Professional Documents
Culture Documents
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
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:
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
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
Twelve weeks
Sixteen weeks
Total score
Grade
poor/fair/good/excellent
Y/N
Annex
Grading Scale
<70:
70 79:
80 89:
90 100:
Poor
Fair
Good
Excellent
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