Randomized Clinical Trials in Orthopaedics

Randomized
Clinical Trials in
Orthopaedics

Tuesday, January 1, 13

Is EBM New?

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1040 Gregorian


Research Methodology
Vs
EBM


Doing
Reseach
Methodology

Research

EBM

Using


http://library.downstate.edu/EBM2/2100.htm


The Oxford 2011 Levels of Evidence

Oxford Centre for Evidence-Based Medicine. http://www.cebm.net/index.aspx?o=5653


What is an RCT?

Planned Experiment (Trial)
Allocation by Chance (Random)
Both arms treated equally (Controlled)
Looking for specific outcomes


What is an RCT?

Golden Standard of Clinical Research

J Androl. 2001 Nov-Dec;22(6):938-43


Types of RCTs

Superiority Trials
Noninferiority Trials
Equivalence Trials
Bioequivalence Trials

Wang, D. (2007). Clinical trials: A practical guide to design, analysis, and reporting. London: Remedica.


How Good Are We Doing?

Only 3% of Orthopedic literature
60% of them were considered lower
quality
72% are Level-IV or V studies

Bhandari M, J Bone Joint Surg Am. 2002;84:388-96.


Things Are Improving
Levels of Evidence in Research
Published in The Journal of Bone and
Joint Surgery (American Volume)
Over the Last Thirty Years.

J Bone Joint Surg Am. 2009 Feb;
91(2):425-8

88% had methodological flaws that could limit their validity


J Am Acad Orthop Surg 2010;18: 454-463


Problem Solution
Orthopaedic culture Accept uncertainty

Limited training in Offer more and better training
research methods
Motivation to pursue research Institutional support for
research research
Give patients a choice (ie,
Patient preference
preference trial)

J Am Acad Orthop Surg 2010;18: 454-463


Surgical RCT challenges
Ethics
Not Always Applicable
Learning Curve for a New Surgical
Intervention
Standardization of Surgical Procedures
Challenging methodologically
Funds and logistics
Ann Surg 2010;251: 409–416


Hazardous journeys

Parachute use to prevent death and major trauma related
to gravitational challenge: systematic review of
randomised controlled trials
Gordon C S Smith, Jill P Pell

Abstract accepted intervention was a fabric device, secured by Department of
Obstetrics and
strings to a harness worn by the participant and Gynaecology,
Objectives To determine whether parachutes are released (either automatically or manually) during free Cambridge
effective in preventing major trauma related to fall with the purpose of limiting the rate of descent. We University,
gravitational challenge. excluded studies that had no control group.
Cambridge
CB2 2QQ
Design Systematic review of randomised controlled
Gordon C S Smith
trials. Definition of outcomes professor
Data sources: Medline, Web of Science, Embase, and The major outcomes studied were death or major Department of
the Cochrane Library databases; appropriate internet trauma, defined as an injury severity score greater than Public Health,
sites and citation lists. 15.6 Greater Glasgow
NHS Board,
Study selection: Studies showing the effects of using Glasgow G3 8YU
Meta-analysis
a parachute during free fall. Jill P Pell
Our statistical apprach was to assess outcomes in para-
Main outcome measure Death or major trauma, consultant
chute and control groups by odds ratios and quantified
defined as an injury severity score > 15. Correspondence to:
the precision of estimates by 95% confidence intervals. G C S Smith
Results We were unable to identify any randomised
We chose the Mantel-Haenszel test to assess hetero- gcss2@cam.ac.uk
controlled trials of parachute intervention.
geneity, and sensitivity and subgroup analyses and
Conclusions As with many interventions intended to BMJ 2003;327:1459–61
fixed effects weighted regression techniques to explore
prevent ill health, the effectiveness of parachutes has

G. C. S. Smith, J. P.
causes of heterogeneity. We selected a funnel plot to
not been subjected to rigorous evaluation by using
assess publication bias visually and Egger’s and Begg’s
randomised controlled trials. Advocates of evidence
tests to test it quantitatively. Stata software, version 7.0,
based medicine have criticised the adoption of
was the tool for all statistical analyses.
interventions evaluated by using only observational
data. We think that everyone might benefit if the most
radical protagonists of evidence based medicine Results Pell, BMJ British
Medical Journal 327,
organised and participated in a double blind,
Our search strategy did not find any randomised
randomised, placebo controlled, crossover trial of the
controlled trials of the parachute.
parachute.

Introduction
The parachute is used in recreational, voluntary sector,
and military settings to reduce the risk of orthopaedic,
Discussion
Evidence based pride and observational prejudice
It is a truth universally acknowledged that a medical
126-128 (2003).
intervention justified by observational data must be in
head, and soft tissue injury after gravitational
want of verification through a randomised controlled
challenge, typically in the context of jumping from an
aircraft. The perception that parachutes are a success-
ful intervention is based largely on anecdotal evidence.
Observational data have shown that their use is associ-
ated with morbidity and mortality, due to both failure
of the intervention1 2 and iatrogenic complications.3 In
addition, “natural history” studies of free fall indicate
that failure to take or deploy a parachute does not
inevitably result in an adverse outcome.4 We therefore
undertook a systematic review of randomised control-
led trials of parachutes.

Methods
Literature search
We conducted the review in accordance with the
QUOROM (quality of reporting of meta-analyses)
guidelines.5 We searched for randomised controlled
trials of parachute use on Medline, Web of Science,
Embase, the Cochrane Library, appropriate internet
HULTON/GETTY

sites, and citation lists. Search words employed were
“parachute” and “trial.” We imposed no language
restriction and included any studies that entailed Parachutes reduce the risk of injury after gravitational challenge, but their effectiveness has
jumping from a height greater than 100 metres. The not been proved with randomised controlled trials

BMJ VOLUME 327 20–27 DECEMBER 2003 bmj.com 1459


How’s the Kingdom doing?

Biomedical Research in Saudi
70% in Riyadh

KSU 29.5%

KFSH&RC 21.5%

only 0.5% in high impact journals

Saudi Med J. 2002 Jan;23(1):20-4


How Many Surgical Trials
from Saudi?

Non Completed
To this date. only one ongoing


Ideas

Pemberton vs Salter
Staples Vs 8 plate
Functional Bracing Vs Casting


Distal Tibia
Fracture


Intramedullary Nailing

The Current Standard of treatment
Hight Union rate



Problems



Problems
• Anterior Knee pain
• Reported as high as 69%



Problems
• Anterior Knee pain
• Reported as high as 69%

• High Malunion Rates 16.2 %

Int Orthop. 2010 Dec;34(8):1285-90.
J Bone Joint Surg Am. 2002 Apr;84-A(4):580-5.


MIPO
• Minimally Invasive
Technique

• Better Control on
the end fragments

• Concerns about
Infection,
neurovascular
injury

J Orthop Trauma 24.1 (2010): 24-9


Question?


Is MIPO better than IM nailing
in treating distal tibia
fractures?


Better In what?


Better In what?

• Union
• Malunion
• Functional outcome
• Radiation
• Infection rate
• OR time
• Cost


Literature
Review

87 Articles reviewed
All are level 3 or level 4
Evidence
One RCT with major flaws


Hypothesis

Is MIPO superior to IM nailing
in terms of malunion?
MIPO is superior to IM nailing
in terms of malunion


How To Answer The
Question?

