antibiotic coated nails in orthopedic, antibiotic nail

Chairperson: Prof & HOD, Dr. Kiran kalaiah
Moderator: Prof, Dr. Mahesh K U
Presenter : Dr. Yashavardhan.T.M
Journal presentation on topic : Role of
antibiotic-impregnated bone cement rod in control
of bone infection and assessing its role in union in
cases of infective non-union of long bones

INTRODUCTION
• Infected non-union of long bones is chronic,
tedious, and huge challenge that presents a huge
problem to the surgeon today in terms of cost of
treatment and time elapsed during the treatment.
• Some of the factors that lead to infected non-
union are open fracture, loss of soft-tissue or
bone infection after internal fixation, chronic
osteomyelitis, pathological fracture, and surgical
debridement of infected bone.

• Almost all of the infections that are encountered in
orthopedic trauma are caused by biofilm-forming
bacteria.
• Biofilm consists of hydrated matrix of polysaccharide
and protein. Once a biofilm is formed, it protects the
microorganism from antimicrobial, opsonization, and
phagocytosis, and thus, it contributes to re-occurrence of
infections.

• To manage and treat biofilm-related infection, the four
principles laid down by Cierny and Mader must be
observed and followed:
• (1) complete surgical debridement with dead space
management,
• (2) fracture/non-union stabilization,
• (3) soft-tissue coverage, and
• (4) adequate antibiotic level.

• The treatment of non-union follows a two-stage procedure.
• Stage 1 is of debridement with or without antibiotic cement
bead insertion along with systemic antibiotic therapy to
change an infected nonunion to aseptic nonunion.
• Stage 2 is carried out to achieve stability which can be
achieved either by external fixation or by internal fixation
with or without bone grafting.

• The use of antibiotic-impregnated cement-coated
intramedullary (IM) nailing for infected non-union of
tibia and femur fractures has been well documented.
• The cement nail which is inserted helps in providing
stability across the fracture site which is essential in the
management of infected nonunion and which cannot be
achieved by cement beads.

• Antibiotic cement release antibiotic at local site up to 36
weeks and it helps in providing a therapeutic effect on
refractory infection and has few side effects.
• Gentamicin has been most frequently used agent which is
followed by vancomycin as they have broad spectrum of
activity, heat stability, and low allergenicity.

NON UNION
Definition A state in which healing process comes to a halt
as judged by clinical & x-ray evidence, beyond the stipulated
period of healing for a particular bone and fracture pattern
due to mechanical or biological failure
The definition of nonunion from Brinker
is probably more appropriate: “A fracture that, in the opinion
of the treating physician, has no possibility of healing
without further intervention.”

CLASSIFICATION OF NON UNION
BASED ON THE EXTENT OF INFECTION
1. NON-INFECTED NON-UNION
2. INFECTED NON-UNION

HYPERTRROPHIC NON-UNION
1 “Elephant foot” non-unions These are hypertrophic and rich in
callus. They result from insecure fixation, inadequate immobilization,
or premature weight bearing in a reduced fracture with viable
fragments.
2 “Horse hoof ” non-unions These are mildly hypertrophic and poor in
callus. They typically occur after a moderately unstable fixation with
plate and screws. The ends of the fragments show some callus,
insufficient for union, and possibly a little sclerosis.
3 Oligotrophic non-unions These are not hypertrophic, but are
vascular, and callus is absent. They typically occur after major
displacement of a fracture, distraction of the fragments, or internal
fixation without accurate apposition of the fragments.

AVASCULAR NON-UNION
1 Torsion wedge nonunions
These are characterized by the presence of an
intermediate fragment in which the blood supply is
decreased or absent. The intermediate fragment has
healed to one main fragment but not to the other.
2 Comminuted nonunions
These are characterized by the presence of one or
more intermediate fragments that are necrotic. The
radiographs show absence of any sign of callus
formation.

