KCE-181158: Feasibility of conducting a pragmatic, randomized trial that compares Immediate versus Optional Delayed surgical repair for treatment of acute anterior cruciate ligament injury - IODA trial

Summary (French or Dutch)

In Belgium, standard care for ACL (acute cruciate ligament) injuries is reconstructive surgery. It was believed for years that reconstruction of the ACL is necessary to restore mechanical knee stability in order to avoid long term disadvantages such as persistent knee instability and episodes of giving away, re-injury and osteoarthritis and ultimately also a prerequisite for a safe return to sport. However, evidence assessing treatment outcomes after surgical ACL reconstruction do not support these beliefs. Therefore, the current surgical treatment standards, which are highly influenced by the biased beliefs of patients and medical doctors towards surgery, should be re-evaluated, and a non-operative approach with rehabilitation should be considered. This should be assessed through a randomized controlled trial that compares the effectiveness of immediate surgical repair versus conservative treatment with optional delayed surgical reconstruction of an acute ACL injury. Furthermore, future research should assess whether it is possible to discern which acute ACL ruptures need surgical treatment, versus which can be treated conservatively.

Before we start with a large, adequately-powered RCT that compares both treatment options, we 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 be done to demonstrate 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.

If recruitment turns out to be feasible, the data of this pilot study will be used in the definitive, full trial. The patients participating in this pilot trial, will be asked to continue with the full trial that will have a longer follow-up period (3 years).

 

Trial Description
Title

Feasibility of conducting a pragmatic, randomized trial that compares Immediate versus Optional Delayed surgical repair for treatment of acute anterior cruciate ligament injury

Participants (P)

Patients presenting to the clinic with an acute anterior cruciate ligament (ACL) injury

Intervention (I)

Rehabilitation and optional delayed ACL reconstruction.

Control (C)

Immediate ACL reconstruction and rehabilitation

Outcome (O)

Number of patients included (to explore the feasibility to recruit ACL deficient patients for a future randomized controlled trial )

Trial Design

A parallel, multicentric, pragmatic, pilot randomised controlled trial comparing immediate ACL reconstructive surgery (control group) with optional delayed surgery (intervention group).

Sample Size

 58

Trial duration

10 months

Budget

€290 000

Status

Open

 

Trial team

Sponsor

UZ Leuven

Chief Investigator

Prof Dr Koen Peers

Participating Investigators

CHU Liège: Prof. Jean-Francois Kaux (Dept. of Physical Medicine and Rehabilitation)

Documents
Protocol  
Report

Q3/2021

Publication

 

References

Clinicaltrials.gov: NCT04408690

 

Funding scheme

2018 Investigator led