RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA
SYNOPSIS
OF
DISSERTATION
“SURGICAL MANAGEMENT OF DISTAL TIBIA FRACTURE BY MIPO USING LOCKING PLATES”
Submitted by
Dr. VIJAY CHANDAR R
MBBS
POST GRADUATE STUDENT IN
ORTHOPAEDICS (M.S.)
Under the guidance of
Dr. GUNNAIAH K G
M.B.B.S, D’ ORTHO, M.S(ORTHO).
PROFESSOR AND HEAD
DEPARTMENT OF ORTHOPAEDICS
S.A.H. & R.C, B.G.NAGARA
DEPARTMENT OF ORTHOPAEDICS
ADICHUNCHANAGIRI INSTITUTE OF MEDICAL SCIENCES,
B.G.NAGARA-571448
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BANGALORE, KARNATAKA
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS OF DISSERTATION
1 / NAME OF THE CANDIDATE AND ADDRESS( in block letters) / DR VIJAY CHANDAR R
NO.106, KALPATARU BHAVANA
P.G IN ORTHOPAEDICS
A.I.M.S., B.G.NAGARA,
NAGAMANGALA TALUK,
MANDYA DISTRICT,
KARNATAKA-571448.
2 / NAME OF THE INSTITUTION / ADICHUNCHANAGIRI INSTITUTE OF MEDICAL SCIENCES, B.G.NAGARA.
3 / COURSE OF STUDY AND SUBJECT / M.S.IN ORTHOPAEDICS
4 / DATE OF ADMISSION TO COURSE / 1ST JULY 2013
5 / TITLE OF THE TOPIC / ‘SURGICAL MANAGEMENT OF DISTAL TIBIA FRACTURE BY MIPO USING LOCKING PLATES’
6 / BRIEF RESUME OF INTENDED WORK / APPENDIX – I
6.1 NEED FOR THE STUDY
6.2 REVIEW OF LITERATURE
6.3 OBJECTIVES OF THE STUDY / APPENDIX – IA
APPENDIX – IB
APPENDIX – IC
7 / MATERIALS AND METHODS / APPENDIX II
7.1 SOURCE OF DATA : DEPARTMENT OF ORTHOPAEDICS
SRI ADICHUNCUNAGIRI INSTITUTE OF MEDICAL SCIENCES
7.2 DOES THE STUDY REQUIRE ANY
INVESTIGATIONS OR INTERVENTIONS YES
TO BE CONDUCTED ON PATIENTS OR OTHER APPENDIX II
ANIMALS, IF SO PLEASE DESCRIBE BRIEFLY
7.3 HAS ETHICAL CLEARANCE BEEN OBTAINED FORM YOUR INSTITUTION IN CASE OF 7.2 /
YES
8 / LIST OF REFERENCES / APPENDIX III
9 / SIGNATURE OF CANDIDATE
10 / REMARKS OF THE GUIDE / Distal tibia fracture is a challenge to orthopedic surgeon because of nature involved, comminution,
Osteoporosis, articular involvement, displacement,
Which are contributary to morbidity even fatal mortality due to embolism.
11 / NAME & DESIGNATION OF
(IN BLOCK LETTERS)
11.1 GUIDE / DR GUNNAIAH K G
M.B.B.S ,D ORTHO ,M.S ORTHO
PROFESSOR AND H.O.D
DEPARTMENT OF ORTHOPAEDICS,
SRI ADICHUNCHUNAGIRI
INSTITUTE OF MEDICAL SCIENCES
11.2 SIGNATURE
11.3 CO-GUIDE / NIL
NAME
SIGNATURE
11.4 REMARKS
11.5 HEAD OF DEPARTMENT / DR GUNNAIAH K G
M.B.B.S ,D ORTHO ,M.S ORTHO
PROFESSOR AND H.O.D
DEPARTMENT OF ORTHOPAEDICS,
SRI ADICHUNCHUNAGIRI
INSTITUTE OF MEDICAL SCIENCES
11.6 SIGNATURE
12.1 REMARKS OF CHAIRMAN AND PRINCIPAL / The facilities required for the investigation will be made available by the college
Dr. SHIVARAMU. M.G., M.B.B.S., M.D.
PRINCIPAL,
AIMS, B.G. NAGARA
12.2 SIGNATURE
APPENDIX- I
6. BRIEF RESUME OF THE INTENDED WORK:
APPENDIX - IA
6.1 NEED FOR THE STUDY:
Treatment of distal tibia fracture is challenging because of its subcutaneous location with precarious blood supply and proximity to the ankle joint. Most of these fractures are managed with an operative intervention such as closed reduction and intramedullary interlocking (IMIL) nailing or open reduction and internal fixation (ORIF) with plating or closed reduction and per cutaneous plating or external fixators.
