RecruitingNot ApplicableNCT04770233

How to Best Treat Anterior Cruciate Ligament Injuries

Improving the Treatment of Anterior Cruciate Ligament Tears in Norway With Register-RCTs - Who Should Have Surgery


Sponsor

University Hospital, Akershus

Enrollment

328 participants

Start Date

Apr 29, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 16 YearsMax Age: 50 Years

Inclusion Criteria4

  • 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

Exclusion Criteria1

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

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Interventions

PROCEDUREEarly ACL reconstruction

ACL reconstruction followed by rehabilitation

PROCEDUREActive rehabilitation

Non-operative treatment with active rehabilitation led by a physiotherapist with optional delayed surgery if indicated.


Locations(2)

Orthopedic Department, Akershus University Hospital

Lørenskog, Akershus, Norway

Orthopedic division, Oslo University Hospital

Oslo, Norway

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NCT04770233


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