<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/NCT02995551</url>
  </required_header>
  <id_info>
    <org_study_id>S-20160151</org_study_id>
    <secondary_id>DFF - 6110-00045</secondary_id>
    <nct_id>NCT02995551</nct_id>
  </id_info>
  <brief_title>Danish Rct on Exercise Versus Arthroscopic Meniscal Surgery for Young Adults</brief_title>
  <acronym>DREAM</acronym>
  <official_title>Danish Rct on Exercise Versus Arthroscopic Meniscal Surgery for Young Adults (DREAM) - A Randomized Controlled Trial of Meniscal Tear Treatment in Young Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aarhus University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Copenhagen University Hospital, Hvidovre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aalborg University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sygehus Lillebaelt</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Naestved Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Slagelse Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Danish Council for Independent Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>IMK Almene Fond</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lundbeck Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Danish Rheumatism Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Spar Nord Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Association of Danish Physiotherapists</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Regionshospitalet Silkeborg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There are two cartilage structures in each knee joint called a meniscus. A torn meniscus can&#xD;
      be caused by either a smaller or larger trauma or be a degenerative age-related tear.&#xD;
      Arthroscopic meniscal surgery is the most common orthopedic procedure, but no high-quality&#xD;
      studies have investigated the efficacy of meniscal surgery for younger patients (i.e. 40&#xD;
      years or younger) in comparison to non-surgical treatments.&#xD;
&#xD;
      The purpose of this study is to determine if a strategy of early arthroscopic meniscal&#xD;
      surgery (repair or resection) is superior to a strategy of initial individualized supervised&#xD;
      exercise therapy including patient education with the option of later surgery if needed in&#xD;
      improving pain, function and quality of life in young patients (18-40 years) with meniscal&#xD;
      tears.&#xD;
&#xD;
      The hypothesis is that patients treated with early arthroscopic meniscal surgery will improve&#xD;
      more than patients treated with exercise and education.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Arthroscopic meniscal surgery is the most common orthopedic procedure. In Denmark, meniscal&#xD;
      surgeries have doubled from around 9.000 yearly procedures in 2000 to more than 17.000 in&#xD;
      2011, with the total number of meniscal surgeries exceeding 150.000 in this period. Similar&#xD;
      trends have been observed in the US, where more than 700.000 orthopedic procedures are&#xD;
      carried out annually. Numerous randomized controlled trials (RCT) have investigated the&#xD;
      efficacy of meniscal surgery compared with placebo surgery, in addition to non-surgical&#xD;
      treatment and in direct comparison to exercise in middle-aged and older patients.&#xD;
&#xD;
      However, no RCTs have investigated the efficacy of meniscal surgery for younger patients&#xD;
      (i.e. 40 years or younger) in comparison to non-surgical treatments. In contrast to&#xD;
      middle-aged and older adults with degenerative meniscal tears of unknown origin, most tears&#xD;
      in younger adults (18-40 years) are of traumatic origin (i.e. such as a sports related&#xD;
      trauma), which highlights the need for a high-quality trial in the younger population.&#xD;
&#xD;
      The aim of this RCT is to investigate if early arthroscopic meniscal surgery (repair or&#xD;
      resection) is superior to individualized supervised exercise therapy and education, with the&#xD;
      option of later surgery if needed, in improving pain, function and quality of life in young&#xD;
      patients (18-40 years) with meniscal tears. The study hypothesis is that patients randomized&#xD;
      to surgery will improve significantly more in pain, function and quality of life after 12&#xD;
      months than those randomized to exercise and education.&#xD;
&#xD;
      Patients fulfilling eligibility criteria and willing to participate in the study will be&#xD;
      randomized to one of the two groups after the baseline assessment with follow-up after 3, 6&#xD;
      and 12 months (Subsequently, a 24-month follow-up has been added):&#xD;
&#xD;
        1. Arthroscopic meniscal surgery: Arthroscopic meniscal repair or resection will be&#xD;
           conducted at the discretion of the operating surgeon (this cannot be determined before&#xD;
           the surgeon has visual confirmation about the exact knee pathology and extend of the&#xD;
           meniscal tear by scope).&#xD;
&#xD;
           After surgery, patients will receive the standard rehabilitation in the postoperative&#xD;
           period depending of type of surgery, since this differs for patients who have had&#xD;
           resection and repair. A standard folder with exercises will be given to those having a&#xD;
           partial meniscectomy to ensure a minimum level of rehabilitation after the surgery&#xD;
           across the hospitals.&#xD;
&#xD;
        2. Exercise therapy and patient education: Patients allocated to exercise therapy and&#xD;
           education will participate in a 12-week (2 exercise sessions per week) supervised&#xD;
           neuromuscular and strengthening exercise program tailored to 18-40 years old patients&#xD;
           with a meniscal tear. Furthermore, they will participate in a patient education program&#xD;
           developed through interviews with pilot study participants, from our experiences from&#xD;
           the Good Life with osteoArthritis in Denmark (GLA:D) program for patients with knee and&#xD;
           hip pain. Both the exercise and education will take place in a number of private&#xD;
           physiotherapy clinics associated with the GLA:D program, specifically trained to&#xD;
           supervise and lead the treatment in this study. A similar exercise program and&#xD;
           educational program have been shown to be effective in improving pain, function and&#xD;
           quality of life in patients with other types of knee injuries and knee pain.&#xD;
&#xD;
      Observational cohort:&#xD;
&#xD;
      Patients fulfilling all eligibility but unwilling to participate in the randomized study and&#xD;
      patients 18-40 years of age with a clinical history and symptoms consistent with a meniscal&#xD;
      tear that does not fulfill the other criteria are asked to participate in an observational&#xD;
      cohort with the same questionnaires as in the RCT, but following usual clinical practice.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">February 2022</completion_date>
  <primary_completion_date type="Actual">February 2021</primary_completion_date>
  <phase>N/A</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the Knee Injury and Osteoarthritis Outcome Score (KOOS4)</measure>
    <time_frame>Primary endpoint: Change from baseline to 12 months.</time_frame>
    <description>The mean score for the KOOS subscales Pain, Symptoms, Function in sports and recreational activities, and Quality of life. All visits (baseline, 3, 6 and 12 months) will be included in the analysis. Will also be assessed after 24 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The five KOOS subscales</measure>