3 Defect nonunions
These are characterized by the loss of a fragment of
the diaphysis of a bone. The ends of the fragments
are viable, but union across the defect is impossible.
As time passes, the ends of the fragments become
atrophic.
4 Atrophic nonunions
These usually are the final result when intermediate
fragments are missing and scar tissue that lacks
osteogenic potential is left in their place. The ends of
the fragments

PALEY ET AL. CLASSIFICATION
Paley et al.classification of non-union
Type A non-unions (<1 cm of bone loss)
A1, lax (mobile)
A2, stiff (nonmobile)
A2-1, no deformity
A2-2, fixed deformity.
Type B nonunions (>1 cm of bone loss)
B1, bony defect, no shortening
B2, shortening, no bony defect;
B3, bony defect and shortening.

WEILAND CLASSIFICATION OF
INFECTED NONUNION
Based on the extend of infection
Type 1
characterised by open and exposed bone without osseous
infection but with soft tissue infection
Type 2
characterised by circumferential cortical and endostesl
infection with often and invlocrum surroundind a
sequestrum
Type 3
characterised by cortical-endosteal infection associated
with a segmental bone defect.

CIERNY MADAR CLASSIFICATION
Cierny and Mader developed a
classification system for chronic
osteomyelitis, based on
physiological and anatomical
criteria, to determine the stage of
infection.
Based on host
class A- NORMAL
class B- COMPROMISED
class C-PROHIBITIVE
Based on anatomy
type 1-MEDULLARY
type 2-SUPERFICIAL
type 3-LOCALISED
type 4-DIFFUSE
pairing of these forms 12 clinical
stages
Clinical Stage
(Type+ Class = Clinical Stage)

UMIAROV’S CLASSIFICATION OF
INFECTED NON-UNION
Based on the viability of bone ends, the presence of limb
shortening, the presence of bone, and soft tissue defect.
type 1 the nonunion is normotrophic without shortening
type 2 the nonunion is hypertrophic with shortening
type 3 the nonunion is atrophic with shortening
type 4 the nonunion is atrophic with bone and soft tissue
defect, in general as a result of an open fracture

G.S KULKARNI CLASSIFICATION OF
INFECTED NON UNION
• Severity of infection
• Apposition of fragments
• Presence or absence of deformity.

TYPE I:
fragments in apposition with mild infection and with or with out
implant
TYPE II:
Fragments in apposition with severe infection with large or small
wound.
TYPE III:
Severe infection with a gap or deformity or shortening.
3A defect with loss of full circumference
3B defect in > 1/3 of cortex
3C infected nonunion with deformity

INVESTIGATIONS
Include - complete blood count
- erythrocyte sedimentation rate (ESR)
- C- reactive protein (CRP)
Plain radiogarphy
Sinography
Radionucleotide scan
MRI
CT-scan
Culture sensitivity
USG

TREATMENT OF INFECTED NON-
UNION.

GOAL 1 : ERADICATE INFECTION
A]. INCREASE HOST RESISTANCE :
Correct host morbidity
-control blood sugar level in diabetic
-smoking cessation
-treatment of liver or renal malfunction
-optimising nutrition
-treatment of chronic disease
Antibiotic therapy according to culture sensitivity reports.
- systemic antibiotic therapy

B]. LOCAL CONTROL OF INFECTION DECREASE
INFECTION LOAD:
• thorough debridement of dead and necrotic tissue
• closed suction antibiotic ingress and egress irrigation
systems.
• negative suction drainage system.
C]. INCREASE LOCAL HOST RESISTANCE:
• PMMA antibiotics beads • biodegradable antibiotic
delivery system

GOAL 2 : TO ACHIEVE UNION
• ADDING BIOLOGY
– Aspirated stem cells (with or without expansion)
– Demineralized Bone Matrix
– Autogenous Cancellous Graft
– Growth Factors
• Platelet derived
• Recombinant BMPs
• Gene Therapy
EXTERNAL STIMULI
-low intensity ultrasound therapy
-electric and electromegnetic therapy

STEM CELLS AND BMP’S.
Aspirated iliac crest stem cells has been shown
to enhance the activity of osteoconductive
grafts.
• There are few commercially available
Recombinant BMP proved to be effective
treating nonunions.

Bone grafting in infected non union
1. Onlay bone grafting:
graft applied or laid on the surface of a bone
2. Inlay bone grafting:
By the inlay technique a slot or rectangular defect is created in the cortex of the
host bone, usually A graft the same size or slightly smaller is then fitted into the
defect

PAPINAEU METHOD OF BONE
GRAFTING
Stage I: Radical debridement
Stage II: bone grafting
Stage III: skin coverage.

