Table 1.

Inclusion and exclusion criteria with reason

Criteria	Reason
Inclusion criteria
Age at least 18 years	Legal self-consent
Current unilateral, bilateral or mixed transtibial amputees with significant dissatisfaction regarding prosthesis fit or pain, mobility, or skin breakdown	Objective, identifiable deficit in current patient lifestyle
Patients with a full lower limb but with pain, deformity or weakness distal to the mid-tibia who desired amputation for pain management or improved mobility following removal of the deformed or weak joint and muscles	Objective, identifiable quality of life impairment that can be objectively improved by amputation, and patients likely would experience better rehabilitation with osseointegration than standard socket prosthesis
Patients with amputations who wished to try osseointegration instead of a traditional socket prosthesis	Honouring patient choice after an ethical, shared and sound decision making process
Patient with sufficient resources and willingness to pursue surgery, postoperative rehabilitation and prosthesis procurement	Rehabilitation and prosthesis fitting are all required for appropriate, safe improvement following osseointegration surgery
Exclusion criteria
Active infection any location	Unacceptably high and modifiable infection risk
Active malignancy or ongoing/planned treatment for malignancy at any location	High risk for infection, impaired biology for osseointegration, impaired patient stamina for rehabilitation
Skeletal immaturity	Unknown risk given the current knowledge of osseointegration outcomes and biological impact
Patients with psychiatric concern identified during preoperative consultation with psychiatrist	Minimise risk of performing surgery for a patient whose expressed deficits are psychiatric-based instead of musculoskeletal-based, and thus unlikely to improve with surgery
Patients considered too medically ill, too muscularly weak or insufficiently dedicated to improve following osseointegration	Avoid harming patients with surgery that may be either unlikely to benefit them or possibly pose a health risk
Insufficient remaining tibia length to accept an implant	Avoid performing surgery for a patient who would be unlikely to achieve successful bone ingrowth to the implant
Uncontrolled diabetes mellitus	Avoid unnecessary, modifiable risk for infection
Women currently or intending to become pregnant within the year following surgery	Unnecessary risk to foetus due to potential for falls or other unforeseen adverse events