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

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ClinicalTrials.gov Identifier: NCT04408690
Recruitment Status : Recruiting
First Posted : May 29, 2020
Last Update Posted : October 20, 2020
Sponsor:
Collaborators:
Federaal Kenniscentrum voor de Gezondheidszorg
Centre Hospitalier Universitaire de Liège
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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.


Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Injuries Procedure: Immediate anterior cruciate ligament reconstruction Other: Rehabilitation Procedure: Optional delayed anterior cruciate ligament reconstruction Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 15, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rehabilitation and optional delayed ACL reconstruction 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.


Active Comparator: Immediate ACL reconstruction + rehabilitation 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04408690


Contacts
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Contact: Annemie Smeets, PhD +32 16345965 annemie.smeets@uzleuven.be
Contact: Koen Peers, MD, PhD +32 16342185 koen.peers@uzleuven.be

Locations
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Belgium
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Koen Peers, MD, PhD    +32 16342185    koen.peers@uzleuven.be   
CHU Liège Not yet recruiting
Liège, Belgium, 4000
Contact: Jean-François Kaux, MD, PhD    +32 43668473    jfkaux@chuliege.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Federaal Kenniscentrum voor de Gezondheidszorg
Centre Hospitalier Universitaire de Liège
Investigators
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Principal Investigator: Koen Peers, MD, PhD UZ Leuven
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT04408690    
Other Study ID Numbers: S62004
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wounds and Injuries
Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries