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Immediate Versus Optional Delayed Surgical Repair for Treatment of Acute ACL Injuries

RecruitingNAAges 16 Years - anyAllUniversitaire Ziekenhuizen KU Leuven
NCT05747079 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 consi

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📋 Eligibility rules (as published)
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.
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What it tests

  • Rehabilitation
  • Optional delayed anterior cruciate ligament reconstruction
  • Immediate anterior cruciate ligament reconstruction
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Where

1 site
UZ Leuven
Leuven, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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