Table 1.
Baseline/ enrolment |
Surgery | Follow-up post injury or surgery | |||||||
14 days | 3 weeks | 4 weeks | 6 weeks | 8 weeks | 12 weeks | 24 weeks | |||
Examination by an orthopaedic surgeon | ● | ● | ● | ● | |||||
Informed consent for research | ● | ||||||||
Medical history | ● | ||||||||
Medications | ● | ● | ● | ● | ● | ||||
Screening pregnancy test | ● | ||||||||
Surgery if necessary | ● | ||||||||
Study drug administration | ● | ● | ● | ||||||
Serum lithium test | ● | ||||||||
Renal blood test* (only if necessary) | ● | ||||||||
X-rays (only until fracture has healed) | ● | ● | ● | ● | ● | ||||
Surveys | ● | ● | ● | ● | ● | ● | |||
Assessment of adverse events† | ● | ● | ● | ● | |||||
Study visit with research assistant | ● | ● | ● |
*Renal blood test only required if 3-week serum lithium blood test measures ≥1.1 mmol/L.
†Adverse events occurring after the first dose of lithium and until the 6 week visit will be collected, reported and followed through to resolution, or until the event is assessed as chronic or stable.