A Randomized Controlled Trial
Superiority Trial Design
Two arm Parallel Design
Against a standered


Primary Outcome


Primary Outcome

Time of Union
Rate of Malunion
Quality of life
Blood Loss
Radiation Exposure
Duration of Surgery
Infection Rate
Hospital Stay

Primary Outcome

Time of Union
Blood LossRate of Malunion
Radiation Exposure
Quality of life
Duration of Surgery
Infection Rate
Hospital Stay

Primary Outcome

Time of Union
Rate Of Malunion
Blood LossRate of Malunion
Radiation Exposure
Quality of life
Duration of Surgery
Infection Rate
Hospital Stay

Primary Outcome

Rate Of Malunion

• More than 5 degree angulation in the anterior-
Time of Union
posterior Loss
Blood or lateral view
Rate of Malunion
Radiation Exposure
• Rotation of more than 10 degrees
Quality of life
Durationmore than 1 cm.
of Surgery
• Shorting of
Infection Rate
Charles A. Rockwood, David P. Green, Robert W. Bucholz, James D. Heckman, Charles M. Court-Brown, Kenneth J. Koval, Paul Tornetta. Rockwood & Green Fractures in Adults.

Hospital Stay
Ed. James D. Heckman, Charles M. Court-Brown, Robert W. Bucholz MD. 6th ed. Vol. 2. 2 vols: Lippincott Williams & Wilkins, 2006


Secondary Outcomes
The Short Form (12) Health
Score (SF-12v2®)
Time Of Fracture Healing
Blood Loss
Radiation exposure
Duration of Surgery
Infection Rate
Hospital Stay

Design

Subjects Inclusion Criteria:
Males And Females 18-60

Closed Tibia Fracture

Müller AO Class 43-A


Outcome
Assessing


Outcome
Assessing

Valid


Outcome
Assessing

Valid
Reliable


Outcome
Assessing

Valid
Reliable
Responsive


Outcome
Assessing

Bilateral Lower Limb CT

Rofo 157.3 (1992): 245-51


Outcome Assessing

Time Of healing
Clinical Criteria: No pain or tenderness while
wight bearing or palpating the fracture site

Radiological Criteria: Bridging of the fracture site
in anterior-posterior and lateral views.

Bone Joint Surg Am 90.9 (2008): 1862-8


Surgery & Surgeons
4 Board certified Surgeons
Surgeon Inclusion Criteria
Standardized Protocol for each
intervention
Methods to detect and report any breach
in surgical protocol

Ann Surg 251.3 (2010): 409-16


Randomization

Concealed
Blocked randomization Computer
Based
Investigators are not involved
2 staged Randomization process

Can J Surg 53.6 (2010)


Randomization
4 Surgeons, 3
experts in nailing and
1 expert in MIPO
The chances of
subjects getting
experts doing their
procedure
75% for nailing group

25% for MIPO group

Clin Orthop Relat Res 466.7 (2008): 1734-44


Subject


Subject

Computerized permuted
blocks


Subject

blocks

MIPO IM


Subject

1st
blocks
Stage

MIPO IM


Subject

1st
blocks
Stage

MIPO IM

Simple Simple


Subject

1st
blocks
Stage

MIPO IM

Simple Simple

A B C D A B C D


Subject

1st
blocks
Stage

MIPO IM

2nd
Simple Simple

A B C D A B C D


Sample Size

Power of 80%

Effective sample
size 150

180 after
considering drop
outs


Ethics


Ethics

The Nuremberg
Code


Ethics

The Nuremberg
Code
Declaration Of
Helsinki


Ethics

The Nuremberg
Code
Declaration Of
Helsinki
The Belmont
Report


I.M Nailing Vs MIPO distal tibia

Clinical Trial Voluntary Participation !"‫ا1*ا'4! )32 ا10/ر.! ا-,+*)(! '& درا‬
Consent !(5(6(3.‫إ‬

Intramedullary nailing Vs. M.I.P.O. in
Tibia Fractures, A Randomized
Controlled Trial
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Ethics
Purpose Of the Research:
To evaluate the healing time in fractured :LMD-‫ ا‬NC ‫9ف‬P-‫ا‬
tibias, and to know wither locked plating is !"#$%‫<;)ر98 و7! إ%$6م ا%543 21 إ+$/.ام ا,+*)خ وا‬
superior to nailing in this type of fracture. .8=>;?‫@ ا‬A)>B%‫+$/.ام ا‬C2

:!"‫ ا-9را‬QR‫و‬
Description of the Research:
We are evaluating two standard methods 8D%)E< FG ‫$)ن‬I‫*)ر‬E< 1$;I3J 89‫ ا%.را+8 <;)ر‬FG K$*+
of treating distal tibial fractures, if you FG 8L‫)ر‬M?‫$3ت ا‬O‫ ا%4)ق. إذا ا‬R< 3*OS‫ ا‬T=#%‫ر ا‬U4L
chose to enroll in this research, you well F$;I3J ‫.ى‬W‫ إ‬X=Y ً )[*A‫ا‬UMY EI‫ز‬U^ K$+ ،8+‫ا%.را‬
be randomly assigned to one of two !*"#$%‫*8 أو ا‬Y)/a%‫+*)خ ا‬S)2 !*"#$%‫ا%$#"*!. إ<) ا‬
groups of treatment. The intramedullary
nailing group or the locked plating group.
Both groups are standard treatments for
1$;I3b%‫ ا‬cL ‫ن‬d2 ً )[e=Y .8=>;?‫.9*8 ا‬E?‫@ ا‬A)>B%)2
.‫ر‬U45%‫ ا‬R< ‫ع‬Ua%‫ا ا‬gh ‫ج‬cY FG ً )[*"J ‫.^)ن‬e$E< ‫;$)ن‬I3J
The Nuremberg
this type of fracture. Before surgery you
well be asked to fill a 12 question survey
about your quality of life before having the
3MY)aj‫ ا‬R< ‫8 إ+$"*)ن‬k"E^ a< l=b*+ 8W‫3ا‬D%‫ ا‬m"7
.345%)2 $2)n‫ إ‬m"7 8*^)*o%‫*8 وا‬oB%‫)%$ ا‬W RY ً,‫ا‬p+
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Code
fracture During and After surgery in both
groups, information well be gathered about $7)*% R< .Ld$%‫. ا‬E2 X>M$4?‫ ا‬R< ‫! %. +$/3ج‬I3r‫أ‬

Declaration Of
t h e t w o p r o c e d u r e s . Yo u w e l l b e 8*"b%‫)ت ا‬e*=E$%)2 ‫ام‬t$%u‫ ا‬a< l=b*+‫"*8 %=/3وج و‬b%‫ا‬
discharged home when your medically fit. v2 ‫ح‬Ue4?‫ ا‬F9."%‫)ط ا‬Ma%‫*8 ا‬W)9 R< 8+‫=")ت ا%.را‬b$<‫و‬
You well be asked to adhere to the ‫)رة‬I‫ ز‬a< l=b*+ %‫. ذ‬E2 .‫ج‬cE%‫3ق ا‬J R< 8;I3J m5%

Helsinki
protocol of the assigned group in terms of
weight baring and physical activity. you 8jcj mL Kj R<‫=*8. و‬eE%‫ ا‬R< ‫)ن‬YU"+‫. إ‬E2 X>M$4?‫ا‬
well be seen again in 2 weeks time and K$*+ ‫ه‬gh 8E2)$?‫$3ة ا‬G ‫ل‬cO .345%‫ ا‬Kk$=I ‫ أن‬X%‫ر ا‬U|}
every three months for two years for re- ‫)ت‬Y)}u‫ ا‬meY ~I3J RY ‫ 73ب‬RY ‫43ك‬L 8ÅWc<
evaluation and information gathering which $%)o2 ‫+$"*)ن ا%/)ص‬u‫8 ا‬k"E^‫8، و‬I3"/?‫ ا‬m*%)o$%‫وا‬

The Belmont
includes blood tests, X-Rays and survey
.8*oB%‫ا‬
filling.

