Evidence-based informed consent form for total knee arthroplasty

Journal of Orthopaedic Surgery and Research, vol. 18, pp. 156

Abstract

INTRODUCTION: Informed consent documentation is often the first area of interest for lawyers and insurers when a medico-legal malpractice suit is concerned. However, there is a lack of uniformity and standard procedure about obtaining informed consent for total knee arthroplasty (TKA). We developed a solution for this need for a pre-designed, evidence-based informed consent form for patients undergoing TKA. MATERIALS AND METHODS: We extensively reviewed the literature on the medico-legal aspects of TKA, medico-legal aspects of informed consent, and medico-legal aspects of informed consent in TKA. We then conducted semi-structured interviews with orthopaedic surgeons and patients who had undergone TKA in the previous year. Based on all of the above, we developed an evidence-based informed consent form. The form was then reviewed by a legal expert, and the final version was used for 1 year in actual TKA patients operated at our institution. RESULTS: Legally sound, evidence-based Informed Consent Form for Total Knee Arthroplasty. CONCLUSION: The use of legally sound, evidence-based informed consent for total knee arthroplasty would be beneficial to orthopaedic surgeons and patients alike. It would uphold the rights of the patient, promote open discussion and transparency. In the event of a lawsuit, it would be a vital document in the defence of the surgeon and withstand the scrutiny of lawyers and the judiciary.

Authors 6

1. Satvik N Pai

   Sri Ramachandra Institute of Higher Education and Research

   Affiliation as printed

   Department of Orthopaedic Surgery, Sri Ramachandra Institute of Higher Education and Research, Chennai, Tamil Nadu, 600116, India

2. Madhan Jeyaraman

   Dr. M.G.R. Educational and Research Institute · Tamil Nadu Dr. M.G.R. Medical University

   Affiliation as printed

   Department of Orthopaedics, Faculty of Medicine - Sri Lalithambigai Medical College and Hospital, Dr MGR Educational and Research Institute, Chennai, Tamil Nadu, 600095, India

   South Texas Orthopedic Research Institute (STORI Inc.), Laredo, TX, 78045, USA

   Department of Orthopaedics, Faculty of Medicine – Sri Lalithambigai Medical College and Hospital, Dr MGR Educational and Research Institute, Chennai, Tamil Nadu, 600095, India

3. Nicola Maffulli

   University of Salerno · Queen Mary University of London · AOU San Giovanni di Dio e Ruggi d'Aragona · Keele University

   Affiliation as printed

   Centre for Sports and Exercise Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, E1 4DG, UK

   Department of Musculoskeletal Disorders, School of Medicine and Surgery, University of Salerno, 84084, Fisciano, Italy

   San Giovanni di Dio e Ruggi D'Aragona Hospital "Clinica Orthopedica" Department, Hospital of Salerno, 84124, Salerno, Italy

   School of Pharmacy and Bioengineering, Keele University School of Medicine, Stoke-On-Trent, ST5 5BG, UK

4. Naveen Jeyaraman
   Affiliation as printed

   Department of Orthopaedics, Atlas Hospitals, Tiruchirappalli, Tamil Nadu, 620002, India

5. Filippo Migliorini corresponding Aachen Department of Orthopaedic, Trauma, and Reconstructive Surgery

   Universitätsklinikum Aachen · RWTH Aachen University

   Affiliation as printed

   Department of Orthopaedic, Trauma, and Reconstructive Surgery, RWTH Aachen University Hospital, Pauwelsstraße 30, 52074, Aachen, Germany. migliorini.md@gmail.com

   Department of Orthopaedic, Trauma, and Reconstructive Surgery, RWTH Aachen University Hospital, Pauwelsstraße 30, 52074, Aachen, Germany

6. Ashim Gupta
   Affiliation as printed

   BioIntegrate, Lawrenceville, GA, 30043, USA

   Future Biologics, Lawrenceville, GA, 30043, USA

   South Texas Orthopedic Research Institute (STORI Inc.), Laredo, TX, 78045, USA