Templet to prepare TITLE & SYNOPSIS

Sr.
Item Guidelines
No.
Analysis of morbidity and mortality pattern in operated
01) Title :-
proximal femur fractures in elderly

Proximal femur fractures includes intracapsular and extracapsular

02) Introduction :-
fractures of proximal femur. Intracapsular fractures included
subcapital and transcervical fractures; extracapsular fractures
included basal, trochanteric, pertrochanteric, and subtrochanteric
fractures (within 5 cm of the lesser trochanter).
Proximal femur fracture is still an important cause of mortality Most
deaths occur in the first 3 to 6 months
Common problems for subtrochanteric femur fractures are delayed
union, malunion and non-union. Malunion in the form of shortening,
angular deformity and rotational malalignment were common after
such fractures
Intertrochanteric (IT) fracture account for nearly 50%of all fracture
of the proximal femur. IT fractures represent a major public health
problem and is most serious complication of osteoporosis in elderly
persons These sort of fractures are prevalent in older people with
osteoporosis following minor trauma and contributes to both
morbidity and mortality in elderly patients

To analyze morbidity and mortality in operated proximal femur

3.1) Primary Research
fractures in elderly.
Question :-

3.2) Secondary
Research Question
1 :-
(if any)

3.3) Secondary
Research Question
2 :-
(if any)
There is an association of the mortality and morbidity
4.1) Primary Hypothesis
in operated proximal femur fractures in elderly.
:-

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 4.2) Other Hypothesis
1:-
(if any)

4.3) Other Hypothesis 2

:-
(if any)

Many studies have been conducted so far to analyze the mortality

05) Review of
and morbidity in operated proximal femur fractures in elderly.
Literature :-
The literature has focused on mortality and morbidity rates.
Sir Astley Cooper (1768-1841), the outstanding English surgeon
published his book on management of fractures and dislocations
(1825). He classified the fractures at the upper end of femur into:
1. Intracapsular fractures
2. Extracapsular fractures
3. Fractures through greater trochanter.
This classification is still valid. He also recognized the difference in
prognosis of intracapsular and extracapsular fractures of neck of
femur
The internal fixation of fractures with metal plates and screws was
reported by Sir Arbuthnol lane of London in 1894 and by
Albinlambotte of Belgium. The introduction of the Tri-flanged nail
by Smith-Peterson (1931) for the treatment of fracture neck of femur
has resulted in a great reduction of mortality and improvement in the
percentage of union
Simmermacher RK et a12 reviewed 191 patients having proximal
femoral fractures treated with proximal femoral nail in one year.
After a follow up period of 4 months technical failures were seen in
just 4.6% of the cases. They concluded that the result of this new
implant compare favourably to the currently available implants for
the treatment of the unstable pertrochanteric femoral fractures.
To study the mortality and morbidity associated with operated
6.1) Primary
proximal femur fractures in elderly
Objectives :-

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 6.2) Other Objectives
1:-
(if any)

6.3) Other Objectives

2:-
(if any)

STUDY DESIGN: Prospective study

07) Methodology :-

SAMPLE SIZE: 120 patients

DURATION OF STUDY: After getting acceptance from

Institutional Ethics committee, the study will be conducted in
duration of 6 months.

SAMPLING METHOD: Simple random sampling

STATISTICAL DATA ANALYSIS: Statistical data analysis will

be done using multivariant ANOVA and descriptive statistics.

INCLUSION CRITERIA:

Patient age >60 years

Operated patients for proximal femur fracture with

hemiarthroplasty , plating and nailing

Patient belonging to both sex

Patient giving consent

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 EXLUSION CRITERIA

Pathological fractures of proximal femur

Patients managed conservatively

Patients suffered multiple fractures due to accident

Patients with Pipkins fracture

Patients with hip dislocation

Patients below age of 60 years

Patients with segmental fracture of femur where the second fracture

is in distal 2/3rd

PLACE AND AREA OF STUDY: Tertiary care centre

METHODOLOGY:
This is a prospective study which will be conducted on elderly
patients over 60 years of age suffering from proximal femur fracture
(intracapsular and extracapsular fracture) admitted in tertiary care
hospital for treatment and were managed operatively
(hemiarthroplasty ,plating and nailing). Patients will be assessed
based on medical records and by and interviewing them. Factors
such age , sex of patient will be taken into consideration. The length
of hospital stay will also be taken into consideration. Quality of life
assessment will be measured by harris proximal femur score.
Scoring of which will be done on the time of discharge and at first ,
second and third month of follow up.

