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

Area of Science:

• Orthopedic Surgery
• Patient Safety
• Informed Consent Law

Background:

• Informed consent is crucial for patient autonomy and safety in surgical procedures.
• Generic consent forms may not adequately convey the specific risks associated with complex orthopedic surgeries like total hip and knee replacements.

Purpose of the Study:

• To analyze the completeness of informed consent documentation for patients undergoing elective primary total hip replacement (THR) or total knee replacement (TKR).
• To evaluate the effectiveness of generic consent forms with blank spaces in documenting surgical complications.

Main Methods:

• Analysis of informed consent documentation from 100 patients (57 male, 43 female; mean age 54) undergoing elective primary THR (n=50) or TKR (n=50).
• Data collected included patient demographics, planned procedure, benefits, risks, and surgeon's grade.
• Consent forms were explained by surgical staff, primarily on the morning of surgery.

Main Results:

• For THR, frequently documented complications included infection (98%), bleeding (96%), and deep vein thrombosis (94%). Less documented risks were prosthesis wear (76%) and dislocation (68%).
• For TKR, infection (96%), bleeding (92%), and deep vein thrombosis (90%) were most common. Less documented risks included prosthesis wear (54%) and knee stiffness (40%).
• Overall documentation of clinically significant complications was insufficient across both procedures using generic forms.

Conclusions:

• Generic informed consent forms with blank spaces are insufficient for documenting all significant complications associated with total hip and knee replacements.
• Standardized, procedure-specific consent forms are recommended to ensure comprehensive patient information and improve informed consent processes.