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

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

Conditions: ACL Injury

Treatments: Other: Rehabilitation; Procedure: Immediate anterior cruciate ligament reconstruction; Procedure: Optional delayed anterior cruciate ligament reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT05747079

S67021

Details and patient eligibility

About

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.

Enrollment: 280 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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280 participants in 2 patient groups

Conservative treatment

Experimental group

Description:

Rehabilitation and optional delayed ACL reconstruction

Treatment:

Procedure: Optional delayed anterior cruciate ligament reconstruction

Other: Rehabilitation

Immediate ACL reconstruction

Experimental group

Description:

Immediate ACL reconstruction + rehabilitation

Treatment:

Procedure: Immediate anterior cruciate ligament reconstruction

Other: Rehabilitation