FCPS Dissertation Research Protocol

Protocol no.

1 Date of

Submission of

Protocol

2 Relevant Faculty Orthopaedic Surgery

of BCPS

3 Name of the D R M O H A M M E D N A Y E M

Examinee H O S S A I N

4 Address of 103, Mission Saleha lodge

correspondence Kakrail, Dhaka.

of the examinee Mobile-01710706705

and contact

phone numbers

5 Title of the Evaluation of neurological outcome of unstable spinal fracture

dissertation managed surgically using pedicular screw rod fixation system.

research

6 Summary The spinal trauma is one of the leading problems in

Orthopaedic practice now a day. The most common causes of
spinal fractures are high-energy traumas, traffic accidents or
falls from heights. Biomechanically, the thoracolumbar junction,
transition zone is susceptible to injury and is the most
commonly injured portion of the spine. Vast majority of spine
fractures in this region are unstable and often associated with
neurological deficit, which is a direct consequence of the spinal
cord damage. Fractures may be treated with surgical or
nonsurgical methods. With the advancement of technology and
better surgical skill modern trends refers to manage the

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 unstable fracture surgically. It is well documented in various
studies that the best result can be obtained by surgical
treatment. The goal of the surgical treatment of unstable
thoracolumbar injuries is optimizing neural decompression
while providing stable internal fixation over the least number of
spinal segments. Transpedicular screw fixation is one of the
methods of surgical treatment. The aim of the present study is
to evaluate effectiveness of spinal stabilization with pedicular
screw in the management of thoraco-lumbar fractures in
restoring structural stability and improving neurological status
of the patient.
This prospective type of study will be carried out in National
Institute of Traumatology and Orthopaedic Rehabilitation
(NITOR) for one year from the date of submission of protocol.
Total 30 patients fulfilling the inclusion criteria will be included
in this study to evaluate the neurological outcome after fixation
of unstable spinal fracture with pedicular screw. Informed
written consent will be taken from the selected patients.
Regular follow up will be done for each patient at least 6(six)
months after operation. Results will be evaluated according to
prescribed scoring system ASA. Data will be analyzed by
SPSS data analysis program version 20. Level of significance
will be set at 0.05 (P<0.05).

7 Study setting / National Institute of Traumatology and Orthopaedic

place of study Rehabilitation (NITOR) and other Specialized Hospitals

8 Study period 1 year from the date of submission of protocol

9 Overview of the The study will be prospective type of study

study design

10 Introduction / Trauma to spine is one of the grave injuries especially if there

is neurological involvement. They cause infinite morbidity and
context
disability to the patient. If not treated promptly and rationally,
2
patient might be confined to bed for his life [1]. This also
causes economic and emotional burden to family in particular
and society in general. Thoracolumbar spinal segment is the
2nd most commonly involved segment after the cervical
segment in spinal injuries, about 30 to 60% of all spinal injuries
and 15 to 20% patients with fracture at thoracolumbar level
have associated neurological injury [2].
The functional consequences of spinal cord injury are usually
described by terms of severity and pattern of neurologic
dysfunction. Complete spinal cord injury, incomplete injury, or
transient spinal cord dysfunction describe different grades of
severity of neurologic injury. The neurological examination of
the patient means a complete examination of sensory, motor,
superficial and deep reflexes. In cases of neurological damage,
it is necessary to determine the exact grade of motor
impairment and of sensory functions [3]. The classification and
gradation of neurological damage in patients with the fractures
of thoracolumbar spine are determined according to the
Frankel scale and ASIA (American Spinal Injury Association)
score [4].
An unstable injury is one in which there is a significant risk of
displacement and consequent damage or further damage to
the neural tissues. In assessing spinal stability, three structural
elements must be considered: the posterior osseoligamentous
complex (or posterior column) consisting of the pedicles, facet
joints, posterior bony arch, interspinous and supraspinous
ligaments; the middle column comprising the posterior half of
the vertebral body, the posterior part of the intervertebral disc
and the posterior longitudinal ligament; and the anterior column
composed of the anterior half of the vertebral body, the anterior
part of the intervertebral disc and the anterior longitudinal
ligament. All fractures involving the middle column and at least
one other column should be regarded as unstable [5].
The treatment options for unstable thoracolumbar spine
3
fractures and fracture dislocation have long been controversial.
Lately consensus is evolving around the world for stabilization
of spine, with fusion and instrumentation [6,7]. The indications
for the surgical treatment of the patient are determined by the
level of fracture stability, neurological status of the patient and
spinal cord injury.
Surgical treatment is generally recommended for patients with
neurologic deficits or in those with severe instability. Common
surgical options include anterior approach decompression and
reconstruction, posterior pedicle screw fixation, and combined
anterior- posterior approach. Each technique has advantages
and disadvantages. No ideal surgical approach exists at
present. By anterior approach we can decompress nerves
sufficiently and provide reliable anterior column support.
However, this approach requires longer operation duration and
the rate of approach related complication and the death rate is
significantly higher than posterior approach. Although the
combination of anterior and posterior approach can provide the
most stable biomechanical repair, the operation time,
complication and morbidity rate might be apparently higher
than that of the single approach [8]. Currently posterior
pedicule screw internal fixation is one of most common
operative approaches to treat unstable fracture in our country.
In pedicular screw instrumentation, fixation is achieved is more
rigid as the screw is passed through force nucleus of the
vertebra. This is the point through which five anatomical
structures – the superior facet, the inferior facet, the lamina the
pedicle and the transverse process; channel all the posterior
forces transmitted to the body [9].

