RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA

SYNOPSIS

OF

DISSERTATION

“SURGICAL MANAGEMENT OF TIBIAL PLATEAU FRACTURE USING MINIMALLY INVASIVE TECHNIQUE WITH LOCKING COMPRESSION PLATE”

Submitted by

Dr. CHETHAN G

MBBS

POST GRADUATE STUDENT IN

ORTHOPAEDICS (M.S.)

Under the guidance of

Dr. ABDUL RAVOOF

M.B.B.S, D’ ORTHO, M.S(ORTHO).

PROFESSOR

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 CHETHAN.G
NO.74, KALPATHARU 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 / 19th JUNE 2013
5 / TITLE OF THE TOPIC / ‘SURGICAL MANAGEMENT OF TIBIAL PLATEAU FRACTURE USING MINIMALLY INVASIVE TECHNIQUE WITH LOCKING COMPRESSION PLATE’
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 IIB
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 (ABOUT 4-6) / APPENDIX III
9 / SIGNATURE OF CANDIDATE
10 / REMARKS OF THE GUIDE / Proximal tibial fractures continue to be problematic for orthopaedic surgeon. It involves problems in their management namely infection,soft tissue necrosis, implant failure and joint stiffness.biological plating and locked internal fixation proposes the advantages of indirect reduction, percutaneous submuscular implant placement like less invasive stabilization system (LISS).
11 / NAME & DESIGNATION OF
(IN BLOCK LETTERS)
11.1 GUIDE / DR ABDUL RAVOOF
M.B.B.S ,D ORTHO ,M.S ORTHO
PROFESSOR
DEPARTMENT OF ORTHOPAEDICS,
SRI ADICHUNCHUNAGIRI
INSTITUTE OF MEDICAL SCIENCES
11.2 SIGNATURE
11.3 CO-GUIDE (IF ANY) / 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:

Incidence of fracture of the tibial plateau are increasing regularly due to RTA and at the same time surgical treatment option for the same are also being modified continuously.1

Proximal tibia being involved in body weight transmission through knee joint and leg, it plays a vital role in knee function and stability9. Fractures of proximal end tibia have historically been difficult to treat because of it’s subcutaneous location of the anteromedial surface of the tibia. Severe bone and soft tissue injuries is not infrequent and there is high incidence of open fracture compared with other long bones10.

The aim of surgical treatment of proximal tibial fractures is to restore and preserve normal knee function, which can be accomplished by anatomical restoration of articular surfaces, maintaining mechanical axis , restoring ligamentous stability and preserving a functional pain free range of motion of knee9.

The various clinical studies established that bone beneath a rigid conventional plate are thin and atropic which are prone for secondary fracture after removal of plate and also fracture site take longer period to osteosynthesis due to soft tissue and periosteal strippening.2

To over come this difficulties and to early restoration of strength of bone and function of knee joint the developed new technology called LCP.3

The LCP is an example of a new technology which combine the principle of limited contact compression plating and locked internal fixation.3

Locking compression plate device offers potential biomechanical advantage over other methods by,

-  Better distribution of forces along the axis of bone

-  They can be inserted with minimal soft tissue stripping using minimally invasive percutaneous plate osteosynthesis(MIPPO)

-  Substantially reducing failure of fixation in osteoporotic bones

-  Reducing the risk of a secondary loss of intraoperative reduction by locking with screws to the plate.

-  Unicortical fixation option

-  Better preservation of blood supply to the bone as a locked plating does not rely on plate bone compression.

-  Provide stable fixation by creating a fixed angle construct and angular stability

-  Early mobilisation.

Locking compression plate has added advantage of the ability to manipulate and reduce the small and often osteoporotic fracture fragments directly.11,12,13.

APPENDIX - IB

6.2 REVIEW OF LITERATURE

Ø  Various modalities for the treatment of tibial plateau have been proposed. Earlier the treatment of these fractures was mostly by closed reduction and immobilization with plaster cast.

Ø  Lambotte6 in 1890 treated oblique tibial intra articular fractures with wires and screws.

Ø  Keetley6 in 1899 described open reduction and wires for lateral condylar fractures.

Ø  Sir Robert Jones26 in 1920 noted in an article by W.H. Threthowan, the importance of realigning the intra articular fractures of proximal tibia by open reduction and fixation by bone pegs and long screws. He also mentioned the need for elevating the depressed fragments from the tibial shaft.

Ø  Wilsons and Jacobs31 in 1952 used the articular surface of the patella for replacing the severely depressed comminuted fractures of lateral condyle.

Ø  Rasmussen S. Poul25 and Gothenburg in 1973 followed a series of 260 fractures of one or both condyles. The main indication for surgical treatment was evidence of instability of extended knee. They treated 44% of patients with either closed traction reduction or internal fixation using a wire loop or open reconstruction of joint surface using autogenous bone grafts. Follow up of 87% of these had an acceptable knee function.

Ø  Schatzker and McBroom26 in 1979 considered that open reduction with anatomical restoration of articular cartilage produces best results. In their study of 70 patients they obtained 78% acceptable results in the operated group as compared 58% in the non operated group.

