Randomized Clinical Trials in Orthopaedics

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Randomized Clinical Trials in Orthopaedics

  1. 1. Randomized Clinical Trials in OrthopaedicsTuesday, January 1, 13
  2. 2. Is EBM New?   #$%&‫  16@:  "!  ا?%>  وا/.+84=  <;:  ا&-ر87  وا&6543  ,2  ا1&.+د  ا/.-,+ت  وا‬AB“ !"   ‫  ا5?+ع‬D  ‫-ل‬F‫+ل  ا‬GF&H‫  ا‬I%$J&1‫  و‬IK6.&L1  +,  24GM  !"  +NO6P  QFR1‫7  و‬K+&N‫ا‬   ”‫راء‬T‫  ,2  ا‬Q4/‫  ا‬D  U%‫;3  ا‬V  ‫&.-ه‬N1‫ه  و‬X4G1  +,  6K+H  !"  ‫ى  و1&%6ى‬Z[‫ا‬ !"#$%‫ا%*)  (  ا‬ ibn al-Haytham 1040 GregorianTuesday, January 1, 13
  3. 3. Research Methodology Vs EBMTuesday, January 1, 13
  4. 4. Doing Reseach Methodology Research EBM UsingTuesday, January 1, 13
  5. 5. http://library.downstate.edu/EBM2/2100.htmTuesday, January 1, 13
  6. 6. The Oxford 2011 Levels of Evidence Oxford Centre for Evidence-Based Medicine. http://www.cebm.net/index.aspx?o=5653Tuesday, January 1, 13
  7. 7. What is an RCT? Planned Experiment (Trial) Allocation by Chance (Random) Both arms treated equally (Controlled) Looking for specific outcomesTuesday, January 1, 13
  8. 8. What is an RCT? Golden Standard of Clinical Research J Androl. 2001 Nov-Dec;22(6):938-43Tuesday, January 1, 13
  9. 9. 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.Tuesday, January 1, 13
  10. 10. 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.Tuesday, January 1, 13
  11. 11. 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 validityTuesday, January 1, 13
  12. 12. J Am Acad Orthop Surg 2010;18: 454-463Tuesday, January 1, 13
  13. 13. 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: 454-463Tuesday, January 1, 13
  14. 14. 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: 454-463Tuesday, January 1, 13
  15. 15. 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: 454-463Tuesday, January 1, 13
  16. 16. 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: 454-463Tuesday, January 1, 13
  17. 17. 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: 454-463Tuesday, January 1, 13
  18. 18. 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: 409–416Tuesday, January 1, 13
  19. 19. 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 1459Tuesday, January 1, 13
  20. 20. 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):20-4Tuesday, January 1, 13
  21. 21. How Many Surgical Trials from Saudi? Non Completed To this date. only one ongoingTuesday, January 1, 13
  22. 22. Ideas Pemberton vs Salter Staples Vs 8 plate Functional Bracing Vs CastingTuesday, January 1, 13
  23. 23. Distal Tibia FractureTuesday, January 1, 13
  24. 24. Intramedullary Nailing The Current Standard of treatment Hight Union rateTuesday, January 1, 13
  25. 25. Intramedullary NailingTuesday, January 1, 13
  26. 26. Intramedullary Nailing ProblemsTuesday, January 1, 13
  27. 27. Intramedullary Nailing ProblemsTuesday, January 1, 13
  28. 28. Intramedullary Nailing ProblemsTuesday, January 1, 13
