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									From,                                                                Date : 15/11/2007
        Dr. SHIVAKUMAR . K. MANAKAR                                  Place :Bellary
        Post Graduate Student in M.S. Orthopaedics,
        Dept. of Orthopaedics,
        VIMS, Bellary.

To
        The Principal,
        Vijayanagar Institute of Medical Sciences,
        Bellary.

                        THROUGH PROPER CHANNEL

Respected Sir,
            Subject : Acceptance of registration and forwarding of
                  dissertation topic,

       In accordance with the above cited subject, I undersigned studying post
graduate course in M.S.Orthopaedics has been allotted the dissertation topic
“A PROSPECTIVE STUDY OF SURGICAL MANAGEMENT OF CLOSED
DIAPHYSEAL FRACTURES OF FEMUR IN ADULTS TREATED BY
CLOSED         REDUCTION          AND       INTERNAL          FIXATION         USING
INTRAMEDULLARY INTER LOCKING NAILS.” From July 2007 to July
2009 under the guidance of Dr. G.V. Guruduth., Professor, Department of
Orthopaedics, VIMS, Bellary.
       I request you to kindly forward the dissertation topic in the prescribed format
to the university for approval.

        Thanking you,

                                                     Yours Faithfully,


                                     (Dr. SHIVA KUMAR . K. MANAKAR)
Signature of the guide


(Dr.G.V. GURUDUTH)
Professor of Orthopaedics,
Department of Orthopaedics,
VIMS Bellary.
From                                                                 Place : Bellary
       The Prof. & Head of Department,                               Date : 15/11/2007
       Department of Orthopaedics,
       VIMS, Bellary.

To,
       The Registrar,
       Rajiv Gandhi University of Health Sciences,
       Bangalore.

                          THROUGH PROPER CHANNEL
Respected Sir,

       As per the regulations of the university for registration of dissertation topic, the
following post graduate student in MS Orthopaedics has been allotted the dissertation topic
as follows by the official registration committee of all qualified and eligible guides of the
Department of Orthopaedics.
            NAME                                TOPIC                         GUIDE
Dr. SHIVAKUMAR . K. “A PROSPECTIVE STUDY (Dr.G.V. GURUDUTH)
MANAKAR                             OF SURGICAL                    Professor of Orthopaedics,
Post Graduate student in            MANAGEMENT OF                  Department of Orthopaedics,
                                    CLOSED DIAPHYSEAL              VIMS, Bellary.
M.S. Orthopaedics,                  FRACTURES OF FEMUR
Dept. of Orthopaedics,              IN ADULTS TREATED BY
VIMS, Bellary.                      CLOSED REDUCTION
                                    AND INTERNAL
                                    FIXATION USING
                                    INTRAMEDULLARY
                                    INTER LOCKING NAILS.”
       Therefore, I kindly request you to communicate the acceptance of the dissertation
topic allotted to the PG student at an early date.

                                       Thanking you

                                                       Yours faithfully,


                                                Dr. PRABHANJAN KUMAR.D.
                                                Professor and Head of the Department,
Signature of the guide.                         Dept. of Orthopaedics,
                                                 VIMS Bellary.

Dr.G.V. GURUDUTH
Professor of Orthopaedics,
Department of Orthopaedics,
VIMS, Bellary.
          RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
                    BANGALORE, KARNATAKA


                       ANNEXURE- II
  SYNOPSIS FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. Name of the Candidate and          Dr. SHIVAKUMAR . K. MANAKAR
   Address
   ( in Block Letters)                Post Graduate student in M.S.
                                      Orthopaedics,
                                      Dept. of Orthopaedics,
                                      VIMS, Bellary -583104
2. Name of the Institution            VIJAYANAGARA INSTITUTE OF
                                      MEDICAL SCIENCES, BELLARY
3. Course of study and subject        M.S. in Orthopaedics
4. Date of Admission to course        23/5/2007
5. Title of Topic :
   “A PROSPECTIVE STUDY OF SURGICAL MANAGEMENT OF
   CLOSED DIAPHYSEAL FRACTURES OF FEMUR IN ADULTS
   TREATED BY CLOSED REDUCTION AND INTERNAL FIXATION
   USING INTRAMEDULLARY INTER LOCKING NAILS.”

