TABLE II.

Time Points and Type of Assessment

	Visit 1 (Day −7 to 0): Screening	Visit 2 (Day 0): Day of Surgery	Visit 3 (Day 1 [± 1 day])	Visit 4 (Day 7 [± 3 days])	Visit 5 (Week 6 [± 1 week)	Visit 6 (Week 12 [± 2 weeks])	Visit 7 (Week 26 [± 3 weeks])
First patient enrolled April 24, 2013
Informed consent, demography, medical history, physical examination, radiographic assessment, randomization	X
Surgery (autologous iliac bone graft or CBVF) and procedure information		X
Adverse events	X	X	X	X	X	X	X
Device symptoms reported		X	X	X	X	X	X
Clinical examination		X	X	X	X	X	X
SF-12	X			X	X	X	X
Pain (VAS)	X		X	X	X	X	X
Assessment of other outcome measures				X	X	X	X
End of the trial							X
Last patient enrolled November 27, 2017
Last follow-up completed June 8, 2018