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									    RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
              BANGALORE, KARNATAKA




                        ANNEXURE 2
         PROFORMA FOR REGISTRATION OF SUBJECTS FOR
                       DISSERTATION

1. NAME OF THE CANDIDATE AND     DR. VIJAY A KULKARNI
   ADDRESS.                      PG IN ORTHOPAEDICS,
                                 KIMS,
                                 HUBLI – 580022

2. NAME OF THE INSTITUTION.      KARNATAKA INSTITUTE OF MEDICAL
                                 SCIENCES, HUBLI

3. COURSE OF STUDY AND SUBJECT   M.S. ORTHOPAEDICS

4. DATE OF ADMISSION             27-04-2010
5. TITLE OF THE TOPIC            PROXIMAL FEMORAL NAIL vs
                                 DYNAMIC HIP SCREW FOR UNSTABLE
                                 INTERTROCHANTERIC FRACTURES –
                                 A COMPARATIVE CLINICAL STUDY




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6.   BRIEF RESUME OF THE INTENDED WORK


     6.1 NEED FOR THE STUDY

                  Pertrochanteric femoral fractures are of intense interest globally. They are the
     most frequently operated fracture type, have the highest post operative fatality rate of
     surgically treated fractures , and have become a serious health resource issue because of the
     high cost of care required after injury. The reason of the high cost of care is primarily
     related to poor recovery of functional independence after conventional fracture care in
     many patients . Interestingly there has been no significant improvement in mortality or
     functional recovery over the past 50 years of surgical treatment.8

            Intertrochanteric fractures account for approximately half of the hip fractures in
     elderly; out of this, more than 50% fractures are unstable.4
            Unstable intertrochanteric fractures are those in which comminution of
     posteromedial buttress exceeds a simple lesser trochanteric fragment or those with
     subtrochanteric extension4.

            The goal of treatment of any intertrochanteric fracture in elderly is to restore
     mobility safely and efficiently while minimizing the risk of medical complications and
     technical failure and to restore the patient to the preoperative status . Restoration of mobility
     in patients with unstable intertrochanteric fracture ultimately depends on the strength of
     surgical construct.4

            The dynamic hip screw (DHS) has gained widespread acceptance in the last decade
     and is currently considered as the standard device for comparison of outcomes. The DHS
     has been shown to produce good results but complications are frequent, particularly in
     unstable pertrochanteric fractures .9

            DHS fixation has been thoroughly assessed and randomized comparison have shown
     it to be superior to fixed nail plates , enders nails , kuntscher Y nails. The DHS has therefore
     become one of the standard treatments of trochanteric fractures .11

            Numerous variations of intramedullary nails have been devised to achieve stable
     fixation and early mobilization of pertrochanteric fractures, Proximal femoral nail (PFN)



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devised by the AO/ASIF group in 1996 has proven to be a promising implant in per-, inter-
or subtrochanteric femoral fractures 2.

        A theoretical advantage of intramedullary fixation is that it provides a more
biomechanically stable construct by reducing the distance between the hip joint and the
implant . Potential disadvantages are related to greater risk of jamming of the sliding
mechanism and stress risers at the site of tip of the nail and distal locking bolts3 .

        It has been suggested , without supporting clinical data , that the the IMNs
(intramedullary nails) are superior for unstable trochanteric fractures , reverse oblique
fractures and subtrochanteric fractures . Controversy , therefore , continues regarding the
optimum choice of implant for these unstable fractures 3.

        The advantages of intramedullary fixation of pertrochanteric hip fractures over
dynamic screw plate devices are still a matter of debate 5.

        Thus this study will help us to understand the management of intertrochanteric
fractures in terms of surgical technique, possible complications, and evaluate the functional
outcomes after fixation with PFN and DHS. It will therefore help us define the role of time
tested DHS with the newer generation intramedullary nail (PFN) in intertrochanteric
fractures.


