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Manindra Protocol
Manindra Protocol
Manindra Protocol
THESIS PROTOCOL
REVIEW OF LITERATURE
STUDY DESIGN
ETHICAL JUSTIFICATION
PREOPERATIVE WORK UP
PROFORMA
FOLLOW UP
CONCLUSION
REFERENCESS
INTRODUCTION
OBJECTIVES
bipolar hemiarthroplasty.
REVIEW OF LITERATURE
These fractures were managed by conservative methods before
1930s when the age of fixation began Conservative treatment
regimes included, simple support with pillows or splinting to the
opposite limb, Buck’s (skin) traction, Well-leg traction, plaster
spica immobilization, Russell’s balanced traction and skeletal
traction through the lower femur or upper tibia. non surgical
treatment usually not preffered due to high mortality rate due to
commonly due to cardiopulmonary complications,
thromboembolism, and sepsis.
EVALUATION OF SURGICAL METHOD:
1).EVANS Classifications:
INTRATRACHANTRIC FRACTURE
REFUSE TO
CONSENT GIVEN GIVE
CONSENT
RANDOMIZATION
CONCLUSION
METHOD
The objectives and importance of this study shall be explained to the patients
recruited in the study and informed consent will be taken from all the patients.
The study proposal and ethical procedures shall be approved by the Ethics
Committee of Manipal hospital,Jaipur.
1) Study area:-
5) Study intervention:-
Evaluation will be done by history and clinical examination..
6) DATA Collection:- After obtaining the Institutional Ethics Committee
permission for the study, patients satisfying the inclusion criteria will be
enrolled in the study. Detailed history of the patient will be elicited from the
patient or the relatives or those accompanying the patient at the time of
admission. The patient will be subjected to clinical examination and laboratory
investigations as mentioned in the visiting schedule format designed for the
study.
8) Period of follow up:- The patients are followed up for a period of 6 month at
1 month , 3 month and 6 month .
9) Criteria for selection of patients:-
INCLUSION CRITERIA
a) AGE.>55 years
EXCLUSION CRITERIA
a) AGE<55 years
b) Bedridden patient before trauma
c) Polytrauma patient
d) Medically unfit for surgery
e) Fracture due to tumor or any other pathological cause
Clinical Evaluation :-
percentages .Student t test and fishers exact test will be applied for
(STATA CORP, TEXAS USA). p value < 0.05 will be considered statistically
significant.
ETHICAL JUSTIFICATION
The study will be conducted after obtaining the Institutional Ethics
Committee permission for the study, patients reporting to department of
orthopedics, Manipal Hospital, Jaipur and satisfying the inclusion criteria.
Informed verbal & written consent will be taken from the subject before
enrollment in the study and will be allowed to opt out any time without
constraints.
__________________________________________________________________________________
_____________________________________________________________________________
1. I confirm that the researcher has explained the nature, purpose and duration of the study.
2. I consent to take part in the study and am aware that my participation is voluntary.
3. I have received the information sheet and was provided adequate time to read and understand it.
5. My consent is voluntary.
6. I can withdraw at any point without giving any reason and this would not affect my future care.
7. My information can be accessed and looked at by the research team and relevant authorities
(including Ethics Committee and audit authorities). I give permission for this.
_______________________ ________________________
Name: Name:
_____________________
Signature of the person conducting the informed consent
Date: Name:
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मरीज सच
ू ना पत्र
1.अध्ययन शीर्षक: ‘इंट्राट्रोकैं ट्रिक फ्रैक्चर के उपचार के लिए दो शल्य क्रिया पो्क्षिमल
मैं डॉ. मनिंद्र सिंह शेखावत, डीएनबी प्रशिक्षु (हड्डी रोग विशेषज्ञ) मणिपाल
मैं आपको यहां आमंत्रित करता हूं और उसी में अपनी स्वैच्छिक भागीदारी का अनुरोध करता
हूं।
2.निमंत्रण अनुच्छे द: आपको एक शोध अध्ययन में भाग लेने के लिए आमंत्रित किया जा
