
AP/LAT

6 Months Follow Up
AP/LAT

1 Year Follow Up
AP/LAT
 BIBLIOGRAPHY

1. A. C. Fairbank et al, stability of reamed and unreamed intramedullary

tibial nails: a biomechanical study, pmid7493789doi10.1016/0020-

1383(95)00056-f, elsevier bv.

2. Alberto jorge-mora et al, commercially available antibiotic-laden pmma-

covered locking nails for the treatment of fracture-related infections,

3. Broughton ii et al ,carl von reyher and the origins of debridement, brief

history of wound care. Plast reconstr surg 117, wounds uk | vol 15 | no 3

(2006).

4. Browner et al,skeletal trauma: basic science, management, and

reconstruction , elsevier health sciences,pub: 01-dec-2014.

5. C.bhatia et al , role of antibiotic cement coated nailing in infected

nonunion of tibia, malays orthop j. 2017 mar; 11(1): 6–11.

6. Catherine et al. “local intramedullary delivery of vancomycin can prevent

the development of long bone staphylococcus aureus infection.” one vol

11,7 e0160187. 29 jul. 2016, doi:10.1371/journal.pone.0160187.

7. Chandan gupta et al.2016, role of external fixator in the management of

compound fractures fractures of leg. Int. journal recent scientific res.

7(12), pp. 14625-14630.

8. Craveiro-lopes n et al . Treatment of open fractures of the tibia with a

locked intramedullary nail with a core release of antibiotics (safe dualcore

universal): comparative study with a standard locked intramedullary nail.

J limb lengthen reconstr 2016;2:17-22.

9. Cross ww et al, Treatment principles in the management of open

fractures. Indian j orthop. 2008;42(4):377–386. Doi:10.4103/0019-

5413.43373.

10. D.A wininger et al, antibiotic-impregnated cement and beads for

orthopedic infections, 1996 dec; 40(12): 2675–2679. Pmcid: pmc163602,

pmid: 9124821.

11. David p. Rowlands et al, the mechanical properties of stainless

steel,stainless steel information series no :3

12. Dilip r. Karnad et al. Intravenous administration of ulinastatin (human

urinary trypsin inhibitor) in severe sepsis: a multicenter randomized

controlled study, intensive care med. 2014; 40(6): 830–838. 2014 apr

16. Doi: 10.1007/s00134-014-3278-8 ulinostatin.

13. Dr Veerakumar et al,versatile external fixator in the management of

difficult fractures,The Tamilnadu Dr .M.G.R Medical University,march

2001

14. Dr.a.saravanan et al, antibiotic cement impregnated nailing in the

management of infected non union of femur and tibia - a prospective

study, The Tamilnadu Dr M.G.R Medical university march-2010.

15. Evans rp et al . Gentamicin-impregnated polymethylmethacrylate beads

compared with systemic antibiotic therapy in the treatment of chronic

osteomyelitis. Clin orthop. 1993;295:37–42

16. Evans rp et al, successful treatment of total hip and knee infection with

articulating antibiotic components: a modified treatment method,pub

med- 2004 oct;(427):37.

17. Gopal s1, et al , fix and flap: the radical orthopaedic and plastic treatment

of severe open fractures of the tibia, j bone joint surg br. 2000

sep;82(7):959-66.

18. Gustilo rn, mendoza rm, williams dn (1984) problems in the management

of type iii (severe) open fractures: a new classification of type iii open

fractures. J traum 24(8): 742-746.

19. Ibrahim da et al . Classifications in brief: the tscherne classification of

soft tissue injury. Clin orthop relat res. 2017 feb;475(2):560-564. Doi:

10.1007/s11999-016-4980-3. Epub 2016 jul 14. Pmid: 27417853; pmcid:

pmc5213932.

20. James f. Kellam md et al, fracture and dislocation classification

compendium—2018, j orthop trauma • volume 32, number 1 supplement,

january 2018

21. James f. Shanahan et al, goodman & gilman's: the pharmacological basis

of therapeutics, thirteenth edition, isbn 978-1-25-958473-2,1059-

1061,section vii.

Journal of bone jt infect 2019; 4(4):155-162. Doi:10.7150/jbji.34072.

22. Keating jf et al, reamed nailing of gustilo grade-iiib tibial fractures, j bone

joint surg br. 2000 nov;82(8):1113-6.

23. Klaus-dieter kühn et al, management of periprosthetic joint infection,

springer, 29-sep-2017 - medical - 366 pages

24. klemm k. Et al, gentamicin-pmma-beads in treating bone and soft tissue

infections, zentralbl chir. 1979;104(14):934-42.

25. Kooistra, bauke et al , the radiographic union scale in tibial fractures:

reliability and validity 2010/03/0 ,24 suppl 1,do -

10.1097/bot.0b013e3181ca3fd1,journal of orthopaedic trauma.

26. Laishram birendro singh et al, treatment of open fractures of tibia by

ilizarov technique, iosr-jdms e-issn: 2279-0853, p-issn: 2279-

0861.volume 15, issue 12 ver. I, pp 18-22.