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 1. Keene GS, Parker MJ, Pryor GA. Mortality and morbidity after
8) Reference Style :-
hip fractures. BMJ. 1993 Nov 13;307(6914):1248-50.
2. Muhm, M., Arend, G., Ruffing, T. et al. Mortality and quality of
life after proximal femur fracture—effect of time until surgery and
reasons for delay. Eur J Trauma Emerg Surg 39, 267–275 (2013).
3. Nasab SAM, Khorramdin E. The assessment of mortality and
quality of life after intertrochanteric fracture of femur in patients
older than 60 at Emam Khomeini Hospital of Ahvaz. Pak J Med Sci.
2017 Jul-Aug;33(4):895-898. doi: 10.12669/pjms.334.13146. PMID:
29067061; PMCID: PMC5648960.
4. Medda S, Reeves RA, Pilson H. Subtrochanteric Femur Fractures.
[Updated 2021 Jun 29]. In: StatPearls [Internet]. Treasure Island
(FL): StatPearls Publishing; 2021 Jan-. Available from:
https://www.ncbi.nlm.nih.gov/books/NBK507803/
5. Garrison I, Domingue G, Honeycutt MW. Subtrochanteric femur
fractures: current review of management. EFORT Open Rev. 2021
Feb 1;6(2):145-151. doi: 10.1302/2058-5241.6.200048. PMID:
33828858; PMCID: PMC8022017.
6. Marks R. Proximal femur fracture epidemiological trends,
outcomes, and risk factors, 1970-2009. Int J Gen Med. 2010 Apr
8;3:1-17. PMID: 20463818; PMCID: PMC2866546.
7. Mnif H, Koubaa M, Zrig M, Trabelsi R, Abid A. Elderly patient's
mortality and morbidity following trochanteric fracture. A
prospective study of 100 cases. Orthop Traumatol Surg Res. 2009
Nov;95(7):505-10. doi: 10.1016/j.otsr.2009.08.001. Epub 2009 Sep
26. PMID: 19783240.
8. Garden RS. Low angle fixation of fractures of the femoral neck. J
Bone Joint
Surg [Br] 1961;43:647-63.

9. Empana JP, Dargent-Molina P, Bréart G. Effect of proximal

femur fracture on
mortality in elderly women: The EPIDOS Prospective Study. J Am
Ger Soc 2004; 52: 685-90.
10. Jarman B, Aylin P, Bottle A. Discharge destination and length of
stay: differences between US and English hospitals for people
aged 65 and over. Br Med J 2004; 328: 605.
11. Zuckerman JD. Proximal femur fracture. N Engl J Med 1996;
334: 1519-25.
12. Roberts SE, Goldacre MJ. Time trends and demography of
mortality after fractured neck of femur in an English population,
1968-98: database study. Br Med J 2003; 327: 771-5.
13. Koval KJ, Skovron ML, Aharonoff GB, Zuckerman JD.
Predictors
of functional recovery after proximal femur fracture in the elderly.
Clin Orthop
1998; 348: 22-8.
14. Magaziner J, Simonsick EM, Kashner TM, Hebel JR, Kenzora
JE.
Predictors of functional recovery one year following hospital
discharge for proximal femur fracture: A prospective study. J
Gerontol 1990;
45: M101-7

