Comparing immediate and delayed surgery for ACL injuries
Comparison of Immediate Versus Optional Delayed Surgical Repair for Treatment of Acute Anterior Cruciate Ligament Injury Through a Parallel, Multicentric, Pragmatic Randomized Controlled Trial
NA · Universitaire Ziekenhuizen KU Leuven · NCT05747079
This study tests whether having surgery right away or waiting to see if it's needed later is better for people with ACL injuries.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven (other) |
| Locations | 1 site (Leuven) |
| Trial ID | NCT05747079 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of immediate versus optional delayed surgical repair for patients with acute anterior cruciate ligament (ACL) injuries. It challenges the prevailing belief that immediate surgery is necessary for a safe return to sports and prevention of knee osteoarthritis. Participants will undergo either immediate ACL reconstruction or a conservative rehabilitation approach with delayed surgery if needed. The study aims to provide scientific evidence on the outcomes of both treatment strategies.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 16 and older who have sustained a rotational knee injury and have been diagnosed with ACL insufficiency within four weeks of the injury.
Not a fit: Patients with a history of previous ACL injuries or knee surgeries, or those requiring immediate surgery due to related injuries, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a more informed choice regarding their treatment options for ACL injuries, potentially reducing unnecessary surgeries.
How similar studies have performed: Previous studies, such as the KANON and COMPARE studies, have not shown significant advantages of immediate reconstruction over conservative treatment, indicating that this approach is still under investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Rotational trauma to a knee that had no previous serious injury and for which medical advice was sought within 4 weeks after the injury. * Medical diagnosis of ACL insufficiency including MRI (both partial and complete ruptures) * Minimum of 16 years Exclusion Criteria: * Participant has a history of a previous ACL injury or knee surgery to the index knee * Indication for acute surgery because of related injuries to the knee * Female who is pregnant or plans to become pregnant in the first 4 months of the trial. Since MRI assessment cannot be performed.
Where this trial is running
Leuven
- UZ Leuven — Leuven, Belgium (RECRUITING)
Study contacts
- Study coordinator: Annemie Smeets, phd
- Email: annemie.smeets@kuleuven.be
- Phone: +32 16 37 91 02
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: ACL Injury, ACL, RCT, Conservative treatment, ACL reconstruction