Feasibility of a RCT That Compares Immediate Versus Optional Delayed Surgical Repair After ACL Injury

Study Overview
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Brief Summary
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Currently, most patients with an anterior cruciate ligament (ACL) injury undergo surgery. There is a general belief that surgical reconstruction is necessary to return to sport safely and to limit premature knee osteoarthrosis or additional meniscal damage. However, there is unsufficient scientific evidence for this belief. Moreover, several studies show that a reconstruction does not guarantee successful return to sports or the prevention of osteoarthritis or meniscal injuries at all. Therefore, an immediate surgery after an ACL injury is more and more questioned. The only qualitative RCT that exists (KANON trial) could not demonstrate that an immediate reconstruction is an added value (in terms of symptoms, knee function, activity level, osteoarthritis or incidental meniscal damage) compared to a conservative approach consisting of progressive rehabilitation and delayed surgery if there was persistent knee instability. In a future multicenter RCT the investigators want to 1) verify these results and 2) search for predictors that predict which patients from the conservative group do well without delayed surgery. This information is invaluable to physicians as it allows them to decide which treatment is best for the patient. Before performing a large, adequately-powered RCT that compares both treatment options, the investigators will run a pilot study that assesses the feasibility to recruit ACL patients for such RCT. This seems necessary, as many patients still believe that timely surgery is a prerequisite for restoring knee function, for returning to sports and for preventing cartilage degeneration. These preferences for surgery might affect recruitment and adherence to the protocol. Therefore, a pilot study will performed that demonstrates whether a large RCT is feasible with regard to 1) participant recruitment, 2) adherence to the treatment arm they were allocated to and 3) protocol feasibility. The findings of this pilot study will help deciding about progressing to a future definitive RCT.

Official Title
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A Pilot Study to Investigate the Feasibility of Conducting a Randomized Controlled Trial That Compares Immediate Versus Optional Delayed Surgical Repair for Treatment of Acute Anterior Cruciate Ligament Injury

Conditions
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Anterior Cruciate Ligament Injuries

Intervention / Treatment
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* Procedure: Immediate anterior cruciate ligament reconstruction
* Other: Rehabilitation
* Procedure: Optional delayed anterior cruciate ligament reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rotational trauma to a previously uninjured knee within the preceding 4 weeks Medical diagnosis of ACL insufficiency including MRI (both partial and complete ruptures) Minimum of 18 years Exclusion Criteria: Patient has history of a previous ACL injury or knee surgery to the index knee. Indication for acute surgery because of related injuries to the knee Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. Female who is pregnant. Since MRI assessment cannot be performed.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rehabilitation and optional delayed ACL reconstruction<br> | Other: Rehabilitation<br>* 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.<br>Procedure: Optional delayed anterior cruciate ligament reconstruction<br>* 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.<br>|
| Active Comparator: Immediate ACL reconstruction + rehabilitation<br> | Procedure: Immediate anterior cruciate ligament reconstruction<br>* 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.<br>Other: Rehabilitation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility to recruit patients: Number of eligible patients that sign the informed consent | Number of eligible patients that sign the informed consent | 4 months after first patient in | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the protocol: Number of patients that complete all assessments | Number of patients that complete all assessments (at baseline and 3 month follow-up) | When 5 patients per site have completed the 3 month follow-up visit |