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

Anterior Cruciate Ligament Injuries Clinical Trial

— IODA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04408690
• Other study ID #: S62004
• Status: Completed
• Phase: Phase 3
• Start date: September 15, 2020
• Est. completion date: March 3, 2023

Study information

• Verified date: November 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 3, 2023
• Est. primary completion date: March 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Wounds and Injuries

Intervention

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.

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.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven
Belgium	CHU Liège	Liège

Sponsors (3)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	Centre Hospitalier Universitaire de Liege, Federaal Kenniscentrum voor de Gezondheidszorg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility to recruit patients: Number of eligible patients that sign the informed consent	Number of eligible patients that sign the informed consent	4 months after first patient in
Secondary	Feasibility of the protocol: Number of patients that complete all assessments	Number of patients that complete all assessments (at baseline and 3 month follow-up)	When 5 patients per site have completed the 3 month follow-up visit