How to Best Treat Anterior Cruciate Ligament Injuries

The project is a pragmatic registry-based RCT aiming to investigate ACL injury treatment. Study results will help fill knowledge gaps, facilitate shared decision making and strengthen patient treatment. Included patients will be randomized to (1) early ACL surgery followed by rehabilitation or (2) active rehabilitation with optional delayed surgery if indicated. Randomization and data collection is conducted through the Norwegian National Knee Ligament Registry (NNKLR) which is a well established population based ACL registry. Participation is based on informed consent to participate in the NNKLR and the registry-based RCT. The study uses the platform and outcome measures of the NNKLR to collect and measure data. The data will be stored as usual in the NNKLR, but RCT specific data will be exported for analysis and stored inTjenester for sensitive data (TSD). Data collected in NNKLR are: patient data (age, height, weight, activity level, smoking-and snuff habits), knee injury data (injury data, injury mechanism, additional knee injury), treatment (non-operative or ACL reconstruction, reoperation), surgical details (operation date, antibiotics, anti-coagulants, graft type and size, approach for femoral tunnel, additional injury and additional surgical procedure) and patient reported knee function at baseline, 2, 5 and 10 years. Also, x-rays and MRIs will be imported for included patients and stored in TSD.

NCT Number	NCT04770233
Lead Sponsor	University Hospital, Akershus Collaborators: Norwegian National Knee Ligament Registry, Sorlandet Hospital HF, Kristiansund Hospital, Asker & Baerum Hospital
Conditions	Anterior Cruciate Ligament Injuries
Enrollment	328 participants
Start Date	2021-04-29
Primary Completion	2026-10 (estimated)
Study Completion	2045-12 (estimated)
Updated on ClinicalTrials.gov	2025-01-28