Comparison of immediate versus optional delayed surgical repair for treatment of acute anterior cruciate ligament injury through a parallel, multicentric, pragmatic randomized controlled trial – IODA trial

Table 2 Overview trial procedures

Procedures/ Assessment	Screening	Randomisation + baseline assessment	Intervention	Follow-Up Visits
Visits	V1	V2		V3	V4	V5	V6	V7
Timing (months)	< 8 weeks after injury	Baseline < 8 weeks after injury		4 months post-injury ± 14 days	7 months post-injury ± 14 days	12 months post-injury ± 14 days	24 months post-injury ± 14 days	36 months post-injury ± 14 days
Enrolment
Eligibility screen	X
Informed consent	X
Randomisation		X
Intervention
1. Rehabilitation + optional delayed surgery			(X)¹	(X)¹	(X)¹	(X)¹	(X)¹	(X)¹
2. Immediate ACL reconstruction			X²
Assessments
MRI	(retrieved from patient record)			X				X
PROMS^#		X		X	X	X	X	X
Adverse events				X	X	X	X	X
Isokinetic strength				X	X	X	X	X
Single leg hop for distance					X	X	X	X

Table 2: Trial procedures for a single patient
^{# l}the following patient reported outcome measures (PROMS) will be assessed at V2-V7: KOOS, return-to-sport, return-to-work, IPQ-R, TSK, EARS and quality of rehabilitation;¹Optional delayed surgery can occur after randomization; ²Immediate ACL reconstruction has to be performed within 12 weeks after injury

ISSN: 2052-1847