6. Brief Resume of the intended work :

   6.1 Need for the study :

   Fractures of the shaft of femur       are among the most common fractures
   encountered in orthopedic practice. Since the femur is the largest bone of the
   body and one of the principal load - bearing bone in the lower extremity,
   fractures   can cause     prolonged morbidity and extensive disability   unless
   treatment as appropriate. Fractures of the femoral shaft often are the result of
   high energy trauma and may be associated with multiple system injuries. Several
   techniques are now available for their treatment, among these, interlocking
   intramedullary nailing currently is considered to be the treatment of choice for
   most femoral shaft fractures1
Femoral nailing has advanced continuously over the past 60 years. The transition
from open nailing techniques to closed techniques using a remote entry site at
the proximal femur       paralleled   the availability of image intensification.
Intramedullary    reaming allowed placement of         larger implants, allowing
improved rotational control and resistance to bending. The introduction and
increased popularity of interlocking nails allowed for improved rotational
control, better maintenance of femoral length, early weight bearing , the use of
smaller implants and improved           control of comminuted and segmental
fractures2.
At present the ideal treatment for skeletally mature patients with femoral shaft
fractures from the level of the lesser trochanter to within 6 to 8 cm of the distal
subchondral bone is closed intra medulary nailing. With new nail designs that
allow locking in the proximal and distal femur, it has become possible to nail
                                              3
virtually any fracture of the femoral shaft
The standard of care today for nearly all fractures of the diaphysis of the femur
is antegrade, interlocked , reamed nailing using closed techniques4



6.2 Review of Literature :
RA Winquist, in his study said that Locked intramedullary nailing has become
the standard of care for most femoral fractures. Originally designed to prevent
rotation and shortening in comminuted fractures of the midshaft, its application
has been extended proximally and distally to nearly all femoral fractures from
the lesser trochanter to the supracondylar area. Achieving a closed reduction
and selecting the proper starting point in the pyriformis region are crucial to
successful results. Following the proper surgical technique for the specific nail
used is more important than nail material or design. Large – diameter reamed
nails provide greater strength than unreamed nails. Static locking has been
shown to yield nearly the same high union rates as dynamic locking and is now
the accepted standard. Distal targeting of the interlocking screw remains the
most difficult aspect of the surgical technique ; most surgeons prefer freehand
targeting with a sharp trocar. Second – Generation (reconstruction) nails, with
screws directed toward the femoral head, have extended the indications for
locked nailing proximally to subtrochantric      fractures and combined femoral
neck – shaft fractures5.
DA Wiss, WW Brien and WB Stetson in their study have absorbed that, Thirty
–three segmental fractures of the shaft of the femur were treated with the
Grosse-Kempf interlocking nail. Twenty-eight of the fractures had been caused
by high-energy trauma. There were twenty-six closed and seven open fractures.
Thirty-two of the thirty-three fractures united, at an average of thirty-two weeks,
without additional intervention other than dynamization of the nail. There were
one non-union, one delayed union, and two malunions. Virtually all fractures
located between the lessertrochanter and the femoral condyles can be nailed,
regardless of the pattern of the fracture or the degree of communution. Closed
interlocked nailing is the treatment of choice for most segmental fractures of the
                  6
shaft of the femur .
DA Wiss, WW Brien and V Becker have absorbed that in their study of Fifty-
six patients who had a fracture of the femur due to a low-velocity gunshot injury
were treated with interlocking nailing with the Grosse-Kempf nail. Patients
who had an isolated fracture were treated by intravenous administration of
antibiotics followed by delayed interlocking nailing. Ninety-three percent of the
fractures had Grade-III or IV comminution. At an average duration of follow-up
of sixteen months (range, twelve to twenty-nine months), the results of closed
interlocking nailing were excellent. All of the fractures united at an average of
twenty-three weeks (range, fourteen to forty weeks) after the nailing. There were
no apparent infections in the entire series. There were two delayed unions and
seven malunions. Five patients had serious associated vascular injury ; four of
the five had interlocking nailing done immediately after vascular repair. The
fractures united without any residual vascular insufficiency7.
Bart Eastwood, DO, Staff physician, Arazi, Mehmat MD; Ogun, Tunc C.MD;
Oktar, M.Nihat MD; Memik, Recep MD, and ; Kotlu, Abdurrahaman MD et all,
in their study have said that, Intromedullary nailing is the criterion standard.
Currently, antegrade reamed interlocked intramedullary nailing is the treatment
of choice for diaphyseal femur fractures. Antegrade reamed locked nailing is
ideal in fracture stabilization. The exposure is small, and soft tissue damage is
limited.
The nail itself has the advantage of being centrally located in the shaft and load
sharing. Antegrade reamed locked nailing promotes healing through abundant
callus formation. The fixation is solid and able to hold length even in the face of
extensive comminution. It allows early and, in some cases, immediate weight
bearing. It is associated with easier nursing care, shorter hospital stays, and
lower morbidity. The results of treatment have been excellent, with 99% rate of
union and 1% incidence of infection. Its use has been studied extensively, and it
                                                   8
has proved effective in the short and long terms       .


