NCT05747079 Immediate Versus Optional Delayed Surgical Repair for Treatment of Acute ACL Injuries
| NCT ID | NCT05747079 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | ACL Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 280 participants |
| Start Date | 2023-03-02 |
| Primary Completion | 2026-03-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 280 participants in total. It began in 2023-03-02 with a primary completion date of 2026-03-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Currently, most patients with an anterior cruciate ligament injury undergo surgery. There is a general belief that surgical reconstruction is necessary to safely return to sports and to prevent early knee osteoarthritis or additional meniscus injuries. But there is insufficient scientific evidence to support this belief. Moreover, several studies show that surgical reconstruction of the cruciate ligament does not guarantee successful return to sports or the prevention of osteoarthritis and secondary meniscus injuries. Therefore, immediate surgery after an anterior cruciate ligament injury is questioned. So far, only two RCTs (KANON study and COMPARE study) have assessed this, and they could not show that immediate reconstruction is an added value (in terms of symptoms, knee function, activity level, osteoarthritis or additional meniscal injuries) compared to a conservative approach consisting of rehabilitation and late surgery for persistent knee instability. Therefore, this additional multicenter RCT, aims to 1) verify these results and 2) to identify predictors that predict which patients in the conservative group will not require late surgery. This has not been investigated to date. It is suspected that factors such as symptoms, strength, findings on the MRI scan and psychological factors may play a role in whether or not a patient will be able to successfully rehabilitate without surgical repair. This information is invaluable to physicians because it allows them to decide which treatment is best for the patient.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05747079 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying ACL Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05747079 currently recruiting?
Yes, NCT05747079 is actively recruiting participants. Contact the research team at annemie.smeets@kuleuven.be for enrollment information.
Where is the NCT05747079 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT05747079 clinical trial?
NCT05747079 is sponsored by Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 280 participants.