The feasibility of conducting a randomized controlled trial that compares immediate versus optional delayed surgical repair for treatment of acute Anterior cruciate ligament injury—results of the IODA pilot trial

Table 1 Overview trial procedures

Procedures/assessment	Screening	Randomization + baseline assessment	Intervention	Follow-up visits
Visits	V1	V2		V3	V4	V5
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
Enrolment
Eligibility screen	X
Informed consent	X
Randomization		X
Intervention
1. Rehabilitation + optional delayed surgery			(X)¹	(X)¹	(X)¹	(X)¹
2. Immediate ACL reconstruction			X²
Assessments*
MRI	(retrieved from patient record)			X
PROMS^#		X		X	X	X
Adverse events				X	X	X
Isokinetic strength				X	X	X
Single leg hop for distance					X	X

The following patient reported outcome measures (PROMS) will be assessed at V2–V5: 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: 2055-5784