메뉴 건너뛰기




Volumn 18, Issue 8, 2010, Pages 454-463

Randomized clinical trials in orthopaedic surgery: Strategies to improve quantity and quality

Author keywords

[No Author keywords available]

Indexed keywords

HUMAN; METHODOLOGY; ORGANIZATION; ORGANIZATION AND MANAGEMENT; ORTHOPEDIC SURGERY; ORTHOPEDICS; OUTCOME ASSESSMENT; RANDOMIZED CONTROLLED TRIAL (TOPIC); STANDARDS;

EID: 77955670023     PISSN: 1067151X     EISSN: None     Source Type: Journal    
DOI: 10.5435/00124635-201008000-00002     Document Type: Review
Times cited : (19)

References (46)
  • 1
    • 0032750122 scopus 로고    scopus 로고
    • Issues in surgical randomized controlled trials
    • McLeod RS: Issues in surgical randomized controlled trials. World J Surg 1999;23(12):1210-1214.
    • (1999) World J Surg , vol.23 , Issue.12 , pp. 1210-1214
    • McLeod, R.S.1
  • 2
    • 0034644397 scopus 로고    scopus 로고
    • Users' guides to the medical literature: XXV. Evidence-based medicine: Principles for applying the users' guides to patient care. Evidence-based medicine working group
    • Guyatt GH, Haynes RB, Jaeschke RZ, et al: Users' guides to the medical literature: XXV. Evidence-based medicine: Principles for applying the users' guides to patient care. Evidence-Based Medicine Working Group. JAMA 2000;284(10):1290-1296.
    • (2000) JAMA , vol.284 , Issue.10 , pp. 1290-1296
    • Guyatt, G.H.1    Haynes, R.B.2    Jaeschke, R.Z.3
  • 4
    • 0036512461 scopus 로고    scopus 로고
    • The quality of reporting of randomized trials in the journal of bone and joint surgery from 1988 through 2000
    • Bhandari M, Richards RR, Sprague S, Schemitsch EH: The quality of reporting of randomized trials in the Journal of Bone and Joint Surgery from 1988 through 2000. J Bone Joint Surg Am 2002;84(3):388-396.
    • (2002) J Bone Joint Surg Am , vol.84 , Issue.3 , pp. 388-396
    • Bhandari, M.1    Richards, R.R.2    Sprague, S.3    Schemitsch, E.H.4
  • 5
    • 0015692118 scopus 로고
    • The nine and ten year results of the low-friction arthroplasty of the hip
    • Charnley J, Cupic Z: The nine and ten year results of the low-friction arthroplasty of the hip. Clin Orthop Relat Res 1973;95:9-25.
    • (1973) Clin Orthop Relat Res , vol.95 , pp. 9-25
    • Charnley, J.1    Cupic, Z.2
  • 6
    • 0000948648 scopus 로고
    • Congenital club foot: The results of treatment
    • Ponseti IV, Smoley EN: Congenital club foot: The results of treatment. J Bone Joint Surg Am 1963;45:261-275, 344.
    • (1963) J Bone Joint Surg Am , vol.45 , Issue.261-275 , pp. 344
    • Ponseti, I.V.1    Smoley, E.N.2
  • 7
    • 0017743113 scopus 로고
    • Extracranial to intracranial vascular anastomosis for occlusive cerebrovascular disease: Experience in 110 patients
    • Popp AJ, Chater N: Extracranial to intracranial vascular anastomosis for occlusive cerebrovascular disease: Experience in 110 patients. Surgery 1977;82(5):648-654.
    • (1977) Surgery , vol.82 , Issue.5 , pp. 648-654
    • Popp, A.J.1    Chater, N.2
  • 8
    • 0022642442 scopus 로고
    • EC/IC bypass study
    • McDowell F, Flamm ES: EC/IC bypass study. Stroke 1986;17(1):1-2.
    • (1986) Stroke , vol.17 , Issue.1 , pp. 1-2
    • McDowell, F.1    Flamm, E.S.2
  • 9
    • 0022359427 scopus 로고
    • Failure of extracranial-intracranial arterial bypass to reduce the risk of ischemic stroke: Results of an international randomized trial. The EC/IC bypass study group
    • Failure of extracranial-intracranial arterial bypass to reduce the risk of ischemic stroke: Results of an international randomized trial. The EC/IC Bypass Study Group. N Engl J Med 1985;313(19):1191-1200.