    <time_frame>Primary endpoint: Change from baseline to 12 months.</time_frame>
    <description>To allow for clinical in-depth interpretation, the primary outcome will be complemented by subscale scores from each of the five individual KOOS subscales. All visits (baseline, 3, 6 and 12 months) will be included in the analysis. Will also be assessed after 24 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Western Ontario Meniscal Evaluation Tool (WOMET)</measure>
    <time_frame>Primary endpoint: Change from baseline to 12 months.</time_frame>
    <description>WOMET is a meniscus specific patient-reported outcome measure that will be used to complement the KOOS score. All visits (baseline, 3, 6 and 12 months) will be included in the analysis. Will also be assessed after 24 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Isometric muscle strength</measure>
    <time_frame>Primary endpoint: Change from baseline to 3 months.</time_frame>
    <description>Isometric muscle strength will be assessed using the FysioMeter. Assessed at baseline, 3 and 12 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The maximum number of knee-bends in 30s</measure>
    <time_frame>Primary endpoint: Change from baseline to 12 months.</time_frame>
    <description>The maximum number of knee-bends in 30s is one of three measures of functional performance. All visits (baseline, 3, 6 and 12 months) will be included in the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The one-leg hop for distance</measure>
    <time_frame>Primary endpoint: 12 months.</time_frame>
    <description>The one-leg hop for distance is one of three measures of functional performance. Assessed only at 12 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The 6 m timed hop</measure>
    <time_frame>Primary endpoint: 12 months.</time_frame>
    <description>The 6 m timed hop is one of three measures of functional performance. Assessed only at 12 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>Primary endpoint: 12 months.</time_frame>
    <description>Adverse events (AE) and serious adverse events (SAE) will be recorded at all follow-ups by asking the participants about potential AEs using open-probe questioning to ensure that all AEs are recorded. Furthermore, the medical records from the participating hospitals will be checked at the primary endpoint (12 months) for all AEs occurring from inclusion until the 12 months follow-up. AEs will be categorized into index knee or other sites and will be recorded and assessed for severity independent of whether or not there is a causal relationship with study treatments. Assessed at 3, 6 and 12 months. Will also be assessed after 24 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Structural knee joint changes</measure>
    <time_frame>Baseline to 24 months</time_frame>
    <description>Structural knee joint changes from baseline to 24 months will be assessed using the Anterior Cruciate Ligament OsteoArthritis Score (ACLOAS).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>EQ-5D</measure>
    <time_frame>Primary endpoint: Change from baseline to 12 months.</time_frame>
    <description>General health will be assessed using the EQ-5D-5L questionnaire (5-level version), both the descriptive index and the EQ-VAS. This will also allow for a later cost-effectiveness analysis. Assessed at baseline, 3, 6 and 12 months. Will also be assessed after 24 months.</description>
  </other_outcome>
  <other_outcome>
    <measure>Questions on function with Short Message Service (SMS)</measure>
    <time_frame>Each week during the first 3 months and after that each month until the 12 months follow-up</time_frame>
    <description>The subscale Sport/Rec from the KOOS</description>
  </other_outcome>
  <other_outcome>
    <measure>Questions on pain with Short Message Service (SMS)</measure>
    <time_frame>Each week during the first 3 months and after that each month until the 12 months follow-up</time_frame>
    <description>Pain intensity going up/down stairs and pain intensity during sitting/lying on a 11-point Numeric Rating Scale (NRS)</description>
  </other_outcome>
  <other_outcome>
    <measure>Physical activity level</measure>
    <time_frame>Primary endpoint: 12 months. Assessed at baseline, 3, 6 and 12 months. Will also be assessed after 24 months.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Participation in sports (Tegner activity scale)</measure>
    <time_frame>Primary endpoint: 12 months. Assessed at baseline, 3, 6 and 12 months. Will also be assessed after 24 months.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Global Perceived Effect (GPE)</measure>
    <time_frame>Primary endpoint: 12 months.</time_frame>
    <description>Answered on 7-point Likert scale. Assessed at 3, 6 and 12 months. Will also be assessed after 24 months.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Acceptable Symptom State (PASS)</measure>
    <time_frame>Primary endpoint: 12 months.</time_frame>
    <description>&quot;When you think of your knee function, will you consider your current condition as satisfying? By knee function, you should take into account your activities of daily living, sport and recreational activities, your pain and other symptoms and your quality of life&quot;. Answered by &quot;yes&quot; or &quot;no&quot;. Assessed at 3, 6 and 12 months. Will also be assessed after 24 months.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient-reported treatment failure.</measure>
    <time_frame>Primary endpoint: 12 months. Will also be assessed after 24 months.</time_frame>
    <description>Only answered by patients answering &quot;no&quot; to PASS. &quot;Would you consider your current state as being so unsatisfactory that you consider the treatment to have failed?&quot;. Answered by &quot;yes&quot; or &quot;no&quot;.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient-reported mechanical symptoms related to the knee</measure>
    <time_frame>Assessed at baseline, 3, 6 and 12 months.</time_frame>
    <description>Patient-reported mechanical symptoms, i.e. catching and locking of the knee. Presence and frequency answered on 5-point scale.</description>
  </other_outcome>
  <other_outcome>
    <measure>Knee instability</measure>
    <time_frame>Assessed at baseline, 3, 6 and 12 months. Will also be assessed after 24 months.</time_frame>
    <description>Patient-reported knee instability. Presence and frequency of knee instability answered on a 6-point scale and how much it affects activity level answered on a 6-point scale.</description>
  </other_outcome>
  <other_outcome>
    <measure>Compliance with exercise (only for patients in the exercise group)</measure>
    <time_frame>Assessed at 3 months</time_frame>
    <description>The number of exercise sessions that the patient participate in out of the total 24 supervised sessions.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient-reported participation in post-surgery exercise (only for patients in the surgery group)</measure>
    <time_frame>Assessed at 3 months</time_frame>
    <description>Supervised or unsupervised and number of sessions.</description>
  </other_outcome>
  <other_outcome>
    <measure>Surgery and other treatments during follow-up</measure>
    <time_frame>Primary endpoint: 12 months.</time_frame>
    <description>Assessed at baseline, 3, 6 and 12 months by self-report and review of medical journals (surgery only). Other knee surgery will also be assessed at 24 months.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pain intensity on a 11-point Numeric Rating Scale (NRS)</measure>
