RESUMEN
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.
RESUMEN
INTRODUCTION: Standard care for anterior cruciate ligament (ACL) injuries includes surgical reconstruction of the ACL. However, two randomised controlled trials (RCTs) concluded that conservative treatment does not result in inferior clinical outcomes compared with immediate ACL reconstruction. More research is needed to in the first place verify these results, and second to assess whether patient-specific parameters determine whether a patient would benefit from one treatment option over the other. However, before running a full RCT, it seems necessary to perform a pilot study that assesses the feasibility of recruiting patients with ACL for such a RCT. This is because recruitment may be challenging as many patients have strong treatment beliefs. Therefore, this pilot study will assess whether a large RCT is feasible with regard to participant recruitment, adherence to the allocated treatment arm and protocol feasibility. These pilot findings will help deciding about progressing to a future full RCT. METHODS AND ANALYSIS: This is a pragmatic, multicentre, randomised controlled pilot trial with two parallel groups. Patients with an acute ACL injury will be recruited from two Belgian hospitals. Patients will be randomised to either conservative treatment or surgical treatment. Patients will be followed-up at 3, 6 and 12 months postrandomisation. Recruitment feasibility will be evaluated by calculating the recruitment rate 4 months after the two sites have been initiated. Clear criteria for progression to a full trial are defined. Adherence to the protocol will be assessed by calculating the proportion of patients who complete the assessments. Furthermore the proportion of patients who cross-over between treatment arms during the follow-up period will be assessed. ETHICS AND DISSEMINATION: The study was approved by the ethical committees: Ethische Commissie Onderzoek UZ/KU Leuven (S62004) and Comité d'Ethique Hospitalo-Facultaire Universitaire de Liège (2020212). Results will be made available to caregivers, researchers and funder. TRIAL REGISTRATION NUMBER: This trial is registered on ClinicalTrials.gov (NCT04408690) on 29 May 2020.