:!3T,M1‫/ت ا‬V/)‫ز‬W‫ وا‬FX/@1‫ا‬

Report
Potential Risks and Discomforts:
Risk of your participation include risks .8=e$o< 3J)/< ‫ل‬U"7 )|*=Y l^3$I 8+‫ ا%.را‬FG $L‫)ر‬M<
related to the surgical procedure which 3J)/< : Fh‫8 و‬W‫3ا‬D%)2 8;=E$< ‫ن‬U5^ .7 3J)/?‫ه ا‬gh
include risks of anesthesia, bleeding,
8<.;< FG ‫,م‬É‫3 ا‬J)/<‫%$|)2)ت و‬u‫ وا‬ÑIta%‫3 وا‬I./$%‫ا‬
infection and anterior knee pain and
surgical wound pain and radiation 8E}Ö% Ü3E^ %gL‫=*8. و‬eE%‫;8 ا‬ba< ‫,م‬É‫"8 أو ا‬L3%‫ا‬
exposure. Certain measures are taken to q*er ‫[) ً أن‬e=Y .345%‫8 ا‬E2)$< ‫ل‬cO‫=*8 و‬eE%‫)ء ا‬aj‫ا‬
avoid theses risks as much as possible. If R< ً )[I‫ل أ‬UBW .aY‫ 2|). و‬gOS‫ ا‬K$I 8<‫)ت ا,ز‬J)*$Wu‫ا‬
any of these complications accrue they 8*"b%‫*3 ا‬I)E?‫ ا‬l4W )|E< m<)E$%‫ ا‬K$*+ ‫>)ت‬Y)á?‫ه ا‬gh
well be dealt with according to the medical
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standards. Discomforts include
‫)رات ا?$5[[3رة‬It%‫ وا‬X>M$4?‫ ا‬FG KIUa$%‫ا‬

43



Clinical Trial Voluntary Participation
hospitalization and the frequent follow ups !"‫ا1*ا'4! )32 ا10/ر.! ا-,+*)(! '& درا‬
!"‫=<; ا":9وج 76 ا54321!. و/. -%", ا"*)( '&%ف إ‬
Consent
after the intervention has been done. !(5(6(3.‫إ‬
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Ethics
In case you are pregnant risks related to
.DEF"‫! ا‬BG NOPQ3"‫ة ا‬STU‫% ً 76 ا‬W'‫9 أ‬OXYZ %OPJ NPQ' A"
the fetus include affect of radiation on the
fetus. None of the investigated devices are
proven to harm your fetus Vs. M.I.P.O. in
Intramedullary nailing !(89:1‫ ا-6@/)(! ?/->=/<; ا‬A/("B‫4/ر8! ا‬C
Tibia Fractures, A Randomized :!"#$%&‫ا,+*ا)( ا‬
Controlled Trial
Potential Benefits: ./ ً %WOPJ ‫, `49ك =^-;ى ا"9ق ا5<3);ة‬F"%<7 A3Oa
&<‫ ا-:0*ا‬IJ‫?/-,*ز‬
Your fracture well be treated by one of the N*Z %34O" D3b'9"‫ ا‬M` .‫ر‬d4e"‫ع 76 ا‬dE"‫ا ا‬gh ,F"%<7
standard methods Research:
Purpose Of the of treatment. None of
i3`‫% ً. و=)2%ر‬WO-‫9ا‬U‫% ً و‬WOPJ ‫9=, وإ?)% 7<3);ة‬F3"‫ا‬
them are experimental. Youtime in fractured
To evaluate the healing well be aiding :LMD-‫ ا‬NC ‫9ف‬P-‫ا‬
in the process of determining the best wayis
tibias, and to know wither locked plating i" ‫3%ح‬Oa %)` .(&/‫ أ‬D3b'9"‫; /. 7<9/, أي ا‬G%43a
!"#$%‫<;)ر98 و7! إ%$6م ا%543 21 إ+$/.ام ا,+*)خ وا‬
of superior to nailing in fracture. of fracture.
treatment of such this type In addition i3"%*= lB<3' %)/ ,PO"‫ة ا‬Y2E5‫ه ا‬gh ./ ‫ج‬M<"‫. ا‬bBZ
.8=>;?‫@ ا‬A)>B%‫+$/.ام ا‬C2
you well be offered to follow up in our .,a‫ه ا";را‬gh ‫ر‬d*7 ,OP"‫ا‬
institute for any treatment related to your :!"‫ ا-9را‬QR‫و‬
Description of the Research:
condition.
We are evaluating two standard methods 8D%)E< FG ‫$)ن‬I‫*)ر‬E< 1$;I3J 89‫ ا%.را+8 <;)ر‬FG K$*+
:‫ا&21و,/.ت‬
of treating distal tibial fractures, if you FG 8L‫)ر‬M?‫$3ت ا‬O‫%رك ا52%ر`,ا‬O3m‫; ا‬EG ‫ول‬o47 N?‫أ‬
6G ,a‫ ا%4)ق. إذا /. ا";را‬R< 3*OS‫ ا‬T=#%‫ر ا‬U4L
Responsibilities:
If you choseenroll in this research,study.well
chose to to participate in the you It F$;I3J ‫.ى‬W‫ إ‬X=Y ً )[*A‫ا‬UMY EI‫ز‬U^ K$+ ،8+‫ا%.را‬
i?‫,. `)% أ‬a‫ ا";را‬l'9/ 67 i" ‫)%ت ا5<%ه‬OB<3"‫%ع ا‬PZ‫إ‬
well berandomly assignedtoto one to the
be your responsibility adhere of two ‫اء‬da Y2EZ ;r 8*Y)/a%‫+*)خ ا‬S)2 !*"#$%‫6 ا‬G ‫ول‬o47
!*"#$%‫1%ت أو ا‬s%&7 ‫6 أي‬G %EsM=‫ا%$#"*!. إ<) إ‬
groups of treatment. The intramedullary
study protocol and instructions. And inform
nailing group or the locked plating group.
the research team of any side effects you
Both groups are standard treatments for
may develop. Your are also required to
‫ول‬o47 i?‫,. `)% أ‬bB<37‫ن‬d2 ً )[eA" ‫, أو‬a‫, =%";را‬bB<37 N?%`
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.‫ر‬U45%‫ ا‬R< ‫ع‬Ua%‫ا ا‬gh ‫ج‬cY ‫%ت‬UMG ,'‫6 أ‬G %?‫%ر‬Pm‫6 إ‬G
‫%رج‬m %T37;:3a‫ أو أدو', إ‬FG ً )[*"J ‫.^)ن‬e$E< ‫;$)ن‬I3J
The Nuremberg
inform the research team of any
medication or treatment you take outside
of the protocol.
.,a‫?%ق ا";را‬
F$%‫8 ا‬W‫3ا‬D%‫ ا‬RY ‫ 2*)9)ت‬qer K$*+ 8W‫3ا‬D%‫. ا‬E2‫)ء و‬aj‫أ‬
Code
groups, information well be gathered about $7)*% R< .Ld$%‫. ا‬E2 X>M$4?‫ ا‬R< ‫ا,765.ت+$/3ج‬
:!"3(4,‫! %. ا‬I3r‫أ‬