  29. 29. Intramedullary Nailing Problems • Anterior Knee pain • Reported as high as 69%Tuesday, January 1, 13
  30. 30. Intramedullary Nailing 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.Tuesday, January 1, 13
  31. 31. Intramedullary Nailing 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.Tuesday, January 1, 13
  32. 32. MIPO • Minimally Invasive Technique • Better Control on the end fragments • Concerns about Infection, neurovascular injury J Orthop Trauma 24.1 (2010): 24-9Tuesday, January 1, 13
  33. 33. Question?Tuesday, January 1, 13
  34. 34. Tuesday, January 1, 13
  35. 35. Is MIPO better than IM nailing in treating distal tibia fractures?Tuesday, January 1, 13
  36. 36. Tuesday, January 1, 13
  37. 37. Better In what?Tuesday, January 1, 13
  38. 38. Better In what? • Union • Malunion • Functional outcome • Radiation • Infection rate • OR time • CostTuesday, January 1, 13
  39. 39. Literature Review 87 Articles reviewed All are level 3 or level 4 Evidence One RCT with major flawsTuesday, January 1, 13
  40. 40. Hypothesis Is MIPO superior to IM nailing in terms of malunion? MIPO is superior to IM nailing in terms of malunionTuesday, January 1, 13
  41. 41. How To Answer The Question? A Randomized Controlled Trial Superiority Trial Design Two arm Parallel Design Against a standeredTuesday, January 1, 13
  42. 42. Primary OutcomeTuesday, January 1, 13
  43. 43. Primary Outcome Time of Union Rate of Malunion Quality of life Blood Loss Radiation Exposure Duration of Surgery Infection Rate Hospital StayTuesday, January 1, 13
  44. 44. Primary Outcome Time of Union Blood LossRate of Malunion Radiation Exposure Quality of life Duration of Surgery Infection Rate Hospital StayTuesday, January 1, 13
  45. 45. Primary Outcome Time of Union Blood LossRate of Malunion Radiation Exposure Quality of life Duration of Surgery Infection Rate Hospital StayTuesday, January 1, 13
  46. 46. Primary Outcome Time of Union Rate Of Malunion Blood LossRate of Malunion Radiation Exposure Quality of life Duration of Surgery Infection Rate Hospital StayTuesday, January 1, 13
  47. 47. 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 RateCharles 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 StayEd. James D. Heckman, Charles M. Court-Brown, Robert W. Bucholz MD. 6th ed. Vol. 2. 2 vols: Lippincott Williams & Wilkins, 2006Tuesday, January 1, 13
  48. 48. Secondary Outcomes The Short Form (12) Health Score (SF-12v2®) Time Of Fracture Healing Blood Loss Radiation exposure Duration of Surgery Infection Rate Hospital StayTuesday, January 1, 13
  49. 49. Design Subjects Inclusion Criteria: Males And Females 18-60 Closed Tibia Fracture Müller AO Class 43-ATuesday, January 1, 13
  50. 50. Outcome AssessingTuesday, January 1, 13
  51. 51. Outcome Assessing ValidTuesday, January 1, 13
  52. 52. Outcome Assessing Valid ReliableTuesday, January 1, 13
