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Overview of randomised controlled trials in orthopaedic research: search for significant findings

  • Hosam E. MatarEmail author
  • Simon R. Platt
General Review • GENERAL ORTHOPAEDICS - RESEARCH
  • 31 Downloads

Abstract

Background

The majority of recent orthopaedics randomised controlled trials (RCTs) have been non-inferiority trials with no significant clinical or statistical differences between treatment groups. The aim of this study was to evaluate randomised trials for significant findings in the orthopaedic literature based on the main elective procedures undertaken across different subspecialties.

Methods

We evaluated the following procedures: anterior cervical discectomy and fusion (ACDF), subacromial decompression (SAD), carpal tunnel decompression (CTD), total hip replacement (THR), anterior cruciate ligament reconstruction (ACLR), total knee replacement (TKR) and hallux valgus correction (HVC). Following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, we searched the Cochrane Central Register of Controlled Trials (CENTRAL, 2018, Issue 1), Ovid MEDLINE (1946 to 12 January 2018) and Embase (1980 to 12 January 2018). Trials that met our inclusion criteria were assessed using a binary outcome measure of whether they reported statistically significant findings.

Results

We included 1078 RCTs across seven most commonly performed elective procedures. Of those, only 16% (172/1078) reported significant findings [ACDF 26/77 (33.8%); SAD 2/22 (9%); CTD 11/72 (15.3%); THR 52/281 (18.5%); ACLR 21/239 (8.8%); TKR 55/357 (15.4%); HVC 5/30 (16.7%)]. The number of RCTs per year of publication has increased dramatically particularly since early 2000s—with over 100 RCTs of those seven procedures published in 2017 alone.

Conclusions

This is the first study to undertake a comprehensive review of orthopaedic RCTs in elective practice. The number of RCTs in orthopaedic research is steadily increasing. However, only 16% of trials reports significant differences between interventions.

Clinical relevance

For trials comparing different surgical techniques, this evidence provides treating surgeons with the flexibility to utilise available resources and infrastructure to deliver patients care without compromising clinical outcomes. Further, for trials comparing different treatment modalities, this study helps to inform the shared decision-making process when counselling patients on the effectiveness of surgical interventions.

Keywords

Orthopaedic interventions Randomised controlled trials Non-inferiority trials 

Notes

Compliance with ethical standards

Conflict of Interest

The author(s) declare that they have no competing interests.

References

  1. 1.
    Altman DG et al (2001) The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 134:663–694CrossRefGoogle Scholar
  2. 2.
    Beard DJ et al (2018) Arthroscopic subacromial decompression for subacromial shoulder pain (CSAW): a multicentre, pragmatic, parallel group, placebo-controlled, three-group, randomised surgical trial. Lancet (London, England) 391:329–338.  https://doi.org/10.1016/s0140-6736(17)32457-1 CrossRefGoogle Scholar
  3. 3.
    Campbell AJ, Bagley A, Van Heest A, James MA (2010) Challenges of randomized controlled surgical trials. Orthop Clin N Am 41:145–155.  https://doi.org/10.1016/j.ocl.2009.11.001 CrossRefGoogle Scholar
  4. 4.
    Carr A et al (2017) Effectiveness of open and arthroscopic rotator cuff repair (UKUFF): a randomised controlled trial. Bone Joint J 99-b:107–115.  https://doi.org/10.1302/0301-620x.99b1.bjj-2016-0424.r1 CrossRefGoogle Scholar
  5. 5.
    Chess LE, Gagnier J (2013) Risk of bias of randomized controlled trials published in orthopaedic journals. BMC Med Res Methodol 13:76.  https://doi.org/10.1186/1471-2288-13-76 CrossRefGoogle Scholar
  6. 6.
    Cook JA (2009) The challenges faced in the design, conduct and analysis of surgical randomised controlled trials. Trials 10:9.  https://doi.org/10.1186/1745-6215-10-9 CrossRefGoogle Scholar
  7. 7.
    Costa ML, Achten J, Parsons NR, Rangan A, Griffin D, Tubeuf S, Lamb SE (2014) Percutaneous fixation with Kirschner wires versus volar locking plate fixation in adults with dorsally displaced fracture of distal radius: randomised controlled trial. BMJ (Clin Res Ed) 349:g4807.  https://doi.org/10.1136/bmj.g4807 Google Scholar
  8. 8.
    Costa ML, Jameson SS, Reed MR (2016) Do large pragmatic randomised trials change clinical practice? Assessing the impact of the Distal Radius Acute Fracture Fixation Trial (DRAFFT). Bone Joint J 98-b:410–413.  https://doi.org/10.1302/0301-620x.98b3.36730 CrossRefGoogle Scholar
  9. 9.
  10. 10.
    Evidence-Based-Medicine-Working-Group (1992) Evidence-based medicine: a new approach to teaching the practice of medicine. JAMA 268:2420–2425CrossRefGoogle Scholar
  11. 11.
    Fayaz HC et al (2013) Improvement of research quality in the fields of orthopaedics and trauma: a global perspective. Int Orthop 37:1205–1212.  https://doi.org/10.1007/s00264-013-1897-2 CrossRefGoogle Scholar
  12. 12.
    Ghert M (2015) The truths we seek and the randomised trial in orthopaedic surgery. Bone Joint Res 4:134–136CrossRefGoogle Scholar
  13. 13.
    Griffin DR et al (2018) Hip arthroscopy versus best conservative care for the treatment of femoroacetabular impingement syndrome (UK FASHIoN): a multicentre randomised controlled trial. Lancet (London, England) 391:2225–2235.  https://doi.org/10.1016/s0140-6736(18)31202-9 CrossRefGoogle Scholar
  14. 14.
    Jefferson L, Brealey S, Handoll H, Keding A, Kottam L, Sbizzera I, Rangan A (2017) Impact of the PROFHER trial findings on surgeons’ clinical practice: an online questionnaire survey. Bone Joint Res 6:590–599.  https://doi.org/10.1302/2046-3758.610.bjr-2017-0170 CrossRefGoogle Scholar
  15. 15.
    Katz JN, Wright JG, Losina E (2011) Clinical trials in orthopaedics research. Part II. Prioritization for randomized controlled clinical trials. J Bone Joint Surg Am 93:e30.  https://doi.org/10.2106/jbjs.j.01039 CrossRefGoogle Scholar
  16. 16.
    Laupacis A et al (1993) The effect of elective total hip replacement on health-related quality of life. J Bone Joint Surg Am 75:1619–1626CrossRefGoogle Scholar
  17. 17.
    Lefebvre C, Manheimer E, Glanville J (2011) Chapter 6: Searching for studies. In: Higgins JPT, Green S (eds) Cochrane Handbook for Systematic Reviews of Interventions. www.cochrane-handbook.org. The Cochrane Collaboration
  18. 18.
    Losina E, Wright J, Katz JN (2012) Clinical trials in orthopaedics research. Part III. Overcoming operational challenges in the design and conduct of randomized clinical trials in orthopaedic surgery. J Bone Joint Surg Am 94:35.  https://doi.org/10.2106/jbjs.k.00009 CrossRefGoogle Scholar
  19. 19.
    McCulloch P, Taylor I, Sasako M, Lovett B, Griffin D (2002) Randomised trials in surgery: problems and possible solutions. BMJ (Clin Res Ed) 324:1448–1451CrossRefGoogle Scholar
  20. 20.
    Moher D, Liberati A, Tetzlaff J, Altman DG (2009) Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med 6:e1000097.  https://doi.org/10.1371/journal.pmed.1000097 CrossRefGoogle Scholar
  21. 21.
    Prescott RJ et al (1999) Factors that limit the quality, number and progress of randomised controlled trials. Health Technol Assess (Winchester, England) 3:1–143Google Scholar
  22. 22.
    Rangan A et al (2015) Surgical vs nonsurgical treatment of adults with displaced fractures of the proximal humerus: the PROFHER randomized clinical trial. JAMA 313:1037–1047.  https://doi.org/10.1001/jama.2015.1629 CrossRefGoogle Scholar
  23. 23.
    Soucacos PN, Johnson EO, Babis G (2008) Randomised controlled trials in orthopaedic surgery and traumatology: overview of parameters and pitfalls. Injury 39:636–642.  https://doi.org/10.1016/j.injury.2008.02.011 CrossRefGoogle Scholar
  24. 24.
    Sung J, Siegel J, Tornetta P, Bhandari M (2008) The orthopaedic trauma literature: an evaluation of statistically significant findings in orthopaedic trauma randomized trials. BMC Musculoskelet Disord 9:14.  https://doi.org/10.1186/1471-2474-9-14 CrossRefGoogle Scholar
  25. 25.
    Vavken P (2011) Rationale for and methods of superiority, noninferiority, or equivalence designs in orthopaedic, controlled trials. Clin Orthop Relat Res 469:2645–2653.  https://doi.org/10.1007/s11999-011-1773-6 CrossRefGoogle Scholar
  26. 26.
    Wolf BR, Buckwalter JA (2006) Randomized surgical trials and “sham” surgery: relevance to modern orthopaedics and minimally invasive surgery. Iowa Orthop J 26:107–111Google Scholar
  27. 27.
    Wright JG, Katz JN, Losina E (2011) Clinical trials in orthopaedics research. Part I. Cultural and practical barriers to randomized trials in orthopaedics. J Bone Joint Surg Am 93:e15.  https://doi.org/10.2106/jbjs.j.00229 CrossRefGoogle Scholar

Copyright information

© Springer-Verlag France SAS, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Department of Trauma and Orthopaedics, Wrightington HospitalWrightington, Wigan and Leigh NHS Foundation TrustLancashireUK
  2. 2.Department of Orthopaedic SurgeryGold Coast University HospitalSouthportAustralia

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