Declaration Of
Alternative Treatments: s . Yo u w e l l b e
the two procedure ‫9ض‬G A3O4/ ,a‫;م ا52%ر`, /. ا";را‬G ‫39ت‬m‫إذا ا‬
8*"b%‫)ت ا‬e*=E$%)2 ‫ام‬t$%u‫ ا‬a< l=b*+‫"*8 %=/3وج و‬b%‫ا‬
If you chose not to participate in the study
discharged home when your medically fit. v2 ‫ح‬Ue4?‫ ا‬F9."%‫)ط ا‬Ma%‫*8 ا‬W)9 R<,OUM<"‫%رات ا‬O:"‫ا‬
.3"‫ج. وا‬M<B" i3OBh‫ أ‬x4- ,O"%3"‫=")ت ا%.را+8 ا‬b$<‫و‬
you canwell be asked to adhere to on
You be offered treatment based the
your eligibility status which include theof ‫)رة‬I‫ ز‬a< l=b*+ %‫. ذ‬E2 .‫ج‬cE%‫3ق ا‬J‫ج‬M<"‫3&)6 ا‬Z
‫ع‬dyd7 ‫ة‬STUI%= NOPQ3"‫ ا‬l'9J 6G R< 8;I3J m5%

Helsinki
protocol of the assigned group in terms
studied procedures or casting which holdyou
weight baring and physical activity. a (2/ ‫39ن =)<;ل‬b'.8*=eE%‫9 ا‬OPF3"‫%ر ا‬O3m‫أو ا‬X>M$4?‫ا‬
8jcj mL Kj R<‫ي و‬g"‫ وا‬R< ‫)ن‬YU"+‫. إ‬E2 .,a‫ا";را‬
high rate ofseen again prolonged disability.
well be failure and in 2 weeks time and K$*+ ‫ه‬gh 8E2)$?‫$3ة ا‬G ‫ل‬cO .345%‫6ا‬G ,r%G|‫ر . وا‬U|}
.‫ل‬dJ‫7. 5;ة أ‬dO"‫2%ط ا‬E"‫ ا‬Kk$=I ‫ أن‬X%‫%". ا‬G
every three months for two years for re- ‫)ت‬Y)}u‫ ا‬meY ~I3J RY ‫ 73ب‬RY ‫43ك‬L 8ÅWc<
Compensation and Treatment:
evaluation and information gathering which :‫ا,$7*38.ت وا,765.ت‬
$%)o2 ‫+$"*)ن ا%/)ص‬u‫8 ا‬k"E^‫8، و‬I3"/?‫ ا‬m*%)o$%‫وا‬

The Belmont
In includes complication happensand survey
case a blood tests, X-Rays from the
,a‫1%ت 76 ا";را‬G%&7 ‫) ا~ -;وث أي‬a Ä ,"%- ./ .8*oB%‫ا‬
intervention that has been done to you.
filling.
You well be offered treatment accordingly. C7 .!12345‫ا ا‬gh ./ i" xa%E5‫ج ا‬M<"‫9 ا‬O/dZ A3O4/
NoPotential Risks and Discomforts:
financial compensation well be given . :!3T,M1‫/ت ا‬V/)‫ز‬W‫ وا‬FX/@1‫ا‬
./ ‫ج‬M<"‫. ا‬Å'Ä .,'‫'&%ت 7%د‬d<Z ‫ي‬Y= ‫ام‬S3"|‫;م ا‬G
pre-existing your participation include risks
Risk of conditions and other medical
problems not the surgical the intervention
related to related to procedure which
well not be covered by the institute.bleeding,
include risks of anesthesia,
.8=e$o< 3J)/< ‫ل‬U"7 )|*=Y l^3$I 8+‫ ا%.را‬FG $L‫)ر‬M<
%T" .3"‫9ى وا‬mI‫, ا‬PO"‫1%ت ا‬G%&5‫ا ا54321! ا‬gh
Ä %)` .,a‫( ا52%ر`, /. ا";را‬Pr ,b=%a .7 3J)/?‫ه ا‬gh
3J)/< : Fh‫8 و‬W‫3ا‬D%)2 8;=E$< ‫ن‬U5^ ‫79اض‬Y= ,rMG Report
Noinfection compensation well be pain and
financial and anterior knee given to ‫ <;.<8 أو‬FG ‫,م‬É‫3 ا‬J)/<‫%$|)2)ت و‬u‫ وا‬ÑIta%‫3 وا‬I./$%‫ا‬
.!12345‫( 76 وإ"! ا‬bE3"‫6 ا‬G ."%7 Ç'd<Z ;Ud'
surgical wound pain and radiation
cover your transportation expenses or any 8E}Ö% Ü3E^ %gL‫=*8. و‬eE%‫;8 ا‬ba< ‫,م‬É‫"8 أو ا‬L3%‫ا‬
‫9ى‬m‫<%ب أ‬Z‫أي أ‬
discomforts that arisemeasures are taken to
exposure. Certain accordingly. q*er ‫[) ً أن‬e=Y .345%‫8 ا‬E2)$< !9‫>=.,/< ا&;.ر‬
: ‫ل‬cO‫=*8 و‬eE%‫)ء ا‬aj‫ا‬
avoid theses risks as much as possible. If R< ً )‫! ا52%رك‬BG ÑO"%eZgOS‫ ا‬K$I 8<‫)ت ا,ز‬J)*$Wu‫ا‬
[I‫ل أ‬UBW .aY‫! ا52%ر`, أي 2|). و‬BG xZ93' Ä
9Os
Expensesthese complications accrue they
any of of Participation: 8*"b%‫*3 ا‬I)E?‫ ا‬l4W )|E< m<)E$%‫ ا‬K$*+ ‫>)ت‬Y)á?‫ه ا‬gh
Participation in this research dose not add .!12345‫( 76 وإ "! ا‬bE3"‫ ا‬ÑO"%eZ
costs other than the transportation from
and to the hospital.
43
44



Voluntary Participation: :!"#$%&'‫ا-,+ر)! ا‬
Your participation the this Participation
Clinical Trial Voluntary trial is totally
hospitalization and in frequent follow ups !"‫ا1*ا'4! )32 ا10/ر.! ا-,+*)(! '& درا‬
!"‫=<; ا":9وج 76 ا54321!. و/. -%", ا"*)( '&%ف إ‬
Consent !" ‫">$ر=<* ;: ا98را60 543210. و.-,+* ا('&%$ب‬
voluntary. And you may done.
after the intervention has been refuse to !(5(6(3.‫إ‬
>?‫ أ‬AB<"‫ ا‬C7 .DEF"‫! ا‬BG ,<HI‫? "!ا‬IJ ‫ه‬MG‫ا98را60 أ‬
?@A‫6@$ب إذا ر‬D‫ ا‬E1F35 ‫9 دون‬J%:7، K<" 9J%:5‫ا‬

Ethics
participate orare pregnant risks related at
In case you withdraw from the trial, to
any fetus include affectpenalty or loss the
the time, without a of radiation on of ..DEF"‫.0 ا‬D ‫&$رة‬N ‫$ر أو‬P" ‫ا"$ت% ًأو‬RA %OPJ NPQ' A"
L;$+" !BG NOPQ3"‫ة ا‬STU‫ 76 ا‬W'‫9 أ‬OXYZ ‫و"! دون أي‬
benefits.
Intramedullary nailing !(89:1‫ ا-6@/)(! ?/->=/<; ا‬A/("B‫4/ر8! ا‬C
Withdrawal and Termination: :!"#$%&‫ا,+*ا)( ا‬
:!)‫ا6543+ب وإ'/+ء ا-,+ر‬
Controlled Trial
You can withdraw from the study any time
Potential Benefits: ?IJً %WOPJ ‫$ءا5<3);ة‬VW5 !" ‫, `49ك =^-;ى‬F"%<7 A3Oa
./ K<" *&T' ‫ .-+,+* ا('&%$ب ا"9ق‬R=‫=-$ ذ‬
&<‫ ا-:0*ا‬IJ‫?/-,*ز‬
without loss wellbenefits. Termination the
Your fracture of be treated by one of of N*Z!" ‫$دة‬T<6(‫ ا‬X<16 09$%9‫ه ا‬Z[ 67 ‫ع‬dE"‫ا ا‬gh‫"! دون‬
%34O" D3b'9"‫ ا‬M` .‫ر‬d4e"‫, 5@$ت. و;: ا‬F"%<7
your participation well happen in case you
failTo are experimental. Youtime infor any
them evaluate the healing well befractured
to adhere to the protocol aiding 0]%9 K9‫9%]0 ">$ر=<* إ‬OPJ ‫ا9@1$'$توإ?)% 7<3);ة‬
i3`‫% ً. و=)2%ر‬WO-‫9ا‬U‫% ً و‬W !" ?-^ :<9‫9=, ا‬F3"‫ا‬
:LMD-‫ ا‬NC ‫9ف‬P-‫ا‬
reason. Data from thewitheryou enrolled to is
tibias, and to know time locked plating
in the process of determining the best way i" ‫3%ح‬Oa %)` .(&/‫ أ‬D3b'9"‫ 7<9/, أي ا‬L"!7‫<;)ر98 و‬
*W5 ‫ ا,+*)خ‬KW2 aT%<9‫* ;: ا‬Vb ./ ;G%43a
!"#$%‫* إ%$6م ا%543 21 إ+$/.اما6<`8ام وا‬c$%&'‫إ‬
thesuperior to nailing in fracture. have been
of treatmentyou such this type of fracture.
minute of withdraw or In addition i3"%*= lB<3' %)/ ,PO"‫ة ا‬Y2E5‫ه ا‬gh ./ ‫ج‬M<"‫. ا‬bBZ
.8=>;?‫@ ا‬A)>B%‫3"$ت.ا‬Wd‫ا‬
‫+$/.ام‬C2
terminatedbe offered to follow up in our
you well well be used in the study. In *2$@5‫$90 28م إ‬b :; 06‫;: ا98را‬ ‫ه‬gh ‫ر‬d*7 ,OP"‫ا‬
.,a‫ ">$ر=<*ا";را‬KeW5 8f
case of for any treatment related right to
institute withdraw you have the to your :!"‫ ا-9را‬QR‫و‬
Description of the Research: $g2$@5‫ إ‬KW2 *5‫8ر‬f ‫$90 28م‬b :; ‫4$ة 9* أو‬d‫1-$ت ا‬W<9‫ا‬
even withdraw your data from the study.
condition. 8D%)E< FG ‫$)ن‬I‫*)ر‬E< 1$;I3J 89‫ ا%.را+8 <;)ر‬FG K$*+
:‫ا&21و,/.ت‬
We are evaluating two standard methods .‫6@$ب‬D‫ "! ا‬h@6 ‫ي‬D
FG 8L‫)ر‬M?‫$3ت ا‬O‫%رك ا52%ر`,ا‬O3m‫; ا‬EG ‫ول‬o47 N?‫أ‬
Duration and Participants:fractures, if you
of treating distal tibial
Responsibilities:
The expectedtotime for participation is well
If you choseenroll in this research,study. 2
chose to participate in the you It F$;I3J ‫.ى‬W‫ إ‬X=Y :‫ا-;ة ا-&$98! وا-&%$#$ن‬
ً )[*A‫ا‬UMY EI‫ز‬U^ K$+ ،8+‫ا%.را‬
i?‫,. `)% أ‬a‫ ا";را‬l'9/ 67 i" ‫)%ت ا5<%ه‬OB<3"‫%ع ا‬PZ‫إ‬
be we are expecting 120to one to the
randomly assignedto adhere of to
volunteers two ‫اء‬da Y2EZ ‫+*)خ6+<$ن. و28د‬S)2 !*"#$%‫6 ا‬G ‫ول‬o47
i=‫>$ر‬d‫; ا‬r 8*Y)/a%‫>$ر=<* [: ا‬d 0f3<d‫8ة ا‬d‫ا‬
!*"#$%‫1%ت أو ا‬s%&7 ‫6 أي‬G %EsM=‫ا%$#"*!. إ<) إ‬

The Nuremberg
years. your responsibility
well be
groups in this study. The intramedullary
participate of treatment.
study protocol and instructions. And inform
nailing group or the locked plating group. ‫ول‬o47 i?‫,. `)% أ‬bB<37‫ن‬d2 ً )[eA" ‫, أو‬a‫, =%";را‬bB<37 N?%`
1$;I3b%‫ ا‬cL 6eZ =Y .‫.9*8">$رك‬E?‫ [3ا‬Lf3<d‫ا‬
.8=>;?‫@ ٠٢١ ا‬A)>B%)2
the research team of any side effects you .‫ر‬U45%‫ ا‬R< ‫ع‬Ua%‫ا ا‬gh ‫ج‬cY ‫%ت‬UMG ,'‫6 أ‬G %?‫%ر‬Pm‫6 إ‬G
Both groups are standard treatments for ‫%رج‬m %T37;:3a‫ أو أدو', إ‬FG ً )[*"J ‫.^)ن‬e$E< ‫;$)ن‬I3J
Confidentiality:
may develop. Your are also required to
Allf o r m t h eidentifyingc h t eorm o f a n y
i n records r e s e a r you a containing
data that can be linked toyou take be kept
medication or treatment you will outside
confidential. Specific personnel from the
of the protocol.
*<.3gc $g4c‫*. أو ر‬c $g4c‫3"$ت ا9<: .-,! ر‬Wd‫ ا‬L1-^
F$%‫8 ا‬W‫3ا‬D%‫ ا‬RY ‫ 2*)9)ت‬qer K$*+$g" p"$<9‫ ا‬X<16
!" nV; i+1" ‫.0 5$"0. أ'$س‬R&c 8W‫3ا‬D%‫. ا‬E2‫)ء و‬aj‫أ‬
.,a‫?%ق ا";را‬
:!<=4'‫ا‬
Code
research center will be granted access to
groups, information well be gathered about $7)*% R< .Ld$%‫. ا‬E2 X>M$4?‫ ا‬R< ‫ا,765.ت+$/3ج‬
‫ع‬rs($c Xg9 E-&16 ‫%$ث‬cD‫ ا‬u=R" ‫!ا98را60 أو‬I3r‫أ‬
:!"3(4,‫ %. ا‬v.R;