    <time_frame>Assessed at 3 months</time_frame>
    <description>Before and after each of the 24 supervised exercise sessions the patients will report their pain intensity. Only the patients in the group randomized to exercise and education.</description>
  </other_outcome>
  <other_outcome>
    <measure>Expanded version of the International Society of Arthroscopy, Knee Surgery and Orthopedic Sports Medicine (ISAKOS) classification of meniscal tears questionnaire</measure>
    <time_frame>Day 1 after surgery</time_frame>
    <description>Information about location of tear, type of tear and type of treatment (repair or resection) will be collected using an expanded version of the International Society of Arthroscopy, Knee Surgery and Orthopedic Sports Medicine (ISAKOS) classification of meniscal tears questionnaire by the operating surgeon. This will be supplemented with data from surgery reports.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">122</enrollment>
  <condition>Tear of Meniscus of Knee</condition>
  <arm_group>
    <arm_group_label>Arthroscopy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arthroscopic meniscal repair or resection will be conducted at the discretion of the operating surgeon (this cannot be determined before the surgeon has visual confirmation about the exact knee pathology and extend of the meniscal tear by scope).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise and Education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients allocated to exercise therapy and education will participate in a 12-week (2 exercise sessions per week) supervised neuromuscular and strengthening exercise program tailored to 18-40 years old patients with a meniscal tear. Furthermore, they will participate in a patient education program developed through interviews with pilot study participants, from our experiences from the Good Life with osteoArthritis in Denmark (GLA:D) program for patients with knee and hip pain. Both the exercise and education will take place in a number of private physiotherapy clinics associated with the GLA:D program, specifically trained to supervise and lead the treatment in this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Arthroscopic meniscal repair or resection</intervention_name>
    <description>Arthroscopic meniscal repair or resection following standard procedures.</description>
    <arm_group_label>Arthroscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise and education</intervention_name>
    <description>A 12-week (2 exercise sessions per week) supervised neuromuscular and strengthening exercise program tailored to 18-40 years old patients with a meniscal tear combined with patient education teaching the participants about their disease and how to manage it through exercise and in their daily life.</description>
    <arm_group_label>Exercise and Education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged 18 to 40 years with knee pain&#xD;
&#xD;
          -  Clinical history and symptoms consistent with meniscal tear and meniscal tear verified&#xD;
             on magnetic resonance imaging (MRI)&#xD;
&#xD;
          -  Deemed eligible for meniscal surgery (i.e. repair or resection) by the examining&#xD;
             orthopedic surgeon&#xD;
&#xD;
          -  Willing to participate in 12 weeks of supervised exercise twice a week or undergo&#xD;
             surgery for the meniscal tear as soon as possible&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous knee surgery on the affected knee&#xD;
&#xD;
          -  Clinical suspicion (acute locking of knee AND/OR extension deficit) of displaced&#xD;
             bucket-handle tear confirmed by MRI&#xD;
&#xD;
          -  Fracture of the affected extremity within the previous 12 months&#xD;
&#xD;
          -  Complete rupture of one or more knee ligaments.&#xD;
&#xD;
          -  Participation in supervised systematic exercise for knee problems within the last 3&#xD;
             months prior to recruitment&#xD;
&#xD;
          -  Other reasons for exclusion (Unable to understand Danish, mentally unable to&#xD;
             participate, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Søren T. Skou, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern Denmark and Næstved-Slagelse-Ringsted Hospitals</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jonas B Thorlund, MSc, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Southern Denmark</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Martin Lind, Prof, MD, PhD, DMSc</last_name>
    <role>Study Chair</role>
    <affiliation>Aarhus University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Per Hölmich, Prof, MD, DMSc</last_name>
    <role>Study Chair</role>
    <affiliation>Copenhagen University Hospital, Amager-Hvidovre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hans P Jensen, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Aalborg University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carsten Jensen, MSc, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Lillebælt Hospital in Kolding</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Muhammad Afzal, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Naestved Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Uffe Jørgensen, Prof, MD, DMSc</last_name>
    <role>Study Chair</role>
    <affiliation>Odense University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mogens Strange Hansen, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Elective Surgery Centre, Regionshospitalet Silkeborg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Orthopedic Surgery, Aalborg University Hospital</name>
      <address>
        <city>Aalborg</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Sports Traumatology, Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Orthopedic Surgery, Copenhagen University Hospital, Amager-Hvidovre</name>
      <address>
        <city>Copenhagen</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Orthopedic Surgery, Lillebælt Hospital in Kolding</name>
      <address>
        <city>Kolding</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Orthopedic Surgery, Næstved Hospital</name>
      <address>
        <city>Naestved</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Orthopedics and Traumatology, Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elective Surgery Centre, Regionshospitalet Silkeborg</name>
      <address>
        <city>Silkeborg</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>January 31, 2022</last_update_submitted>
  <last_update_submitted_qc>January 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern Denmark</investigator_affiliation>
    <investigator_full_name>Søren Thorgaard Skou</investigator_full_name>
    <investigator_title>PT, PhD, Professor</investigator_title>
  </responsible_party>
  <keyword>Menisci, Tibial</keyword>
  <keyword>Knee Injuries</keyword>
  <keyword>Arthroscopy</keyword>
  <keyword>Exercise</keyword>
  <keyword>Young adults</keyword>
  <keyword>Treatment Outcome</keyword>
  <keyword>Humans</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT02995551
org study id: S-20160151
secondary id: DFF - 6110-00045
nct id: NCT02995551
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has dmc: No
There are two cartilage structures in each knee joint called a meniscus. A torn meniscus can
      be caused by either a smaller or larger trauma or be a degenerative age-related tear.
      Arthroscopic meniscal surgery is the most common orthopedic procedure, but no high-quality
      studies have investigated the efficacy of meniscal surgery for younger patients (i.e. 40
      years or younger) in comparison to non-surgical treatments.