In this study, we will stabilize cases of thoracic and lumbar

unstable spinal lesions with pedicle screw and rod fixation and
evaluated all patients for neurological improvement after
stabilization.
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11 Rationale of the Management of unstable fracture manage is a real challenge
for a orthopaedic surgeon in our context. The treatment of such
study
patients is long, expensive and followed by permanent
disability of patients. Different schools of thoughts for each
modality, ranging from conservative management to
anterior/posterior instrumentation systems for fixation, have
proved that neither is an ideal method. Nonoperative treatment
of fractures without neurologic deficits with bed rest, postural
reduction, and bracing has been proposed, with variable
results [10]. After conservative treatments, there are many
reports on worsening spinal stenosis, increasing the pressure
on the vertebral body and deteriorating the neurological
functions as well as risk of complication due to recumbency. In
contrast, although the surgical therapy is physically invasive for
patients, it can offer immediate spinal stability, early
mobilization, decompression of neural elements, and more
reliable correction of deformity. [11,12].
Surgical stabilization and fracture fixation lead to better
neurological functioning in patients with the spinal cord injury,
especially in early surgical decompressions, stabilizations and
fixations [13]. The main advantages of the internal fixation of
unstable spine fractures are shorter hospitalization stay, early
rehabilitation, deformity prevention and prevention of other
complications which are caused in non- surgically treated
patients. In a country like Bangladesh, where there is acute
shortage of hospital facilities and trained manpower.
conservative management, more often end up as benign
negligence. Internal fixation and stabilization of spinal lesion
allows early mobilization of all patients, regardless of
neurological deficit, while protecting the neurological structures
from further injury and enhancing their recovery [14].
The main goals of surgical treatment are to achieve reduction,
stability, and early painless mobilization and to provide a
reasonable chance of neurological recovery [15]. The pedicle
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 screw plate or rod construct helps to achieve all these [16].
Hence, the present study aimed to determine the role of
fixation and stabilization in the management of unstable spinal
fracture by pedicular screw and assess postoperative results
by performing objective evaluation of patients.
12 Research Short segment trans-pedicle posterior fixation is helpful for not
only stabilization of the fractures and restoration of anatomy of
question/
unstable spinal fracture but also good neurological outcome.
hypothesis

13 Objectives a. General objectives:

To assess the neurological and functional outcome in the

unstable spinal fracture with incomplete neurological deficit

after stabilize with pedicular screw and rod system.

b. Specific objectives

Specific objectives of the present study will be to

i. assess preoperative neurological status using ASIA scale.
ii. assess the stability of fracture clinically and radiologicaly.
iii. stabilize the fractures using pedicular screw.
iv. immediate post operative evaluation of neurological status.
v. find out post operative complications in consecutive follow-
ups. (per-operative and post operative)
vi. compare neurological status of last follow-up with
preoperative status.