Declaration Of
the h e t w o Treatments: s . Yo u w e l l b e
Alternative p rwithout e violating your
t records o c e d u r p= ‫9ضأن‬G‫)ت‬e*=E$%)2 ‫ام‬t$%u‫ ا‬a< l=b*+‫"*8 %=/3وج و‬b%‫ا‬
8*"b%‫. ا‬i=‫>$ر‬d‫;0 [3.0 ا‬R" ‫ 28م‬L"‫;م‬G ‫39ت‬m‫ا‬KW2
$-= A3O4/ ,a‫إذا ا9@1$'$ت ا52%ر`, /. ا";را‬
confidentiality. home participatethat can be
If you chose not to when your in the study
discharged personal data medically fit. v2 ‫ح‬Ue4?‫ ا‬F9."%‫)ط ا‬Ma%‫ ا‬KV@<6 ,OUM<"‫%رات ا‬O:"‫ا‬
‫ي‬wc 0"$W9 R;3<5 !9‫.0 و‬R6 8*W)9 R<0x$`9‫3"$ت ا‬Wd‫ا‬
linked towell be asked be made publicly
you can you offered treatment based on
You be well never to adhere to the
available. of the assigned group in terms of
your eligibility status which include the ‫)رة‬I‫ ز‬a< l=b*+ %‫. ذ‬E2 .‫ج‬cE%‫3ق ا‬J‫ج‬M<"‫$ل "! ا‬b
‫ع‬dyd7 ‫ة‬STUI%= NOPQ3"‫ ا‬l'9J 6G R< 8;I3J m5% 6)&3Z

Helsinki
protocol .‫3ال‬bD‫ا‬
Contact: ofseen again prolonged disability.
high rate failure and in 2 weeks time and
well be K$*+ ‫ه‬gh 8E2)$?‫$3ة ا‬G ‫ل‬cO .345%‫6ا‬G ,r%G|‫ر . وا‬U|}
.‫ل‬dJ‫7. 5;ة أ‬dO"‫2%ط ا‬E"‫ ا‬Kk$=I ‫ا6@?+ل:أن‬ X%‫%". ا‬G
If you have anymonths forbefore, during or
every three question two years for re- ،06‫8 ا98را‬c ‫ أو أ{+$ء أو‬p@f ‫6|ال‬RY ‫43ك‬L‫إذا =$ن‬
‫)ت‬Y)}u‫ ا‬meY ~I3J RY ‫8 98.* أي 73ب‬ÅWc<
after the trialand information gathering which
Compensation and Treatment: Husam
evaluation please contact Dr. :‫ا,$7*38.ت وا,765.ت‬
$%)o2 ‫+$"*)ن ا%/)ص‬u‫8 ا‬k"E^‫ـ: و‬c ‫.-,+* ا(5~$ل‬ ،8I3"/?‫ ا‬m*%)o$%‫وا‬

The Belmont
AL-Rumaihcomplication happensand survey
In includes Mobile:__________________
filling. E1"R9‫&$م ا‬b .‫د‬
Results: be offered treatment accordingly.
You well C7 .!12345‫ا ا‬gh ./ i" xa%E5‫ج ا‬M<"‫9 ا‬O/dZ A3O4/
After finishing from the trial you well be.
financial compensation well be given :!3T,M1‫/ت ا‬V/)‫ز‬W‫ وا‬FX/@1‫ا‬

Report
‫^3ال:ــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ‬
informedof your participation we reached
pre-existing conditions and other medical
Risk about the results that include risks .8=e$o< 3J)/< ‫ل‬U"7 )|*=Y l^3$I 8+‫ ا%.را‬FG $L‫)ر‬M<
related to related to procedure which Ä %)` .,a‫( ا52%ر`, /. ا";را‬Pr ,b=%a .7 3J)/?‫ه ا‬gh
3J)/< : Fh‫8 و‬W‫3ا‬D%)2 8;=E$< ‫ن‬U5^ ‫79اض‬Y= ,rMG :AB+&C'‫ا‬
financial and anterior knee given to ‫ <;.<8 أو‬FG $[R;353J)/<‫%$|)2)ت و‬u‫ وا‬ÑIta%‫3 وا‬I./$%‫ا‬
8c *9‫,م وذ‬É‫$ل ا‬b (bE3"‫6 ا‬GÄ$<+c ‫@$رك‬N‫ إ‬X<16
.!12345‫ 7%". ا98را60 76 وإ"! ا‬Ç'd<Z ;Ud'
cover your transportation expenses or any 8E}Ö% Ü3E^ %gL‫=*8. و‬eE%‫;8 ا‬ba< ‫,م‬É‫"8 أو ا‬L3%‫ا‬ 06‫$ء "! ا98را‬g<'(‫ا‬
exposure. Certain accordingly. q*er ‫[) ً أن‬e=Y .345%‫8 ا‬E2)$< !9‫>=.,/< ا&;.ر‬: ‫ل‬cO‫=*8 و‬eE%‫)ء ا‬aj‫ا‬
avoid theses risks as much as possible. If R< ً )‫! ا52%رك‬BG ÑO"%eZgOS‫ ا‬K$I 8<‫)ت ا,ز‬J)*$Wu‫ا‬
[I‫ل أ‬UBW .aY‫! ا52%ر`, أي 2|). و‬BG xZ93' Ä
9Os
43
45
44


I.MI.M Nailing Vs MIPO distal tibia
Nailing Vs MIPO distal tibia

Voluntary Participation: understanding this
After Reading and !"# $%&'‫ا-,+ر)! ا'&%$#"!: ا2)10&/. أ-, +*)ا‬
‫+:9 -,اء7$ و'5*$ 254ه‬
hospitalization and in this Participation
Clinical Trial Voluntary !"‫ا1*ا'4! )32 ا10/ر.! ا-,+*)(! '& درا‬
!"‫/ ا2%@)#0/ '$ ?4ه ا29را>/. =< ا"*)( '&%ف إ‬A‫ر‬BCD‫ا‬
Your participation theagreetrial follow ups
legal document I frequent isvoluntary
Consent
on totally !" ‫=<; ا":9وج 76 ا54321!. و/.و.-,+* ا('&%$ب‬
$7‫">$ر=<* ;: ا98را60 543210. -%", #"*$ +&9ر‬
voluntary. Andthis research. done.
after the intervention has may Knowing to
participation in you been refuse that !(5(6(3.‫إ‬
>?‫ أ‬AB<"‫ ا‬C7 .DEF"‫ ا‬H2‫"! دون'$ ذ‬B=?IJ ‫ه‬MG‫ا98را60 أ‬
?@A‫6@$ب إذا ر‬D‫ ا‬E1F35 JFK‫9ر‬J%:7، K<" 9J%:5‫ا‬
‫ت‬B:F7 ‫! و+9ون‬BG ,<HI‫ا‬ !%= ‫ب‬BMNOP‫#"! ا‬

