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

Comparison of Immediate Versus Optional Delayed Surgical Repair for Treatment of Acute Anterior Cruciate Ligament Injury Through a Parallel, Multicentric, Pragmatic Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: ACL Injury
• Intervention / Treatment: Other: Rehabilitation; Procedure: Optional delayed anterior cruciate ligament reconstruction; Procedure: Immediate anterior cruciate ligament reconstruction

• Study Type: Interventional
• Enrollment (Estimated): 280
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annemie Smeets, phd; Phone Number: +32 16 37 91 02; Email: annemie.smeets@kuleuven.be

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven
    • Contact: Koen Peers, MD, PhD; Phone Number: +32 16342185; Email: koen.peers@uzleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conservative treatment; Rehabilitation and optional delayed ACL reconstruction	Other: 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.; Procedure: 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.
Experimental: Immediate ACL reconstruction; Immediate ACL reconstruction + rehabilitation	Other: 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.; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediction analysis to identify patient-specific factors that predict whether (or not) a patient will require delayed surgery	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	36 months post-injury

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: Centre Hospitalier Universitaire de Liege; CHC MontLégia; Belgian Health Care Knowledge Centre; Jessa Ziekenhuis Hasselt; Clinique Saint-Luc Bouge

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2023
• Primary Completion (Estimated): March 2, 2026
• Study Completion (Estimated): March 2, 2028

Study Registration Dates

• First Submitted: February 10, 2023
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): February 28, 2023

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: ACL; RCT; ACL reconstruction; Conservative treatment
• Additional Relevant MeSH Terms: Leg Injuries; Knee Injuries; Wounds and Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: S67021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No