  53. 53. Outcome Assessing Valid Reliable ResponsiveTuesday, January 1, 13
  54. 54. Outcome Assessing Bilateral Lower Limb CT Rofo 157.3 (1992): 245-51Tuesday, January 1, 13
  55. 55. 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): 1862-8Tuesday, January 1, 13
  56. 56. 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): 409-16Tuesday, January 1, 13
  57. 57. Randomization Concealed Blocked randomization Computer Based Investigators are not involved 2 staged Randomization process Can J Surg 53.6 (2010)Tuesday, January 1, 13
  58. 58. 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): 1734-44Tuesday, January 1, 13
  59. 59. Tuesday, January 1, 13
  60. 60. SubjectTuesday, January 1, 13
  61. 61. Subject Computerized permuted blocksTuesday, January 1, 13
  62. 62. Subject Computerized permuted blocks MIPO IMTuesday, January 1, 13
  63. 63. Subject Computerized permuted 1st blocks Stage MIPO IMTuesday, January 1, 13
  64. 64. Subject Computerized permuted 1st blocks Stage MIPO IM Simple SimpleTuesday, January 1, 13
  65. 65. Subject Computerized permuted 1st blocks Stage MIPO IM Simple Simple A B C D A B C DTuesday, January 1, 13
  66. 66. Subject Computerized permuted 1st blocks Stage MIPO IM 2nd Simple Simple A B C D A B C DTuesday, January 1, 13
  67. 67. Sample Size Power of 80% Effective sample size 150 180 after considering drop outsTuesday, January 1, 13
  68. 68. EthicsTuesday, January 1, 13
  69. 69. Ethics The Nuremberg CodeTuesday, January 1, 13
  70. 70. Ethics The Nuremberg Code Declaration Of HelsinkiTuesday, January 1, 13
  71. 71. Ethics The Nuremberg Code Declaration Of Helsinki The Belmont ReportTuesday, January 1, 13
  72. 72. I.M Nailing Vs MIPO distal tibia Clinical Trial Voluntary Participation !"‫ا1*ا4! )32 ا10/ر.! ا-,+*)(! & درا‬ Consent !(5(6(3.‫إ‬ Intramedullary nailing Vs. M.I.P.O. in Tibia Fractures, A Randomized Controlled Trial !(89:1‫ ا-6@/)(! ?/->=/<; ا‬A/("B‫4/ر8! ا‬C !DE‫ا‬FC !5(6(3.‫. درا"! إ‬G/H-‫*ر ا‬H. & !3=41‫ا‬ &<‫ ا-:0*ا‬IJ‫?/-,*ز‬ 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+ F$%‫8 ا‬W‫3ا‬D%‫ ا‬RY ‫ 2*)9)ت‬qer K$*+ 8W‫3ا‬D%‫. ا‬E2‫)ء و‬aj‫أ‬ 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$*+ ‫>)ت‬Y)á?‫ه ا‬gh well be dealt with according to the medical RY ‫")رة‬Y 8L‫)ر‬M?‫ ا‬X=Y 8"^3$?‫)ت ا‬r)Yt9u‫8. ا‬E"$?‫ا‬ standards. Discomforts include ‫)رات ا?$5[[3رة‬It%‫ وا‬X>M$4?‫ ا‬FG KIUa$%‫ا‬ 43Tuesday, January 1, 13
  73. 73. I.M Nailing Vs MIPO distal tibia I.M Nailing Vs MIPO distal tibia Clinical Trial Voluntary Participation hospitalization and the frequent follow ups !"‫ا1*ا4! )32 ا10/ر.! ا-,+*)(! & درا‬ !"‫=<; ا":9وج 76 ا54321!. و/. -%", ا"*)( &%ف إ‬ Consent after the intervention has been done. !(5(6(3.‫إ‬ >?‫ أ‬AB<"‫ ا‬C7 .DEF"‫! ا‬BG ,<HI‫9 ا‬J%:7، ‫ه‬MG‫9 أ‬J%:5‫ا‬ Ethics In case you are pregnant risks related to .DEF"‫! ا‬BG NOPQ3"‫ة ا‬STU‫% ً 76 ا‬W‫9 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 :!"