    • (1985) N Engl J Med , vol.313 , Issue.19 , pp. 1191-1200
  • 10
    • 0030292685 scopus 로고    scopus 로고
    • EC-IC bypass 10 years later: Is it valuable?
    • Caplan LR, Piepgras DG, Quest DO, et al: EC-IC bypass 10 years later: Is it valuable? Surg Neurol 1996;46(5):416-423.
    • (1996) Surg Neurol , vol.46 , Issue.5 , pp. 416-423
    • Caplan, L.R.1    Piepgras, D.G.2    Quest, D.O.3
  • 11
    • 34547809557 scopus 로고    scopus 로고
    • Symposium: How to participate in orthopaedic randomized clinical trials
    • Trippel SB, Bosse MJ, Heck DA, Wright JG: Symposium: How to participate in orthopaedic randomized clinical trials. J Bone Joint Surg Am 2007;89(8):1856-1864.
    • (2007) J Bone Joint Surg Am , vol.89 , Issue.8 , pp. 1856-1864
    • Trippel, S.B.1    Bosse, M.J.2    Heck, D.A.3    Wright, J.G.4
  • 12
    • 2342436795 scopus 로고    scopus 로고
    • Ethics and evidence based surgery
    • Stirrat GM: Ethics and evidence based surgery. J Med Ethics 2004;30(2):160-165.
    • (2004) J Med Ethics , vol.30 , Issue.2 , pp. 160-165
    • Stirrat, G.M.1
  • 17
    • 65349131165 scopus 로고    scopus 로고
    • The American Orthopaedic Association clinical trials curriculum
    • Diamond IR, Murray C, Bosse MJ, et al: The American Orthopaedic Association clinical trials curriculum. J Bone Joint Surg Am 2009;91(4):1007-1011.
    • (2009) J Bone Joint Surg Am , vol.91 , Issue.4 , pp. 1007-1011
    • Diamond, I.R.1    Murray, C.2    Bosse, M.J.3
  • 19
    • 39549102834 scopus 로고    scopus 로고
    • Surgical versus nonsurgical therapy for lumbar spinal stenosis
    • Weinstein JN, Tosteson TD, Lurie JD, et al: Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med 2008;358(8):794-810.
    • (2008) N Engl J Med , vol.358 , Issue.8 , pp. 794-810
    • Weinstein, J.N.1    Tosteson, T.D.2    Lurie, J.D.3
  • 20
    • 33751217149 scopus 로고    scopus 로고
    • Surgical vs nonoperative treatment for lumbar disk herniation: The Spine Patient Outcomes Research Trial (SPORT). A randomized trial
    • Weinstein JN, Tosteson TD, Lurie JD, et al: Surgical vs nonoperative treatment for lumbar disk herniation: The Spine Patient Outcomes Research Trial (SPORT). A randomized trial. JAMA 2006;296(20):2441-2450.
    • (2006) JAMA , vol.296 , Issue.20 , pp. 2441-2450
    • Weinstein, J.N.1    Tosteson, T.D.2    Lurie, J.D.3
  • 21
    • 34249830160 scopus 로고    scopus 로고
    • Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis
    • Weinstein JN, Lurie JD, Tosteson TD, et al: Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. N Engl J Med 2007;356(22):2257-2270.
    • (2007) N Engl J Med , vol.356 , Issue.22 , pp. 2257-2270
    • Weinstein, J.N.1    Lurie, J.D.2    Tosteson, T.D.3
  • 22
    • 34247885985 scopus 로고    scopus 로고
    • The 2007 ABJS Marshall Urist award: The impact of direct-to-consumer advertising in orthopaedics
    • Bozic KJ, Smith AR, Hariri S, et al: The 2007 ABJS Marshall Urist Award: The impact of direct-to-consumer advertising in orthopaedics. Clin Orthop Relat Res 2007;458:202-219.
    • (2007) Clin Orthop Relat Res , vol.458 , pp. 202-219
    • Bozic, K.J.1    Smith, A.R.2    Hariri, S.3
  • 23
    • 0033954803 scopus 로고    scopus 로고
    • The use of rhBMP-2 in interbody fusion cages: Definitive evidence of osteoinduction in humans. A preliminary report
    • Boden SD, Zdeblick TA, Sandhu HS, Heim SE: The use of rhBMP-2 in interbody fusion cages: Definitive evidence of osteoinduction in humans. A preliminary report. Spine (Phila Pa 1976,)2000;25(3):376-381.
    • (2000) Spine (Phila Pa 1976) , vol.25 , Issue.3 , pp. 376-381