      The purpose of this study is to determine if a strategy of early arthroscopic meniscal
      surgery (repair or resection) is superior to a strategy of initial individualized supervised
      exercise therapy including patient education with the option of later surgery if needed in
      improving pain, function and quality of life in young patients (18-40 years) with meniscal
      tears.

      The hypothesis is that patients treated with early arthroscopic meniscal surgery will improve
      more than patients treated with exercise and education.
Arthroscopic meniscal surgery is the most common orthopedic procedure. In Denmark, meniscal
      surgeries have doubled from around 9.000 yearly procedures in 2000 to more than 17.000 in
      2011, with the total number of meniscal surgeries exceeding 150.000 in this period. Similar
      trends have been observed in the US, where more than 700.000 orthopedic procedures are
      carried out annually. Numerous randomized controlled trials (RCT) have investigated the
      efficacy of meniscal surgery compared with placebo surgery, in addition to non-surgical
      treatment and in direct comparison to exercise in middle-aged and older patients.

      However, no RCTs have investigated the efficacy of meniscal surgery for younger patients
      (i.e. 40 years or younger) in comparison to non-surgical treatments. In contrast to
      middle-aged and older adults with degenerative meniscal tears of unknown origin, most tears
      in younger adults (18-40 years) are of traumatic origin (i.e. such as a sports related
      trauma), which highlights the need for a high-quality trial in the younger population.