14 Materials and a. Main outcome Age, sex, hospital stay, treatment

methods variables to be outcome, type of operative procedure,

studied complication, pattern of fracture,

mechanism of injury, type of

neurological involvement.

b. Confounding Implant failure, Complication,

6
variables rehabilitation facilities

c.Study Patients with unstable thoracolumbar

population fracture treated by pedicular screw

fixation in the National Institute of

Tramatology and Orthopaedic

Rehabil;itation (NITOR), Dhaka will

be taken as study population.

d. Sample size Sample size will be calculated by using

the following formula.

Z2 pq
d2
n=

n= required sample size

z= confidence limit = 1.96

p= prevalence = 1%= 0.99

q= 1-p= 1-0.1= 0.99

d= acceptable standard error = 0.5

(1.96)2 x 0.01 x 0.99
n= (0.5)2

= 15

According to this formula the required

sample is 15. So, 30 samples will be

taken for good result.

e.Screening Clinical and Radiological

methods

f. Sampling Purposive and convenient

methods

g. Inclusion and Inclusion criteria:

7
exclusion criteria

1. Unstable fractures with incomplete

neurological deficits.
2. Unstable fractures with greater
than 20 degree kyphotic deformity
and 50% decrease in vertebral
height collapse without
neurological deficits.
3. Patients with complete spinal cord
injury for the purpose of
stabilization.
4. Contiguous fractures of
thoracolumbar spine.

Exclusion criteria:

Pathological fractures.
2. Fractures managed conservatively.
3. Patients not willing to undergo
surgery.
4. Medically unfit for surgery
5. The patients with pre-existing
systemic illness or associated extra
spinal injuries.
h. Operational N/A

definition

i. Flow chart Planning for research

Discussion with supervisor & selection

of the title for research

8
 Study population

Study sample

Preparation of the questionnaire to

collect socio-demographic & other

relevant data

Pretesting of the research instrument

Submission of research protocol for

approval

Data collection

Data processing & analysis

Report writing

Submission of research findings

to BCPS for dissertation

i. Procedures of Information about patients will be taken

by the researcher.
preparing and 1. Records of particulars of the
patients, physical examination will
organizing
be taken from research
materials
associates/admission form.
9
 2. Details about the operative
findings from the operation notes.
3. Post operative outcome will be
assessed by regular follow-up
and recording of that data.
k.Quality All data collection tools will be
pretested.
control:
The investigator himself will collect
the data
Data will be shown to the the
corresponding Guide/Supervisor
weekly for feedback and necessary
correction.
l. Randomization N/A

and blinding

methods

m. Equipments to Equipments (including common &

be used special instruments) for the study are

available

n. Procedures of Detail history, physical examination,

necessary laboratory and radiological
collecting data
investigations, the details of the operative
procedure and post operative finding will
be recorded in a pre-designed case record
form.
o. Professional My guide & other teachers of

assistance from Orthopaedic surgery.

experts

p. Procedure of Collected data will be clean & edited.

data analysis of Data will be analyzed using computer

10
 interpretation based programme statistical package

for social science (SPSS) for windows

version 20. Using appropriate test will

be done at significance level (P<0.05).

q. Quality The data was collected by the

assurance researcher himself

strategy

r. Time table 1 year from the date of submission of

protocol.

15 Ethical Written informed consent will be taken from each patient. Prior

implication to consent they will be explained the aim and purpose of the

research. No data or any information will be collected without

permission of the patient. The respondents will remain entirely

free to withdraw their participation at any stage or at any time

of the study. Confidentiality will be assured and anonymity will

be maintained. Ethical permission will be taken from the

institutional ethical committee.

16 Total budget Eighty thousand taka (instrument purchase, printing, binding

etc)

17 Source of Self funding

funding

18 Facilities 1. Independent spinal unit.

available at the 2. Separate paraplegic ward.

place of study 3. Well equipped duty doctor room.

4. Well equipped spinal operation theatre with C-arm

11
 support.

19 Other facilities Department of physical medicine provide physiotherapy to

needed patients at NITOR

20 Dissemination The findings derived from the study will be disseminated

and use of the through scientific seminar and publication of the same in

findings scientific journal.

21 References 1. Robert W. Bucholz, James D. Heckman. Rockwood and

Greens Fractures in adults. Lippincott Williams and Wilkins.

5th edition; Volume 2; 1293-1466, 2001.

2. Riggins RS. Kraus JF. The risk of neurological damage with

fractures of the vertebrae. Journal of Trauma 1977; 126-

133.

