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

Not Applicable

Recruiting

• Conditions: ACL Injury
• Interventions: Other: Rehabilitation; Procedure: Immediate anterior cruciate ligament reconstruction; Procedure: Optional delayed anterior cruciate ligament reconstruction

• Registration Number: NCT05747079
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-10
• Study First Submitted QC: 2023-02-27
• Study First Posted: 2023-02-28
• Study Start: 2023-03-02
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-06-28
• Primary Completion: 2026-03-02
• Study Completion: 2028-03-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 280

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conservative treatment	Rehabilitation	Rehabilitation and optional delayed ACL reconstruction
Immediate ACL reconstruction	Immediate anterior cruciate ligament reconstruction	Immediate ACL reconstruction + rehabilitation
Immediate ACL reconstruction	Rehabilitation	Immediate ACL reconstruction + rehabilitation
Conservative treatment	Optional delayed anterior cruciate ligament reconstruction	Rehabilitation and optional delayed ACL reconstruction

Primary Outcome Measures

Name	Time	Method
Clinical effectiveness (long-term)	12 months post-injury	Knee Injury and Osteoarthritis Outcome Score - Subscale Quality of Life (score between 0-100, higher scores mean better outcome)
Clinical effectiveness (short-term)	7 months post-injury	Knee Injury and Osteoarthritis Outcome Score - Subscale Quality of Life (score between 0-100, higher scores mean better outcome)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium