Comparing Immediate Versus Optional Delayed Surgery for Acute ACL Knee Injuries
A Multicenter Randomized Trial Evaluating Rehabilitation and Surgical Outcomes
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-06-28
280
Participants Needed
1
Research Sites
104 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the best timing for surgery after an anterior cruciate ligament ACL injury, a condition where the knee ligament is damaged. The study compares immediate ACL reconstruction surgery to a conservative approach of rehabilitation with optional delayed surgery if needed. This trial seeks to confirm previous findings that immediate surgery may not always be necessary and aims to identify factors that predict which patients might avoid later surgery. Understanding these factors will help doctors decide the best treatment for each patient.
Participants are randomly assigned to one of two groups one group receives rehabilitation with their own physiotherapist and may have delayed ACL surgery if persistent knee instability occurs after 12 weeks. The other group undergoes immediate ACL reconstruction surgery within 12 weeks of injury, followed by rehabilitation. The type of surgery and graft used is decided by the orthopedic surgeon, allowing flexibility in treatment.
During the study, patients are followed up at 7 months and 12 months after injury to measure clinical effectiveness, including knee symptoms and function. Researchers will also analyze data over 36 months to identify patient-specific factors like symptoms, strength, MRI findings, and psychological aspects that predict the need for delayed surgery. This long-term monitoring will help assess outcomes and improve personalized treatment decisions for ACL injuries.
CONDITIONS
Brief Title
Immediate Versus Optional Delayed Surgical Repair for Treatment of Acute ACL Injuries
Research Team
A
Annemie Smeets, phd
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Rotational trauma to a knee with no prior serious injury and medical advice sought within 4 weeks after injury
Medical diagnosis of ACL insufficiency confirmed by MRI, including partial or complete ruptures
Age 16 years or older
You will not qualify if you...
History of previous ACL injury or knee surgery on the injured knee
Need for acute surgery due to related knee injuries
Female who is pregnant or plans to become pregnant in the first 4 months of the trial due to MRI restrictions
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Up to 12 weeks for immediate surgery; rehabilitation and delayed surgery if necessary thereafter
Participants receive either immediate anterior cruciate ligament reconstruction surgery within 12 weeks after injury plus rehabilitation, or rehabilitation with optional delayed ACL reconstruction if needed after 12 weeks.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Comparison of immediate versus optional delayed surgical repair for treatment of acute anterior cruciate ligament injury through a parallel, multicentric, pragmatic randomized controlled trial - IODA trial.