SPINE Volume 44, Number 1, pp E1–E6

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RANDOMIZED TRIAL

Six versus 12 Months of Anti Tubercular Therapy

in Patients With Biopsy Proven
Spinal Tuberculosis
A Single Center, Open Labeled, Prospective Randomized Clinical Trial—A Pilot study

Abhay M. Nene, MS(Ortho), Sanganagouda Patil, DNB(Ortho), FNB(Spine surg),

Ambadas P. Kathare, MS(Ortho), MCh,y Premik Nagad, DNB(Ortho),y
Amita Nene, MD, FCCP,z and Farhad Kapadia, MD, FRCP y
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of therapy. All patients completed scheduled duration of ATT,

Study Design. A single center pilot study, open labeled,
prospective randomized clinical trial.
Objective. To compare six versus 12 months of anti TB therapy
in patients with biopsy proven spinal TB.
Summary of Background Data. There is no clear consensus
or evidence based guidelines for the duration of treatment of
spinal tuberculosis. We studied if 6 and 12 months of anti
tubercular therapy (ATT) had equivalent outcomes at 24 months
from completion of therapy.
Methods. A prospective randomized open labeled clinical trial
of 6 versus 12 months ATT in patients with biopsy proven
spinal-vertebral tuberculosis. The primary end point was absence
of recurrence 24 months after completing therapy. Secondary
end points were clinical cure at the end of therapy, significant
adverse effect of ATT, need for delayed surgery, and residual
neurological dysfunction.
Results. Hundred patients, randomized to 6 or 12 months ATT,
were followed up for a minimum of 24 months from completion
with one crossover from 6 months ATT group to 12 months.
There were no recurrences of disease on the 24 months follow
up following completion of ATT. All 100 patients met criteria for
cure at time of stopping medicines. One patient (12 months
group) had residual neurological dysfunction at the time of
stopping treatment, which completely resolved over the next 12
months.
There were no patients with major drug induced hepatitis. One
patient (12 months group) needed percutaneous drainage of an
abscess. None needed surgical re-exploration for persistent
infection of implant removal.
Conclusion. This pilot study concludes that, in patients with
biopsy proven spinal-vertebral, TB, 6 and 12 months of ATT give
similar clinical outcomes at 24 months of completion of therapy.
Key words: anti-tuberculosis treatment, biopsy proven
tuberculosis, open label, pilot study, prospective randomised
clinical trial.
Level of Evidence: 2
Spine 2019;44:E1–E6

From the Division of Spine Surgery, Department of Orthopaedics, Hinduja

National Hospital, Mumbai, Maharashtra, India; yHinduja National Hospi-
tal & MRC, Mumbai, Maharashtra, India; and zBombay Hospital & MRC,

Mumbai, Maharashtra, India.
Acknowledgment date: January 18, 2018. First revision date: April 19, 2018.
Acceptance date: May 24, 2018.
The manuscript submitted does not contain information about medical
device(s)/drug(s).
The National Health and Education Society, P. D. Hinduja National
Hospital and Medical Research Center funds were received in support of
this work.
Relevant financial activities outside the submitted work: board membership.
Address correspondence and reprint requests to Abhay M. Nene, MS Ortho,
Division of Spine Surgery, Department of Orthopaedics, 1877, Doctor
Anandrao Nair Marg, Agripada, Mumbai Central East, Mumbai, Mahara-
shtra-400011, India; E-mail: abhaynene@yahoo.com; Sanganagouda S.
Patil, DNB Ortho, FNB Spine Surgery, Division of Spine Surgery, Depart-
ment of Orthopaedics, 1877, Doctor Anandrao Nair Marg, Agripada,
Mumbai Central East, Mumbai, Maharashtra-400011, India;
E-mail: sanganpatil9@gmail.com
DOI: 10.1097/BRS.0000000000002811
Spine
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T
he duration of chemotherapy in tuberculosis (TB) is
unclear1 and this has lead to inconsistent treatment
regimens. This could contribute to the emergence of
multi drug resistant tubercular bacilli (MDR TB) and
worsen medical and surgical complications.2,3 The total
duration of suggested anti tubercular therapy (ATT) for
spinal TB varies from 6 to 24 months, though the commoner
regimes are for 9 to 12 months. Most of the studies on
duration of ATT in spinal TB have been observational. The
lack of a clear endpoint(s), clinical, radiological, or labora-
tory has further confounded uniform treatment practices
and patterns.4
This study aims to determine whether a 6 versus
12 months of ATT had equivalent outcomes at 24 months
from completion of therapy, in patients with biopsy proven
spinal-vertebral TB.
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 RANDOMIZED TRIAL Six vs. 12 Months of ATT in Patients With Biopsy Proven Spinal TB  Nene et al

