Investigating the best treatments for ACL injuries
Improving the Treatment of Anterior Cruciate Ligament Tears in Norway With Register-RCTs - Who Should Have Surgery
NA · University Hospital, Akershus · NCT04770233
This study is testing whether early surgery followed by rehab or just rehab with possible later surgery works better for people with ACL injuries.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 328 (estimated) |
| Ages | 16 Years to 50 Years |
| Sex | All |
| Sponsor | University Hospital, Akershus (other) |
| Locations | 2 sites (Lørenskog, Akershus and 1 other locations) |
| Trial ID | NCT04770233 on ClinicalTrials.gov |
What this trial studies
This project is a pragmatic registry-based randomized controlled trial (RCT) aimed at determining the most effective treatment for anterior cruciate ligament (ACL) injuries. Participants will be randomized into two groups: one receiving early ACL surgery followed by rehabilitation, and the other undergoing active rehabilitation with the option for delayed surgery if necessary. The study leverages the Norwegian National Knee Ligament Registry (NNKLR) for data collection, which includes a comprehensive database of ACL injuries and treatments. By utilizing this established registry, the study aims to provide valuable insights into treatment effectiveness for over 4,000 patients annually in Norway.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 16-50 who have sustained an acute ACL injury and can undergo both surgery and rehabilitation.
Not a fit: Patients who are elite athletes in pivoting sports or those with additional knee injuries requiring repair may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more informed treatment decisions for ACL injuries, potentially improving recovery outcomes for patients.
How similar studies have performed: Previous studies have shown promising results in comparing surgical and non-surgical treatments for ACL injuries, suggesting that this approach is both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lørenskog, Akershus and 1 other locations
- Orthopedic Department, Akershus University Hospital — Lørenskog, Akershus, Norway (RECRUITING)
- Orthopedic division, Oslo University Hospital — Oslo, Norway (RECRUITING)
Study contacts
- Study coordinator: Rune Jakobsen, PhD/MD
- Email: r.b.jakobsen@medisin.uio.no
- Phone: 92092973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anterior Cruciate Ligament Injuries, acl, anterior cruciate ligament injury, anterior cruciate ligament rupture, anterior cruciate ligament tear, secondary meniscal tear, ACL reconstruction, ACL rehabilitation