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

  • General Review • GENERAL ORTHOPAEDICS - RESEARCH
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European Journal of Orthopaedic Surgery & Traumatology Aims and scope Submit manuscript

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.

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References

  1. Altman DG et al (2001) The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 134:663–694

    Article  CAS  PubMed  Google Scholar 

  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

    Article  Google Scholar 

  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

    Article  Google Scholar 

  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

    Article  CAS  PubMed  Google Scholar 

  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

    Article  PubMed  PubMed Central  Google Scholar 

  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

    Article  PubMed  PubMed Central  Google Scholar 

  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

    Article  Google Scholar 

  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

    Article  CAS  PubMed  Google Scholar 

  9. EuroStat https://ec.europa.eu/eurostat/web/products-datasets/-/hlth_sha11_hc. 5th Jan 2018

  10. Evidence-Based-Medicine-Working-Group (1992) Evidence-based medicine: a new approach to teaching the practice of medicine. JAMA 268:2420–2425

    Article  Google Scholar 

  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

    Article  PubMed  PubMed Central  Google Scholar 

  12. Ghert M (2015) The truths we seek and the randomised trial in orthopaedic surgery. Bone Joint Res 4:134–136

    Article  PubMed Central  Google Scholar 

  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

    Article  Google Scholar 

  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

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  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

    Article  PubMed  PubMed Central  Google Scholar 

  16. Laupacis A et al (1993) The effect of elective total hip replacement on health-related quality of life. J Bone Joint Surg Am 75:1619–1626

    Article  CAS  PubMed  Google Scholar 

  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. 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

    Article  Google Scholar 

  19. McCulloch P, Taylor I, Sasako M, Lovett B, Griffin D (2002) Randomised trials in surgery: problems and possible solutions. BMJ (Clin Res Ed) 324:1448–1451

    Article  Google Scholar 

  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

    Article  PubMed  PubMed Central  Google Scholar 

  21. Prescott RJ et al (1999) Factors that limit the quality, number and progress of randomised controlled trials. Health Technol Assess (Winchester, England) 3:1–143

    CAS  Google Scholar 

  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

    Article  CAS  PubMed  Google Scholar 

  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

    Article  PubMed  Google Scholar 

  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

    Article  PubMed  PubMed Central  Google Scholar 

  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

    Article  PubMed  PubMed Central  Google Scholar 

  26. Wolf BR, Buckwalter JA (2006) Randomized surgical trials and “sham” surgery: relevance to modern orthopaedics and minimally invasive surgery. Iowa Orthop J 26:107–111

    PubMed  PubMed Central  Google Scholar 

  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

    Article  PubMed  PubMed Central  Google Scholar 

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Authors and Affiliations

  1. Department of Trauma and Orthopaedics, Wrightington Hospital, Wrightington, Wigan and Leigh NHS Foundation Trust, Lancashire, UK

    Hosam E. Matar

  2. Department of Orthopaedic Surgery, Gold Coast University Hospital, Hospital Blvd, Southport, Australia

    Simon R. Platt

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Correspondence to Hosam E. Matar.

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Appendix 1: References for RCTs with significant findings

Appendix 1: References for RCTs with significant findings

Anterior cervical discectomy and fusion (26 trials/45 publications)

Farrokhi 2017, Rožanković 2017, Xia 2017, Lee 2016, Loumeau 2016, Hou 2016, Engquist 2015, Mariappan 2015, Luo 2015, Vaccaro 2013, Chen 2013, Abbott 2013, Auerbach 2011, Cheng 2011, Coric 2011, Garrido 2010, Riina 2008, Wang 2008, Nabhan 2007, Zoega 2000. RCTs with multiple related publications: (Lanman 2017, Gornet 2017), (Sasso 2017, Sasso 2007, Sasso 2011, Heller 2009, Anderson 2008), (Park 2011, Phillips 2015, Phillips 2013), (Hisey 2016, Radcliff 2016, Ament 2016, Jackson 2016, Hisey 2015, Davis 2015, Hisey 2014, Ament 2014, Davis 2013, Radcliff 2016), (Delamarter 2013, Zigler 2013, Murrey 2009), (Mummaneni 2007, Burkus 2014).

