Clinical trial Recruiting at 1 site Interventional Ages 16 and up

Comparing immediate and delayed surgery for ACL injuries

Official title: Comparison of Immediate Versus Optional Delayed Surgical Repair for Treatment of Acute Anterior Cruciate Ligament Injury Through a Parallel, Multicentric, Pragmatic Randomized Controlled Trial

Run by Universitaire Ziekenhuizen KU Leuven · NCT05747079 · Data updated 2026-11-12

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

Study typeInterventional
Ages16 Years and up
SexAll
Enrollment280 (estimated)
SponsorUniversitaire Ziekenhuizen KU Leuven
Academic / other
Locations1 site (Leuven)
StatusRecruiting
StartedMarch 2, 2023
Main results expectedMarch 2, 2026
Study endsMarch 2, 2028
Registry record updatedJune 28, 2024
Trial IDNCT05747079 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • UZ Leuven
    Leuven, Belgium
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.