MATERIALS AND METHODS Diagnostic Criteria

We conducted a pilot study on prospective, open labeled,
randomized, single center clinical trial on duration of ATT
in spinal TB. Consecutive consenting patients of biopsy
proven spinal TB were randomized to receive 6 or
12 months of ATT. The primary end point was clinical
cure with absence of recurrence at 24 months, after com-
pleting therapy (Figure 1).
The patients presenting with spinal pain and disability,
with clinico-radiological suspicion of spinal TB were sub-
jected to computed tomography (CT) guided biopsy to
prove the diagnosis.
Diagnostic Procedure
All patients underwent a complete coagulation profile study
prior to CT guided biopsy procedure. CT guided biopsy was
performed by the interventional radiologist under standard
aseptic conditions. The level of biopsy, site of needle place-
ment, and approach to the lesion to be biopsied was based
on magnetic resonance imaging (MRI) scan films. The
samples obtained were immediately sent in sterile containers
for histopathology study, TB, aerobic and anaerobic culture
with appropriate drug sensitivity tests.
The patients were considered to have proven disease if
either the histopathology or the microbiology was diagnos-
tic of TB.
A granulomatous inflammation comprising of caseation
necrosis, with lymphocytic and/or histiocytic cell infiltra-
tions, epitheloid and Langhan’s type giant cells on histopa-
thology, was considered to be suggestive of TB. Smear
microscopy (with carbol fuchsin and fluorochrome
such as auramine/rhodamine) was performed to detect
Mycobacerium tuberculosis (M.TB) in clinical specimens.
The biopsy sample was cultured in modified Middlebrook’s
7H9 broth for M.TB, in growth indicator tubes (TB MGIT).
Informed and written consent was obtained from the
patients who were then randomized to either 6 or 12 months
of therapy.
Chemotherapy Regimens, Dosages, and Changes
Before starting the ATT, all patients underwent a whole set
of investigations including a complete hemogram (complete
blood count [CBC], erythrocyte sedimentation rate (ESR), C
reactive protein), vitamin D3 assessment, renal function
tests, liver function tests, and a chest roentgenograph.
The ATT was started and monitored by a qualified TB
physician in consultation with the spine surgeon, through-
out the study. This initial phase consisted of the four
standard first line medications for 2 months (isoniazide
5 mg/kg, rifampicin 10 mg/kg, ethambutol 15 mg/kg, and
pyrazinamide 25 mg/kg). The maintenance phase consisted

168 Patients screened

68 patients excluded
- Did not meet the inclusion and exclusion criteria
- On prior ATT
- MDR
- Consent refusal
100 randomized

52 patients assigned 6 months ATT 48 received 12 months ATT

52 received 6 months ATT 0 early death
0 early death 0 consent withdrawal
0 consent withdrawal 0 problem in drug therapy
0 problem in drug therapy

1 pt crossed over to 12 months ATT 0 discontinued treatment

group 0 lost to follow-up
0 discontinued treatment
0 lost to follow-up

52 patients analysed 48 patients analysed

52 main endpoint 48 main endpoint
52 24 months follow-up 48 24 months follow-up

Figure 1. Flow chart that shows how many patients were screened, randomized, treated and followed up.