#$%&‫ا,+*ا)( ا‬ !DE‫ا‬FC !5(6(3.‫. درا"! إ‬G/H-‫*ر ا‬H. & !3=41‫ا‬ Controlled Trial Potential Benefits: ./ ً %WOPJ ‫, `49ك =^-;ى ا"9ق ا5<3);ة‬F"%<7 A3Oa &<‫ ا-:0*ا‬IJ‫?/-,*ز‬ Your fracture well be treated by one of the N*Z %34O" D3b9"‫ ا‬M` .‫ر‬d4e"‫ع 76 ا‬dE"‫ا ا‬gh ,F"%<7 standard methods Research: Purpose Of the of treatment. None of i3`‫% ً. و=)2%ر‬WO-‫9ا‬U‫% ً و‬WOPJ ‫9=, وإ?)% 7<3);ة‬F3"‫ا‬ them are experimental. Youtime in fractured To evaluate the healing well be aiding :LMD-‫ ا‬NC ‫9ف‬P-‫ا‬ in the process of determining the best wayis tibias, and to know wither locked plating i" ‫3%ح‬Oa %)` .(&/‫ أ‬D3b9"‫; /. 7<9/, أي ا‬G%43a !"#$%‫<;)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$+ ،8+‫ا%.را‬ i?‫,. `)% أ‬a‫ ا";را‬l9/ 67 i" ‫)%ت ا5<%ه‬OB<3"‫%ع ا‬PZ‫إ‬ well berandomly assignedtoto one to the be your responsibility adhere of two ‫اء‬da Y2EZ ;r 8*Y)/a%‫+*)خ ا‬S)2 !*"#$%‫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?%` 1$;I3b%‫ ا‬cL 6eZ =Y .8=>;?‫.9*8 ا‬E?‫@ ا‬A)>B%)2 .‫ر‬U45%‫ ا‬R< ‫ع‬Ua%‫ا ا‬gh ‫ج‬cY ‫%ت‬UMG ,‫6 أ‬G %?‫%ر‬Pm‫6 إ‬G ‫%رج‬m %T37;:3a‫ أو أدو, إ‬FG ً )[*"J ‫.^)ن‬e$E< ‫;$)ن‬I3J The Nuremberg this type of fracture. Before surgery you inform the research team of any well be asked to fill a 12 question survey medication or treatment you take outside about your quality of life before having the of the protocol. 3MY)aj‫ ا‬R< ‫8 إ+$"*)ن‬k"E^ a< l=b*+ 8W‫3ا‬D%‫ ا‬m"7 .,a‫?%ق ا";را‬ .345%)2 $2)n‫ إ‬m"7 8*^)*o%‫*8 وا‬oB%‫)%$ ا‬W RY ً,‫ا‬p+ F$%‫8 ا‬W‫3ا‬D%‫ ا‬RY ‫ 2*)9)ت‬qer K$*+ 8W‫3ا‬D%‫. ا‬E2‫)ء و‬aj‫أ‬ Code fracture During and After surgery in both 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"‫ ا‬l9J 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$%‫وا‬ The Belmont In includes complication happensand survey case a blood tests, X-Rays from the ,a‫1%ت 76 ا";را‬G%&7 ‫) ا~ -;وث أي‬a Ä ,"%- ./ .8*oB%‫ا‬ intervention that has been done to you. filling. You well be offered treatment accordingly. C7 .!12345‫ا ا‬gh ./ i" xa%E5‫ج ا‬M<"‫9 ا‬O/dZ A3O4/ NoPotential Risks and Discomforts: financial compensation well be given . :!3T,M1‫/ت ا‬V/)‫ز‬W‫ وا‬FX/@1‫ا‬ ./ ‫ج‬M<"‫. ا‬ÅÄ .,‫&%ت 7%د‬d<Z ‫ي‬Y= ‫ام‬S3"|‫;م ا‬G pre-existing your participation include risks Risk of conditions and other medical problems not the surgical the intervention related to related to procedure which well not be covered by the institute.bleeding, include risks of anesthesia, .8=e$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 Çd<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$*+ ‫>)ت‬Y)á?‫ه ا‬gh well be dealt with according to the medical Participation in this research dose not add .!12345‫( 76 وإ "! ا‬bE3"‫ ا‬ÑO"%eZ RY ‫")رة‬Y 8L‫)ر‬M?‫ ا‬X=Y 8"^3$?‫)ت ا‬r)Yt9u‫8. ا‬E"$?‫ا‬ standards. Discomforts include costs other than the transportation from ‫)رات ا?$5[[3رة‬It%‫ وا‬X>M$4?‫ ا‬FG KIUa$%‫ا‬ and to the hospital. 43 44Tuesday, January 1, 13