HARMONS’ POSTEROLATERAL GRAFT
Bone grafting on the interosseous membrane to obtain a long
synostosis with fibula, spanning the tibial defect.

FREE VASCULARISED BONE
TRANSFER
Free vascularised bone transfer
• Rib, fibula, iliac crest.
• Isolation of a segment of contra lateral fibula with
attached nutrient artery and vein.
• Length of graft should be 4 cm longer than defect
to allow 2 cm overlap at the proximal and distal
ends.

ULTRASOUND THERAPY
It cause increases in cellular activity at
osteotomy sites and increases in mineralization
of the bone and metabolic activity.
It promotes bone healing because it stimulates
the genes involved in inflammation and bone
regeneration.
It increases blood flow through dilation of
capillaries and enhancement of angiogenesis,
increasing the flow of nutrients to the fracture
site.
Used : for 20 min / day

ELECTRICAL AND
ELECTROMAGNETIC STIMULATION
Used for 3 or more hours per day has been successful in
healing nonunions of long and short bones, open or closed
fractures, long-standing nonunions, infected nonunions,
and those with fracture gaps up to 1 cm.

The three methods of administering electric stimulation are shown in
this diagram.
(a) Direct current (DC): A cathode is implanted at the fracture site
which is attached to either a subcutaneous
power source or an external power source to generate an electric field
at the fracture site.
(b) Capacitive coupling(CC): Two capacitive coupled electrodes are
situated on the skin on either sides of the fracture site. An external
power source is then attached to the electrodes, which induces an
electric field at the fracture site.
(c) Inductive coupling (IC): An electromagnetic current carrying coil
is placed on the skin overlying the fracture site, which is attached to an
external power source. The coil generates a magnetic field, which
induces an electrical field at the fracture site.

GOAL NO.3 SOFT TISSUE PROBLEMS:
The transfer of vascularized muscle tissue improves
the local biological environment by bringing in a
blood supply that is important in the host's defense
mechanisms and for antibiotic delivery and osseous
and soft tissue healing
DEFORMITY AND SHORTENING: - Ilizarov
is the gold standard treatment to correct deformity
and shortening and eradicate infection at the same
time

MASQUELET TECHNIQUE
Induced membrane favours revascularization and
consolidation of the bone graft.
Original masquelets technique no antibiotic cement was
used and he believed that “good debridement is the key to
control infection”.
Induced membrane is richly vascularized by numerous
small capillaries and high concentrations of bone
morphogenic protein-2 (BMP-2), vascular endothelial
growth factor, and transforming growth factor-ß1.
The membrane prevent soft tissue protrusion in the bone
defect site, provides a scaffold for osteo conduction.

OPERATIVE PROCEDURE.
Technique involves 2 surgeries:
Stage I surgery :irrigation and debridement of the infected soft
tissue and bone, along with fracture stabilization with external
fixators. Bone cement spacer without antibiotic was then introduced
in the bone gap in a semisolid stage.
Stage II surgery :Performed after 4–6 weeks of stage I surgery in
the absence of any clinical signs of infection includes removal of the
cement-spacer, with preservation of the induced membrane formed at
the spacer surface and filling the bony defect space with
morselized iliac crest bone graft.

ELIMINATION OF INFECTION IN ILIZAROV
METHOD
Resection of infected bone and subsequent
intercalary bone lengthening
gradual bone transport of one wall of the cavity
Controlled osteogenesis, filling of cavities by
newly formed tissue
A corticotomy is performed to fracture the bone
into two segments, and the two bone ends of the
bone are gradually moved apart during the
distraction phase, allowing new bone to form in
the gap. When the desired or possible length is
reached, a consolidation phase follows in which the
bone is allowed to keep healing.