Each of these techniques has their own merits and demerits. IMIL nailing has been reported with higher rate of malunion because it is difficult to achieve two distally locking screws.1-4 Wound infection, skin breakdown and delayed union or non union requiring secondary procedures like bone grafting are some of the complications associated with conventional osteosynthesis with plates.4-7
Similarly, pin tract infection, pin loosening, malunion and nonunion leading to osteomyelitis is potential complication of external fixators and hence not preferred as definitive fixation method.1-4
Recently, techniques of closed reduction and minimally invasive plate osteosynthesis (MIPO) with locking compression plate (LCP) has emerged as an alternative treatment option for distal tibia fracture. When applied subcutaneously, LCP does not endanger periosteal blood supply, respect fracture heamtoma and also provides biomechanicaly stable construct.12,13 Numbers of previous clinical studies have established MIPO with LCP as a biologically friendly and technically sound method of fixation for distal tibia fracture 1-3Here we ascess the results of treatment of Distal Tibial Fracture by Minimally Invasive Percutaneous Plate Osteosynthesis using Locking Compression Plate -a prospective study.
APPENDIX - IB
6.2 REVIEW OF LITERATURE
Ø Hansmann developed the first bone plate in Germany in 1880’s.
Ø Mehmet et al studied Thirty-five patients (23 males, 12 females) who were Operated on MIPPO principles for tibial diaphysis and distal tibial fractures.Twenty-eight were closed and seven were open fractures The mean duration Of the union was 20.7 (range: 16 to 28) weeks and 17.96 (range: 10 to 36) Weeks in open and closed fractures, respectively. All cases showed union Except one who had an implant failure. Necrosis at the wound developed in One case and infection in another.
Ø J. J. Guo,et al,in their study A total of 85 patients were randomised to Operative stabilisation either by a closed intramedullary nail (44) or by Minimally invasive osteosynthesis with a compression plate n conclude that Both closed intramedullary nailing and a percutaneous locked compression Plate can be used safely to treat Orthopaedic Trauma Association type-43A distal metaphyseal fractures of the tibia.
Ø Ghulam shabir et al in a study on 73 patients concluded mipo is an effective method of treating distal tibia fracture decreasing the surgical trauma to soft tissues .
Ø syah bahari et al in a study on 43 patient reported satisfactory outcomes With the use of the AO distal tibia locking plate in treatment of unstable distal tibial fractures.All fractures united with acceptable alignment and angulation. Two cases of superficial infection were noted, with one case of deep infection.
Ø Francois et al In his retrospective study results and complications of ten consecutive patients treatedwith percutaneous plating for fractures of the distal tibia and plafond with a minimum follow-up periodof one year were studied. No significant soft tissue problems occurred.. All fractures healed within one year ;there was no fracture malunion.
Ø Borens et al conducted study on 17 patient for tibial plafond Fracture with newly designed low profile plate and concluded That it is good for fracture healing and soft tissue trauma.
Ø Mario Ronga et al in April 2010 studied the effectiveness of minimally invasive locked plates among 21 patients for a minimum period of 2 years (average: 2.8 years). According to the AO classification, there were 12 Type A, 5 Type B, and 4 Type C fractures. Two patients were lost to follow-up. Union was achieved in all but one patient by the 24th postoperative week. Four patients had angular deformity less than 7°. No patient had a leg-length discrepancy more than 1.1cm. Five patients had ankle range of motion less than 20° compared with the contra lateral side. Sixteen patients had not returned to their pre-injury sporting or leisure activities. Three patients developed a delayed infection.
Ø Abid Mushtaq, et al in April 2009 reported that distal tibia, because being more superficial and having less soft tissue coverage when fractured, the treatment becomes challenging. The study aimed to see the results of distal tibia fractures fixation with locking compression plate (LCP) using minimally invasive percutaneous plate osteosynthesis (MIPPO). Mean time for union was 5.5 months. Ultimately all fractures with good functional outcome. They concluded minimally invasive plate osteosynthesis technique for distal tibia fractures is associated with good results and additional advantages. Early mobilization without risk of secondary displacement helps to prevent stiffness and contracture.
APPENDIX - IC
6.3 AIMS AND OBJECTIVES OF THE STUDY
1) To study and evaluate the clinical outcome of Pilon fracture with MIPO using LCP.
2) To evaluate the incidence of complications in these .
