Actively Recruiting

Phase Not Applicable
Age: 16Years - 50Years
All Genders
NCT04770233

How to Best Treat Anterior Cruciate Ligament Injuries

Led by University Hospital, Akershus · Updated on 2025-01-28

328

Participants Needed

2

Research Sites

1283 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Akershus

Lead Sponsor

N

Norwegian National Knee Ligament Registry

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

How to Best Treat Anterior Cruciate Ligament Injuries

Who Can Participate

Age: 16Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Orthopedic Department, Akershus University Hospital

Lørenskog, Akershus, Norway, 1478

Actively Recruiting

2

Orthopedic division, Oslo University Hospital

Oslo, Norway, 0850

Actively Recruiting

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Research Team

R

Rune Jakobsen, PhD/MD

CONTACT

G

Guri Ekås, PhD/MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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