Table 2

Data collection at each visit

Assessment parameters	Visit 1	Visit 2	Visit 3	Preoperative, intraoperative and postoperative visits*				Additional visits†
	Visit 1	Visit 2	Visit 3	Visit 4	Visit 5	Visit 6	Visit 7	Additional visits†
	Screening/preoperative	Treatment (day 0)	3–8 weeks	3 months (±2 weeks)	6 months (±4 weeks)	12 months (±4 weeks)	24 months (±8 weeks)	According to standard of care
Eligibility	X
Patient information/consent	X
Demographics and baseline information	X
Fracture and trauma details	X
Treatment details		X						X
Radiographic outcomes			X	X	X	X	X	X
Clinical/functional outcomes‡			X	X	X	X	X	X
Patient-reported outcomes‡			X	X	X	X	X	X
Adverse events		X	X	X	X	X	X	X

Informed consent must be obtained the latest on visit 3, if this was not obtained at visit 1 or visit 2.
*Timing of postoperative follow-ups is calculated from the day of treatment (day 0).
†Conducted as needed or according to the local standard.
‡Final clinical/functional outcomes should always be assessed at the final visit in the hospital.