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 RANDOMIZED TRIAL Six vs. 12 Months of ATT in Patients With Biopsy Proven Spinal TB  Nene et al

of isoniazide and rifampicin for the remaining duration of
the therapy. Ethambutol was continued in the maintenance
phase where INH sensitivity was not known.
Patients who had previous ATT and those with docu-
mented MDR TB were excluded from the study. Randomi-
zation was done using patented hospital software by the
statistician of the research department.
Patients presenting with severe-progressive neurologic
deficits or with severe mechanical spinal pain and those
with radiologic spine at risk signs, underwent spinal surgery,
with or without spinal instrumentation. They remained in
the study group to which they were randomized. The physi-
cian saw patients at the beginning of therapy and then as
needed. The surgeons saw patients at 3 monthly intervals till
completion of therapy and then 6 monthly intervals till
24 months after completion of ATT.
The criteria for cure of disease were based upon compos-
ite of clinical, laboratory (normal CBC, ESR), and radiolog-
ical factors. This primary outcome was documented at
24 months after completion of ATT. Clinically, patients
with a significant improvement in spinal signs (pain/tender-
ness and paraspinal muscle spasm), return to pre disease
functional status with weight gain, and no residual instabil-
ity or neurological deficits were considered to be ‘‘healed’’ at
the final follow up. Radiologically, a significant regression
in the epidural or paraspinal abscess/granulation tissue,
marrow reconversion, and fatty reconstitution of the dis-
eased bone at the final follow up was called as healed.
Secondary end points were significant adverse effect of
ATT, need for delayed surgery and residual neurological
dysfunction.
Statistics
The sample size was determined by convenience sampling
using ‘‘Sample Size. Calculator – The Survey System.’’ We
assumed an enrollment rate of one to two patients per
month and anticipated duration of the enrolment period
of 4 to 5 years giving us a sample size or a total population
under study (N) ¼ 100.
The study was conducted after approval from institu-
tional review board (IRB) of the P D Hinduja National
Hospital, Bombay, India.
RESULTS
Hundred consenting, consecutive patients of biopsy proven
spinal TB, from August 2008 to January 2013 were studied.
A total of 168 patients were screened of whom 68 were not
enrolled either because they did not meet inclusion criteria,
had earlier received or already initiated ATT, or were
documented to have resistant TB. All 100 enrolled patients
were followed up for a minimum of 24 months from
completion of therapy. The patient characteristics and
nature of the TB lesions are as shown in Table 1.
All patients completed scheduled duration of ATT. There
was one crossover from 6 months ATT group to 12 months, due
to persistent sterile discharge from the psoas abscess site. All

TABLE 1. Patient Characteristics

Parameters 12 Months Anti Tubercular 6 Months Anti Tubercular Total (n ¼ 100)
Therapy Group (n ¼ 48) Therapy Group (n ¼ 52)
Average age 52 (16–91) y 36.5 (12–71) y 41 (12–91) y
Males 23 (48%) 26 (50%) 49 (%)
Females 25 (52%) 26 (50%) 51 (%)
Lesion characteristics:
Discitis 38 (79%) 38 (73%) 76%
Vertebral body 9 (19%) 8 (15%) 17%
Multilevel 1 (2%) 6 (12%) 7%
Levels
Cervical 3 (7%) 5 (10%) 8%
Cervico-thoracic 4 (8%) 3 (6%) 7%
Thoracic 16 (33%) 15 (29%) 31%
Thoraco-lumbar 11 (23%) 11 (21%) 22%
Lumbar 11 (23%) 10 (19%) 21%
Lumbo-sacral 1 (2%) 2 (4%) 3%
Sacral 1 (2%) Nil 1%
Multifocal 1 (2%) 6 (11%) 7%
Presentation Spinal pain-all Spinal pain- all 27 (27%)
Neurologic deficit (<than Neurologic deficit (<than
Frankel Grade C) 15 (31%) Frankel Grade C) 12 (23%)
Diagnosis
Smear positive 11 (23%) 12 (23%) 23 (23%)
Culture positive 13 (27%) 14 (27%) 27 (27%)
Initial surgery needed (28/42 vs 18/52)

