Evidence first, practice second in arthroscopic surgery: use of placebo surgery in randomised controlled trial.

The application of evidence-based medicine helps clinicians avoid unnecessary procedures and decreases unnecessary harm for future patients while sparing economic burdens. Randomised controlled trials (RCTs) most accurately produce best research evidence. In arthroscopic surgery, however, many procedures have been extensively used without supportive evidence verified with RCTs. In this paper, we introduce two procedures (arthroscopic partial menisectomy for degenerative knees and arthroscopic subacromial decompression for subacromial pain syndrome), where over 30 years of procedure usage has continued prior to garnering evidence for the inefficacy of the procedures. The situations are attributed to the fact that clinical trials in arthroscopic surgeries are challenging given the use of placebo controls. A placebo-control RCT can accurately answer research questions about efficacy and safety of surgical procedures; however, the majority of arthroscopic surgeries in practice have not been rigorously tested against placebo surgeries. This is because preparing surgical placebo controls, known as sham surgeries, are ethically controversial. Also considering that high-quality study results often do not change clinical practice due to insufficient knowledge translation, the benefits of such trials may be uncertain to society at large. Additionally, there are a lack of clear guidelines for conducting arthroscopic placebo surgeries in RCTs. We hope that this article helps drive discussion about appropriate use of placebo surgeries in RCTs to produce the best quality evidence in arthroscopic surgery.

Evaluation of the informed consent procedure for total knee arthroplasty patients in Turkey.

OBJECTIVE: The purpose of this research is to evaluate the ethical aspects of informed consent process of total knee arthroplasty (TKA) patients in Turkey. METHODS: The study included 50 patients undergoing TKA in Gazi Mustafa Kemal State Hospital Orthopedics Clinic. A face to face survey was conducted to determine the ethical appropriateness of the main components of informed consent process such as; disclosure of material information about the disease and alternative treatment options, understanding the disclosed information, comprehending the written consent form and voluntariness in deciding. RESULTS: The survey revealed that all TKA patients signed informed consent form, 80% of the participants received material information about their disease, 62% were disclosed information about TKA operation, 56% read (in personal or with the assistance of a relative) the written informed consent form, 28% received information regarding possible complications of TKA and 85% were not given any information about the alternative treatments. CONCLUSIONS: Informed consent process in TKA patients have flourished compared to previous years, but still there are some aspects in need of improvement. Using short and understandable language, developing multi-media sources and involving patients to informed consent form development process would contribute to the process.

Assessing the adequacy of procedure-specific consent forms in orthopaedic surgery against current methods of operative consent.

INTRODUCTION: This is an audit of patient understanding following their consent for orthopaedic procedures and uses information on new Orthoconsent forms endorsed by the British Orthopaedic Association as the set standard. The objectives were to: (i) assess whether patients' understanding of knee arthroscopy (KA) and total knee replacement (TKR) at the point of confirming their consent reaches the set standard; and (ii) to ascertain whether issuing procedure-specific Orthoconsent forms to patients can improve this understanding. SUBJECTS AND METHODS: This was a prospective audit using questionnaires consisting of 26 (for KA) or 35 (for TKR) questions based on the appropriate Orthoconsent form in a department of orthopaedic surgery within a UK hospital. Participants were 100 patients undergoing KA and 60 patients undergoing TKR between February and July 2008. Participants were identified from sequential operating lists and all had capacity to give consent. During the first audit cycle, consent was discussed with the patient and documented on standard yellow NHS Trust approved generic consent forms. During the second audit cycle, patients were additionally supplied with the appropriate procedure-specific consent form downloaded from which they were required to read at home and sign on the morning of surgery. RESULTS: Knee arthroscopy patients consented with only the standard yellow forms scored an average of 56.7%, rising to 80.5% with use of Orthoconsent forms. Similarly, total knee replacement patients' averages rose from 57.6% to 81.6%. CONCLUSIONS: Providing patients with an Orthoconsent form significantly improves knowledge of their planned procedure as well as constituting a more robust means of information provision and consent documentation.

Minimally invasive navigated knee surgery: a European perspective.

European surgeons and North American surgeons have different approaches to minimally invasive total knee arthroplasty (TKA). Computer-assisted navigation emphasizes these differences. In this article, the author rethinks what surgeons are trying to achieve and notes that quality control is demanded by patients and surgeons. Although minimally invasive TKA is an accepted procedure, reflection on the facts suggests that the use of minimally invasive surgery and TKA navigation are intertwined and cannot be separated.

Minimally invasive navigated knee surgery: an American perspective.

Minimally invasive total knee replacement surgery may make it possible for patients to undergo the procedure with less pain and recover from the surgery more quickly than has been previously possible. However, minimally invasive techniques have the potential for being associated with a number of complications, including implant and limb malalignment. Computer-assisted technologies used in conjunction with minimally invasive techniques allow the accuracy with which the procedures are performed to be retained.