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Completed

NCT Number: NCT04408690

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

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.

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Key information

Conditions

Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UZ Leuven, Leuven, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Immediate anterior cruciate ligament reconstruction

Procedure

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.

rehabilitation

Other

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.

Optional delayed anterior cruciate ligament reconstruction

Procedure

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.

Primary outcomes

  1. Feasibility to recruit patients: Number of eligible patients that sign the informed consent

    Time frame: 4 months after first patient in

    Number of eligible patients that sign the informed consent

Secondary outcomes

  1. Feasibility of the protocol: Number of patients that complete all assessments

    Time frame: When 5 patients per site have completed the 3 month follow-up visit

    Number of patients that complete all assessments (at baseline and 3 month follow-up)

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Centre Hospitalier Universitaire de Liege
  • Federaal Kenniscentrum voor de Gezondheidszorg

Registry information

Official study 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

Acronym: IODA

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 29, 2020
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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