“DISTRACTION OSTEOGENESIS “ refers to the
production of new bone between vascular bone surfaces
created by an osteotomy and separated by gradual distraction

ANTIBIOTIC COATED RODS TREAT
INFECTION, STABILIZE DEFECTS
• Systemic antibiotics may have limited efficacy in decreasing the
risk of infection associated with the use of foreign bodies such
as prostheses and osteosynthetic devices.
• Bacteria can colonize the surface of an implant, forming a
biofilm of an extracellular polysaccharide matrix (glycocalyx)
that protects the bacteria from the antimicrobial action of
systemic antibiotics.
• Furthermore, systemically delivered antibiotics might not reach
the medullar canal of long bones when blood flow has been
disrupted by trauma or intramedullary nailing.
• Therefore, implant-related infection often requires aggressive
treatment including removal of the implant, multiple revisions
with surgical debridement and long-term antibiotic therapy

• To improve prophylaxis against implant-related infections,
various systems have been developed for the local delivery
of antibiotics at the tissue-implant interface. Gentamicin
polymethylmethacrylate (PMMA) bead chains and
gentamicin-coated collagen sponges (Sulmycin; Septocoll)
can reduce the risk of infection directly at the site of the
implant and its surrounding tissue [3, 9, 17].
• However, PMMA beads must be removed after 4–6 weeks
[3] and collagen sponges do not allow for continuous and
controlled release of the antibiotic.

BONE CEMENT
Sir Charnley states that, Bone cement acts as a “grout”
and not as a “glue.”
Physical properties of bone cement.
1. Not a glue
2. Mechanical bond
3. Well secured to cancellous bone
4. Lower Modulus of Elasticity
5. Strength half of compact bone
6. Withstand 3 times compression well.
7. Fails under shear tension.

CHEMICAL COMPOSISTION.
Liqiud
Monomer-Methyl methacrylate
Stabiliser-Hydroquinone, Ascorbic acid.. Ethyl Alcohol-
Vehicle to enhance stabilisation of Asc Acid
Activator-N N dimethyl P toluidine
Powder component
Polymethylmethacrylate
Barium Sulphate
Catalyst-Benzyl Peroxide

EFFECTS CAUSED BY BONE
CEMENT.LOCAL
1. Heat of polymerisation-coagulation of protein
2. Occlusion of nutrient metaphyseal arteries and Bone
necrosis
3. Cytotoxic lipolytic effects
SYSTEMIC
1. Vasodilatation –dec BP
2. Cardiovascular Toxicity
3. Others— Thrombophlebitis, Haemorrhage
LATE
1. Aseptic Loosening
2. Osteolysis
3. Acrylic cracking, Fragmentation.

STERLIZATION
OF BONE CEMENT
Bone cement Liquid-Microfilter
Packs of liquid –Ethylene Oxide
Powder-Gamma Radiation
EFFECTS OF ANTIBIOTIS IN CEMENT
It decreases fatigue strength
Should be in powdered form
Heat stable
Eg. Genta,tobra,cephalosporins
Colouring agents to detect cement during revision.
CONTRAINDICATIONS Hypersensitivity reaction Infections
Mysthenia grevis Children

AIMS AND OBJECTIVES
To assess the role of antibiotic-impregnated bone
cement rod in control of bone infection and assess
its role in union in cases of infective non-union of
long bones.

MATERIALS AND METHODS
• This was a prospective study comprising of 30 cases of
established infected nonunion of long bones carried out in a
tertiary care center in Western Maharashtra for 2 years from
June 2014 to July 2016
• Inclusion criteria: Patients of nonunion of long bones
diaphysis with established clinical and laboratory evidence of
infection were included in the study
• Exclusion criteria: Patient with immature bony skeleton,
bone gaps, or infection involving the joint were excluded
from this study
• Wound and sinus swabs were sent for gram stain and
culture sensitivity
• Antibiotics used in cement were vancomycin and
gentamicin due to their heat-stable properties.

RESULTS
• In our study, we included 30 patients in total of
infective nonunion of long bones. Out of 30
patients, male patients were 22 and we had 8
female patients in our study.
• Out of 30 patients [Figure 1], 21 patients were of
femur non-union and 9 were of tibia nonunion.
The age range of the patients was 18–45 years
with a mean age of 34.5 years. Twenty patients had
a culture of Staphylococcus aureus from a
preoperative or an intraoperative specimen. Six
patients had a culture that was positive for
Enterobacter.