6.2 REVIEW OF LITERATURE
        .
(1) BRIAN AROS MD,MS, ANNA N.A , TOSTESON ScD , DANIEL J, GOTTLIEB MS,
KENNETH J.KOVAL MD, (2008) performed a study to determine whether patients who
sustain an intertrochanteric fracture have better outcomes when stabilized using a sliding
hip screw or an intramedullary nail. A 20% sample of Part A and B entitled Medicare
beneficiaries 65 years or older was used to generate a cohort of patients who sustained
intertrochanteric femur fractures between 1999 and 2001. The cohort consisted of 43,659
patients. Patients treated with an intramedullary nail had higher rates of revision surgery
during the first year than those treated with a sliding hip screw (7.2% intramedullary nail
versus 5.5% sliding hip screw). Mortality rates at 30 days (14.2% intramedullary nail versus
15.8% sliding hip screw) and 1 year (30.7% intramedullary nail versus 32.5% sliding hip


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screw) were similar. Adjusted secondary outcome measures showed significant increases in
the intramedullary nail group relative to the sliding hip screw group for index
hospital length of stay, days of rehabilitation services in the first 6 months after discharge,
and total expenditures for doctor and hospital services.


(2) W.M.GADEGONE, Y.S.SALPHALE (2007) studied 100 cases of proximal femoral
fractures treated with proximal femoral nail with an average follow up of 1 year came out
with a conclusion that PFN offers the advantages of high rotational stability of the head-
neck fragment, and undreamed implantation technique and the possibility of static or
dynamic distal locking

(3) HENRY WYNN JONES, PHILLIP JOHNSTON, MARTYN PARKER (2006),
Performed the meta-analysis of 24 studies involving 3,279 fractures to compare the fixation
outcome between the sliding hip screw (SHS) and intramedullary nails (IMN) in stable and
unstable extracapsular proximal femoral fractures. All randomised controlled studies
comparing IMNs with a SHS were considered for inclusion. Data was independently
extracted and trial methodology assessed. Twentyfour randomised trials involving 3,202
patients with 3,279 fractures were included. Pooled results gave no statistically significant
difference in the cut-out rate between the IMN and SHS (41/1,556 vs 37/1,626; relative risk
1.19; 95% confidence interval 0.78–1.82). Total failure rate (1,03/1,495
and 58/1,565, relative risk 1.83; 95% confidence interval 1.35–2.50) and re-operation rate
(57/1,357 and 35/1,415, relative risk 1.63; 95% confidence interval 1.11–2.40) were
greater with the IMN compared with the SHS. There was no evidence for a reduced failure
rate with IMN in unstable trochanteric fractures.


(4) SUDHIR S BABHULKAR (2006)in his IOA white paper states that with personal
experience of more than 10 years of Gamma nailing, Russell Taylor nail and Proximal
Femoral Nails with a follow up of more than 2 years, the outcome of this fracture appears
good and excellent in the majority of the patients with unstable proximal femoral fractures.


(5) F. FOGAGNOLO, M. KFURI Jr , C.A.J.PACCOLA (2004) studied the intramedullary



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fixation of pertrochanteric hip fractures with short AO/ASIF proximal femoral nail in 46
consecutive patients and 47 fractures between july 1998 and may 2001 and concluded that
the PFN is a suitable implant for unstable fractures, but the high reoperation rate precludes
its routine use for every pertrochanteric fracture.


(6) DOUSA P, BARTONICEK J, JEHLICKA D, SKALA-ROSENBAUM J (2002) showed
the Presentation of the existing experience in the use of Proximal Femoral Nail Synthes
(PFN) in trochanteric fractures and concluded that PFN is a method of choice in
trochanteric fractures, namely in high subtrochanteric fractures .




