Table III.

List of ‘expected’ adverse events for the ACTIVE Trial.

Wound complications (e.g. delayed healing)

Infection at the surgical site or adjacent joint

Pin site infection requiring procedure, antibiotics, or admission

Damage to a nerve or blood vessel

Breakage of orthopaedic hardware

Thromboembolic events

Secondary operations for or to prevent infection, malunion, nonunion, or for symptoms related to the metalwork

Wire breakage and removal / exchange of wire

Partial/complete frame removal

Chronic Regional Pain Syndrome

Amputation

Elective admissions to hospital for the ankle

Abnormal blood results related to an infection