• Rest of the patient had a sterile culture despite
obvious signs of infection. All the patients were
treated with the same regimen.
• First, all the wounds and sinus were properly
cleaned and culture swabs were taken and sent for
evaluation, and later on, patients were treated with
open reduction and internal fixation with
antibiotic-coated cement rod.
• Sterile dressing was done on day 2, day 5, and day
8, and sutures were removed on day 14.
Twenty-six cases showed complete union at 6
months or earlier.

• Two more cases showed significant callus
formation. In two cases, there was no callus
formation at fracture site till 6 months. Fracture
union occurred at 6 months or earlier in eight
cases.
• Four cases showed solid bony union at 8
months. No refractures occurred in these cases.
In one case where infection healed but
nonunion persisted, she was given an external
fixator. Later, the patient obtained a satisfactory
union. However, two patients continued to have
an infected nonunion.

• In both of these cases, the Rod with anti-biotic
cement was removed and patients given external
fixator. Twenty-three patients experienced no
recurrence of infection. Four patients continued
to have draining wounds, but the discharge was
significantly reduced.
• In two cases, it was a thin watery fluid, and in
two other cases, the discharge persisted as a
purulent discharge, which was greatly reduced in
volume. Patients were discharged after suture
removal and were followed up in outpatient
department at regular intervals of 2 weeks each
to assess the progress.

DISCUSSION
• IM infection is a well-recognized complication of
IM nailing for trauma. Infected nonunions of long
bones are particularly very difficult to treat.
• The combination of mechanical instability and
infection of the fractured bone provides an
unfavorable condition for fracture healing.
• Thirty patients who had an infected nonunion of
the long bone were treated using antibiotic bone
cement rod.
• Twenty-one femurs and 9 tibias were treated.

• The age range of the patients was 18–45 years
with a mean age of 34.5 years.
• In present journal study, we had used 40 g of plain
cement mixed with 1 g of injection vancomycin
powder or 40 g of gentamicin bone cement alone
or in combination with 1 g of injection
vancomycin powder. Sterling et al. confirmed that
gentamicin and vancomycin are antibiotics which
maintain activity even after being exposed to the
high temperatures resulting from poly(methyl
methacrylate) hardening.

• Klekamp et al. recommended combining
vancomycin and an aminoglycoside in bone
cement for their potential synergistic effect in the
treatment of severe infections caused by resistant
S. aureus.
• This was confirmed by studies of González Della
Valle et al. Miller et al. confirmed that when
infection is associated with fractures, stability is
important in the treatment of infection.
• The antibiotic-impregnated cement rod fills dead
space while locally eluting high concentrations of
antibiotics. It simultaneously provides mechanical
support for the bone.

• In our study, we found that twenty-three patients
experienced no recurrence of infection. Four
patients continued to have draining wounds, but
the discharge was significantly reduced. In two
cases, it was a thin watery fluid, and in two other
cases, the discharge persisted as a purulent
discharge, which was greatly reduced in volume.
• Schlatterer and Anders (2005) in their study
encountered one case that required re-debridement
and exchange antibiotic re-rodding after 6 weeks.

• This patient went on to full recovery and one
case had persisting discharging sinus. In the study
done by Paley and Herzenberg to treat IM
infections with antibiotic cement rods, they noted
no recurrence of infection in any of the nine
cases studied by them.
• Emami et al. treated 37 cases of infected tibia
nonunion. Twenty-one patients required repeat
debridement. No recurrence of infection was
noted in any cases for 2 years of follow-up.

• We found that in our study, we had achieved 26
cases of complete union at 6 months or earlier.
Two more cases showed significant callus
formation.
• In two cases, there was no callus formation at
fracture site till 6 months. In the study done by
Paley and Herzenberg to treat IM infected
nonunions in three cases with antibiotic cement
rods, they achieved fracture healing after re-nailing
or plating once infection healed.

• Ueng et al. obtained bony union in diaphyseal
infected non-unions in 15 patients with antibiotic
beads, external skeletal fixation, and staged bone
grafting. Fifteen cases were considered and all
united. External fixator was removed at 7–15
months (average 9 months).

CONCLUSION
On the basis of our study conducted, we recommend the
use of antibiotic-impregnated bone cement rod in control of
bone infection and that it significantly helps in union of
infective nonunion of long bones.

antibiotic coated nails in orthopedic, antibiotic nail

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