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

Abstract

Abstract Background: Standard care for anterior cruciate ligament (ACL) injuries often includes surgical reconstruction of the ACL. However, two randomized controlled trials (1, 2) (RCT) concluded that conservative treatment does not result in inferior clinical outcomes compared to immediate ACL reconstruction. More research is needed to verify these results and assess whether patient-specific parameters determine if a patient would benefit from one treatment option over the other. Methods: This is a pragmatic, multi-center RCT with two parallel groups. Patients with an acute ACL injury will be recruited from Belgian hospitals. Patients will be randomized to conservative treatment (rehabilitation + optional delayed surgery) or immediate ACL reconstruction (<12 weeks). The primary outcome is the Knee injury and Osteoarthritis Outcome Score (KOOS) at 7 months (short term) and 1-year long term) post-injury. These following additional outcomes will be administered at 4 and 7 months (short term) and 1, 2, and 3 years post-injury (long term): patient-reported outcomes concerning knee symptoms, knee function and quality of life, functional knee tests, time to return to pre-injury activity level and return to work, structural knee joint damage and cartilage health (only at 4 months and 3 years post-injury), as well as adverse events such as re-rupture rates. Furthermore, the secondary objective is to identify (through a predictive analysis) individuals who would benefit the most from early reconstruction versus those who should rather be treated conservatively. Discussion: This large RCT will assess the clinical effectiveness of both surgical and conservative treatment. In addition, it will be the first study that provides insights into which patient-specific factors predict successful outcomes after conservative treatment of ACL injuries. These results will be the first step toward early patient identification regarding treatment decisions. This is urgently needed to avoid 1) delayed surgeries and prolonged rehabilitation and 2) unnecessary surgeries. Trial registration: this trial was registered on ClinicalTrials.gov (NCT05747079) on 10/02/2023.