Actively Recruiting

Phase Not Applicable
Age: 16Years +
All Genders
ID05747079

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

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-06-28

280

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

Sponsors

U

Universitaire Ziekenhuizen KU Leuven

Lead Sponsor

B

Belgian Health Care Knowledge Centre

Collaborating Sponsor

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

Who Can Participate

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

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

AI-Screening

AI-Powered Screening

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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.

Trial Site Locations

Total: 1 location

1

UZ Leuven

Leuven, Belgium, 3000

Actively Recruiting

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Research Team

A

Annemie Smeets, phd

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.

Annemie Smeets, Feryal Ghafelzadeh Ahwaz, Stijn Bogaerts...

https://pubmed.ncbi.nlm.nih.gov/38238809