The feasibility of performing a randomised controlled trial for femoroacetabular impingement surgery

Bone and Joint Research

Volumn 2, Issue 2, 2013, Pages 33-40

  Palmer, A J R ^a   Thomas, G E R ^a   Pollard, T C B ^a   Rombach, I ^a   Taylor, A ^a,c   Arden, N ^a   Beard, D J ^a   Andrade, A J ^a,b   Carr, A J ^a   Glyn Jones, S ^a  

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b ROYAL BERKSHIRE HOSPITAL   (United Kingdom)

^c NUFFIELD ORTHOPAEDIC CENTRE   (United Kingdom)

Author keywords

Equipoise; Feasibility; Femoroacetabular impingement; Hip; Randomised controlled trial; Trial design

Indexed keywords

EID: 84924262899     PISSN: None     EISSN: 20463758     Source Type: Journal    
DOI: 10.1302/2046-3758.22.2000137     Document Type: Article

References (37)

1. McLeod R. Randomized, controlled trials: is there a role for them in surgery? Ann Surg 2006;244:684-685.
2. McCulloch P, Taylor I, Sasako M, Lovett B, Griffin D. Randomised trials in surgery: problems and possible solutions. BMJ 2002;324:1448-1451.
3. Solomon MJ, McLeod RS. Clinical studies in surgical journals: have we improved? Dis Colon Rectum 1993;36:43-48.
4. Ellis J, Mulligan I, Rowe J, Sackett DL. Inpatient general medicine is evidence based: A-Team, Nuffield Department of Clinical Medicine. Lancet 1995;346:407-410.
5. Howes N, Chagla L, Thorpe M, McCulloch P. Surgical practice is evidence based. Br J Surg 1997;84:1220-1223.
6. Black N. Why we need observational studies to evaluate the effectiveness of health care. BMJ 1996;312:1215-1218.
7. Young JM, Solomon MJ, Harrison JD, Salkeld G, Butow P. Measuring patient preference and surgeon choice. Surgery 2008;143:582-588.
8. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med 1987;317:141-145.
9. Miller FG. Clinical equipoise and risk-benefit assessment. Clin Trials 2012;9:621-627.
10. Young JM, Solomon MJ, Harrison JD, Salkeld G, Butow P. Measuring patient preference and surgeon choice. Surgery 2008;143:582-588.
11. Ross S, Grant A, Counsell C, et al. Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiol 1999;52:1143-1156.
12. Solomon MJ, McLeod RS. Should we be performing more randomized controlled trials evaluating surgical operations? Surgery 1995;118:459-467.
13. Arain M, Campbell MJ, Cooper CL, Lancaster GA. What is a pilot or feasibility study?: A review of current practice and editorial policy. BMC Med Res Methodol 2010;10:67.
14. Ganz R, Parvizi J, Beck M, et al. Femoroacetabular impingement: a cause for osteoarthritis of the hip. Clin Orthop Relat Res 2003;417:112-120.
15. Tibor LM, Leunig M. The pathoanatomy and arthroscopic management of femoroacetabular impingement. Bone Joint Res 2012;1:245-257.
16. Thomas GE, Kiran A, Batra RN, et al. The association between hip morphology and endstage osteoarthritis at 12-year follow up. Osteoarthritis Cartilage 2012;20(Suppl 1):S204.
17. Clohisy JC, Dobson MA, Robison JF, et al. Radiographic structural abnormalities associated with premature, natural hip-joint failure. J Bone Joint Surg [Am] 2011;93-A(Suppl 2):3-9.
18. Reichenbach S, Leunig M, Werlen S, et al. Association between cam-type deformities and magnetic resonance imaging-detected structural hip damage: a cross-sectional study in young men. Arthritis Rheum 2011;63:4023-4030.
19. Pollard TC, McNally EG, Wilson DC, et al. Localized cartilage assessment with three-dimensional dGEMRIC in asymptomatic hips with normal morphology and cam deformity. J Bone Joint Surg [Am] 2010;92-A:2557-2569.
20. No authors listed. Hospital Episode Statistics. http://www.hesonline.nhs.uk (date last accessed 5 December 2012).
21. Clohisy JC, St John LC, Schutz AL. Surgical treatment of femoroacetabular impingement: a systematic review of the literature. Clin Orthop Relat Res 2010;468:555-564.
22. Ng VY, Arora N, Best TM, Pan X, Ellis TJ. Efficacy of surgery for femoroacetabular impingement: a systematic review. Am J Sports Med 2010;38:2337-2345.
23. Bedi A, Chen N, Robertson W, Kelly BT. The management of labral tears and femoroacetabular impingement of the hip in the young, active patient. Arthroscopy 2008;24:1135-1145.
24. Christensen CP, Althausen PL, Mittleman MA, Lee JA, McCarthy JC. The nonarthritic hip score: reliable and validated. Clin Orthop Relat Res 2003;406:75-83.
25. Dawson J, Fitzpatrick R, Carr A, Murray D. Questionnaire on the perceptions of patients about total hip replacement. J Bone Joint Surg [Br] 1996;78-B:185-190.
26. Klässbo M, Larsson E, Mannevik E. Hip disability and osteoarthritis outcome score: an extension of the Western Ontario and McMaster Universities Osteoarthritis Index. Scand J Rheumatol 2003;32:46-51.
27. Harris WH. Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold arthroplasty: an end-result study using a new method of result evaluation. J Bone Joint Surg [Am] 1969;51-A:737-755.
28. Martin RL, Kelly BT, Philippon MJ. Evidence of validity for the hip outcome score. Arthroscopy 2006;22:1304-1311.
29. Johnson N, Lilford RJ, Brazier W. At what level of collective equipoise does a clinical trial become ethical? J Med Ethics 1991;17:30-34.
30. Markman M. Ethical difficulties with randomized clinical trials involving cancer patients: examples from the field of gynecologic oncology. J Clin Ethics 1992;3:193-195.
31. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med 1987;317:141-145.
32. Roos EM, Dahlberg L. Positive effects of moderate exercise on glycosaminoglycan content in knee cartilage: a four-month, randomized, controlled trial in patients at risk of osteoarthritis. Arthritis Rheum 2005;52:3507-3514.
33. Kellgren JH, Lawrence JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis 1957;16:494-502.
34. Tönnis D. Normal values of the hip joint for the evaluation of X-rays in children and adults. Clin Orthop Relat Res 1976;119:39-47.
35. Abraham NS, Hewett P, Young JM, Solomon MJ. Non-entry of eligible patients into the Australasian Laparoscopic Colon Cancer Study. ANZ J Surg 2006;76:825-829.
36. Solomon MJ, Pager CK, Keshava A, et al. What do patients want?: patient preferences and surrogate decision making in the treatment of colorectal cancer. Dis Colon Rectum 2003;46:1351-1357.
37. Solomon MJ, Pager CK, Young JM, Roberts R, Butow P. Patient entry into randomized controlled trials of colorectal cancer treatment: factors influencing participation. Surgery 2003;133:608-613.