3. McCullen GM, Yuan HA, Fredrickson BE. Thoracolumbar

Spine injuries. In:AnHS,ed.Spine surgery. Baltimore:

Williams&Wilkins,1997:359-84.

4. Milenković S, Saveski J, Trajkovska N, Vidić G, Radenković

M .Transpedicular Screw Fixation of Thoracolumbar Spine

Fractures.Scientific Journal of the Faculty of Medicine in

Niš 2010;27(2):63-68

5. Louis Solomon, David Warwick, Selvadurai Nayagam.

Apley’s System of Orthopaedics and Fractures, Hodder

Arnold, 9th edition ,805, 2010.

6. Rae R Jacobs, Michael P. Casey. Surgical management of

thoracolumbar spine injuries.Clinical Orthopaedics and

related research 1984; 189 : 22-34.

7. Danisa OA, Shaffrey CI, Jane JA. Surgical approaches for

12
 correction of unstable thoracolumbar burst fracture: A

retrospective analysis. J Neurosurgery 1995; 83 :977.

8. Kothe R, Panjabi MM, Liu W. Multidirectional instability of

the thoracic spine due to iatrogenic pedicle injuries during

transpedicular fixation. A biomechanical investigation.

Spine (Phila Pa 1976) 1997; 22:1836-42.

9. Francaviglia N, Bragazzi R, Maniello M, Berucci C: Surgical

treatment of fracture of thoracic and lumbar spine via the

transpedicular route. British Journal of Neurosurgery. 1995;

9(4): 511-8.

10. Marvin R Leventhal. Fracture, dislocations, and fracture

dislocation of spine, chapter 35, vol 2 10 th edition. Edt

Canale S. Terry Missouri, Mosby 2003; 1597-1690.

11. J. Siebenga, V. J.M. Leferink, M. J. M. Segers et al.,

“Treatment of traumatic thoracolumbar spine fractures: a

multicenter prospective randomized study of operative

versus nonsurgical treatment,” Spine, vol. 31, no. 25, pp.

2881–2890, 2006.

12. H. Y. Kim, H. S. Kim, S. W. Kim et al., “Short segment

screw fixation without fusion for unstable thoracolumbar

and lumbar burst fracture : a prospective study on selective

consecutive patients,” Journal of Korean Neurosurgical

Society, vol. 51, no. 4, pp. 203–207, 2012.

13. Roop Singh1, Rajesh Kumar Rohilla1, Kulbhushan Kamboj1

Outcome of Pedicle Screw Fixation and Monosegmental Fusion

In Patients with Fresh Thoracolumbar Fractures .Asian Spine J

13
 2014;8(3):298-308.

14. Southwick WO, Robinson RA. Surgical approaches to

vertebral bodies in cervical and lumbar region.JBJS Am

1957; 39(A): 631-644.

15. Khare S, Sharma V. Surgical outcome of posterior short

segment trans-pedicle screw fixation for thoracolumbar

fractures. j o u r n a l of or t h o p a e d i c s 1 0 ( 2 0 1 3 )

1 6 2 e1 6 7

16. V.M. Thomson, Arun B, Anwar Marthya. Thoracolumbar

vertebral fractures - A review of literature. J Orthopaedics

2004; 1(2): 4.

22 Any other N/A

relevant

information

23 I solemnly pledge that this research protocol shall be implemented in accordance

with the relevant ordinance / circulars of BCPS and funding agencies as and when

it may be applicable.

I hereby declare that no part of the proposed research has been used in any

thesis / dissertation in partial fulfillment of any degree / fellowship or in any

publication.

I also understand that the BCPS reserves the right of accepting or rejecting this

protocol

14
 ……………………….. …………………………………….

Date Signature of the researcher

24

………………………………....

Signature of the supervisor

Dr. Md. Shah Alam

FCPS (Surgery), MS (Orthopedic surgery),
FRCS(Orthopedic surgery)
Professor of Ortho & Spine Surgery Department,
NITOR

Seal:

INFORMED WRITTEN CONSENT

1. Protocol ID.

15
1. Title of the study: Evaluation of neurological status after spinal stabilization with

pedicular screw rod fixation system in unstable spinal fracture.

3. Investigator name: Dr. MOHAMMED NAYEM HOSSAIN

4. Institution: NITOR, Dhaka.

5 Purpose & nature of the study: To determine the neurological outcomes after

spinal stabilization with pedicular screw rod fixation system in unstable spinal

fracture.

