<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04408690</url>
  </required_header>
  <id_info>
    <org_study_id>S62004</org_study_id>
    <nct_id>NCT04408690</nct_id>
  </id_info>
  <brief_title>Feasibility of a RCT That Compares Immediate Versus Optional Delayed Surgical Repair After ACL Injury</brief_title>
  <acronym>IODA</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Federaal Kenniscentrum voor de Gezondheidszorg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier Universitaire de Liege</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Currently, most patients with an anterior cruciate ligament (ACL) injury undergo surgery.&#xD;
      There is a general belief that surgical reconstruction is necessary to return to sport safely&#xD;
      and to limit premature knee osteoarthrosis or additional meniscal damage. However, there is&#xD;
      unsufficient scientific evidence for this belief. Moreover, several studies show that a&#xD;
      reconstruction does not guarantee successful return to sports or the prevention of&#xD;
      osteoarthritis or meniscal injuries at all. Therefore, an immediate surgery after an ACL&#xD;
      injury is more and more questioned. The only qualitative RCT that exists (KANON trial) could&#xD;
      not demonstrate that an immediate reconstruction is an added value (in terms of symptoms,&#xD;
      knee function, activity level, osteoarthritis or incidental meniscal damage) compared to a&#xD;
      conservative approach consisting of progressive rehabilitation and delayed surgery if there&#xD;
      was persistent knee instability.&#xD;
&#xD;
      In a future multicenter RCT the investigators want to 1) verify these results and 2) search&#xD;
      for predictors that predict which patients from the conservative group do well without&#xD;
      delayed surgery. This information is invaluable to physicians as it allows them to decide&#xD;
      which treatment is best for the patient.&#xD;
&#xD;
      Before performing a large, adequately-powered RCT that compares both treatment options, the&#xD;
      investigators will run a pilot study that assesses the feasibility to recruit ACL patients&#xD;
      for such RCT. This seems necessary, as many patients still believe that timely surgery is a&#xD;
      prerequisite for restoring knee function, for returning to sports and for preventing&#xD;
      cartilage degeneration. These preferences for surgery might affect recruitment and adherence&#xD;
      to the protocol. Therefore, a pilot study will performed that demonstrates whether a large&#xD;
      RCT is feasible with regard to 1) participant recruitment, 2) adherence to the treatment arm&#xD;
      they were allocated to and 3) protocol feasibility. The findings of this pilot study will&#xD;
      help deciding about progressing to a future definitive RCT.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 15, 2020</start_date>
  <completion_date type="Anticipated">July 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility to recruit patients: Number of eligible patients that sign the informed consent</measure>
    <time_frame>4 months after first patient in</time_frame>
    <description>Number of eligible patients that sign the informed consent</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility of the protocol: Number of patients that complete all assessments</measure>
    <time_frame>When 5 patients per site have completed the 3 month follow-up visit</time_frame>
    <description>Number of patients that complete all assessments (at baseline and 3 month follow-up)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Anterior Cruciate Ligament Injuries</condition>
  <arm_group>
    <arm_group_label>Rehabilitation and optional delayed ACL reconstruction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Immediate ACL reconstruction + rehabilitation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Immediate anterior cruciate ligament reconstruction</intervention_name>
    <description>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.&#xD;
This surgery will be performed within 12 weeks after the ACL injury.</description>
    <arm_group_label>Immediate ACL reconstruction + rehabilitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Rehabilitation</intervention_name>
    <description>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.</description>
    <arm_group_label>Immediate ACL reconstruction + rehabilitation</arm_group_label>
    <arm_group_label>Rehabilitation and optional delayed ACL reconstruction</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Optional delayed anterior cruciate ligament reconstruction</intervention_name>
    <description>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.&#xD;
This surgery will not be performed within the first 12 weeks after the ACL injury.</description>
    <arm_group_label>Rehabilitation and optional delayed ACL reconstruction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Rotational trauma to a previously uninjured knee within the preceding 4 weeks&#xD;
&#xD;
          -  Medical diagnosis of ACL insufficiency including MRI (both partial and complete&#xD;
             ruptures)&#xD;
&#xD;
          -  Minimum of 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has history of a previous ACL injury or knee surgery to the index knee.&#xD;
&#xD;
          -  Indication for acute surgery because of related injuries to the knee&#xD;
&#xD;
          -  Any disorder, which in the investigator's opinion might jeopardise participant's&#xD;
             safety or compliance with the protocol.&#xD;
&#xD;
          -  Female who is pregnant. Since MRI assessment cannot be performed.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Koen Peers, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Liège</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 11, 2023</last_update_submitted>
  <last_update_submitted_qc>May 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Anterior Cruciate Ligament Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04408690
org study id: S62004
nct id: NCT04408690
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Feasibility to recruit patients: Number of eligible patients that sign the informed consent
time frame: 4 months after first patient in
description: Number of eligible patients that sign the informed consent
measure: 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
description: Number of patients that complete all assessments (at baseline and 3 month follow-up)
arm group label: Rehabilitation and optional delayed ACL reconstruction
arm group type: Experimental
arm group label: Immediate ACL reconstruction + rehabilitation
arm group type: Active Comparator
intervention type: Procedure
intervention name: Immediate anterior cruciate ligament reconstruction
description: 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.
arm group label: Immediate ACL reconstruction + rehabilitation
intervention type: Other
intervention name: Rehabilitation
description: 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.
arm group label: Immediate ACL reconstruction + rehabilitation
arm group label: Rehabilitation and optional delayed ACL reconstruction
intervention type: Procedure
intervention name: Optional delayed anterior cruciate ligament reconstruction
description: 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.
arm group label: Rehabilitation and optional delayed ACL reconstruction
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Koen Peers, MD, PhD
role: Principal Investigator
affiliation: UZ Leuven
facility: 
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Wounds and Injuries
mesh term: Anterior Cruciate Ligament Injuries
sharing ipd: Undecided