Subacromial decompression

Jacquot 2014, Rahme 1998.

Carpal tunnel decompression

De Kleermaeker 2017, Gutiérrez-Monclus 2017, Orak 2016, Tarallo 2014, Chandra 2013, Sørensen 2013, Drosos 2013, Cresswell 2008, Gentili 2003, Padua 2003, Jugovac 2002.

Total hip replacement

Bargar 2017, Atrey 2017, Schouten 2017, Dahlstrand 2017, Scemama 2017, Broomfield 2017, Verdier 2016, Langlois 2015, Gofton 2015, Mjaaland 2015, Briggs 2015, Glyn-Jones 2015, Gerhardt 2015, Meermans 2014, Gustafson 2014, Dienstknecht 2014, Small 2014, Lass 2014, Engh 2014, Tiusanen 2013, Lorenzen 2013, Vendittoli 2013, Penny 2013, Engh 2012, Howie 2012, Stocks 2011, Corten 2011, Thomas 2011, Corten 2011, Mutimer 2010, Smolders, 2010, Stilling 2009, Calvert 2009, Glyn-Jones 2008, Geerdink 2006, Grübl 2006, Luites 2006, Schauss 2006, Faris 2006, Wembridge 2006, von Schewelov 2005, Kalteis 2005, Kim 2005, Flivik 2005, Brodner 2003, Martell 2003, Freund 2003, Visser 2002, Tanzer 2001, Koessler 2001, Bose 2000, Berger 1997.

Anterior cruciate ligament reconstruction

Khare 2017, Mutsuzaki 2017, Venosa 2017, Reda 2016, Bottoni 2014, Kim 2013, Takeda 2013, Mirzatolooei 2012, Sørensen 2011, Zaffagnini 2011, Vogrin 2010, Ferretti 2008, Siebold 2008, Jepsen 2007, Zhao 2007, Zaffagnini 2006, Drogset 2006, Krywulak 2005, Yasuda 1997, Cameron 1995, Dahlstedt 1990.

Total knee replacement

De Vloo 2017, Zhang 2017, Wang 2017, Vide 2017, Li 2017, Todesca 2017, Calliess 2017, Kim 2017, Jawhar 2016, Ahn 2016, Morrison 2016, Bell 2016, Camp 2015, Chen 2015, Alomran 2015, Fransen 2015, Hutt 2015, Dossett 2014, Nam 2014, Pornrattanama-neewong 2013, Altay 2012, Meijerink 2011, Blakeney 2011, van Jonbergen 2011, Zhang 2011, Varela-Egocheaga 2010, Higuchi 2009, Dutton 2008, Confalonieri 2007, Mullaji 2007, Chin 2007, Weeden 2007, Matziolis 2007, Kalairajah 2006, Cobb 2006, Ishii 2005, Bäthis 2005, Carlsson 2005, Decking 2005, Chauhan 2004, Sparmann 2003, Waters 2003, Price 2003, Reed 2002, Chiu 2002, Wood 2002, Stukenborg-Colsman 2001, Chiu 2001, Roysam 2001, Waikakul 2000, Levy 1999, Jorn 1999, Nilsson 1998, Newman 1998, Abdel-Salam 1995.

Hallux valgus correction

Irha 2016, Buciuto 2014, Torkki 2001, Calder 1999, Klosok 1993.

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Matar, H.E., Platt, S.R. Overview of randomised controlled trials in orthopaedic research: search for significant findings. Eur J Orthop Surg Traumatol 29, 1163–1168 (2019). https://doi.org/10.1007/s00590-019-02436-0

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