IODA: A pragmatic, randomized trial that compares Immediate

Summary (French or Dutch)

The IODA study is a randomised clinical trial comparing 2 treatment strategies after anterior cruciate ligament rupture:

1) Immediate surgery + rehabilitation

2) Rehabilitation + optional late surgery if there is persistent instability

After suffering an anterior cruciate ligament injury, most people in Belgium undergo surgery. It used to be thought that surgical repair of the anterior cruciate ligament is necessary to return to everyday (sports) activities and to prevent premature wear of cartilage and meniscus damage. However, this belief is based on insufficient scientific evidence. Surgery may not be necessary in everyone. This study will firstly compare both treatments. Second, it will examine which patients require early surgery and which patients are successful without surgery.

TRIAL DESCRIPTION

Title	A pragmatic, randomized trial that compares Immediate versus Optional Delayed surgical repair for treatment of acute anterior cruciate ligament injury
Participants (P)	Patients presenting to the clinic with an acute anterior cruciate ligament (ACL) injury
Intervention (I)	Rehabilitation and optional delayed ACL reconstruction.
Control (C)	Immediate ACL reconstruction and rehabilitation
Outcome (O)	1) Non-inferiority testing at 1 year follow-up for the primary outcome (difference in mean change between baseline to 1 year follow-up on the KOOS QOL between both groups) 2) Superiority testing at 7 months follow-up for the primary outcome (difference in mean change between baseline and 7 months follow-up on the KOOS QOL between both groups)
Trial Design	A parallel, multicentric, pragmatic, randomised controlled trial
Sample Size	280
Trial duration	60 months
Budget	€1.6 MIO