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 type | Interventional |
|---|---|
| Ages | 16 Years and up |
| Sex | All |
| Enrollment | 280 (estimated) |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Status | Recruiting |
| Started | March 2, 2023 |
| Main results expected | March 2, 2026 |
| Study ends | March 2, 2028 |
| Registry record updated | June 28, 2024 |
| Trial ID | NCT05747079 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
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UZ Leuven
Leuven, Belgium Recruiting
Study contacts
- Study coordinator: Annemie Smeets, phd
- Email: annemie.smeets@kuleuven.be
- Phone: +32 16 37 91 02
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Motor imagery–enhanced rehab after ACL reconstruction
This study tests whether mentally practicing movement can improve knee function and brain activity after ACL reconstruction, in comparison with standard rehab.
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Functional Movement Training vs Functional Stability Training after ACL Surgery
This randomized trial tests whether a functional movement program or a stability-focused program helps 18-35 year old athletes recover after ACL surgery.
-
Intraoperative Energy Use During ACL Surgery
This study tests how much workload a surgeon experiences during ACL reconstruction procedures while wearing a Hexoskin shirt.
-
Differences in Outcomes After Allograft vs Autograft in Revision ACL Repair
This study looks at whether using donor tissue (allograft) versus the patient’s own tissue (autograft) in revision ACL surgery leads to different results.
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Functional brain signal changes after ACL reconstruction with targeted neuromotor training
This project will test whether targeted neuromotor training after ACL reconstruction changes brain activity patterns in active adults aged 18–30.
-
Assessing ACL injury risk in healthy athletes
This study is trying to see how muscle strength and movement patterns in healthy athletes can help predict the risk of ACL injuries over a year.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.