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How to Best Treat Anterior Cruciate Ligament Injuries

NCT04770233 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 328

Last updated 2025-01-28

No results posted yet for this study

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.

Conditions

  • Anterior Cruciate Ligament Injuries

Interventions

PROCEDURE

Early ACL reconstruction

ACL reconstruction followed by rehabilitation

PROCEDURE

Active rehabilitation

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

Sponsors & Collaborators

  • Norwegian National Knee Ligament Registry

    collaborator UNKNOWN

  • Sorlandet Hospital HF

    collaborator OTHER_GOV

  • Kristiansund Hospital

    collaborator OTHER

  • Asker & Baerum Hospital

    collaborator OTHER

  • University Hospital, Akershus

    lead OTHER

Principal Investigators

  • Rune Jakobsen, PhD/MD · Akershus University Hospital, University of Oslo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-29
Primary Completion
2026-10-31
Completion
2045-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04770233 on ClinicalTrials.gov