Hierarchy of evidence: Differences in results between non-randomized studies and randomized trials in patients with femoral neck fractures

Archives of Orthopaedic and Trauma Surgery

Volumn 124, Issue 1, 2004, Pages 10-16

  Bhandari, Mohit ^a   Tornetta III, Paul ^b   Ellis, Thomas ^c   Audige, Laurent ^d   Sprague, Sheila ^a   Kuo, Jonathan C ^b   Swiontkowski, Marc F ^e  

^a MCMASTER UNIVERSITY MEDICAL CENTRE   (Canada)

^b BOSTON UNIVERSITY   (United States)

^c OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^d AO Clinical Investigation and Documentation   (Switzerland)

^e UNIVERSITY OF MINNESOTA   (United States)

Author keywords

Arthroplasty; Bias; Hip fractures; Internal fixation; Randomized controlled trials; Research design; Systematic review

Indexed keywords

ARTICLE; CLINICAL STUDY; CLINICAL TRIAL; COCHRANE LIBRARY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEMOGRAPHY; FEMUR NECK FRACTURE; HIP ARTHROPLASTY; HUMAN; MEDLINE; META ANALYSIS; MORTALITY; OSTEOSYNTHESIS; OUTCOMES RESEARCH; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK BENEFIT ANALYSIS; SURGICAL RISK;

ARTHROPLASTY, REPLACEMENT, HIP; CONFIDENCE INTERVALS; CONTROLLED CLINICAL TRIALS; FEMALE; FEMORAL NECK FRACTURES; FRACTURE FIXATION, INTERNAL; FRACTURE HEALING; HUMANS; MALE; RANDOMIZED CONTROLLED TRIALS; RANGE OF MOTION, ARTICULAR; RECOVERY OF FUNCTION; RISK ASSESSMENT; SENSITIVITY AND SPECIFICITY; TREATMENT OUTCOME;

EID: 1342326075     PISSN: 09368051     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00402-003-0559-z     Document Type: Article

References (43)