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 15. Lyons AR. Clinical outcomes and treatment of proximal femur
fractures.
Am J Med 1997; 103: 51S-64S.
16. Schroder HM, Erlandsen M. Age and sex as determinants of
mortality after proximal femur fracture: 3895 patients followed for
2.5-18.5
years. J Orthop Trauma 1993; 7: 525-31.
17. Clague JE, Craddock E, Andrew G, Horan MA, Pendleton N.
Predictors of outcome following proximal femur fracture. Admission
time predicts
length of stay and in-hospital mortality. Injury 2002; 33: 1-6.
18. Marcantonio ER, Flacker JM, Michaels M, Resnick NM.
Delirium
is independently associated with poor functional recovery after
proximal femur
fracture. J Am Geriatr Soc 2000; 48: 618-24.
19. Myers AH, Robinson EG, Van Natta ML, Michelson JD, Collins
K, Baker SP. Proximal femur fractures among the elderly: factors
associated
with in-hospital mortality. Am J Epidem 1991; 134: 1128-37
20. Dzupa V, Bartonícek J, Skála-Rosenbaum J, Príkazský V. Umrtí
pacientů se zlomeninou proximálního femuru v průbĕhu prvního
roku po úrazu [Mortality in patients with proximal femoral fractures
during the first year after the injury]. Acta Chir Orthop Traumatol
Cech. 2002;69(1):39-44. Czech. PMID: 11951568.
21. Negrete-Corona J, Alvarado-Soriano JC, Reyes-Santiago LA.
Fractura de cadera como factor de riesgo en la mortalidad en
pacientes mayores de 65 años. Estudio de casos y controles [Hip
fracture as risk factor for mortality in patients over 65 years of age.
Case-control study]. Acta Ortop Mex. 2014 Nov-Dec;28(6):352-62.
Spanish. PMID: 26016287.

BIBLIOGRAPHY
DD Tanna. Tanna’s Interlocking nailing. Fourth edition.
2016.chapter 13. Subtrochanteric fractures. Page no.103

9) Timeline/Gantt The research will be completed in 6 month duration.

Chart :-

10) Annexures :-
1. Patient information sheet in English, Hindi and Marathi
PATIENT INFORMATION SHEET

A study is being conducted by the undersigned in the Dept. of

Orthopaedics on “Analysis of morbidity and mortality pattern in
operated proximal femur fractures in elderly.”
You are invited to participate in the above-mentioned study. This
study is purely observational study and does not involve any

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 additional invasive procedures or tests and hence does not carry any
additional harm to your patient. The study is sanctioned by the
Institutional Ethics Committee.
Baseline history taking, clinical evaluation, detailed examination
will be done. We will take radiographs of affected bone. The
standard of care for your fracture will not be affected by the study.
You will not be given any compensation for participating in the
study. Your participation is voluntary and refusal to participate
would not affect your patient’s treatment in any way. You have a
right to withdraw at any point of time without giving any reasons.
Your/ your patient’s personal details and reports will be kept
confidential.
We are thankful for your co-operation.

रोगी सूचना पत्र

अधोहस्ताक्षरी द्वारा ऑर्थोपेडिक्स विभाग, में " बुजर्गों
ु में संचालित समीपस्थ फीमर
फ्रैक्चर में रुग्णता और मृत्यु दर का विश्लेषण " पर एक अध्ययन किया जा रहा है।
आपको उपर्युक्त अध्ययन में भाग लेने के लिए आमंत्रित किया जाता है। यह
अध्ययन विशुद्ध रूप से अवलोकन अध्ययन है और इसमें कोई अतिरिक्त
आक्रामक प्रक्रिया या परीक्षण शामिल नहीं है और इसलिए आपके रोगी को कोई
अतिरिक्त नुकसान नहीं पहुंचाता है। अध्ययन को संस्थागत आचार समिति द्वारा
अनुमोदित किया गया है।
बेसलाइन हिस्ट्री लेना, क्लिनिकल मूल्यांकन, विस्तृत जांच की जाएगी। हम
प्रभावित हड्डी की रेडियोग्राफ लेंगे । आपके फ्रैक्चर की दे खभाल का मानक
अध्ययन से प्रभावित नहीं होगा। आपको अध्ययन में भाग लेने के लिए कोई
मुआवजा नहीं दिया जाएगा। आपकी भागीदारी स्वैच्छिक है और भाग लेने से
इनकार करने से आपके रोगी के उपचार पर किसी भी तरह का प्रभाव नहीं पड़ेगा।
आपको बिना कोई कारण बताए किसी भी समय वापस लेने का अधिकार है।
आपके/आपके रोगी के व्यक्तिगत विवरण और रिपोर्ट को गोपनीय रखा जाएगा।