6.3 Objective of the Study :


a) To study the outcome of surgically managed closed diaphyseal fractures of
femur in adults.
b) To reestablish the anatomy of shaft of femur and to gain almost complete
functional outcome of the thigh, perfectly by operative treatment with closed
intramedulary interlocking nails.
c) To assess the union of fractures after the surgical treatment.
    Materials and methods :
7
    7.1 Source of data :
    The patients admitted to Department of Orthopeadics in Vijayanagar Institute of
    Medical Sciences, Bellary with closed diaphyseal fractures of femur in adults
    during 1/07/2007 to 31/07/2009 are selected. All the patients who will be
    operated during this period are included in the study. Those patients who are
    above 20 years of age and managed surgically are included in the study.


    7.2 Method of Collection of Data (Including the sampling procedure if any)
    Our study is a prospective, observational, randomized and open study, to be
    conducted during the period from 1st July, 2007 to 31st July 2009. The complete
    data is collected from the patients in a specially designed Case Record Form
    (CRF) by taking history of illness and by doing detailed clinical examination
    and relevant investigations. Finally after diagnosis the patients are selected for
    the study depending on the inclusion and exclusion criteria. Post procedure all
    the cases are followed for the minimum period of 6 months.


    Inclusion Criteria :
    a) Those patients who are above 20 years and managed surgically are included
    in the study.
    b) All fractures of shaft of femur that is upper 1/3, middle 1/3 and lower 1/3
    right from subtrochantric level to supracondylar level.


    Exclusion Criteria :
    a) Those patients who are below 20 years of age are not included in the study.
    b) Those cases which are treated non surgically are exculed.
    c) Fractures above the subtrochanter and below the lower 1/3 of shaft of femur
    are excluded.
7.3 Does the study requires any investigations or interventions to be
   conducted on patients or other human 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, Urine Microscopy)
   3. Radiological examination pre operatively are done.
      Clinical assessment of thigh/hip function will be done regularly. 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.
        Radiological examination will be repeated postoperatively and at the
      end of 6 weeks, 12 weeks, 6 months, 9 months intervals.
      Patients will be followed up at 3 weeks, 6 weeks, 12 weeks, 6 months and
      9 months.


7.4 Has ethical clearance been obtained from your institution in case of 7.3?
    YES, Ethical clearance has been obtained from VIMS INSTITUTIONAL
    ETHICS COMMITTEE, Bellary.
8   List of References :
                           I.TEXT BOOK REFERENCES
          1. CAMPBELL’S OPERATIVE ORTHOPAEDICS, 10th Edition by
             S.TERRY, CANALE , MD : Volume 3. Page No. 2825.
          2. ROCKWOOD AND GREEN’S FRACTURE IN ADULTS . 6th
             Edition edited by 1. ROBERT W. BUCHOLZ MD, 2. JAMES D
             HECKMAN MD, 3. CHARLES M COURT-BROWN MD. Vol -2.
             Page No. 1845 to 1910
          3. SKELETAL TRAUMA, (FRACTURES, DISLOCATIONS AND
             LIGAMENTS INJURIES) Second edition Vol- 2 Page No. from
             1927-2023
          4. CHAPMAN’S ORTHOPAEDICS SURGERY, BY MICHAEL
             W.CHAPMAN. 3RD EDITION Vol -1 Page No. 671 to 705

                              II. JOURNAL REFERENCES
          5. RA Winquist, Locked Femoral Nailing, Journal of the American
             Academy of Orthopaedic Surgeons, Vol -1, Issue 2 95-105, 1993 by
             the American Academy of Orthopedic Surgeons.
          6. DA Wiss, WW Brien and WB Stetson, Interlocked nailing for
             treatment of segmental fractures of the femur, The journal of Bone and
             joint Surgery, vol 72, Issue 5 724-728, 1990 by journal of Bone and
             joint Surgery.
          7. DA Wiss, WW Brien and V Becker, Interlocking nailing for the
             treatment of femoral fractures due to gunshot wounds, The journal of
             Bone and joint Surgery, vol 73, Issue 4 598-606, 1991 by journal of
             Bone and joint Surgery.
          8. Bart Eastwood, Do, Staff physician, Arazi, Mehmet MD; Ogun, Tunc
             C. MD; Oktar, M. Nihat MD; Memik, Recep MD, and ; Kutlu,
             Abdurrahman MD, et all Intramedulary rod placement, Journal of
             Trauma-Injury Infection & Critical Care . 50 (4) : 711-716 April
             2001.
9   Signature of the Candidate :




10 Remarks of the Guide :


11 Name and Designation of : ( In   (Dr.G.V. GURUDUTH)
   block letter)                    Professor of Orthopaedics,
   11.1 Guide                       Department of Orthopaedics,
                                    VIMS, Bellary.

    11.2 Signature




    11.3 Co- guide if any


    11.4 Signature


    11.5 Head of the Department     Dr. PRABHANJAN KUMAR.D.
                                    Professor and Head of the
                                    Department,
                                    Dept. of Orthopaedics,
                                    VIMS Bellary.

    11.6 Signature




12 12.1 Remarks of Chairman &
   Principal

    12.2 Signature

								
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