Clinical trial NCT04408690: Feasibility of a RCT That Compares Immediate Versus Optional Delayed Surgical Repair After ACL Injury
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anterior Cruciate Ligament Injuries
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Federaal Kenniscentrum voor de Gezondheidszorg
name: Centre Hospitalier Universitaire de Liege
First posted: 2020-05-29
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility to recruit patients: Number of eligible patients that sign the informed consent
timeFrame: 4 months after first patient in
Secondary outcomes:
measure: Feasibility of the protocol: Number of patients that complete all assessments
timeFrame: When 5 patients per site have completed the 3 month follow-up visit
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: CHU Liège
Study officials:
affiliation: UZ Leuven
name: Koen Peers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smeets A, Ghafelzadeh Ahwaz F, Bogaerts S, De Groef A, Berger P, Kaux JF, Daniel C, Croisier JL, Delvaux F, Laenen A, Staes F, Peers K. 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. BMJ Open. 2022 Mar 11;12(3):e055349. doi: 10.1136/bmjopen-2021-055349.