Post Market Study of Cerament V/G in Pedal Osteomyelitis

Freedom from clinical or radiological osteomyelitis in the same or adjacent bone (recorded as yes or no)

Clinical osteomyelitis: positive bone biopsy in the setting of bone necrosis or purulent fluid containing pathogenic organisms emanating from exposed bone end. Radiological osteomyelitis: osteolysis or periosteal reaction on radiograph in affected or adjacent bone(s). This is checked at each follow up visit, at 1, 6 and 12 months post-implantation.

Surgical site infection requiring further course of antibiotics (recorded as yes or no)

If there is infection at the surgical site, requiring a further course of antibiotics, this will be recorded.

Major or minor amputation of study limb (recorded as yes or no with amputation details)

If major or minor amputation of study limb occurs, this will be recorded.

Serious adverse events related to Cerament V/G (number and type of event are recorded)

A serious adverse event (SAE) refers to any expected or unexpected adverse event, related to ceramist, that results in any of the following outcomes: death, a life-threatening adverse event, requires inpatient hospitalisation (not required as part of the treatment) or prolongation of existing hospitalisation, a persistent or significant disability or incapacity, or cancer, or a congenital anomaly or birth defect.

Total treatment costs for osteomyelitis (total cost is calculated in GB pounds)

Treatment costs will be collected through the use of a Client Service Research Inventory focussed on surgical, community and further treatment costs over a 12 month follow up. These will be recorded by the patient as they occur and checked at each visit and cross reference with hospital medical records.