6. Selection of participant: Patients suffering from unstable thoracolumbar fracture.

But there is no slandered study about neurological outcome after stabilization

with pedicular screw and rod system surgical management till date. The study will

provide some important information in our national data base.

7. Expectation from and involvement of the participant: the participants will be

hospital admitted patient at first. Relevant history, clinical examination findings &

investigations report will be recorded. The selected patient will under gone

operative procedure after proper counseling. Treatment outcome will be observed

at postoperative follow up subsequently.

8. Risk and benefits: Neurological status improvement, prevent complications of

paraperesis, early rehabilitation. Risks are hazards of anaesthesia and

complications of major surgery. Proper counselling, Preoperative investigations

& check up and physiotherapy will be done to combat the risks.

16
9. Privacy, anonymity and confidentiality: During study the privacy, anonymity and

confidentiality of the patient will be safeguarded.

10.Right to withdraw: It is declared that participant shall have the right to withdraw

from this study at any point of time.

11.The investigator’s responsibility for medical care: During study period the

investigator will maintain an intimate relationship regarding history taking, clinical

examination, investigations, counseling, preoperative, preoperative and

postoperative care.

If you agree to my proposal enrolling you in my study, please indicate that by putting

your signature or your left thumb impression at the specified space below.

Thank you for your cooperation.

Signature or left thumb impression Signature or left thumb of the

participant. Attendant/guardian.

17
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18
 DATA COLLECTION SHEET

Case no:

Particulars of the Patient:

Name-

Age-

Sex-

Occupation-

Address:

Hospital Information

Unit-

Ward-

Bed no

Reg.no

Date of admission-

Date of examination-

Date of Operation-

Date of Discharge-

Date of last follow up

Economic Status:

Etiology of spinal fracture:

 Fall from hight

 Road traffic accident

 Others

19
  Type of nurological involvement

 Mild

 Moderate

 Severe

Clinical presentation on admission:

Common symptom
Back Pain
Numbness
Paresthesia
Paraplegia/Paraparesis
Shock
Retention of urine
Common signs

Spinal Shock
Sensory loss
Motor weakness
Bowel and bladder dysfunction

Grade of neurological deficit

 Mild

 Moderate

 Severe

General Examination:

Appearance: Pulse:

Intelligence: Temperature:

Body built Respiratory rate:

Decubitus: B.P:

Anaemia:

Jaundice:

Cyanosis:

20
Clubbing

Neck gland

Systemic Exam:

Cardiovascular System

Respiratory System

Alimentary system

Renal System

Clinical diagnosis

X-ray Findings:

 Anteroposterior view

 Lateral view

 Oblique view

MRI Findings:

CT Scan

Others

Fracture level :

Diagnosis

i) Burst fracture

ii) Compression fracture

Pre-operative

ASIA grade :
21
 Cobb angle :

Beck index :

Kyphotic deformation of the vertebral body :

Measurement of vertebral body compression :

Plan of Management:

Conservative

Operative

Operation Note:

Date : Assistant:

Time Anesthesia:

indication : Approach:

Name of operation Findings

Surgeon

Per operative Complication

Dural tear

Root injury

Undue bleeding

Post operative complication

 Wound infection :
22
  Breakage of implant / Hardware failure

 Persistent Pain

 Worsening of neurological status

Results

 Excellent

 Good

 Fair

 Poor

Condition on discharge:

Yes No
1. Can walk unsupported
2. Need support for walk
3. Can’t walk even with support
4. Bladder problem
5. ASIA impairment score

Advice given

REHABILATION

Follow-up (After 6 weeks)

Infection :

Pain :

ASIA score improvement :

Follow up (After 3 months)

Infection :

Pain :
23
ASIA score improvement

Follow up (After 6 months)

Infection :

Pain :

ASIA score improvement

Final evaluation

Modified Macnab criteria for characterizing outcome after surgery (Macnab 1971)

Result Criteria
Excellent No pain, no restriction of mobility, return to work and level of
activity.
Good Occasional non-radiated pain, relief of presenting symptoms,
able to return to modified work.
Fair Some improved functional capacity, still handicapped and
unemployed.
Poor Continued objective symptoms of root involvement, additional
operative intervention need at the index level irrespective of
length of post operative follow-up.

 Satisfactory = Excellent + Good

 Unsatisfactory = Fair + Poor

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