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SYNOPSIS for FCPS Part II

To evaluate the outcome of Type C fractures of distal Radius


managed with Volar LCP plates.

By
Dr. Sami Raza
TR, FCPS II
Orthopaedic Surgery

Supervisor
Prof. Shafiue Ahmad Shafaq
FCPS, AO fellow (Germany)
Head, Department of Orthopaedic Surgery
Shaikh Zayed Federal Postgraduate Medical Institute,
Lahore
INTRODUCTION

Distal radius fractures represent approximately one-sixth of all fractures treated


in emergency departments. The incidence of this injury appears to be both gender and age
specific. There are three main peaks of fracture distribution: the first peak is in children
ages 5 to 14, the second is in males under age 50, and the third peak is in females over the
age of 40 years.
Distal radius fractures in the elderly may represent an insufficiency fracture associated
with all of the risk factors for osteoporosis.
The majority of osteoporotic fractures occur as the result of a fall , while the majority of
injuries in the younger patients are secondary to motor vehicle accidents and sports. Risk
factors for distal radius fractures in the elderly have been studied extensively. Decreased
bone mineral density, female gender, ethnicity, heredity, and early menopause have all
been shown to be risk factors.
The optimal management of distal radius fractures has changed dramatically over the
previous two decades from almost universal use of cast immobilization to a variety of
highly sophisticated operative interventions.
OBJECTIVES
The study is being undertaken so as to determine the best evidence
based practice for the operative management of proximal femoral extra-articular
(sub-trochenteric and pertrochenteric) fractures. The objective of the study is to
compare the outcome of two fixation methods of extra-articular proximal femoral
fractures by dynamic hip screw (DHS) and proximal femoral nail (PFN) in terms
of functional outcome. Outcome of the surgery will be measured at 8, 12, and 16
weeks post-op in terms of functional outcome.

Functional outcome of the surgery which will be measured by Modified Harris


Hip Score10, and will be graded as excellent, good, fair or poor. Excellent and
good outcomes at 16 weeks would indicate recovery of walking ability.

RATIONALE
The study is being conducted so as to determine the best practice for the
treatment of our local population with the available resources considering there
are currently no reliable studies available on the subject.
MATERIALS AND METHODS
STUDY DESIGN
A randomized clinical trial
PLACE OF STUDY
Department of Orthopaedics, Shaikh Zayed Hospital, Lahore after approval by
hospital ethical committee.
DURATION OF STUDY
It will be completed in six months after the approval of the synopsis.
SAMPLE SIZE
The sample size was estimated by using 5% level of significance, 80% power of
test with expected outcome for walking ability for PFN and DHS 76.2% 6 and
53.7%6 respectively with a hypothesis that PFN is superior to DHS with reference
to final outcome.The estimated sample size is 54 for each group.
SAMPLING TECHNIQUE

Pt will be prepared for surgery and operation theatre will be ready for both
procedures. Just before the surgery an envelope from two identical envelopes of
DHS and PFN each will be randomly chosen and proceed with that surgery.

Inclusion criteria
1) Age:

25 85 yrs of both sexes.

2) Type of fracture: All extra-articular proximal femoral fractures (pertrochenteric and


subtrochenteric) will be included in the study

Exclusion criteria
1) Patient unwilling to participate in the study
2) Patients with associated fractures of the lower limbs, pelvis or the spine
3) Patients with pre-existing condition of the hips e.g. rheumatoid arthritis,
advanced osteoarthritis, infective arthritis, gouty arthritis, ankylosing spondylitis etc
assessed by history and pre-op x-rays..
4) Patients unfit for surgery on the basis of pre operative evaluation
5) Age less than 25 and more than 85 will be excluded

