IODA: Eine pragmatische, randomisierte Studie zum Vergleich

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