Informed consent documentation for total hip and knee replacement using generic forms with blank spaces.

PURPOSE To analyse informed consent documentation of 100 patients undergoing elective primary total hip replacement (THR) or total knee replacement (TKR) using generic forms with blank spaces. METHODS Informed consent documentation of 57 men and 43 women (mean age, 54 years) undergoing elective primary THR (n=50) or TKR (n=50) using generic forms with blank spaces were analysed. The consent forms were explained to the patients mostly on the morning of surgery by a consultant surgeon (n=21), specialist registrar (n=23), or senior house officer (n=56). Data on patient demographics, planned procedure, benefits and risks of surgery, and the grade of the surgeon were collected. RESULTS In the consent forms for THR, the most frequently documented complications included infection (98%), bleeding (96%), deep vein thrombosis (94%), nerve damage (94%), blood vessel damage (94%), and pain (90%). Common complications (2-5% of occurrence) that were less frequently documented included prosthesis wear or loosening (76%), dislocation (68%), and leg length discrepancy (62%). In the consent forms for TKR, the most frequently documented complications included infection (96%), bleeding (92%), deep vein thrombosis (90%), nerve damage (90%), and blood vessel damage (90%). Common risks (2-5% of occurrence) that were less frequently documented included pain (84%), prosthesis wear or loosening (54%), and knee stiffness (40%). CONCLUSION Documentation of all clinically significant complications was insufficient when generic informed consent forms with blank spaces were used. The use of standardised procedure-specific consent forms is recommended.