  74. 74. I.M Nailing Vs MIPO distal tibia I.M Nailing Vs MIPO distal tibia I.M Nailing Vs MIPO distal tibia Voluntary Participation: :!"#$%&‫ا-,+ر)! ا‬ Your participation the this Participation Clinical Trial Voluntary trial is totally hospitalization and in frequent follow ups !"‫ا1*ا4! )32 ا10/ر.! ا-,+*)(! & درا‬ !"‫=<; ا":9وج 76 ا54321!. و/. -%", ا"*)( &%ف إ‬ Consent !" ‫">$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 ا‬W‫9 أ‬OXYZ ‫و"! دون أي‬ benefits. 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 Withdrawal and Termination: :!"#$%&‫ا,+*ا)( ا‬ :!)‫ا6543+ب وإ/+ء ا-,+ر‬ !DE‫ا‬FC !5(6(3.‫. درا"! إ‬G/H-‫*ر ا‬H. & !3=41‫ا‬ Controlled Trial You can withdraw from the study any time Potential Benefits: ?IJً %WOPJ ‫$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" D3b9"‫ ا‬M` .‫ر‬d4e"‫, 5@$ت. و;: ا‬F"%<7 standard methods Research: Purpose Of the of treatment. None of your participation well happen in case you failTo are experimental. Youtime infor any them evaluate the healing well befractured to adhere to the protocol aiding 0]%9 K9‫9%]0 ">$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 %)` .(&/‫ أ‬D3b9"‫ 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 6G ,a‫ ا%4)ق. إذا /. ا";را‬R< 3*OS‫ ا‬T=#%‫ر ا‬U4L 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";را‬l9/ 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 this type of fracture. Before surgery you 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 well be asked to fill a 12 question survey data that can be linked toyou take be kept medication or treatment you will outside about your quality of life before having the confidential. Specific personnel from the of the protocol. 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+ *<.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 :!<=4‫ا‬ Code fracture During and After surgery in both 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 .3"‫ج. وا‬M<B" i3OBh‫ أ‬x4- ,O"%3"‫=")ت ا%.را+8 ا‬b$<‫و‬ ‫ي‬wc 0"$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"‫ ا‬l9J 6G R< 8;I3J m5% 6)&3Z Helsinki protocol .‫3ال‬bD‫ا‬ studied procedures or casting which holdyou weight baring and physical activity. a (2/ ‫39ن =)<;ل‬b.8*=eE%‫9 ا‬OPF3"‫%ر ا‬O3m‫أو ا‬X>M$4?‫ا‬ 8jcj mL Kj R<‫ي و‬g"‫ وا‬R< ‫)ن‬YU"+‫. إ‬E2 .,a‫ا";را‬ Contact: ofseen again prolonged disability. high rate failure and in 2 weeks time and well be K$*+ ‫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:__________________ 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. E1"R9‫&$م ا‬b .‫د‬ Results: be offered treatment accordingly. You well C7 .!12345‫ا ا‬gh ./ i" xa%E5‫ج ا‬M<"‫9 ا‬O/dZ A3O4/ After finishing from the trial you well be. NoPotential Risks and Discomforts: financial compensation well be given :!3T,M1‫/ت ا‬V/)‫ز‬W‫ وا‬FX/@1‫ا‬ ./ ‫ج‬M<"‫. ا‬ÅÄ .,‫&%ت 7%د‬d<Z ‫ي‬Y= ‫ام‬S3"|‫;م ا‬G Report ‫^3ال:ــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ‬ informedof your participation we reached pre-existing conditions and other medical Risk about the results that include risks .8=e$o< 3J)/< ‫ل‬U"7 )|*=Y l^3$I 8+‫ ا%.