APPENDIX II
7. MATERIALS AND METHODS
APPENDIX - IIA
7.1 SOURCE OF DATA:
1) Patients with distal tibia fracture, who are admitted in Sri Adichunchanagiri Institute of Medical Sciences, will be taken for study after obtaining their consent.
2) Fractures will be classified according to AO Classification-Distal Tibial fractures .
3) Follow up of the case will be done for a period of 18 months with 4 visits(6weeks,3months,6months and 12months).
Statistical Analysis: Proportions and Chi square test.
Inclusion Criteria:
1. Age more than 18 years both males and females.
2. AO Classification-Distal Tibial fractures
3. Patient fit for surgery
4. Fracture associated with osteoporosis, bone loss, intra-articular extension.
Exclusion Criteria:
- Patients less than 18 years of age
- Patients unfit for surgery
- Gustillo Anderson Type-III open fractures
- Associated vascular injuries
5. Pathological fractures
APPENDIX – II B
7.2 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so, please describe briefly
Yes, In our study the following investigations are conducted in each patient. All the patients included in the study are investigated thoroughly with
1. Routine blood investigations ( Complete Blood Count, Random Blood Sugar,
blood urea , Serum Creatinine )
2. Urine routine ( Albumin, Sugar, Microscopy )
3. Radiological examination pre operatively are done.
X rays of tibia full length
-AP view
-Lateral view
X rays of leg with ankle joint
-AP view
-Lateral view
Computed tomography
Radiological examination will be repeated post-operatively and at the end of 3weeks, 6 weeks, 12 weeks and 6 months intervals.
Before subjecting the patients for investigations and surgical procedures written/informed consent will be obtained from each patient/ legal guardian.
Patients will be followed up at 3weeks, 6 weeks, 12 weeks and at 6 months interval.
FOLLOW UP: Assessment at 6 weeks as advised in discharge card:
- Interaction with patient about pain at fracture site/stiffness
- Ankle function/range of motion/ movements at ankle joint.
- X-ray assessment of Union and implant status.
Assessment at 12 weeks as advised in discharge card:
- Assessment of fracture union clinically and radiologically.
- Any complications may be noted.
Assessment at 6 months:
- Assessment of result with reference to scoring system
APPENDIX-IIC
PROFORMA APPLICATION FOR ETHICS COMMITTEE APPROVAL
SECTION Aa / TITLE OF THE STUDY / ‘SURGICAL MANAGEMENT OF DISTAL TIBIA FRACTURE BY MIPO USING LOCKING PLATES’
b / PRINCIPLE INVESTIGATOR ( NAME AND DESIGNATION ) / DR VIJAY CHANDAR.R
POST GRADUATE STUDENT IN ORTHOPAEDICS
A.I.M.S ,B.G.NAGAR
c / CO-INVESTIGATOR
(NAME AND DESIGNATION) / DR GUNNAIAH K G
M.B.B.S ,D ORTHO ,M.S ORTHO
PROFESSOR AND H.O.D
DEPARTMENT OF ORTHOPAEDICS,
SRI ADICHUNCHUNAGIRI
INSTITUTE OF MEDICAL SCIENCES,B.G. NAGAR
d / NAME OF COLLABORATING DEPARTMENT /INSTITUTIONS / NO
e / WHETHER PERMISSION HAS BEEN OBTAINED FROM THE HEADS OF COLLABORATING DEPARTMENT & INSTITUTION / NA
SECTION – B
SUMMARY OF THE PROJECT / APPENDIX I
SECTION – C
OBJECTIVES OF THE STUDY
SECTION – D
METHODOLOGY / APPENDIX II
A / WHERE THE PROPOSED STUDY WILL BE UNDERTAKEN / DEPARTMENT OF ORTHOPAEDICS
S.A.H & R.C.,B.G.NAGARA
B. / DURATION OF THE PROJECT / 36 MONTHS FROM JUNE 2013
C / NATURE OF THE SUBJECT:
DOES OF THE STUDY INVOLVE ADULT PATIENTS?
DOES THE STUDY INVOLVE CHILDREN?
DOES THE STUDY INVOLVE NORMAL VOLUNTEERS?
DOES THE STUDY INVOLVE PSYCHIATRIC PATIENTS?
DOES THE STUDY INVOLVE PREGNANT WOMEN? / YES
NO
NO
NO
NO
D / IF THE STUDY INVOLVES HEALTH VOLUNTEERS
I. WILL THEY BE INSTITUTE STUDENTS?
II. WILL THEY BE INSTITUTE EMPLOYEES?
III WILL THEY BE PAID ?
