NCT04770233 How to Best Treat Anterior Cruciate Ligament Injuries
| NCT ID | NCT04770233 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Akershus |
| Condition | Anterior Cruciate Ligament Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 328 participants |
| Start Date | 2021-04-29 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 328 participants in total. It began in 2021-04-29 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: • Elite athletes (Tegner 10) in pivoting sports and patients with additional knee injuries warranting repair
Contact & Investigator
Rune Jakobsen, PhD/MD
STUDY CHAIR
Akershus University Hospital, University of Oslo
Frequently Asked Questions
Who can join the NCT04770233 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 50 Years, studying Anterior Cruciate Ligament Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04770233 currently recruiting?
Yes, NCT04770233 is actively recruiting participants. Contact the research team at r.b.jakobsen@medisin.uio.no for enrollment information.
Where is the NCT04770233 trial being conducted?
This trial is being conducted at Lørenskog, Norway, Oslo, Norway.
Who is sponsoring the NCT04770233 clinical trial?
NCT04770233 is sponsored by University Hospital, Akershus. The principal investigator is Rune Jakobsen, PhD/MD at Akershus University Hospital, University of Oslo. The trial plans to enroll 328 participants.