(7) CAMPBELL’S OPERATIVE ORTHOPEDICS , 11th edition , volume 3 , 3237- 3308.
Two broad categories of internal fixation devices are commonly used for intertrochanteric
femoral fractures : sliding compression hip screws with side plate assemblies and
intramedullary fixation devices .
The preferred type of device is controversial . Intramedullary nails have a biomechanical
and biological advantage over standard compression hip screws . Intramedullary nails can
be inserted with less exposure of fracture and less blood loss , although they require more
fluoroscopic exposure and have been associated with fracture communition .
biomechanically nails allow for stable anatomical fixation of more comminuted fractures
without shortening the abductor movement arm or changing the proximal femoral anatomy .
these devices provide fracture stability by virtue of allowing lateral aspect of head and neck
to come to rest against the nail in the medullary canal


(8) ROCKWOOD AND GREEN’S FRACTURES IN ADULTS , seventh edition , volume
2 Intertrochanteric fractures by Thomas A Russel , 1597-1640.
 The results of most studies that have compared intramedullary hip screws and sliding hip
screws have revealed no significant differences with respect to operating time, duration of
hospital stay, infection rate, wound complications, implant failure, screw cut-out, or screw
sliding for stable fracture patterns . Patients treated with an intramedullary hip screw,
however, have been at increased risk for femoral shaft fracture at the nail tip and the



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insertion sites of the distal locking screws.
.
6.3 OBJECTIVE OF STUDY               1) to compare the clinical outcome of unstable
intertrochanteric fractures treated randomly with proximal femoral nail (PFN) and dynamic
hip screws (DHS).
2) to evaluate the advantages, disadvantages and possible complications associated with
fixation of unstable intertrocanteric fractures with proximal femoral nail (PFN) and
dynamic hip screw (DHS).


7. MATERIALS AND METHODS


7.1 SOURCE OF DATA
            Patients with unstable intertrochanteric fracture8,4 and who meet the inclusion
criteria admitted in KIMS, Hubli.


7..2 METHOD OF COLLECTION OF DATA
       Study design
            The study will be prospective, time bound, hospital based, randomized
comparative study. Cases satisfying the inclusion criteria admitted in KIMS during the
study period of November 2010 to October 2011will be included. Patients will be followed
up for a period of 6 months to 1 year and evaluated clinically with MODIFIED HARRIS
HIP SCORE 10 and the outcome will be used for comparison.
     Sample size
           Cases satisfying the inclusion criteria admitted in KIMS, Hubli during the study
    period of November 2010 to October 2011 will be included. As per the previous records
    around 50 cases can be taken under this study in the stipulated study period.
       Inclusion criteria
            Adult patients with unstable intertrochanteric fractures which include
posteromedial large separate fragmentation, basicervical patterns, reverse obliquity patterns,
displaced greater trochanteric (lateral wall fractures) and failure to reduce the fracture
before internal fixation 8 or those with subtrochanteric extension4.

       Exclusion criteria
          Paediatric age group


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           Stable fractures


       Period of follow-up
        The patients are followed up for a period of 1year at regular intervals.



      Parameters for evaluation
               The clinical data collected and evaluated with pre injury activity and present
functional levels with modified harris hip score`10



       Statistical tests:
             The collected data will be evaluated using appropriate statistical methods.


7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR
INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS
OR ANIMALS? IF SO DESCRIBE BRIEFLY.
           Yes, the study requires routine investigations and appropriate radiological
investigations. Surgical intervention will be under taken after adequate pre operative
assessment is made and only after taking informed consent.
    Investigations:
       1) Basic investigations
       Haemoglobin %, Total WBC count, differential count,esr,bleeding time, clottong
        time
       Blood urea, serum creatinine, random blood glucose
       ECG, 2D ECHO if required
       Doppler if required


       2) Radiological investigations
       Plain x-ray of relevant parts in anteroposterior and lateral views
       Traction and internal rotation x-rays if required




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7.4 HAS THE ETHICAL CLEARENCE BEEN OBTAINED FROM YOUR
INSTITUTION IN CASE OF 7.3?
    Yes, ethical clearance has been obtained from the ethical committee of KIMS Hubli.