    • Boden, S.D.1    Zdeblick, T.A.2    Sandhu, H.S.3    Heim, S.E.4
  • 24
    • 0036695527 scopus 로고    scopus 로고
    • The 2 "Es" of research: Efficacy and effectiveness trials
    • Streiner DL: The 2 "Es" of research: Efficacy and effectiveness trials. Can J Psychiatry 2002;47(6):552-556.
    • (2002) Can J Psychiatry , vol.47 , Issue.6 , pp. 552-556
    • Streiner, D.L.1
  • 25
    • 29344445226 scopus 로고    scopus 로고
    • When and how to assess fast-changing technologies: A comparative study of medical applications of four generic technologies
    • Mowatt G, Bower DJ, Brebner J, Cairns JA, Grant AM, McKee L: When and how to assess fast-changing technologies: A comparative study of medical applications of four generic technologies. Health Technol Assess 1997;1(14):1-149.
    • (1997) Health Technol Assess , vol.1 , Issue.14 , pp. 1-149
    • Mowatt, G.1    Bower, D.J.2    Brebner, J.3    Cairns, J.A.4    Grant, A.M.5    McKee, L.6
  • 26
    • 19944425951 scopus 로고    scopus 로고
    • Need for expertise based randomised controlled trials
    • Devereaux PJ, Bhandari M, Clarke M, et al: Need for expertise based randomised controlled trials. BMJ 2005;330(7482):88-91.
    • (2005) BMJ , vol.330 , Issue.7482 , pp. 88-91
    • Devereaux, P.J.1    Bhandari, M.2    Clarke, M.3
  • 27
    • 0034897418 scopus 로고    scopus 로고
    • Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implications for required sample sizes using WOMAC and SF-36 quality of life measurement instruments in patients with osteoarthritis of the lower extremities
    • Angst F, Aeschlimann A, Stucki G: Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implications for required sample sizes using WOMAC and SF-36 quality of life measurement instruments in patients with osteoarthritis of the lower extremities. Arthritis Rheum 2001;45(4):384-391.
    • (2001) Arthritis Rheum , vol.45 , Issue.4 , pp. 384-391
    • Angst, F.1    Aeschlimann, A.2    Stucki, G.3
  • 28
    • 33644840887 scopus 로고    scopus 로고
    • Issues in the planning and conduct of randomised trials
    • Bhandari M, Pape HC, Giannoudis PV: Issues in the planning and conduct of randomised trials. Injury 2006;37(4):349-354.
    • (2006) Injury , vol.37 , Issue.4 , pp. 349-354
    • Bhandari, M.1    Pape, H.C.2    Giannoudis, P.V.3
  • 29
    • 33947727535 scopus 로고    scopus 로고
    • Sample size calculations in randomized trials: Common pitfalls
    • Brasher PM, Brant RF: Sample size calculations in randomized trials: Common pitfalls. Can J Anaesth 2007;54(2):103-106.
    • (2007) Can J Anaesth , vol.54 , Issue.2 , pp. 103-106
    • Brasher, P.M.1    Brant, R.F.2
  • 30
    • 10944254940 scopus 로고    scopus 로고
    • Design and conduct issues in surgical clinical trials
    • Neumayer L: Design and conduct issues in surgical clinical trials. Am J Surg 2004;188(6A suppl):17S-21S.
    • (2004) Am J Surg , vol.188 , Issue.6 A SUPPL.
    • Neumayer, L.1
  • 31
    • 0036191550 scopus 로고    scopus 로고
    • Many faces of the minimal clinically important difference (MCID): A literature review and directions for future research
    • Beaton DE, Boers M, Wells GA: Many faces of the minimal clinically important difference (MCID): A literature review and directions for future research. Curr Opin Rheumatol 2002;14(2):109-114.
    • (2002) Curr Opin Rheumatol , vol.14 , Issue.2 , pp. 109-114
    • Beaton, D.E.1    Boers, M.2    Wells, G.A.3
  • 32
    • 34748883705 scopus 로고    scopus 로고
    • Understanding the minimum clinically important difference: A review of concepts and methods