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 RANDOMIZED TRIAL Six vs. 12 Months of ATT in Patients With Biopsy Proven Spinal TB  Nene et al
TABLE 2. Outcomes
12 Months Anti Tubercular
Parameters Therapy Group (n ¼ 48)
Average follow-up 51 (26–75) months
Primary endpoint: -Cure þ No 48
recurrence
Cure at the end of treatment 47 patients
Anti-tubercular therapy alone 20 (41.7%)
Surgery needed 28 (58.3%)
Drugs withdrawn (because of side 2 patients (ethambutol discontinued
effects) due to visual complaints)
ATT indicates anti tubercular therapy.
100 patients met the criteria for cure at the time of completion
of ATT. One patient in the 12 months group had residual
neurological dysfunction at the time of completion of treat-
ment, which completely resolved over the next 12 months.
There was no recurrence of disease in any of the 100 patients in
the 24 months follow up following completion of ATT. There
were no major drug induced hepatitis necessitating alteration of
drug regime. Two patients (both in 12 months group) devel-
oped visual symptoms and ethambutol was withdrawn. One
patient (12 months group) needed delayed percutaneous drain-
age of an abscess. None needed surgical re-exploration for
persistent infection or implant removal (Table 2).
DISCUSSION
A recent review1 on the management of tuberculosis has made
the following observations. A 6-month course drug therapy
with appropriate doses of the four standard first line drugs
(isoniazide, rifampicin, ethambutol, and pyrazinamide) is the
standard form of therapy. This regime results in cure of drug-
susceptible tuberculosis, with less than a 5% to 8% chance of
relapse.2,5,6 When relapse occurs, it usually happens within
12 months after the completion of therapy, indicating that the
disease was incompletely treated.7 The authors also note that
though all the guidelines recommend use of the same regimen
for the treatment of drug-susceptible tuberculosis, there are
some variations in regime and duration. World Health Orga-
nization (WHO)8 does not recommend extension of treat-
ment for any patients, Indian guidelines9 recommend
continuation of ethambutol for the full 6-month course,
US guidelines10 suggest that persons with a cavity on the
baseline chest film and a positive sputum culture at 2 months
should receive an additional 3 months of consolidation ther-
apy, German guidelines11 suggest extending therapy in the
case of persistent bacteria in a smear or extensive disease, and
Canadian guidelines12 recommend extending treatment if
cultures remain positive or cavities persist.
There are no robust guidelines on the optimum duration of
ATT for spinal TB. All recommendations are based on
extrapolation of guidelines used for duration of chemother-
apy for pulmonary or other forms of TB, with variation of
reported practice patterns.13–16 There are no defined
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6 Months Anti Tubercular
Therapy Group (n ¼ 52)
57 (28–78) months 52 (26–78) months
52
51 (one patient in 6 mo group failed,
and continued ATT for 12 mo)
34 (65%) 53 (53%)
18 (35%) 47 (47%)
None
reference points for ‘‘healed status’’ whether it is clinical,
radiological, or on laboratory parameters.4 Repeat tissue
sampling at the end of treatment or at a later point would
be considered proof of cure, but this is not pragmatic for
spinal TB. Expert groups and earlier practices suggest longer
durations of ATT, citing a variety of plausible but unproven
reasons, including poor penetration of ATT drugs in the
nervous and skeletal system, or poor radiological resolution
of the lesions.
Our center, a tertiary care hospital has been academically
and clinically involved all aspects of management of TB,
including development of newer diagnostic tests17,18, and
documenting and managing drug resistant TB.19–21 We
have previously documented the reducing needs for surgery
for thoracic and lumbo-sacral TB22–24 and have also
highlighted the emerging problem of spinal MDR-TB.3
The medical and orthopedic departments have been spread-
ing awareness about importance of establishing diagnosis
and need for systematic and competent treatment.25 The
two basic tenants emphasized in the orthopedic community
are the need for tissue diagnosis, preferably microbiological,
and the need for specialist supervision of the ATT regime. It
is further emphasized that starting or changing an ATT
regime, based only on clinical evaluation, is leading to an
epidemic of inadequately treated and resistant form of
spinal TB. This has resulted in an increasing number of
early referrals, prior to the empirical initial of ATT.