1. Benson K, Hartz AJ (2000) A comparison of observational studies and randomized, controlled trials. N Engl J Med 342: 1878-1886
2. Bracey DJ (1977) A comparison of internal fixation and prosthetic replacement in the treatment of displaced subcapital fractures. Injury 9:1-4
3. Breslow NE, Day DE (1980) Combination of results from a series of 2×2 tables;control of confounding. In: Statistical methods in cancer research, Vol 1. The analysis of case-control studies. International Agency for Research on Cancer, Lyon, pp 136-146
4. Broos P, Stappaerts K, Luiten EJ, Gruwez JA (1987) Endoprosthesis. The best way to treat unstable intracapsular hip fractures in elderly patients. Unfallchirurg 90:347-350
5. Chalmers TC, Celano P, Sacks HS, Smith H Jr (1983) Bias in treatment assignment in controlled clinical trials. N Engl J Med 309:1358-1361
6. Chua D, Jaglal S, Schatzker J (1997) An orthopaedic surgeon survey on the treatment of displaced femoral neck fracture: opposing views. Can J Surg 40:271-277
7. Colditz GA, Miller JN, Mosteller F (1989) How study design affects outcomes in comparisons of therapy. I. Medical. Stat Med 8:441-454
8. Concato J, Shah N, Horwitz RI (2000) Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 342:1887-1894
9. Davison JNS, Calder SJ, Anderson GH, Ward G, Jagger C, Harper WM, Gregg PJ (2001) Treatment of displaced intracapsular fracture of the proximal femur: a prospective randomized trial in patients aged 65-79 years. J Bone Joint Surg Br 83: 206-212
10. DerSimonian R, Laird N (1986) Meta-analysis of clinical trials. Cont Clin Trials 7:177-188
11. Emerson JD, Burdick E, Hoaglin DC et al (1990) An empirical study of the possible relation of treatment differences to quality scores in controlled randomized clinical trials. Controlled Clin Trials 11:339-352
12. Guyatt GH, Rennie D (eds) (2001) User's guides to the medical literature: a manual for evidence-based clinical practice. American Medical Association Press, Chicago
13. Heikkinen T, Wingstrand H, Partanen J, Karl-Goran T, Jalovaara P (2002) Hemiarthroplasty or osteosynthesis in cervical hip fractures: matched pair analysis in 892 patients. Arch Orthop Trauma Surg 122:143-147
14. Hudson JI, Kenzora JE, Hebel JR, Gardner JF, Scherlis L, Epstein RS, Magaziner JS (1998) Eight-year outcome associated with clinical options in the management of femoral neck fractures. Clin Orthop 348:59-66
15. Hui AC, Anderson GH, Choudhry R, Boyle J, Gregg PJ (1994) Internal fixation or hemiarthroplasty for undisplaced fractures of the femoral neck in octogenarians. J Bone Joint Surg Br 76: 891-894
16. Hunter GA (1969) A comparison of the use of internal fixation and prosthetic replacement for fresh fractures of the neck of the femur. Br J Surg 56:229-232
17. Hunter GA (1974) A further comparison of the use of internal fixation and prosthetic replacement for fresh fractures of the neck of the femur. Br J Surg 61:382-384
18. Ioannidis JP, Haidich AB, Pappa M, Pantazis N, Kokori SI, Tektonidou MG, Contopoulos-Ioannidis DG, Lau J (2001) Comparison of evidence of treatment effects in randomized and nonrandomized studies. JAMA 286:821-830
19. Jensen J, Rasmussen T, Christensen S, Holm-Moller S, Lauritzen J (1984) Internal fixation or prosthetic replacement in fresh femoral neck fractures. Acta Orthop Scand 55:712
20. Johansson T, Jacobsson SA, Ivarsson I, Knutsson A, Wahlstrom O (2000) Internal fixation versus total hip arthroplasty in the treatment of displaced femoral neck fractures: a prospective randomized study of 100 hips. Acta Orthop Scand 71:597-602
21. Johnson J, Crothers O (1975) Nailing vs prosthesis for femoral neck fractures: a critical review of long term results in two hundred thirty nine consecutive private patients. J Bone Joint Surg Am 57:686-692
22. Jonnson B, Sernbo I, Carlsson A, Fredin H, Johnell O (1996) Social function after cervical hip fracture: a comparison of hook-pins and total hip replacement in 47 patients. Acta Orthop Scand 67:431-434
23. Kunz R, Oxman AD (1998) The unpredictability paradox: review of empirical comparisons of randomised and non-randomised clinical trials. BMJ 317:1185-1190
24. Magaziner J, Simonsick E, Kashner T, Hebel J, Kenzora J (1990) Predictors of functional recovery one year following hospital discharge for hip fracture. A prospective study. J Gerontol 45:101-107
25. Neander G, Adolphson P, Sivers K von, Dahlborn M, Dalen N (1997) Bone and muscle mass after femoral neck fracture: a controlled quantitative computed tomographic study of osteosynthesis versus primary total hip arthroplasty. Arch Orthop Trauma Surg 116:470-474
26. Nicoll EA (1953) The unsolved fracture. J Bone Joint Surg 35:805-821
27. Parker M, Blundell C (1998) Choice of implant for internal fixation of femoral neck fractures: meta-analysis of 25 randomized trials including 4,925 patients. Acta Orthop Scand 69:138-143
28. Parker MJ (1992) Internal fixation or arthroplasty for displaced subcapital fractures in the elderly? Injury 23:521-524
29. Parker MJ, Pryor GA (2000) Internal fixation or arthroplasty for displaced cervical hip fractures in the elderly: a randomised controlled trial of 208 patients. Acta Orthop Scand 7:440-446
30. Puolakka TJS, Laine H, Tarvainen T, Aho H (2001) Thompson hemi-arthroplasty is superior to ulleval screws in treating displaced femoral neck fractures in patients over 75 years. A prospective randomized two-year follow up. Ann Chirurg Gynaecol 90:225-228
31. Raine GE (1973) A comparison of internal fixation and prosthetic replacement for recent displaced subcapital fractures of the neck of the femur. Injury 5:25-30
32. Ravikumar KJ, Marsh G (2000) Internal fixation versus hemiarthroplasty versus total hip arthroplasty for displaced subcapital fractures of femur - 13 year results of a prospective randomised study. Injury 31:793-797
33. Rodriguez J, Herrara A, Canales V, Serrano S (1987) Epidemiologic factors, morbidity and mortality after femoral neck fractures in the elderly. A comparative study: internal fixation vs. hemiarthroplasty. Acta Orthop Belg 53:472-479
34. Rogmark C, Carlsson, Jonnell O, Sernbo I (2002) A prospective randomized trial of internal fixation versus arthroplasty for displaced fractures of the femur. J Bone Joint Surg Br 84:183-188
35. Sackett DL, Haynes RB, Guyatt GH, Tugwell P (1991) Clinical epidemiology, a basic science for clinical medicine, 2nd edn. Little Brown, Boston
36. Sacks HS, Chalmers TC, Smith H Jr (1983) Sensitivity and specificity of clinical trials. Randomized v historical controls. Arch Intern Med 143:753-755
37. Sikorski JM, Barrington R (1981) Internal fixation versus hemiarthroplasty for the displaced subcapital fracture of the femur. A prospective randomised study. J Bone Joint Surg Br 63:357-361
38. Soreide O, Molster A, Raugstad TS (1979) Internal fixation versus primary prosthetic replacement in acute femoral neck fractures: a prospective, randomized clinical study. Br J Surg 66:56-60
39. Stewart H (1987) Pugh's nail fixation versus Thompson's prosthesis for displaced subcapital fractures of the femur. Injury 15:227-231
40. Tidermark J, Ponzer S, Svensson O, Tornkvist H (1999) Internal fixation versus primary hip arthoplasty for dislocated femoral neck fractures: a prospective randomized study. Presented at the 15th annual meeting of the Orthopaedic Trauma Association, Charlotte, NC, October 1999, pp112-113
41. Turcotte R, Godin C, Duchesne R, Jodoin A (1990) Hip fractures in Parkinson's disease: a clinical review of 94 fractures treated surgically. Clin Orthop 256:132-136
42. Van Dortmont LM, Douw CM, Breukelen AM van, Laurens DR, Mulder PG, Wereldsma JC, Vugt AB van (2000) Cannulated screws versus hemiarthroplasty for displaced intracapsular femoral neck fractures in demented patients. Ann Chir Gynaecol 89:132-137
43. Van Vugt AB, Oosterwijk WM, Goris RJ (1993) Osteosynthesis versus endoprosthesis in the treatment of unstable intracapsular hip fractures in the elderly. A randomised clinical trial. Arch Orthop Trauma Surg 113:39-45