Ethics
participate orare to withdraw from the study
Ini have the right pregnant risks related at
case you withdraw from the trial, to
any fetus include affectpenalty or loss need
the time, without consentradiation the the
and withdraw my a of without on of ..DEF"‫.0 ا‬D ‫&$رة‬N ‫$ر أو‬P" ‫ا"$ت% ًأو‬RA %OPJ NPQ' A"
L;$+" !BG NOPQ3"‫ة ا‬STU‫ 76 ا‬W'‫9 أ‬OXYZ ‫و"! #"$. أي‬
‫ دون‬Q7,%7
benefits.
of an explanation or without any penalty or
loss of benefits. nailing
Intramedullary !(89:1‫ ا-6@/)(! ?/->=/<; ا‬A/("B‫4/ر8! ا‬C
Withdrawal and Termination: :!"#$%&‫ا,+*ا)( ا‬
:!)‫ا6543+ب وإ'/+ء ا-,+ر‬
Controlled Trial
You can withdraw from the study any time
Potential Benefits:
Name:____________________________ ?IJً %WOPJ ‫$ءا5<3);ة‬VW5 !" ‫, `49ك =^-;ى‬F"%<7 A3Oa
‫:ــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ‬S>P‫ا‬
./ K<" *&T' ‫ .-+,+* ا('&%$ب ا"9ق‬R=‫=-$ ذ‬
&<‫ ا-:0*ا‬IJ‫?/-,*ز‬
without loss wellbenefits. Termination the
Your fracture of be treated by one of of N*Z!" ‫$دة‬T<6(‫ ا‬X<16 09$%9‫ه ا‬Z[ 67 ‫ع‬dE"‫ا ا‬gh‫"! دون‬
%34O" D3b'9"‫ ا‬M` .‫ر‬d4e"‫, 5@$ت. و;: ا‬F"%<7
your participation well happen in case you
Date:_____________________________ ‫:ــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ‬TU‫ر‬B%2‫ا‬
failTo are experimental. Youtime infor any
them evaluate the healing well befractured
to adhere to the protocol aiding 0]%9 K9‫9%]0 ">$ر=<* إ‬OPJ ‫ا9@1$'$توإ?)% 7<3);ة‬
i3`‫% ً. و=)2%ر‬WO-‫9ا‬U‫% ً و‬W !" ?-^ :<9‫9=, ا‬F3"‫ا‬ :LMD-‫ ا‬NC ‫9ف‬P-‫ا‬
reason. Data from thewitheryou enrolled to is
tibias, and to know time locked plating
inSignature:_________________________
the process of determining the best way i" ‫3%ح‬Oa %)` .(&/‫ أ‬D3b'9"‫ 7<9/, أي ا‬L"!7‫<;)ر98 و‬
*W5 ‫ ا,+*)خ‬KW2 aT%<9‫* ;: ا‬Vb ./ ;G%43a
!"#$%‫* إ%$6م ا%543 21 إ+$/.اما6<`8ام وا‬c$%&'‫إ‬
‫ا2%)-0<:ــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ‬
thesuperior to nailing in fracture. have been
of treatmentyou such this type of fracture.
minute of withdraw or In addition i3"%*= lB<3' %)/ ,PO"‫ة ا‬Y2E5‫ه ا‬gh ./ ‫ج‬M<"‫. ا‬bBZ
.8=>;?‫@ ا‬A)>B%‫3"$ت.ا‬Wd‫ا‬ ‫+$/.ام‬C2
terminatedbe offered to follow up in our
you well well be used in the study. In *2$@5‫$90 28م إ‬b :; 06‫;: ا98را‬ ‫ه‬gh ‫ر‬d*7 ,OP"‫ا‬
.,a‫ ">$ر=<*ا";را‬KeW5 8f
case of for any treatment related right to
institute withdraw you have the to your :!"‫ ا-9را‬QR‫و‬
Description of the Research: $g2$@5‫ إ‬KW2 *5‫8ر‬f ‫$90 28م‬b :; ‫4$ة 9* أو‬d‫1-$ت ا‬W<9‫ا‬
even withdraw your data from the study.
condition. 8D%)E< FG ‫$)ن‬I‫*)ر‬E< 1$;I3J 89‫ ا%.را+8 <;)ر‬FG K$*+ :‫ا&21و,/.ت‬
We are evaluating two standard methods .‫6@$ب‬D‫ "! ا‬h@6 ‫ي‬D
FG 8L‫)ر‬M?‫$3ت ا‬O‫%رك ا52%ر`,ا‬O3m‫; ا‬EG ‫ول‬o47 N?‫أ‬
Duration and Participants:fractures, if you
of treating distal tibial
Responsibilities:Husam A. AL-Rumaih
Investigator: Dr.
The expectedtotime for participation is well
If you choseenroll in this research,study. 2
chose to participate in the you It i?‫,. `)% أ‬a‫ ا";را‬l'9/ 67 i" ‫م ا5<%ه‬BNX .‫: د‬ZXBF2‫ا‬
F$;I3J ‫.ى‬W‫ إ‬X=Y :‫)%توا-&%$#$ن‬OB<3"‫%ع ا‬PZ‫إ‬ V0=,2‫ ا‬K$+ ،8+‫ا%.را‬
ً )[*A‫ا‬UMY EI‫ز‬U^!89$&-‫ا-;ة ا‬
be we are expecting 120to one to the
randomly assignedto adhere of to
volunteers two ‫اء‬da Y2EZ ‫+*)خ6+<$ن. و28د‬S)2 !*"#$%‫6 ا‬G ‫ول‬o47
i=‫>$ر‬d‫; ا‬r 8*Y)/a%‫>$ر=<* [: ا‬d 0f3<d‫8ة ا‬d‫ا‬
!*"#$%‫1%ت أو ا‬s%&7 ‫6 أي‬G %EsM=‫ا%$#"*!. إ<) إ‬