IV IF THEY ARE TO BE PAID, HOW MUCH
PER SESSION ?
/ NO
NO
NO
NO
E / IS THE STUDY A PART OF MULTI CENTRAL TRIAL? / NO
F / IF YES, WHO IS THE COORDINATOR ?
(NAME AND DESIGNATION)
HAS THE TRIAL BEEN APPROVED BY THE ETHICS, COMMITTEE OF THE OTHER CENTERS?
IF THE STUDY INVOLVES THE USE OF DRUGS PLEASE INDICATE WHETHER.
I. THE DRUG IS MARKETED IN INDIA FOR
THE INDICATION IN WHICH IT WILL BE
USED IN THE STUDY.
II, THE DRUG IS MARKETED IN INDIA BUT
NOT FOR THE INDICATION IN WHICH IT
WILL BE USED IN THE STUDY
III. THE DRUG IS ONLY USED FOR
EXPERIMENTAL USE IN HUMANS.
IV. CLEARANCE OF THE DRUG CONTROLLER
OF INDIA HAS BEEN OBTAINED FOR :
USE OF THE DRUG IN HEALTHY VOLUNTEERS
USE OF THE DRUG IN-PATIENTS FOR
A NEW INDICATION.
· PHASE ONE AND TWO CLINCIAL TRIALS
· EXPERIMENTAL USE IN –PATIENTS
AND HEALTHY VOLUNTEERS. / NA
-
-
NA
NA
NA
NA
NA
G / HOW DO YOU PROPOSE TO OBTAIN THE DRUG TO BE USED IN THE STUDY?
-4 GIFT FROM A DRUG COMPANY
-5 HOSPITAL SUPPLIES
-6 PATIENTS WILL BE ASKED TO PURCHASE
-7 OTHER SOURCE (EXPLAIN) / NA
H / FUNDING (IF ANY) FOR THE PROJECT PLEASE STATE
-8 NONE
-9 AMOUNT
-10 SOURCE
-11 TO WHOM PAYABLE / NO
I / DOES ANY AGENCY HAVE A VESTED INTEREST IN THE OUT COME OF THE
PROJECT? / NO
J / WILL DATA RELATING TO SUBJECT/CONTROLS BE STORED IN A COMPUTER? / YES
K / WILL THE DATA ANALYSIS BE DONE BY
-12 THE RESEARCHER?
-13 THE FUNDING AGENT / YES
NO
L / WILL TECHNICAL /NURSING HELP BE REQUIRED FROM THE STAFF OF HOSPITAL.
IF YES, WILL IT INTERFERE WITH THEIR DUTIES?
WILL YOU RECRUIT OTHER STAFF FOR THE DURATION OF THE STUDY?
IF YES GIVE DETAILS OF
I. DESIGNATION
II. QUALIFICATION
III. NUMBER
IV. DURATION OF EMPLOYMENT / NO
NO
NO
NA
NA
NA
NA
M / WILL INFORMED CONSENT BE TAKEN ? IF YES
WILL IT BE WRITTEN INFORMED CONSENT:
WILL IT BE ORAL CONSENT?
WILL IT BE TAEKN FROM THE SUBJECT THEMSELVES?
WILL IT BE FROM THE LEGAL GUARDIAN? IF NO, GIVE REASON : / YES , CONSENT WILL BE
TAKEN FROM THE PATIENT
N / DESCRIBE DESIGN, METHODOLOGY AND TECHNIQUES / APPENDIX II
ETHICAL CLEARANCE HAS BEEN ACCORDED
CHAIRMAN,
P.G.TRAINING-CUM RESEARCH COMMITTEE,
A.I.M.S., B.G.NAGARA
DATE:
APPENDIX III
LIST OF REFERENCES:
1. S. Terry Canale’s Campbells Operative Orthopaedics. Volume 3, 11th edition. Pg. 3123-31
2. 2.Shrestha D, Acharya BM, Shrestha PM Minimally Invasive Plate Osteosynthesis with Locking Compression Plate for Distal Diametaphyseal Tibia Fracture Kathmandu Univ Med J 2011;34(2)62-8.
3. Abdulla S. Abu Senna Minimally Invasive Plate Osteosynthesis for Distal Tibial Fractures Journal of American Science2013;9(10)
4. Cyril MAUFFREY, Gabriel VASARiO, Bruno BATTiSTOn, Charlie LEwiS, James BEAzLEY, David SELiGSOn Tibial pilon fractures :A review of incidence, diagnosis, treatment, and complications Acta Orthop. Belg., 2011, 77, 432-440