8. LIST OF REFERENCES


   1) Brian Aros MD,MS, Anna.N.A, Tostesonb ScD, Daniel J, Gottlieb MS, Kenneth J
     Koval. MD, IS SLIDING HIP SCREW OR IM NAIL THE PREFERRED
     IMPLANT FOR INTERTROCHANTERIC FRACTURES , clinical orthop relat res
     (2008) 466: 2827-2832


   2) W M Gadegone, Y S Salphale. PROXIMAL FEMORAL NAIL – AN ANALYSIS
     OF 100 CASES OF PROXIMAL FEMOREAL FRACTURES WITH AN
     AVERAGE FOLLOW UP OF 1 YEAR , international orthopaedics
     (SICOT)(2007)31:403-408,


   3) Henry wynn Jones, Philip Johnston, Martyn Parker. ARE SHORT FEMORAL
     NAILS SUPERIOR TO SLIDING HIP SCREW? A META-ANALYSIS OF 24
     STUDIES INVOLVING 3,279 FRACTURES, international orthopaedics
     (SICOT)(2006) 30:69-78


   4) Sudhir S Babhulkar, MANAGEMENT OF TROCHANTERIC FRACTURES,
     indian journal of orthopaedics, October 2006,volume 40: number 4: p.210-218


  5) F Fogagnolo, M Kfuri, C A J Paccola ,INTRAMEDULLARY FIXATION OF
     PERTROCHANTERIC HIP FRACTURES                  WITH SHORT AO-ASIF
     PROXIMAL FEMORAL NAIL, arch orthop trauma surg (2004) 124:31-37


   6) Dousa P, Bartonicek J, Skala-Rosenbaum J )OSTEOSYNTHESIS OF
     TROCHANTERIC FRACTURES USING PROXIMAL FEMORAL NAILS, Acta


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       clin orthop traumatology,( 2002)


    7) CAMPBELLS OPERATIVE ORTHOPEDICS 11th edition vol 3 , page no 3237-
       3308 David G lavelle.


    8)ROCKWOOD AND GREENS FRACTURE IN ADULTS, seventh edition, volume 2
       intertrochanteric fractures by Thomas A Russel page no 1597 – 1640


    9) Y Z Xu, D C Geng, HQ Mao, XS Zhu, H L Yang, A COMPARISON OF THE
       PROXIMAL FEMORAL ANTIROTATION DEVICE AND DYNAMIC HIP
       SCREW IN THE TREATMRNT OF UNSTABLE PERTROCHANTERIC
       FRACTURES, the journal of international medical research, (2010); 38; 1266-1275


    10) Franco lavini. L, Renzi-Brivio, R Aulisa, F Cherubino, P L Di Seglio, N Galante,
       W Leonardi, M Manca , THE TREATMENT OF STABLE AND UNSTABLE
       PROXIMAL FEMORAL FRACTURES WITH A NEW TROCHANTERIC NAIL:
       RESULTS OF MULTICENTRE STUDY WITH THE VERO NAIL , strat traum
       limb recon (2008) 3: 15-22
`
    11) I. Saarenpää , T. Heikkinen , J. Ristiniemi , P. Hyvönen , J. Leppilahti , P. Jalovaara
      Functional comparison of the dynamic hip screw and the Gamma locking nail in
      trochanteric hip fractures:a matched-pair study of 268 patients, International
      Orthopaedics (SICOT) (2009) 33:255–260




                                                                                                  9
9    Signature of candidate


                                    DUE TO THE COMPLEXITY OF
10   Remarks of guide               THE MANAGEMENT AND THE
                                    RESULTS OF THE UNSTABLE
                                    INTERTROCHANTERIC
                                    FRACTURES, THE PRESENT
                                    STUDY IS TAKEN UP


11   Name and designation           DR. SURYAKANTA K
     11.1 Guide                     PROFESSOR
                                    DEPT OF ORTHOPAEDICS
                                    KIMS, HUBLI




     11.2 Signature



     11.3 Head of the department    DR SURESH KORLHALLI
                                    PROFESSOR
                                    DEPT OF ORTHOPAEDICS
                                    KIMS, HUBLI




     11.4 Signature




12   12.1 Remarks of the Chairman
     and principal




     12.2 Signature
                                                               10
11

								
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