    • Copay AG, Subach BR, Glassman SD, Polly DW Jr, Schuler TC: Understanding the minimum clinically important difference: A review of concepts and methods. Spine J 2007;7(5):541-546.
    • (2007) Spine J , vol.7 , Issue.5 , pp. 541-546
    • Copay, A.G.1    Subach, B.R.2    Glassman, S.D.3    Polly Jr., D.W.4    Schuler, T.C.5
  • 33
    • 41849129555 scopus 로고    scopus 로고
    • Simple Bone Cyst Trial Group: A randomized clinical trial comparing intralesional bone marrow and steroid injections for simple bone cysts
    • Wright JG, Yandow S, Donaldson S, Marley L, Simple Bone Cyst Trial Group: A randomized clinical trial comparing intralesional bone marrow and steroid injections for simple bone cysts. J Bone Joint Surg Am 2008;90(4):722-730.
    • (2008) J Bone Joint Surg Am , vol.90 , Issue.4 , pp. 722-730
    • Wright, J.G.1    Yandow, S.2    Donaldson, S.3    Marley, L.4
  • 34
    • 0002848242 scopus 로고    scopus 로고
    • Centralized treatment allocation in comparative clinical trials
    • Buyse M: Centralized treatment allocation in comparative clinical trials. Applied Clinical Trials 2000;9:32-37.
    • (2000) Applied Clinical Trials , vol.9 , pp. 32-37
    • Buyse, M.1
  • 35
    • 0022349969 scopus 로고
    • The randomized clinical trial in orthopaedics: Obligation or option?
    • Rudicel S, Esdaile J: The randomized clinical trial in orthopaedics: Obligation or option? J Bone Joint Surg Am 1985;67:1284-1293.
    • (1985) J Bone Joint Surg Am , vol.67 , pp. 1284-1293
    • Rudicel, S.1    Esdaile, J.2
  • 36
    • 15744388502 scopus 로고    scopus 로고
    • Treatments for paediatric femoral fractures: A randomised trial
    • Wright JG, Wang EE, Owen JL, et al: Treatments for paediatric femoral fractures: A randomised trial. Lancet 2005;365(9465):1153-1158.
    • (2005) Lancet , vol.365 , Issue.9465 , pp. 1153-1158
    • Wright, J.G.1    Wang, E.E.2    Owen, J.L.3
  • 38
    • 15044345639 scopus 로고    scopus 로고
    • Sham surgery controls are mitigated trolleys
    • Albin RL: Sham surgery controls are mitigated trolleys. J Med Ethics 2005;31(3):149-152.
    • (2005) J Med Ethics , vol.31 , Issue.3 , pp. 149-152
    • Albin, R.L.1
  • 39
    • 33746771342 scopus 로고    scopus 로고
    • Placebo surgery research: A blinding imperative
    • Heckerling PS: Placebo surgery research: A blinding imperative. J Clin Epidemiol 2006;59(9):876-880.
    • (2006) J Clin Epidemiol , vol.59 , Issue.9 , pp. 876-880
    • Heckerling, P.S.1
  • 42
    • 0037006675 scopus 로고    scopus 로고
    • Sample size slippages in randomised trials: Exclusions and the lost and wayward
    • Schulz KF, Grimes DA: Sample size slippages in randomised trials: Exclusions and the lost and wayward. Lancet 2002;359(9308):781-785.
    • (2002) Lancet , vol.359 , Issue.9308 , pp. 781-785
    • Schulz, K.F.1    Grimes, D.A.2
  • 43
    • 0031949762 scopus 로고    scopus 로고
    • Methods for locating missing patients for the purpose of long-term clinical studies
    • Smith JS, Watts HG: Methods for locating missing patients for the purpose of long-term clinical studies. J Bone Joint Surg Am 1998;80(3):431-438.
    • (1998) J Bone Joint Surg Am , vol.80 , Issue.3 , pp. 431-438
    • Smith, J.S.1    Watts, H.G.2
  • 44
    • 0344687464 scopus 로고    scopus 로고
    • Limiting loss to follow-up in a multicenter randomized trial in orthopedic surgery
    • Sprague S, Leece P, Bhandari M, et al: Limiting loss to follow-up in a multicenter randomized trial in orthopedic surgery. Control Clin Trials 2003;24(6):719-725.
    • (2003) Control Clin Trials , vol.24 , Issue.6 , pp. 719-725
    • Sprague, S.1    Leece, P.2    Bhandari, M.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.