27. Lucian fodor et al, mangled lower extremity: can we trust the amputation

scores?, int j burn trauma 2012;2(1):51-58, published february 28, 2012.

28. M. Chohfi et al, pharmacokinetics, uses, and limitations of vancomycin-

loaded bone cement, international orthopaedics (sicot) (1998) 22:171–

177

29. Mcmurtry j, mounasamy v et al (2016) antibiotic intramedullary nail in

the management of infected ununited tibial fractures - case report,

technique and review of literature. J clin stud med case rep 3: 031

30. Michele bisaccia et al ,the history of external fixation, a revolution idea

for the treatment of limb’s traumatized and deformities: from hippocrates

to today, canadian open orthopaedics and traumatology journal vol. 3, no.

4, september 2016, pp. 1-9. Open fractures of long bones: retrospective

and prospective analyses prevention of infection in the treatment of one

 thousand and twenty-five, rb gustilo and jt anderson j bone joint surg am.

1976;58:453-458.

31. Pedro antich-adrover et al,external fixation and secondary intramedullary

nailing of open tibial fractures, j bone joint surg [br] 1997;79-b:433-7

32. Poletti et al,current concepts and principles in open tibial fractures - part

i historical background and classification system, volume 8 issue 2 –

2017, april 24, 2017, moj orthopedics & rheumatology

33. Rafael valadares oliveira et al , comparative accuracy assessment of the

gustilo and tscherne classification systems as predictors of infection in

open fractures, rev. Bras. Ortop. Vol.53 no.3 são paulo may/june 2018

34. S. Rajasekaran et al, a score for predicting salvage and outcome in gustilo

type-iiia and type-iiib open tibial fractures,ijo, year : 2005 | volume: 39 |

issue number: 1 | page: 4-13

35. springer bd et al, systemic safety of high-dose antibiotic-loaded cement

spacers after resection of an infected total knee arthroplasty,pub med,

2004 oct;(427):47-51

36. Stefanos tsourvakas et al. Selected topics in plastic reconstructive

surgery,chapter, local antibiotic therapy in the treatment of bone and soft

tissue infections,published: january 20th 2012doi: 10.5772/1292isbn:

978-953-307-836-6copyright year: 2012 ,alexander fleming

37. Sudhakar g. Madanagopal et al, the antibiotic cement nail for infection

after tibial nailing,orthoblue journal, july 2004 | volume 27 • number 7.

38. Susan standring et al,grays antomy,40th edition,lower limb,regional

antomy,leg page1414-1426published date: 25th september 2008

39. Thomas p. Rüedi et al, ao principles of fracture management, volume 2,

ao publishing, 2007 - fractures - 947 pages.

40. Veliskakis kp et al (1959) primary internal fixation in open fractures of

the tibia shaft; the problem of wound healing. J bone joint surg br. 41b(2):

342-354

41. Wahlig h et al. The release of gentamicin from polymethylmethacrylate

beads. An experimental and pharmacokinetic study. J bone joint surg.

42. Younis kamal et al. Role of primary intramedullary interlocking nail in

compound gustilo-iiia tibia fracture in developing world, international

journal of health sciences and research www.ijhsr.org issn: 2249-9571

1978;60b:270–275 local antibiotic therapy.

43. Zhimin ying et al, gas gangrene in orthopaedic patients, case rep orthop

v.2013; 2013pmc3830836.
 ANNEXURE
Patient’s evaluation form
Name : Age/Sex :
IP No :
Address :

Phone No :
Mechanism of injury :
Place of injury :
Associated factors
influencing injury :
side involved
H/O Epilepsy :
Alcoholism :
Any other consumption :
Time of presentation :
Associated General :
Illness : DM/HT/Any other :

Type of fracture :
Open: Grade of fracture: I /II / III A / III B
Associated other injuries :
Vascular / Nerve injury / Crush injury of foot / Metatarsal fractures /
Calcaneal fractures / Pelvic & sacral injury.
Time of presentation :
Injury to Admission (Hrs) :
Time delay :
Time of intramedullary nailing :
Nail size :
Soft tissue cover
- SSG /Flap cover :
Soft tissue complications :
Infection
- No infection
- Superficial infection
- Deep infection
Non union :
- Absent
- Aseptic nonunion
- Infective nonunion
SECONDARY PROCEDURE :
- Dynamization
- Bone grafting
Exchange nailing
Follow up :
- Month
- Visit
RUST SCORE:
• Fracture not healed
• Fracture healing
• Fully united
INFORMED CONSENT FORM
STUDY : A Prospective study on Clinical, Functional and Radiological outcome of
Compound Both Bone Leg Fractures Managed with Versatile Antibiotic
Intramedullary Inter Locking Nailing ”
STUDY CENTRE : Department of Orthopaedics
Govt.Kilpauk Medical College Hospital, Chennai.
PATIENT’S NAME :
PATIENT’S AGE :
I.P NO. :
Patient may check ( ) these boxes
I confirm that I understood the purpose of the procedure for the above study.
( )
I had the opportunity to ask question and all my questions and doubts have been
answered to my complete satisfaction. ( )
I understand that my participation in the study is voluntary and that I am free to
withdraw at any time without giving reason, without my legal rights being affected.
( )
I understand that the ethical committee members and the regulatory authorities will
not need my permission to look at my health records, both in respect of the current
study and any further research that may be conducted in relation to it, even if I
withdraw from the study I agree to this access.
( )
However, I understand that my identity will not be revealed in any information
released to third parties or published, unless as required under the law.
( )
I agree not to restrict the use of any data or results that arise from the study.
( )
I agree to take part in the above study and to comply with the instructions given
during the study and faithfully co-operate with the study team and to immediately
inform the study staff if I suffer from any deterioration in my health or well being or
any unexpected or unusual symptoms. ( )

