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Participating in Multi-
center Trials Is It Worth It?
How Did I Get Started? John K Sontich, M.D.
Associate Professor Orthopaedic Surgery
Case School of Medicine
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Conflict of Interest
• Stryker Trauma Consultant
• Smith-Nephew TSF Teaching Consultant
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Multi-center Trials
Are They Worth it?
HECK YES
• Combined Data Pool
• Reduces length
• Funding provided
• Varied bias cancels out
• Strict protocols
• Good for the institution
• Peer alliances
HECK NO
• Different surgical
techniques
• Reduces individual
accolades
• May not agree with all the
rules
• Has to still pass through
Hospitals’ IRBs
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Be realistic
• How will you
spend your time?
• EXPECT that
research will take
more time than
you think!
clinical
admin
research
education
personal
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Stay on the sidelines if…
• You are strongly bias
• You hate the protocol
• You have no passion
for the subject
• Don’t have the time
• Don’t have the
support
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How did I get started?
• It helps to be in the right place at the right
time … LEAP Study
• Communicate with the primary institution
and try to influence with your perspective
• Talk amongst colleagues
• OTA, POSNA, AOFAS, LLRS etc.
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LEAP (lower extremity
assessment project) • Prospective ( Non-randomized ) cohort of 601
patients admitted to 8 level I trauma centers
• I was the lone Ilizarov surgeon
• Followed from 0 – 84 months
• IIIB and C, selected IIIA, dysvascular limbs,
crush injuries, severe foot and pilon fractures
7
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Injury Severity Score
• None of the scoring systems were found to
be valid
• DON’T USE SCORES TO PREDICT
AMPUTATION
8 Bosse MJ et al JBJS jan 2001; vol83(1) 3-13
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OUTCOMES salvage and amps
• No difference in functional outcome
between amputation group and limb
salvage at 24 months
• Poor outcomes- older age, female sex,
nonwhite, low education, smoking, poor
health before injury, disability litigation,
severe soft tissue injury, crush foot,
infections.
9 Bosse MJ N Engl J Med 2002;347:1924-1931
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Surgeon and Patients disagree
regarding outcomes
• LEAP study group
• Outcome based
sickness impact
profile (SIP)
• Satisfied outcome
– surgeons 59%
– Patients 40%
10
Outsole RV et al. J Orthop Trauma Vol23(10) dec2009:716-723
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LEAP WAS LACKING
• Compared
standard salvage
techniques
• Minimal use of
Ilizarov or TSF
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METRC STUDIES
• $200,000,000.00
from DOD
• Largest
orthopaedic
research fund in
history.
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METRC FIXIT
Internal vs External Fixation
INCLUSION CRITERIA
• ALL OPEN TIBIA FRACTURES and
– Type IIIB
– Type IIIA and extensive muscle damage
– Type IIIA with bone loss >1cm after I and D
– Type IIIA with fasciotomies, not closable
• Suitable for ring or internal fixation
• Maybe treated with temporary simple frame
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METRC FIXIT
Internal vs External Fixation
Special Circumstances
• All patients randomized before definitive
fixation
• If refused randomization, can wait 24
hours and be consented for observational
arm of the study
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METRC FIXIT
Internal vs External Fixation
RANDOMIZATION • Randomization
• Login to https://metrcdata.org/redcap/
• Username: HVallier Password: Lifeflight1
• Click METRC – FIXIT
• Click Data Entry (Left Hand Side)
• Choose the correct FIXIT patient number (this corresponds to the
FIXIT number given at time of screening form CRF00). If a
screening form has not been completed for patient, enter one at this
time (take a paper form from Ortho Conference Room & fill out
information, then enter in website. Leave form in Alysse Boyd’s
mailbox).
• Go through randomization process on website.
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MOST IMPORTANT
• Research Coordinator: Alysse Boyd,
• Ext 83657, Cell (330) 388-5400
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METRC STUDIES
•Bioburden - The primary objective of this study
is to characterize the contemporary extremity
wound “bioburden” at the time of definitive wound
coverage or closure of severe extremity wounds
employing newpolymerase chain reaction PCR
technology.
•OUTLET - The purpose of this study is to
compare 18 month functional outcomes of patients
undergoing salvage versus amputation following
severe distal tibia, ankle and/or foot injuries.
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METRC • POvIV – Oral antibiotics Vs IV antibiotics for acute
orthopaedic infections with a plate
• pTOG – BMP-2 Vs ICBG for the treatemnt of open tibia
fractures with a bone defect
• TCC - This study will evaluate the effectiveness of
Trauma Collaborative Care (TCC) in improving outcomes
for patients with severe orthopaedic trauma.
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Define Responsibilities
•
• A. Database and registries
• 1) Fracture database (Microsoft access)
• - Data collection and entry
• - Maintain paper records
• - Maintain regulatory standards
• - Reconcile resident records with OR cases
• - Implement updates from OTA
• - Produce reports as requested for quality, education, or research
•
• 2) Outcomes database (Microsoft excel and access)
• - Data collection scoring and entry
• - Maintain paper records
• - Update master excel sheet quarterly
•
• 3) Fixation timing database (Microsoft excel and SPSS)
• - Maintenance of paper and electronic records
• - Purchase and implement software updates (SPSS)
•
• 4) METRC (Red Cap)
• - Data collection and entry
• - Maintain paper records
• - Maintain regulatory standards
• - Reconcile resident records with surgeons
• - Develop and maintain linking file
• - Complete continuing reviews for IRB
• - Interface with coordinating center
•
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GET PEOPLE INVOLVED
Career stage dependent
– Student
– Resident
– Fellow
– Practicing physician
• Early vs. experienced
• Academic vs. non-academic
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Negotiate
• Time
• Resources
• Money
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Once in the fold….
• Celebrate
• No rest for the weary
• Keep accurate records
• Submit reports on time
• Let people know!
• Build relationships
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RUN OVER
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TEMPORARY FRAME
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Orif fib, stable frame, excision dead
bone, free flap
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Transport
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Transport
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On the other hand
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LOOKS GOOD
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Shit show
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Filet of foot
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WORTH the EFFORT
• Provides reliable
answers
• Bigger than us
• Affect limb
salvage in the
future
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Only those who dare to fail greatly
can ever achieve greatly.
Robert F. Kennedy (1925 - 1968)
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THANK YOU