The Nuremberg
years. your responsibility
well be
Date:____________________________
groups in this study. The intramedullary
participate of treatment.
study protocol and instructions. And inform ‫:ــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ‬TU‫ر‬B%2‫ا‬
nailing group or the locked plating group. ‫ول‬o47 i?‫,. `)% أ‬bB<37‫ن‬d2 ً )[eA" ‫, أو‬a‫, =%";را‬bB<37 N?%`
1$;I3b%‫ ا‬cL 6eZ =Y .‫.9*8">$رك‬E?‫ [3ا‬Lf3<d‫ا‬
.8=>;?‫@ ٠٢١ ا‬A)>B%)2
the research team of any side effects you
Signature:_________________________ .‫ر‬U45%‫ ا‬R< ‫ع‬Ua%‫ا ا‬gh ‫ج‬cY ‫%ت‬UMG ,'‫6 أ‬G %?‫%ر‬Pm‫6 إ‬G
Both groups are standard treatments for ‫%رج‬m %T37;:3a‫ أو أدو', إ‬FG ً )[*"J ‫.^)ن‬e$E< ‫;$)ن‬I3J
Confidentiality:
may develop. Your are also required to ‫ا2%)-0<:ــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ‬
Allf o r m t h eidentifyingc h t eorm o f a n y
i n records r e s e a r you a containing
data that can be linked theyoutake be kept
medicationwas treatment you will outside
A copy or given to to subject
• about your quality of life before having the
confidential. Specific personnel from the
of the protocol.
*<.3gc $g4c‫*. أو ر‬c $g4c‫3"$ت ا9<: .-,! ر‬Wd‫ ا‬L1-^
F$%‫8 ا‬W‫3ا‬D%‫ ا‬RY ‫ 2*)9)ت‬qer K$*+$g" p"$<9‫ءا‬B@#‫ إ‬S7
!" nV; i+1" ‫.0 5$"0. أ'$س‬R&c 8W‫3ا‬D%‫. ا‬E2‫)ء و‬aj‫أ‬
.,a‫?%ق ا";را‬
:!<=4'‫ا‬
Code
fracture During and After surgery in both ‫رك‬BC*"2 ]NO X<16
research center will be granted access to
groups, information well be gathered about .Ld$%‫. ا‬E2 X>M$4?‫ ا‬R< ‫ا,765.ت+$/3ج‬
$7)*% R< Xg9 E-&16 ‫%$ث‬cD‫ ا‬u=R" ‫!ا98را60 أو‬I3r‫أ‬
‫ع‬rs($c
:!"3(4,‫ %. ا‬v.R;

Declaration Of
the h e t w o Treatments: s . Yo u w e l l b e
Alternative p rwithout e violating your
t records o c e d u r p= ‫9ضأن‬G‫)ت‬e*=E$%)2 ‫ام‬t$%u‫ ا‬a< l=b*+‫"*8 %=/3وج و‬b%‫ا‬
8*"b%‫. ا‬i=‫>$ر‬d‫;0 [3.0 ا‬R" ‫ 28م‬L"‫;م‬G ‫39ت‬m‫ا‬KW2
$-= A3O4/ ,a‫إذا ا9@1$'$ت ا52%ر`, /. ا";را‬
confidentiality. home participatethat can be
If you chose not to when your in the study
discharged personal data medically fit. v2 ‫ح‬Ue4?‫ ا‬F9."%‫)ط ا‬Ma%‫ ا‬KV@<6 ,OUM<"‫%رات ا‬O:"‫ا‬
‫ي‬wc 0"$W9 R;3<5 !9‫.0 و‬R6 8*W)9 R<0x$`9‫3"$ت ا‬Wd‫ا‬
linked towell be asked be made publicly
you can you offered treatment based on
You be well never to adhere to the
available. of the assigned group in terms of
your eligibility status which include the ‫)رة‬I‫ ز‬a< l=b*+ %‫. ذ‬E2 .‫ج‬cE%‫3ق ا‬J‫ج‬M<"‫$ل "! ا‬b
‫ع‬dyd7 ‫ة‬STUI%= NOPQ3"‫ ا‬l'9J 6G R< 8;I3J m5% 6)&3Z

Helsinki
protocol .‫3ال‬bD‫ا‬
Contact: ofseen again prolonged disability.
high rate failure and in 2 weeks time and
well be K$*+ ‫ه‬gh 8E2)$?‫$3ة ا‬G ‫ل‬cO .345%‫6ا‬G ,r%G|‫ر . وا‬U|}
.‫ل‬dJ‫7. 5;ة أ‬dO"‫2%ط ا‬E"‫ ا‬Kk$=I ‫ا6@?+ل:أن‬ X%‫%". ا‬G
If you have anymonths forbefore, during or
every three question two years for re- ،06‫8 ا98را‬c ‫ أو أ{+$ء أو‬p@f ‫6|ال‬RY ‫43ك‬L‫إذا =$ن‬
‫)ت‬Y)}u‫ ا‬meY ~I3J RY ‫8 98.* أي 73ب‬ÅWc<
after the trialand information gathering which
Compensation and Treatment: Husam
evaluation please contact Dr. :‫ا,$7*38.ت وا,765.ت‬
$%)o2 ‫+$"*)ن ا%/)ص‬u‫8 ا‬k"E^‫ـ: و‬c ‫.-,+* ا(5~$ل‬ ،8I3"/?‫ ا‬m*%)o$%‫وا‬

The Belmont
AL-Rumaihcomplication happensand survey
In includes Mobile:__________________
filling. E1"R9‫&$م ا‬b .‫د‬
Results: be offered treatment accordingly.
You well C7 .!12345‫ا ا‬gh ./ i" xa%E5‫ج ا‬M<"‫9 ا‬O/dZ A3O4/
After finishing from the trial you well be.
financial compensation well be given :!3T,M1‫/ت ا‬V/)‫ز‬W‫ وا‬FX/@1‫ا‬

Report
‫^3ال:ــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ‬
informedof your participation we reached
pre-existing conditions and other medical
Risk about the results that include risks .8=e$o< 3J)/< ‫ل‬U"7 )|*=Y l^3$I 8+‫ ا%.را‬FG $L‫)ر‬M<
related to related to procedure which Ä %)` .,a‫( ا52%ر`, /. ا";را‬Pr ,b=%a .7 3J)/?‫ه ا‬gh
3J)/< : Fh‫8 و‬W‫3ا‬D%)2 8;=E$< ‫ن‬U5^ ‫79اض‬Y= ,rMG :AB+&C'‫ا‬
financial and anterior knee given to ‫ <;.<8 أو‬FG $[R;353J)/<‫%$|)2)ت و‬u‫ وا‬ÑIta%‫3 وا‬I./$%‫ا‬
8c *9‫,م وذ‬É‫$ل ا‬b (bE3"‫6 ا‬GÄ$<+c ‫@$رك‬N‫ إ‬X<16
.!12345‫ 7%". ا98را60 76 وإ"! ا‬Ç'd<Z ;Ud'
cover your transportation expenses or any 8E}Ö% Ü3E^ %gL‫=*8. و‬eE%‫;8 ا‬ba< ‫,م‬É‫"8 أو ا‬L3%‫ا‬ 06‫$ء "! ا98را‬g<'(‫ا‬
exposure. Certain accordingly. q*er ‫[) ً أن‬e=Y .345%‫8 ا‬E2)$< !9‫>=.,/< ا&;.ر‬
: ‫ل‬cO‫=*8 و‬eE%‫)ء ا‬aj‫ا‬
avoid theses risks as much as possible. If
9Os ً )‫! ا52%رك‬BG ÑO"%eZgOS‫ ا‬K$I 8<‫)ت ا,ز‬J)*$Wu‫ا‬
R< [I‫ل أ‬UBW .aY‫! ا52%ر`, أي 2|). و‬BG xZ93' Ä
43
45
4446


Randomized Clinical Trials in Orthopaedics

Randomized Clinical Trials in Orthopaedics

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