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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

Conflict of Interest

• Stryker Trauma Consultant

• Smith-Nephew TSF Teaching Consultant

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

Be realistic

• How will you

spend your time?

• EXPECT that

research will take

more time than

you think!

clinical

admin

research

education

personal

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

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.

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

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

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

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

LEAP WAS LACKING

• Compared

standard salvage

techniques

• Minimal use of

Ilizarov or TSF

METRC STUDIES

• $200,000,000.00

from DOD

• Largest

orthopaedic

research fund in

history.

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

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

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.

MOST IMPORTANT

• Research Coordinator: Alysse Boyd,

ABoyd1@metrohealth.org

• Ext 83657, Cell (330) 388-5400

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.

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.

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

•

GET PEOPLE INVOLVED

Career stage dependent

– Student

– Resident

– Fellow

– Practicing physician

• Early vs. experienced

• Academic vs. non-academic

Negotiate

• Time

• Resources

• Money

Once in the fold….

• Celebrate

• No rest for the weary

• Keep accurate records

• Submit reports on time

• Let people know!

• Build relationships

RUN OVER

TEMPORARY FRAME

Orif fib, stable frame, excision dead

bone, free flap

Transport

Transport

On the other hand

LOOKS GOOD

Shit show

Filet of foot

WORTH the EFFORT

• Provides reliable

answers

• Bigger than us

• Affect limb

salvage in the

future

Only those who dare to fail greatly

can ever achieve greatly.

Robert F. Kennedy (1925 - 1968)

THANK YOU