रुग्ण माहिती पत्र

" वृद्धांमध्‍ये ऑपरेटेड प्रॉक्सिमल फेमर फ्रॅक्चरमध्‍ये विकृती आणि मृत्‍यु दराचे विश्‍
लेषण”.
आपल्याला उपरोक्त अभ्यासामध्ये भाग घेण्यासाठी आमंत्रित केले आहे. हा

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 अभ्यास पूर्णपणे निरिक्षणात्मक अभ्यास आहे आणि यात कोणत्याही अतिरिक्त
हल्ल्याची प्रक्रिया किंवा चाचण्यांचा समावेश नाही आणि म्हणूनच आपल्या
रुग्णाला कोणतीही अतिरिक्त हानी पोहोचवत नाही. संस्थात्मक नीतिशास्त्र
समितीने हा अभ्यास मंजूर केला आहे.

बेसलाइन माहिती घेणे, क्लिनिकल मूल्यांकन, सविस्तर तपासणी केली जाईल.

आम्ही प्रभावित हाडाचे रेडियोग्राफ घेऊ. आपल्या फ्रॅक्चरच्या काळजीच्या

मानकांचा अभ्यासावर परिणाम होणार नाही. अभ्यासा मध्ये भाग घेण्यासाठी

आपल्याला कोणतीही भरपाई दिली जाणार नाही. तुमचा सहभाग ऐच्छिक आहे

आणि सहभागी होण्यास नकार दिल्याने तुमच्या रुग्णाच्या उपचारांवर कोणत्याही

प्रकारे परिणाम होणार नाही. आपणास कोणतेही कारण न दे ता कोणत्याही वेळी

माघार घेण्याचा हक्क आहे. तुमचा/ तुमच्या रुग्णाचा वैयक्तिक तपशील आणि

अहवाल गोपनीय ठे वला जाईल

2. CASE RECORD FORM

TOPIC: Analysis of morbidity and mortality pattern in operated
proximal femur fractures in elderly

Name:

Age /sex:

O.P.D no/ Casualty no:

Address:

Date of trauma:

Date of surgery:

Diagnosis:

Type of surgery :

Associated comorbidities :

Scoring Chart
Name of Discharge 1st month 2nd month 3rd month
patient day follow up follow up follow up

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 3. Informed consent form in English , Hindi and Marathi

INFORMED CONSENT FORM

“Analysis of morbidity and mortality pattern in operated

proximal femur fractures in elderly.”
● I/we have been explained about this study in the language
which I understand (______) and all my questions have been
answered satisfactorily.

● I/we have been told that this is an observational study and no

additional invasion will be done.

● I/we have been told that my participation in above study is

voluntary and I am/ we are free to withdraw at any point of
time without giving any reason to do so.

● I am /we are also hereby informed that my refusal to

participate in the above study will not affect my treatment by
any means.

● I/we hereby give you the permit to publish information

regarding or obtained as a result of my participation in the
study.

● I/we understand that medical records that reveal my identity

will remain confidential unless required by the law or as
stated above.

● I/we understand that I/we will not get any financial

incentives for participation in this study.
I hereby agree to participate in the study and I shall fully
cooperate with my doctors throughout the study.