DATA COLLECTION PROCEDURE


All the patients between 25 - 85 years of age with extra-articular proximal
femoral fractures will be admitted in the orthopaedic department through
emergency department or OPD. Demographic data and history will be taken
relevant to the mode of injury and time since injury. All the patients will be
examined and diagnosis will be confirmed with radiographic examination. Skin
traction will be applied to the affected limb. Baseline investigations will be done
and fitness for anesthesia and surgery will be obtained preoperatively. Informed
written consent will be obtained from all patients preoperatively for surgery

including for research inclusion also. Pt will be prepared for surgery and
operation theatre will be ready for both procedures. Just before the surgery an
envelope from two identical envelopes of DHS and PFN each will be randomly
chosen and allocated to that particular group. All the patients will be operated on
next regular list. All the patients will be operated on the fracture table by the
researcher. Standard anteroposterior and lateral radiographs will be done in the
ward postoperatively. All patients will be given intravenous antibiotics
preoperatively and for few days post operatively. Drains will be removed after 48
hours. Patient will be encouraged to mobilize 1 2 days post-operatively. They
will be advised to commence weight bearing with support as tolerated after 2
weeks.
The patients will be seen at two weeks post-op for wound check and stitch
removal. Further follow-up visits in outpatients department at 8, 12, and 16
weeks. Variables of Modified Harris Hip Score will be recorded on every follow
up. Total score will be calculated and graded. Failure of fixation will be reported
as a discredit to the procedure.

DATA ANALYSIS
All the data will be entered and processed in SPSS 15.0
Harris Hip score will be presented by using mean +/- S.D for both groups at 8,
12 and 16 weeks. Comparison for above variables will be performed by using ttest or mannwhitney U-test depending on normality of date.
Gender, functional outcome and complications will be processed by using
frequencies and percentages for both groups.
Comparison for these qualitative variables will be performed by using Chi 2 test
and z-test for proportion.
P- Value < 0.05 will be considered statistically significant.
5

PROFORMA
Comparative study of outcome of extra-articular proximal femoral
fractures treated with DHS and PFN
Case No..................
Hospital no
Group......................
Date: ..
(Group A patients treated with DHS, Group B patients treated with PFN)
Name.............................................................................Age...........Sex................
Address:.................................................................................................................
Profession.....................................................................
Mode of injury:
Date of admission:...................................Date of operation:.................................
Date of discharge:...................................Time of procedure:.
VARIABLES

Modified Harris Hip Score


Eight weeks

Twelve weeks

Sixteen weeks

Total score
Grade

Functional outcome at 16 weeks:


Final walking ability attained:

poor/fair/good/excellent
Y/N

Annex

Grading Scale
<70:
70 79:
80 89:
90 100:

Poor
Fair
Good
Excellent

REFERENCES
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Epidemiology of hip fractures. Bone, 1996; 18: 57 63.
3. Carmen A. Brauer, MD, Marcelo Coca-Perraillon, MA; David M. Cutler, Allison
B. Rosen. Incidence and Mortality of Hip Fractures in the United States. JAMA,
2009 ; 302(14): 1573-1579
4. Evans EM. Trochanteric fractures. A review of 110 cases treated by nail plate
fixation. J Bone J Surg, 1951; 33-B: 192.
5. Dousa P, Bartonicek J, Jehlicka D, Skala-Rosenbaum J. Osteosynthesis of
trochanteric fracture using proximal femoral nail. Acta Chir Orthop Traumatol
Cech, 2002; 69: 22 30.
6. Pajarinen J, Lindahl J, Michelsson O, Savolainen V, Hirvensalo E.
Pertrochanteric femoral fractures treated with a dynamic hip screw or a proximal
femoral nail. A RANDOMISED STUDY COMPARING POST-OPERATIVE
REHABILITATION. J Bone J Surg, 2005; 87-B, 76 - 81.
7. Pavelka T, Matejka J, Cervenkova H. Complications of internal fixation by a
short proximal femoral nail. Acta Chir Orthop Traumatol Cech, 2005; 72: 344
54.
8. Lavini F, Renzi-Brivio L, Aulisa R, Cherubino F, Di Seglio PL, Galante N,
Leonardi W, Manca M. The treatment of stable and unstable proximal femoral
fractures with a new trochanteric nail: results of a multicentre study with the
Veronail. , 2008; 3(1): 15 - 22.
9. Jiang LS, Shen L, Dai LY. Intramedullary fixation of subtrochanteric fractures
with long proximal femoral nail or long gamma nail: technical notes and
preliminary results. Ann Acad Med Singapore, 2007; 36: 821 6.
10. Harris WH. Traumatic arthritis of the hip after dislocation and acetabular
fractures: treatment by mold arthroplasty. An end-result study using a new
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