रहा है । इससे पहले कि आप तय करें कि यह आपके लिए महत्वपूर्ण है ? यह समझने के
लिए कि अनुसंधान क्यों किया जा रहा है ? और इसमें क्या शामिल होगा? कृपया पढ़ने के
लिए समय निकालें,निम्नलिखित जानकारी को ध्यान से पढ़ें ,अगर वहाँ कुछ भी अस्पष्ट है
तो हमसे संपर्क करें तथा तय करें कि आप हिस्सा लेना चाहते हैं या नहीं।
के 2 शल्य उपचार पो्क्षिमल फीमोरल नैल एवं बाइपोलर हे मी आथो्प्लास्टी के परीणामो एवं
जटिलता का मल्
ु यांकन करना है
4. जोखिम: दर्द, इस अध्ययन की भागीदारी इससे अलग कुछ
7.अध्ययन से पीछे हटने का अधिकार: आपको अध्ययन के दौरान कभी भी अपनी भागीदारी
वापस लेने का अधिकार है । किसी भी स्तर पर अध्ययन में भाग लेने का विकल्प चुनने या
बाहर निकलने का आपका निर्णय इस संस्था में आपके द्वारा प्राप्त उपचार को प्रभावित नहीं
करे गा।
8.संपर्क विवरण: आपसे अनुरोध है कि इस अध्ययन या इसमें आपकी भागीदारी के बारे में
किसी भी प्रश्न के लिए मझ
ु से मेरे फोन नंबर (9509894557) पर संपर्क करें । मझ
ु े आपकी
बात सुनकर खुशी होगी। इसमें आपकी भागीदारी, इस अध्ययन में एक प्रतिभागी के रूप में
आपके अधिकार और आपकी शिकायतों का निवारण, यदि इस समय किसी भी अध्ययन में
आपकी भागीदारी से कोई समस्या उत्पन्न होती है ।
9. प्रक्रिया: इस अध्ययन में हम इंट्राट्रोकैं ट्रिक फ्रैक्चर के उपचार के लिए दो शल्य क्रिया पो्क्षिमल
और जटिलता का मल्
ु यांकन करें गे
10. गोपनीयता : मैं यहां घोषित करता हूं कि आपकी पहचान और चिकित्सा रिकॉर्ड परू ी
तरह से गोपनीय रखा जाएगा। मैं आपसे अनरु ोध करता हूं कि आप स्वेच्छा से इस अध्ययन
में भाग लें और मझ
ु े नीचे उपयक्
ु त स्थानों पर हस्ताक्षर करके अपने मेडिकल रिकॉर्ड तक
पहुंचने की अनम
ु ति दें |
PATIENT INFORMATION SHEET
PREOPERATIVE-WORK UP
Investigations
Blood – CBC
Urine – Routine and Micro.
Blood grouping and Rh typing
PT with INR , APTT
HIV, HbsAg, HCV
Blood Urea
Serum Creatinine
Blood sugar Level
Liver function test
Serum electrolytes
ECG
2 D Echocardiography(if required)
Chest X –ray PA.
Other if required
Physician opinion will be taken as to the fitness of patient before surgery and
when necessary.
Operative procedure:-
PFN:
Anesthesia:
Spinal anesthesia
Pre Operative antibiotics:
Patients will be given injection Cefuroxime 1.5 gm intravenously 30 minutes
before incision.
BIPOLAR HEMIARTHROPLASTY:
Anesthesia: spinal anesthesia
Pre Operative antibiotics:
Patients will be given injection cefuroxime 1.5 gm intravenously 30 minutes
before incision.
Position: Lateral decubitus position
Technique: After induction of anaesthesia patient put on lateral decubitus
position.MooreS approach for all the cases.10 cm curved incision centering over
GT. Short external rotators ligated and cut. Removal of head in
intertrochanteric fracture is difficult. Head extractor is put and capsule is
released all around.Other option is to cut it subcapitally with saw as in neck
femur fracture and then remove remaining neck with piecemeal. Fracture
pattern is assessed. Usually LT is reconstructed first to get a anatomical
landmark using SS wire. Then Canal is reamed and serially broached. Trial stem
put. Final stem is put with/without cement. Final head put after trial reduction.
Greater trochanter then fixed with k wires /encirclage/tension band wiring
depending on fracture pattern. Wound closed over negative suction drain.
Post Operative Management
Patients kept nil orally for 4 to 6 hours post-operatively. Intravenous fluid will
given if needed.
Antibiotics will continue for 7 days. (first 2 days iv then next 5 days oral
antibiotics.)
Analgesics and tranquilizers will given according to the needs of the patient.
Drain removed at POD-1.
Post operatively Abduction pillow kept .Side turning and sitting will be
allowed. All patient started full weight bearing walking with walker support
from POD-1.
The wound will inspect at 2ndpostoperative day.
Patient will discharge at around 2-3 days post-operatively. Suture/staple
removal will done on 15th postoperative day.
All patient will given DVT prophylaxis like aspirin/ DVT exercises till 3
month.
Follow up:
All patients will be followed up 1 month ,3 month and 6 month.
At each follow up patients will be assessed clinically for pain ,complications.
