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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-02

Study Completion Date

2028-03-02

Brief Summary

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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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Detailed Description

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Conditions

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ACL Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Conservative treatment

Rehabilitation and optional delayed ACL reconstruction

Group Type EXPERIMENTAL

Rehabilitation

Intervention Type 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

Intervention Type 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 ACL reconstruction

Immediate ACL reconstruction + rehabilitation

Group Type EXPERIMENTAL

Rehabilitation

Intervention Type 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.

Immediate anterior cruciate ligament reconstruction

Intervention Type 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.

Interventions

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Rehabilitation

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.

Intervention Type OTHER

Optional delayed anterior cruciate ligament reconstruction

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.

Intervention Type PROCEDURE

Immediate anterior cruciate ligament reconstruction

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No