را‬FG $L‫)ر‬M< %T" .3"‫9ى وا‬mI‫, ا‬PO"‫1%ت ا‬G%&5‫ا ا54321! ا‬gh problems not the surgical the intervention related to related to procedure which Ä %)` .,a‫( ا52%ر`, /. ا";را‬Pr ,b=%a .7 3J)/?‫ه ا‬gh 3J)/< : Fh‫8 و‬W‫3ا‬D%)2 8;=E$< ‫ن‬U5^ ‫79اض‬Y= ,rMG :AB+&C‫ا‬ well not be covered by the institute.bleeding, include risks of anesthesia, Noinfection compensation well be pain and 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"! ا‬Çd<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 06‫$ء "! ا98را‬g<(‫ا‬ ‫9ى‬m‫<%ب أ‬Z‫أي أ‬ discomforts that arisemeasures are taken to exposure. Certain accordingly. q*er ‫[) ً أن‬e=Y .345%‫8 ا‬E2)$< !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 well be dealt with according to the medical Participation in this research dose not add .!12345‫( 76 وإ "! ا‬bE3"‫ ا‬ÑO"%eZ RY ‫")رة‬Y 8L‫)ر‬M?‫ ا‬X=Y 8"^3$?‫)ت ا‬r)Yt9u‫8. ا‬E"$?‫ا‬ standards. Discomforts include costs other than the transportation from ‫)رات ا?$5[[3رة‬It%‫ وا‬X>M$4?‫ ا‬FG KIUa$%‫ا‬ and to the hospital. 43 45 44Tuesday, January 1, 13
  75. 75. I.MI.M Nailing Vs MIPO distal tibia I.M Nailing Vs MIPO distal tibia Nailing Vs MIPO distal tibia I.M Nailing Vs MIPO distal tibia Voluntary Participation: understanding this After Reading and !"# $%&‫ا-,+ر)! ا&%$#"!: ا2)10&/. أ-, +*)ا‬ ‫+:9 -,اء7$ و5*$ 254ه‬ hospitalization and in this Participation Clinical Trial Voluntary !"‫ا1*ا4! )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;$+" !BG NOPQ3"‫ة ا‬STU‫ 76 ا‬W‫9 أ‬OXYZ ‫و"! #"$. أي‬ ‫ دون‬Q7,%7 benefits. fetus. None of the investigated devices are of an explanation or without any penalty or proven to harm your fetus Vs. M.I.P.O. in loss of benefits. nailing Intramedullary !(89:1‫ ا-6@/)(! ?/->=/<; ا‬A/("B‫4/ر8! ا‬C Tibia Fractures, A Randomized Withdrawal and Termination: :!"#$%&‫ا,+*ا)( ا‬ :!)‫ا6543+ب وإ/+ء ا-,+ر‬ !DE‫ا‬FC !5(6(3.‫. درا"! إ‬G/H-‫*ر ا‬H. & !3=41‫ا‬ Controlled Trial You can withdraw from the study any time Potential Benefits: Name:____________________________ ?IJً %WOPJ ‫$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" D3b9"‫ ا‬M` .‫ر‬d4e"‫, 5@$ت. و;: ا‬F"%<7 standard methods Research: Purpose Of the of treatment. None of your participation well happen in case you Date:_____________________________ ‫:ــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ‬TU‫ر‬B%2‫ا‬ failTo are experimental. Youtime infor any them evaluate the healing well befractured to adhere to the protocol aiding 0]%9 K9‫9%]0 ">$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 %)` .(&/‫ أ‬D3b9"‫ 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 6G ,a‫ ا%4)ق. إذا /. ا";را‬R< 3*OS‫ ا‬T=#%‫ر ا‬U4L 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";را‬l9/ 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 this type of fracture. Before surgery you 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 well be asked to fill a 12 question survey 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. 