We used 6 months as the minimum acceptable treatment
duration, as this remains the standard set by the WHO for
treatment of TB. Twelve months of ATT has been the most
commonly duration amongst the key opinion leaders and
this also seemed to work well for our more than 200
unpublished historical controls.
Many spine surgeons feel compelled to continue medica-
tions when the MRI shows ‘‘residual soft tissue,’’ even though
the patient is clinically improved, or when the MRI has
resolved but the patient continues to have back pain at the
site of the disease. Clearly, both approaches are faulty, as MRI
cannot differentiate active infection from sterile residual soft
tissue, and many patients continue to have back pain due to
several reasons even after TB has healed. The only other way,
January 2019
 RANDOMIZED TRIAL Six vs. 12 Months of ATT in Patients With Biopsy Proven Spinal TB  Nene et al
then to prove that the infection has actually been eradicated
would be when the patient continues to improve clinically
and radiologically for a reasonable time period after stop-
ping ATT. We considered 2 years post completion of ATT
to be a reasonable time period, to consider that the original
disease had healed, and any infection after this could be
considered disease recurrence rather than residual infec-
tion.
This study has several strengths in terms of its biopsy
proven diagnosis of spinal TB, its prospective randomized
design, and extended duration of 2 years of follow up, after
completion of ATT. Our study has some weaknesses that
need to be considered. It was a single center study. Previously,
many patients would be referred after unproven diagnosis
and/or failing treatment. With growing awareness, a large
number of patients are now referred early for diagnosis and
treatment. This resulted in a compliant and motivated cohort
of patients, which explains the 100% rate of compliance for
both the diagnostic procedures and therapy. Another weak-
ness was that it was an open labeled study. It was not
pragmatic for a single center investigator initiated study to
dispense the whole drug regime including a placebo regime
for the second 6 months for the patients in the shorter regime
group. The third potential weakness is that despite randomi-
zation, there were more patients requiring surgery at presen-
tation in the 12-month group (28/48 vs. 18/52 P ¼ 0.0268). It
is possible that this biased the results in favor of 6 months,
though our high 100% success rate suggests that 6 months is
effective in the surgical subgroup. The fourth potential weak-
ness is the sample size. Despite being a large tertiary referral
center with previous experience, there were still a limited
number of patients we could enroll. For a non-inferiority
study, if we assumed a base line recurrence rate of 4%, with a
4% non-inferiority limit, we would have required a sample
size either of 824 or 594 patients for a 90% or 80% power,
respectively. This would not be feasible or pragmatic for a
single center investigator initiated study. Another potential
weakness is that either histopathology or microbiology was
taken as a proven diagnosis. Ideally microbiology alone
should be the diagnostic criteria, but this is known to be
negative in many forms of TB and would result in too many
false negative diagnoses. At the time of patient enrollment, we
did not routinely use molecular diagnostics that can give early
diagnosis, but now do it routinely. The limitation of these
techniques (M.Tb.Gene Xpert or Line Probe Assay) is that
they detect TB DNA and hence cannot differentiate between
live or dead bacteria, though this is of more relevance in those
who have previously received ATT.
CONCLUSION
In this pilot study we found that, in patients with biopsy
proven spinal-vertebral TB, 6 and 12 months of ATT give
similar clinical outcomes at 24 months. This suggests that
therapy can be safely stopped at the end of 6 months in
patients without drug resistance, who meet criteria of clini-
cal and radiological of cure.
Spine
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Key Points
This is a single center pilot study on, prospective
randomized clinical trial.
The study, compares 6 months of ATT to 12
months, in biopsy proven spinal TB. Healing was
assessed at 2 years post completion of ATT.
Out of 100 patients who met criteria for cure at
completion of treatment, there were no disease
recurrences on the 24 months follow-up following
after completion of ATT.
This study concludes that, in patients with biopsy
proven spinal-vertebral, TB, 6 and 12 months of
ATT give similar clinical outcomes.
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