I hereby consent to participate in this study. ( )

I hereby give permission to undergo complete clinical examination and surgical
fixation , diagnostic tests including haematological, biochemical, radiological tests.
( )
Signature / thumb impression
Patient’s name and address:
Place:
Date:

Signature of the investigator:

Study investigator’s name:
Place:
Date:
 MASTERCHARTS

S.No Name Age Side Gustilo- Fractute Time Sec. Deformity Rust Non- wound FOLLOW
/Sex Anderson Site Delay Proc Criteria Union status UP(IN
Grade Of (post op MONTHS
Surgery infectio )
n if any

1 Chinrasu 20/M Left Grade 3b Distal 6 Hrs Dynm. Nil 10/12 NIL nil 1,3,6,9
Third
2 Banu 33/F Left Grade3b Middle 24hrs Z Plasty Equinus 10/12 NIL nil 1,3,6,9
Third
3 Mani 63/M Right Grade 2 Middle 6 Hrs Nil Nil 12/12 NIL nil 1,3,6,9
Third
4 Palanisamy 68/M Left Grade 2 Middle 12 Hrs Nil Nil 12/12 NIL nil 1,3,6,9
Third
5 Ramakrishn 50/M Left Grade3b Distal 24 Hrs Nil Nil 12/12 NIL nil 1,3,6,9
an Third
6 Banumatgh 45/F Right Grade 3a Middle 24 Hrs Nil Nil 12/12 Nil nil 1,3,6,9
i Third
7 Arulmariraj 25/M Left Grade 2 Distal 24 Hrs Nil Varus 10/12 Nil nil 1,3,6,9
Third Deformity
8 Kanniapan 41/M Left Grade 3a Middle 48 Hrs Exchange - - - deep LOST
Third Nailing infectio FOLLOW
n UP
9 32/M Right Grade2 Proximal 16 Hrs Nil Nil 10/12 Nil superfi 1,3,6,9
Mohan Third cial
infectio
n
10 56/M Right Grade2 Distal 24 Hrs Nil Nil 12/12 Nil nil 1,3,6,9
Azar Third
Rahman
11 49/M Left Grade 3a Proximal 24 Hrs Dynm Nil 12/12 Nil nil 1,3,6,9
Elumalai Third
12 Vivekanand 26/M Right Grade 2 Distal 36 Hrs Exchange Nil 10/12 Nil superfi 1,3,6,9
han Third Nailing cial
infectio
n
13 31/M Left Grade 2 Middle 12 Hrs Nil Nil 8/12 Nil nil 1,3,6,9
Sathish Third
Kumar
14 31/M Right Grade 3b Distal 24 Hrs Nil Nil 10/12 Nil nil 1,3,6,9
Velu Third
15 Yuvraj 45/M Right Grade 2 Proximal 12 Hrs Nil Nil 10/12 Nil nil 1,3,6,9
Third
16 Chinna Raj 38/M Left Grade 3a Middle 16 Hrs Dynm Nil 10/12 Nil nil 1,3,6,9
Third
17 Kathirvel 27/M Right Grade 3a Middle 24 Hrs Exchange Nil 8/12 Non deep 1,3,6,9
Third Nailing Union infectio
n
18 Selvam 35/M Left Grade 2 Proximal 24 Hrs Nil Nil 10/12 Nil nil 1,3,6,9
Third
19 50/M Left Grade 2 Middle 12 Hrs Nil Nil 12/12 Nil nil 1,3,6,9
Dheenaday Third
alan
20 Johnson 56/M Left Grade 3b Proximal 36 Hrs Nil Equinus 8/12 Nil nil 1,3,6,9
Third Deformity
21 42/M Left Grade 2 Distal 24 Hrs Nil Nil 12/12 Nil nil 1,3,6,9
Sankar Third
Kandan
22 54/M Left Grade 2 Distal 36 Hrs Exchange Nil 4/12 Non nil 1,3,6,9
Giri Third Nail Union
23 Srinivasan 47/M Left Grade 2 Distal 12 Hrs Nil Nil 10 /12 Nil nil 1,3,6,9
Third
24 Ramesh 28/M Right Grade 2 Proximal 36 Hrs Exchange Nil 8/12 Non Deep 1,3,6,9
Third Nailing Union
infectio
n