Investigator’s sign: Guardian sign:

Name: Name:
Date: Date:

Impartial Witness’ sign:

Name:
Date:

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 सहमती
" बुजुर्गों में संचालित समीपस्थ फीमर फ्रैक्चर में रुग्णता और मृत्यु
दर का विश्लेषण "
 मुझे / हमें इस अध्ययन के बारे में मुझे समझने वाली भाषा
(___________________) में समझाया गया है, और मेरे सभी सवालों
का संतोषजनक जवाब दिया गया है।
 मुझे / हमें बताया गया है कि यह एक अवलोकन आधारित अध्ययन है,
और कोई अतिरिक्त प्रयोग नहीं किए जाएंगे।
 मुझे / हमे यह बताया गया है कि मेरी इस अध्ययन मे सहभागिता ऐच्छिक
है तथा मै / हम इस सहभागिता से पूर्वसूचना दिये बिना कभी भी इसे छोड
सकते है या निकल सकते है ।
 मुझे / हमे यह भी सूचित किया गया है कि इस अध्ययन मे सहभागिता को
इनकार करने से इलाज पर किसी भी प्रकार का विपरितअसर नही होगा ।
 मै / हम इस अध्ययन मे सहभागिता से प्राप्त जानकारी को प्रकाशित करने
की अनुमति प्रदान करते है ।
 मै / हम समझते है कि मेरी पहचान दर्शानेवाला वैद्यकीय अभिलेक गुप्त
रखा जाएगा तथा केवल कानूनी या अन्य आवश्यकता के समय उसे प्रकट
किया जाएगा ।
 मै / हम जानते है कि मुझे / हमे इस अध्ययन मे सहभागिता के लिये कोई
आर्थिक लाभ या मानधननही मिलेगा मेरी इस अध्ययन मे सहभागिता के
लिये अनुमति है तथा चिकित्सकों (डॉक्टर्स) से संपर्ण
ू अध्ययन मे सहकार्य
रहेगा ।

अन्वेषक के हस्ताक्षर माता-पिता /

पालक के हस्ताक्षर
नाम : नाम :
दिनांक : दिनांक :

निष्पक्ष गवाह का हस्ताक्षर

नाम :
दिनांक :

सूचित सहमती
प्रपत्र
‍ े ऑपरेटेड प्रॉक्सिमल फेमर फ्रॅक्चरमध्य
" वृद्धांमध्य ‍ े विकृती आणि मृत्य ‍ ु दराचे
विश्ल‍ ेषण .”
 मला/आम्हाला या अध्ययनाबाबत मला समजणार्य ‍ ा भाषेत (मराठी)
समजविण्यात आले आहे.
 मला/आम्हाला सांगण्यात आले आहे की हे अवलोकन आधारित अध्ययन

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 आहे, इतर कुठल्याही प्रकिया किंवा तपासण्या कराव्या लागणार नाहीत.
 मला/आम्हाला सांगण्यात आले आहे की या अध्ययनात सहभागी होणे
ऐच्छीक आहे आणि मी/आम्ही या अध्ययनात सहभागी होण्यातून
कोणतीही सूचना दिल्याशिवाय निघून जाऊ शकतो किंवा सोडू शकतो.
 मी/आम्ही अध्ययनातील सहभाग घेणे मध्येच सोडू न दिल्याने रुग्णाच्या
दे खभालीवर कुठलाही विपरित परिणाम होणार नाही.
 मी/आम्ही या अध्ययनात सहभागी झाल्यानंतर प्राप्त झालेली माहिती
प्रकाशित करण्य़ाची परवानगी दे त आहोत.
 मी/आम्ही समजून आहोत की या अध्ययनातील सहभागी रुग्णाची अणि
त्याच्या पालकांची वैद्यकीय व अन्य माहिती गुप्त ठे वली जाईल आणि
कायदे शीर बाबी किंवा अन्य आवश्यकतां करिताच ही माहिती उघड केली
जाईल.
 मी/आम्ही समजून आहोत की या अध्ययनात सहभागी होण्याकरिता
सहभागिला कुठलेही मानधन दिले जाणार नाही.

माझी या अध्ययनात सहभागी होण्याला परवानगी आहे, आणि अध्ययन

‍ ा डॉक्टरांना माझे संपर्ण
संचालित करणार्य ू अध्ययनात सहकार्य राहील.

शोधकर्त्याचे हस्ताक्षर माता

पिता/पालक हस्ताक्षर
नाव : नाव :
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C:\Users\admin\Desktop\Title and synopsis final.doc [Page : 11]