SECTION III REGULAR AND SPECIAL FEATURES Informed Consent Is Not Routinely Documented for Procedures Using Allografts Scott E. Porter, MD; Douglass Stull, MD; Jeffrey S. Kneisl, MD; and Steven L. Frick, MD Patients who receive musculoskeletal allografts may have se- vere postoperative infections develop. Media reports have heightened public awareness of the risk of allograft use. Ex- plaining these risks to patients preoperatively has become more important as attention to informed consent issues has increased. This study retrospectively investigated the pat- terns of informed consent for allograft bone used during elective orthopaedic procedures at a major teaching hospital. Forty-seven (32%) of 148 patients had preoperative discus- sions of allograft risks and benefits documented with a signed preoperative consent. In nearly 70% of the cases in which structural allograft was used, preoperative consent was documented. Only 8% of cases in which nonstructural, highly processed allograft was used had documented preop- erative consent. Forty-eight (32%) of 148 patients were treated with allograft and autograft. Consent was obtained for the harvesting and use of autograft from 90% of these patients. In none of these patients was consent obtained for the allograft used. Although risks of disease transmission vary widely with the degree of allograft processing and the source of its procurement, informed consent for any allograft use should be a routine part of preoperative discussions of risks and benefits in elective orthopaedic surgeries. The majority of allograft tissues are processed heavily before distribution and implantation. Despite this, recipi- ents of musculoskeletal allografts have had severe and often fatal postoperative infections develop. 3,9,13 These complications have resulted in increased moral and med- icolegal scrutiny of allograft tissue transplants by the lay population. Tissue donors are subjected to rigorous testing to ensure patient and product safety, and to minimize in- fection risks after transplant. 4,15 Bacterial and viral infec- tions continue to be potential complications associated with allograft bone use. Although the risks of infection associated with allografts should be communicated preop- eratively and documented by informed consent, nearly 1 /4 of orthopaedic surgeons polled during a recent national meeting failed to complete this step. 19 We hypothesized that orthopaedic surgeons in an aca- demic hospital would discuss the risks, benefits, and al- ternatives to allograft use and thoroughly document patient consent before elective surgeries in which allograft bone may be used. This study retrospectively investigated the patterns of informed consent for allograft bone used during elective orthopaedic procedures at a major teaching hos- pital. MATERIALS AND METHODS The study design was a retrospective chart review of operative procedures done at a major teaching hospital between July 1, 2001 and December 31, 2001. The cases were limited to those Received: September 29, 2003 Revised: December 19, 2003 Accepted: February 4, 2004 From the Department of Orthopaedic Surgery, Carolinas Medical Center, Charlotte, NC. Each author certifies that he has no commercial associations that might pose a conflict of interest in connection with the submitted article. Each author certifies that his institution has approved the reporting of this case report, and that all investigations were conducted in conformity with ethical principles of research. Correspondence to: Steven L. Frick, MD, Department of Orthopaedic Sur- gery, Carolinas Medical Center, MEB Suite 503, PO Box 32861, Charlotte, NC 28232. Phone: 704-355-4257; Fax: 704-355-6041; E-mail: steven. frick@carolinashealthcare.org. DOI: 10.1097/01.blo.0000130201.44637.aa CLINICAL ORTHOPAEDICS AND RELATED RESEARCH Number 423, pp. 287–290 © 2004 Lippincott Williams & Wilkins 287