NCT04408690: IODA

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

Completed Phase 3 Last updated 15 November 2023

What this trial tests

Phase 3 trial testing Immediate anterior cruciate ligament reconstruction in Anterior Cruciate Ligament Injuries in 29 participants. Completed in 3 March 2023.

Timeline

15 September 2020

Primary endpoint
3 March 2023

3 March 2023

Quick facts

Lead sponsor	Universitaire Ziekenhuizen KU Leuven
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	29
Start date	15 September 2020
Primary completion	3 March 2023
Estimated completion	3 March 2023
Sites	2 locations across Belgium

Drugs / interventions tested

• Immediate anterior cruciate ligament reconstruction
• Rehabilitation
• Optional delayed anterior cruciate ligament reconstruction

Conditions studied

• Anterior Cruciate Ligament Injuries — all drugs for Anterior Cruciate Ligament Injuries →

Sponsor

Universitaire Ziekenhuizen KU Leuven — full company profile →

Who can join

18 and older, any sex, with Anterior Cruciate Ligament Injuries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pilot study to investigate the feasibility of conducting a randomised controlled trial that compares Immediate versus Optional Delayed surgical repair for treatment of acute Anterior cruciate ligament injury: IODA pilot trial.
   Smeets A, Ghafelzadeh Ahwaz F, Bogaerts S, De Groef A, et al · · 2022 · cited 4× · PMID 35277406 · DOI 10.1136/bmjopen-2021-055349
2. The feasibility of conducting a randomized controlled trial that compares immediate versus optional delayed surgical repair for treatment of acute Anterior cruciate ligament injury-results of the IODA pilot trial.
   Ghafelzadeh Ahwaz F, Smeets A, Bogaerts S, Berger P, et al · · 2025 · PMID 40340976 · DOI 10.1186/s40814-025-01652-2