Literature DB >> 16789458

Randomized surgical trials and "sham" surgery: relevance to modern orthopaedics and minimally invasive surgery.

Brian R Wolf1, Joseph A Buckwalter.   

Abstract

Surgical techniques are constantly changing and evolving, though research trials supporting the value of a specific surgical intervention are often limited by the lack of a legitimate control group. In surgical trials, the use of a placebo, or a "sham" surgery, is controversial. This article explores the debate regarding the use of sham surgeries and summarizes the few surgical studies that have used them. Arguments for and against their use in research are presented.

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Year:  2006        PMID: 16789458      PMCID: PMC1888585     

Source DB:  PubMed          Journal:  Iowa Orthop J        ISSN: 1541-5457


  22 in total

1.  The physician's role, "sham surgery," and trust: a conflict of duties?

Authors:  Chalmers C Clark
Journal:  Am J Bioeth       Date:  2003       Impact factor: 11.229

2.  Sham surgery and genuine standards of care: can the two be reconciled?

Authors:  Alex John London; Joseph B Kadane
Journal:  Am J Bioeth       Date:  2003       Impact factor: 11.229

3.  Sham surgery in research: a surgeon's view.

Authors:  Peter Angelos
Journal:  Am J Bioeth       Date:  2003       Impact factor: 11.229

4.  Sham surgery: an ethical analysis.

Authors:  Franklin G Miller
Journal:  Am J Bioeth       Date:  2003       Impact factor: 11.229

5.  Surgical research, an elusive entity.

Authors:  Angelique M Reitsma; Jonathan D Moreno
Journal:  Am J Bioeth       Date:  2003       Impact factor: 11.229

6.  Social aspects of sham surgeries.

Authors:  Hilary S Leeds
Journal:  Am J Bioeth       Date:  2003       Impact factor: 11.229

7.  Surgery as placebo. A quantitative study of bias.

Authors:  H K BEECHER
Journal:  JAMA       Date:  1961-07-01       Impact factor: 56.272

8.  Autologous chondrocyte implantation compared with microfracture in the knee. A randomized trial.

Authors:  Gunnar Knutsen; Lars Engebretsen; Tom C Ludvigsen; Jon Olav Drogset; Torbjørn Grøntvedt; Eirik Solheim; Torbjørn Strand; Sally Roberts; Vidar Isaksen; Oddmund Johansen
Journal:  J Bone Joint Surg Am       Date:  2004-03       Impact factor: 5.284

9.  A controlled trial of arthroscopic surgery for osteoarthritis of the knee.

Authors:  J Bruce Moseley; Kimberly O'Malley; Nancy J Petersen; Terri J Menke; Baruch A Brody; David H Kuykendall; John C Hollingsworth; Carol M Ashton; Nelda P Wray
Journal:  N Engl J Med       Date:  2002-07-11       Impact factor: 91.245

10.  Does placebo surgery-controlled research call for new provisions to protect human research participants?

Authors:  Dorothy E Vawter; Karen G Gervais; Thomas B Freeman
Journal:  Am J Bioeth       Date:  2003       Impact factor: 11.229

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  11 in total

1.  Randomised clinical trials in surgery: a look at the ethical and practical issues.

Authors:  Anjan Kumar Das
Journal:  Indian J Surg       Date:  2011-05-19       Impact factor: 0.656

Review 2.  Controversial role of arthroscopic meniscectomy of the knee: A review.

Authors:  Austin Y Ha; Robert M Shalvoy; Anne Voisinet; Jennifer Racine; Roy K Aaron
Journal:  World J Orthop       Date:  2016-05-18

3.  Effectiveness of blinding: sham suprapubic incisions in a randomized trial of retropubic midurethral sling in women undergoing vaginal prolapse surgery.

Authors:  Linda Brubaker; Charles W Nager; Holly E Richter; Alison C Weidner; Yvonne Hsu; Clifford Y Wai; Marie Paraiso; Tracy L Nolen; Dennis Wallace; Susan Meikle
Journal:  Am J Obstet Gynecol       Date:  2014-07-11       Impact factor: 8.661

4.  Developing a placebo-controlled trial in surgery: issues of design, acceptability and feasibility.

Authors:  M K Campbell; V A Entwistle; B H Cuthbertson; Z C Skea; A G Sutherland; A M McDonald; J D Norrie; R V Carlson; S Bridgman
Journal:  Trials       Date:  2011-02-21       Impact factor: 2.279

Review 5.  Design and execution of clinical trials in orthopaedic surgery.

Authors:  R Mundi; H Chaudhry; S Mundi; K Godin; M Bhandari
Journal:  Bone Joint Res       Date:  2014-05       Impact factor: 5.853

6.  Strengthening the ethical assessment of placebo-controlled surgical trials: three proposals.

Authors:  Wendy Rogers; Katrina Hutchison; Zoë C Skea; Marion K Campbell
Journal:  BMC Med Ethics       Date:  2014-10-23       Impact factor: 2.652

7.  Lay attitudes toward deception in medicine: Theoretical considerations and empirical evidence.

Authors:  Jonathan Pugh; Guy Kahane; Hannah Maslen; Julian Savulescu
Journal:  AJOB Empir Bioeth       Date:  2015-11-16

8.  Randomized trial of radiofrequency ablation versus conventional surgery for superficial venous insufficiency: if you don't tell, they won't know.

Authors:  Cynthia de Almeida Mendes; Alexandre de Arruda Martins; Juliana Maria Fukuda; José Ben-Hur Ferraz Parente; Marco Antonio Soares Munia; Alexandre Fioranelli; Marcelo Passos Teivelis; Andrea Yasbek Monteiro Varella; Roberto Augusto Caffaro; Sergio Kuzniec; Nelson Wolosker
Journal:  Clinics (Sao Paulo)       Date:  2016-11-01       Impact factor: 2.365

9.  Treatment Patterns, Complications, and Health Care Utilization Among Endometriosis Patients Undergoing a Laparoscopy or a Hysterectomy: A Retrospective Claims Analysis.

Authors:  Eric S Surrey; Ahmed M Soliman; Hongbo Yang; Ella Xiaoyan Du; Bowdoin Su
Journal:  Adv Ther       Date:  2017-10-16       Impact factor: 3.845

10.  How does surgery compare to sham surgery or physiotherapy as a treatment for tendinopathy? A systematic review of randomised trials.

Authors:  Dimitrios Challoumas; Christopher Clifford; Paul Kirwan; Neal L Millar
Journal:  BMJ Open Sport Exerc Med       Date:  2019-04-24
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