How to Best Treat Anterior Cruciate Ligament Injuries

Recruiting now · Not applicable

Conditions studied: Anterior Cruciate Ligament Injuries

In brief

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.

Key facts

Study ID

NCT04770233

Run by

University Hospital, Akershus

People needed

328

Starts

2021-04-29

Expected to finish

2045-12-01

Last updated by the study team

2025-01-28

Who can join

Age: 16 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who have sustained an acute ACL injury (must be possible to perform the "early surgery" treatment option within 12 weeks)
• Age 16-50 years and skeletally mature
• No previous surgery in the index knee or knee injury which influences rehabilitation
• Patient capable to undergo both surgery and rehabilitation

You may not qualify if…

• Elite athletes (Tegner 10) in pivoting sports and patients with additional knee injuries warranting repair

Where it is running

• Orthopedic Department, Akershus University Hospital — Lørenskog, Akershus, Norway (enrolling)
• Orthopedic division, Oslo University Hospital — Oslo, Norway (enrolling)

Full record on ClinicalTrials.gov

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