Post op picture of an IT fracture operated with Bipolar Hemiarthroplasty
PROFORMA
Name :
MRN No. :
Age/Sex :
Occupation :
Address :
Date of admission :
Date of surgery :
Date of discharge :
HISTORY :
Presenting complaints:
FAMILY HISTORY:
PAST HISTORY:
Diabetes
Hypertension
Ischemic heart disease
Asthma
Fracture or same event
Others
DRUG HISTORY:
a) Steroids
b) Aromatase inhibitor and Androgen deprivation therapy
c) Depo-Provera (Medroxyprogesteron)
d) Proton pump inhibitor
e) Selective serotonin reuptake inhibitor
f) Thiazolidenediones
g) Antiepileptics
h) Steroids
i) Other
EXAMINATION:
1. Genera examination: Vitals
Pulse______ /min Temp______ 0F
SpO2 _______%
B.P. __________ mm of Hg R.R. ______ /min
2. Systemic examination:
Per Abdomen
Cardiovascular system
Respiratory system
Central nervous system
Local examination
ii) Bruising
iii) Ecchymosis
iv) Abrasion
v) Tenting of skin
vi) Scar
vii) Sinus
viii)Attitude
x) Range of motion
Palpation:- i) Tenderness
ii)Swelling
iii) Crepitus
iv)limb shortening
v) Deformity and Other findings
Neurovascular status
Investigation:
X-RAY:
lateral views
Antibiotics :
Wound healing :
Capillary refilling:
COMPLICATIONS
a) Intra-operative
Neurovascular injury:
b) Post-operative:
Early
Pain
Sepsis
Late
Infection
Malrotation deformity
FOLLOW UP
In follow up, we will assess patients clinically, at 1 month , 3 month
and 6 month
Clinical assessment:
Pain
Gait
Wound if any
Any discharge
SLR
ROM
Distal pulsation
Capillary refilling
1.Dr. Rottela Shiva Kumar, Dr. Guru Prasad Sultanpurkar, DR. K Harsha
Vikram and Dr. Harshavardhan Raorane ,Comparative study between
proximal femoral nail and bipolar prosthesis in intertrochanteric fracture femur,
International Journal of Orthopaedics Sciences 2018;4(1):708-713
2. Wayan Suryanto Dusak*, Herryanto Agustriadi Simanjuntak, I Gusti
Ngurah Paramartha Wijaya Putra , Comparison between the results of
proximal femur nail anti-rotation and cemented bipolar hemiarthroplasty in
treatment of intertrochanteric fractures in Sanglah Hospital in 2016,
Int j Res Med Sci.2019;sep 7(9):3475-3479
3. Saraf H, Munot S., Comparative study of PFN antirotation vs bipolar
hemiarthroplasty in unstable senile intertrochanteric fractures. Indian J Orthop
Surg. 2018;4(4):380-385.
4. Shenghu Zhou1,2†, Jun Liu2†, Ping Zhen2,Weiwei Shen2, Yanfeng
Chang2, Haoqiang Zhang2, QingshengZhu1* and Xusheng Li2*Proximal
femoral nail anti-rotation versus cementless bipolar hemiarthroplasty for
unstable femoral intertrochanteric fracture in the elderly: a retrospective
study,BMC Musculoskeletal Disorders (2019)20:500
5. Dr. Amandeep Singh Bakshi, Dr. Pardeep Kumar, Dr. BS Brar ,
Comparative study between DHS and PFN in intertrochanteric fractures of
femur , International Journal of Orthopaedics Sciences 2018; 4(1): 259-262
6. Swaroop Das D, Kalambe HV, Handralmath SP. Comparative
study of unstable intertrochanteric fracture treatment by trochanteric
femoral nail versus hip hemiarthroplasty. Int J Orthop. 2017;3(4):548-52.
7. Suh Y-S, Nho J-H, Kim S-M, Hong S, Choi H-S, Park J-S. Clinical and
Radiologic Outcomes among Bipolar Hemiarthroplasty, Compression Hip
Screw and Proximal Femur Nail Antirotation in Treating Comminuted
Intertrochanteric Fractures , Hip Pelvis. 2015;27(1):30
8. Xu YZ, Geng DC, Mao HQ, Zhu XS, Yang HL. A comparison of the proximal
nail antirotation device and dynamic hip screw in the treatment of unstable, The
Journal of International Medical Research 2010; 38: 1266 – 1275
9. K-L Ma , X Wang , F-J Luan , H-T Xu , Y Fang , J Min , H-X
Luan , F Yang , H Zheng , S-J He Proximal femoral nails antirotation,
Gamma nails, and dynamic hip screws for fixation of intertrochanteric
fractures of femur: A meta-analysis , Orthop Traumatol Surg Res. 2014
Dec;100(8):859-66.
10.L Shen , Y Zhang, Y Shen, Z Cui ,Antirotation proximal femoral
nail versus dynamic hip screw for intertrochanteric fractures: a meta-
analysis of randomized controlled studies Orthop Traumatol Surg
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13.. [Internet].
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from: http://www.rguhs.ac.in/cdc/onlinecdc/uploads/01_M009_45215.doc