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+ *<.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 :!<=4‫ا‬ 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 .3"‫ج. وا‬M<B" i3OBh‫ أ‬x4- ,O"%3"‫=")ت ا%.را+8 ا‬b$<‫و‬ ‫ي‬wc 0"$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"‫ ا‬l9J 6G R< 8;I3J m5% 6)&3Z Helsinki protocol .‫3ال‬bD‫ا‬ studied procedures or casting which holdyou weight baring and physical activity. a (2/ ‫39ن =)<;ل‬b.8*=eE%‫9 ا‬OPF3"‫%ر ا‬O3m‫أو ا‬X>M$4?‫ا‬ 8jcj mL Kj R<‫ي و‬g"‫ وا‬R< ‫)ن‬YU"+‫. إ‬E2 .,a‫ا";را‬ Contact: ofseen again prolonged disability. high rate failure and in 2 weeks time and well be K$*+ ‫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:__________________ 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. E1"R9‫&$م ا‬b .‫د‬ Results: be offered treatment accordingly. You well C7 .!12345‫ا ا‬gh ./ i" xa%E5‫ج ا‬M<"‫9 ا‬O/dZ A3O4/ After finishing from the trial you well be. NoPotential Risks and Discomforts: financial compensation well be given :!3T,M1‫/ت ا‬V/)‫ز‬W‫ وا‬FX/@1‫ا‬ ./ ‫ج‬M<"‫. ا‬ÅÄ .,‫&%ت 7%د‬d<Z ‫ي‬Y= ‫ام‬S3"|‫;م ا‬G Report ‫^3ال:ــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ‬ informedof your participation we reached pre-existing conditions and other medical Risk about the results that include risks .8=e$o< 3J)/< ‫ل‬U"7 )|*=Y l^3$I 8+‫ ا%.را‬FG $L‫)ر‬M< %T" .3"‫9ى وا‬mI‫, ا‬PO"‫1%ت ا‬G%&5‫ا ا54321! ا‬gh problems not the surgical the intervention related to related to procedure which Ä %)` .,a‫( ا52%ر`, /. ا";را‬Pr ,b=%a .7 3J)/?‫ه ا‬gh 3J)/< : Fh‫8 و‬W‫3ا‬D%)2 8;=E$< ‫ن‬U5^ ‫79اض‬Y= ,rMG :AB+&C‫ا‬ well not be covered by the institute.bleeding, include risks of anesthesia, Noinfection compensation well be pain and 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"! ا‬Çd<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 06‫$ء "! ا98را‬g<(‫ا‬ ‫9ى‬m‫<%ب أ‬Z‫أي أ‬ discomforts that arisemeasures are taken to exposure. Certain accordingly. q*er ‫[) ً أن‬e=Y .345%‫8 ا‬E2)$< !9‫>=.,/< ا&;.ر‬ : ‫ل‬cO‫=*8 و‬eE%‫)ء ا‬aj‫ا‬ avoid theses risks as much as possible. If 9Os ً )‫! ا52%رك‬BG ÑO"%eZgOS‫ ا‬K$I 8<‫)ت ا,ز‬J)*$Wu‫ا‬ R< [I‫ل أ‬UBW .aY‫! ا52%ر`, أي 2|). و‬BG xZ93 Ä Expensesthese complications accrue they any of of Participation: 8*"b%‫*3 ا‬I)E?‫ ا‬l4W )|E< m<)E$%‫ ا‬K$*+ ‫>)ت‬Y)á?‫ه ا‬gh well be dealt with according to the medical Participation in this research dose not add .!12345‫( 76 وإ "! ا‬bE3"‫ ا‬ÑO"%eZ RY ‫")رة‬Y 8L‫)ر‬M?‫ ا‬X=Y 8"^3$?‫)ت ا‬r)Yt9u‫8. ا‬E"$?‫ا‬ standards. Discomforts include costs other than the transportation from ‫)رات ا?$5[[3رة‬It%‫ وا‬X>M$4?‫ ا‬FG KIUa$%‫ا‬ and to the hospital. 43 45 4446Tuesday, January 1, 13

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