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NCT Number: NCT05747079

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

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.

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Key information

Conditions

ACL Injury Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rehabilitation

Other

All patients complete rehabilitation under supervision of their own physiotherapist. The investigators will provide some guidelines and criteria, but it is the physiotherapist's choice how to implement these guidelines in clinical practice.

Optional delayed anterior cruciate ligament reconstruction

Procedure

If a patient complains about persistent symptomatic instability of the knee or the inability to progress in rehabilitation, delayed surgery can be considered. ACL insufficiency induced instability in combination with a positive pivot shift and an additional MRI are needed to confirm the cause of instability.

This surgery will not be performed within the first 12 weeks after the ACL injury.

Immediate anterior cruciate ligament reconstruction

Procedure

No guidelines on type of ACL reconstruction will be imposed to keep the trial pragmatic. The decision of graft type and surgery technique is a clinical decision made by the orthopaedic surgeons of the participating centra.

This surgery will be performed within 12 weeks after the ACL injury.

Primary outcomes

  1. Clinical effectiveness (long-term)

    Time frame: 12 months post-injury

    Knee Injury and Osteoarthritis Outcome Score - Subscale Quality of Life (score between 0-100, higher scores mean better outcome)

  2. Clinical effectiveness (short-term)

    Time frame: 7 months post-injury

    Knee Injury and Osteoarthritis Outcome Score - Subscale Quality of Life (score between 0-100, higher scores mean better outcome)

Secondary outcomes

  1. Prediction analysis to identify patient-specific factors that predict whether (or not) a patient will require delayed surgery

    Time frame: 36 months post-injury

    Dependent variable = whether or not delayed surgery is performed (binary event)

    Independent variables (candidate predictors):

    • Knee Injury and Osteoarthritis Outcome Score - Subscale Quality of Life at baseline
    • MRI findings at baseline scored with the modified ACLOAS (Anterior Cruciate Ligament OsteoArthritis Score)
    • Degree of hemarthrosis determined by MRI at baseline
    • Expectations regarding the effectiveness of physical therapy at baseline, measured with the illness perception questionnaire
    • Pre-injury activity level, measured with the Tegner Activity Score

Study contacts

Contact information is provided by the study sponsor or research team.

Annemie Smeets, phd

CONTACT

[email protected]

+32 16 37 91 02

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Belgian Health Care Knowledge Centre
  • Centre Hospitalier Universitaire de Liege
  • Clinique Saint-Luc Bouge
  • Jessa Ziekenhuis Hasselt
  • University Hospital Brussel

Registry information

Official study 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

Acronym: IODA

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Feb 28, 2023
Registry last updated
Jun 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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