Ø  During the 1980’s the AO/ASIF group started to work on new plate design to minimise disadvantages of plating with respect to cortical perfusion. To overcome to negative effects of compression forces on the periosteum, a new generation of plates were created. The key to these internal fixators is the locking mechanism of the screws in implant, which provides angular stability and technical details ensures that compression forces on the bone surface are not necessary to gain stability of bone implant construct and also provides excellent holding force even in osteoporotic bone

Ø  Blokker et. al in1984 reviewed 60 tibial plateau fractures 38 of these fractures were treated by open reduction and internal fixation and 22 treated by closed methods. 75% of the patients had satisfactory results. They considered that the single most important factor in predicting the outcome in a patient with tibial plateau fracture was adequacy of reduction. The method of achieving the reduction and the length of immobilization period of the knee was not crucial.

Ø  Tscherene and Loben29 in 1993 studied 190 out of 255 cases concluded that open reduction and internal fixation with the objective being, precise reconstruction of the articular surface, stable fragment fixation and allowing early motion and repair of all concomitant lesion, achieved good results even in extremely difficult fractures after open reduction.

Ø  The operative treatment of the fracture using plates and screws is a successful technique. Internal fixation with plates and screws leads to additional trauma and disturbance of blood supply to bone. To, overcome these difficulties the recently developed locking compression plating is gaining popularity

Ø  In a study conducted for proximal tibial fractures in 20 cases in a Japanese hospital, LCP were applied and treatment outcome was examined. In this study good treatment outcome was obtained.14

Ø  Cole, Peter A, MD colleagues studied on proximal tibial fractures using LISS in which 91%(total 77 pts.) healed without major complications and concluded that LISS provides stable fixation(97%), high rate of union(97%) and low rate of infection (4%) for proximal tibial fractures.11

Ø  Egol, Kenneth A et al conducted a study on the treatment of complex tibial plateau fractures using LISS on 38 pts. The cohort of the patients was evaluated clinically and radiographically for outcomes at a mean 15 months and observed that 36 to 38 (95%) pt’s fractures had united at 4 months after surgery with no loss of fixation or infection. Significant loss of knee range of motion was seen in 5 patients.12

Ø  Sommer et al reported very good outcome of surgical treatment with LCP in their retrospective study of 90 patients older than 70 yrs. with osteoporosis who were treated using LCP.13

Ø  Partenheimer A et al in yr 2007 concluded that unilateral locked screw plating is a good alternative in treatment of problematic fractures of tibial plateaus that are associated with Soft Tissue Damage and metaphyseal communition.15

Ø  In the year 2008, Beck M et al were able to show that tibial LISS is a suitable implant for the treatment of proximal segmental tibia fractures with an acceptable rate of complications.

Ø  Fan Liu in year 2009 concluded that LISS system fixation is adequate enough to maintain alignment and obtain union with a low incidence of complications even in patients with osteoporotic bone.16

Ø  APPENDIX – IC

6.3 AIMS AND OBJECTIVES OF THE STUDY

1.  To study the functional outcome of fractures of tibial plateau.

2.  To study the duration of union in tibial plateau fracture treated with LCP

3.  To assess the range of motion of knee joint and functional outcome after surgical management.

APPENDIX II

7. MATERIALS AND METHODS

APPENDIX - IIA

7.1 SOURCE OF DATA:

1)  Patients with tibial plateau 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 Schatzker classification of tibial plateau 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. The patient with injuries associated with the tibial plateau fractures of Schatzker Type 1 to type 4 with a articular displacement of <5 mm.
  2. Age Limit: 20 years to 70 years
  3. Both males and females
  4. Patients with Gustilo-Anderson Type 1 and 2 fractures.

EXCLUSION CRITERIA:

  1. Patients with Neurovascular deficits.
  1. Patients with Pathological fractures other than osteoporosis.
  1. Patients with Gustilo- Anderson Type 3 proximal tibial fractures .
  1. Patients with head and chest injuries

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,

1. X-ray of the knee joint with upper half of tibia

-  Ap view

-  Lateral view

2. Routine investigation to evaluate fitness for surgery.

  1. Complete hemogram
  2. Blood urea
  3. Serum creatinine
  4. Serum electrolytes
  5. Blood grouping and Rh typing
  6. BT, CT
  7. Urine routine
  8. RBS
  9. Hbs Ag
  10. HIV 1 and 2
  11. ECG

3. CT knee joint

4. Arterial Doppler to check for vascular damage

Before subjecting the patients for investigations and surgical procedures written/informed consent will be obtained from each patient/ legal guardian.

All the investigations and surgical procedures will be undertaken under the direct guidance and supervision of our guide.

APPENDIX-IIC

PROFORMA APPLICATION FOR ETHICS COMMITTEE APPROVAL

SECTION A
A / TITLE OF THE STUDY / “SURGICAL MANAGEMENT OF TIBIAL PLATEAU FRACTURE USING MINIMALLY INVASIVE TECHNIQUE WITH LOCKING COMPRESSION PLATE”
b / PRINCIPLE INVESTIGATOR ( NAME AND DESIGNATION ) / DR CHETHAN.G
P.G IN ORTHOPAEDICS
AIMS
BG NAGARA, BELLUR
c / CO-INVESTIGATOR
(NAME AND DESIGNATION) / DR ABDUL RAVOOF
M.B.B.S ,D ORTHO ,M.S ORTHO
PROFESSOR
DEPARTMENT OF ORTHOPAEDICS,
SRI ADICHUNCHUNAGIRI
INSTITUTE OF MEDICAL SCIENCES
d / NAME OF COLLABORATING DEPARTMENT /INSTITUTIONS / NA
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