Grade I
Any deviation from the normal postoperative course without the need for additional medical therapy, physical therapy, or surgical interventions. Such complications require no treatment and have no significant clinical relevance
Examples:
• Nonsymptomatic persistent edema following digital surgery
• Nonpainful hypertrophic scar formation
• Nonsymptomatic limited motion following bunion surgery
Grade II
A deviation from the normal postoperative course requiring unplanned physical therapy, or pharmacologic therapy
Examples:
• Symptomatic limited motion following total ankle joint replacement requiring physical therapy
• Postoperative infection requiring antibiotic therapy
• Transfer metatarsalgia requiring orthotic or shoe therapy
Grade III
A deviation from the normal postoperative course requiring surgical intervention
Examples:
• Postoperative infection requiring incision and drainage
• Osteotomy malalignment requiring revision
• Revision of a symptomatic arthrodesis or osteotomy nonunion
• Symptomatic nerve entrapment requiring operative intervention
A. Not requiring general anesthesia
B. Requiring general anesthesia
Grade IV
A deviation from the normal postoperative course which is limb threatening
Examples:
• Necrotizing fascial infection requiring extensive incision and debridement
• Acute vascular compromise to the foot or leg
• Compartment syndrome requiring fasciotomies
Grade V
A deviation from the normal postoperative course which is threatening to quality of life
Examples:
• Postoperative complex regional pain syndrome
• Significant limb shortening following total ankle joint infection and revision
Grade VI
A deviation from the normal postoperative course which is potentially life-threatening
Examples:
• DVT ± pulmonary embolism
• Malignant hyperthermia
• Organ failure (e.g., renal failure, cardiac failure)
Complication and the Surgical Patient
A ubiquity of complications may occur in association with foot and ankle surgery. There are virtually no surgical procedures without the potential for complication. Ingrown toenail correction, for example, can be associated with persistent pain or swelling, chemical burns, contact allergy, primary irritant sensitivity, infection, regrowth of the nail, spiculization, or acosmetically displeasing result.
Not infrequently, complications may result in a request for medical records by the patient and result in an allegation of malpractice. It is imperative that all patients have a clear understanding of the potential for complications to occur even when the best care has been rendered.
In some cases, the evaluation and treatment of complications following surgery will result in significant unanticipated inconvenience to the patient and considerable increased cost associated with care, again, unanticipated by the patient. These factors are superimposed on what may be a less than optimal outcome than had been perceived by the patient.
It is important that the surgeon appropriately recognize complications and appropriately treat such complications. It is equally important that the surgeon communicate with the patient regarding the nature of the complication and potential impact of the complication and express to the patient an understanding of the effects of additional delay in healing and financial burdens.
An acknowledgment of the complication should be made by the surgeon to the patient/family. Studies have demonstrated that a patient is more likely to seek medical-legal action against a provider if that physician does not disclose the complication and effectively communicate this information to the patient [11]. It should always be recalled that in most instances, a complication does not imply negligent care. However, when a complication does occur, the question of negligence arises when such complications are not recognized in a timely manner and treated in an appropriate manner.
In the case of surgical error or complication, an acknowledgment of the patient’s emotions and increased physical as well as financial burden is helpful in maintaining the ability to assist the patient in resolving such complications.
In discussing the etiology of malpractice litigation, Nisselle discussed three major factors: poor patient rapport, unmet expectations, and a “big bill” [12]. Similarly, in a review of those factors leading patients to sue their doctors, insensitive handling of the incident, poor communication following the incident, and a less than satisfactory explanation are the most commonly cited factors [13]. Studies have demonstrated that a problematic doctor-patient relationship, a sense that the surgeon was abandoning the patient in the face of a complication, a devaluation of the patient and family views, a poor informational delivery, and a failure of the surgeon to understand the perspective of the patient and family are recognized as causes a patient with complications to seek litigation [14]. It is critical that faced with a complication, the surgeon communicate with and work closely with the patient.
Complications and Surgical Consent Forms
Because complications, failure to achieve the desired surgical outcome, or known common sequela may occur following any surgical procedure, the process of informed consent is required for surgical procedures.
The process of informed consent is more than obtaining a signature on a routine consent form. It is a process of communication between the patient and surgeon.
Informed consent should include a verbal or written explanation to the patient of the most common possible complications and sequela of surgical procedures. Generally, with reference to complications, surgeons rely on a standard consent form, frequently not unique or specific to the surgical procedure to be performed.
The American Medical Association has noted that forms which serve mainly to satisfy all legal requirements (e.g., “all material risks have been explained to me”) may not preclude a patient from asserting that the actual disclosure did not include risks that the patient unfortunately discovered after treatment. Consequently, such consent forms may not prove to be sufficient in a court of law.
In discussing the potential for complications, the severity of potential complications relative to each patient should be considered. For example, osteomyelitis as a complication of great toe implant arthroplasty may have significantly greater impact on a competition ballroom dancer than an individual who is sedentary. Another common example is the patient who is a runner, or otherwise very athletically active, in whom the complication of avascular necrosis following bunionectomy could be much more significant than in a less athletic individual. In discussing complications, reasonable information should be provided to any patient given their individual circumstances. With regard to complications, informed consent disclosure should be tailored to the patient’s individual situation thus requiring a combination of good judgment and communication skills.