      The aim of this RCT is to investigate if early arthroscopic meniscal surgery (repair or
      resection) is superior to individualized supervised exercise therapy and education, with the
      option of later surgery if needed, in improving pain, function and quality of life in young
      patients (18-40 years) with meniscal tears. The study hypothesis is that patients randomized
      to surgery will improve significantly more in pain, function and quality of life after 12
      months than those randomized to exercise and education.

      Patients fulfilling eligibility criteria and willing to participate in the study will be
      randomized to one of the two groups after the baseline assessment with follow-up after 3, 6
      and 12 months (Subsequently, a 24-month follow-up has been added):

        1. Arthroscopic meniscal surgery: Arthroscopic meniscal repair or resection will be
           conducted at the discretion of the operating surgeon (this cannot be determined before
           the surgeon has visual confirmation about the exact knee pathology and extend of the
           meniscal tear by scope).

           After surgery, patients will receive the standard rehabilitation in the postoperative
           period depending of type of surgery, since this differs for patients who have had
           resection and repair. A standard folder with exercises will be given to those having a
           partial meniscectomy to ensure a minimum level of rehabilitation after the surgery
           across the hospitals.

        2. Exercise therapy and patient education: Patients allocated to exercise therapy and
           education will participate in a 12-week (2 exercise sessions per week) supervised
           neuromuscular and strengthening exercise program tailored to 18-40 years old patients
           with a meniscal tear. Furthermore, they will participate in a patient education program
           developed through interviews with pilot study participants, from our experiences from
           the Good Life with osteoArthritis in Denmark (GLA:D) program for patients with knee and
           hip pain. Both the exercise and education will take place in a number of private
           physiotherapy clinics associated with the GLA:D program, specifically trained to
           supervise and lead the treatment in this study. A similar exercise program and
           educational program have been shown to be effective in improving pain, function and
           quality of life in patients with other types of knee injuries and knee pain.

      Observational cohort:

      Patients fulfilling all eligibility but unwilling to participate in the randomized study and
      patients 18-40 years of age with a clinical history and symptoms consistent with a meniscal
      tear that does not fulfill the other criteria are asked to participate in an observational
      cohort with the same questionnaires as in the RCT, but following usual clinical practice.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: the Knee Injury and Osteoarthritis Outcome Score (KOOS4)
time frame: Primary endpoint: Change from baseline to 12 months.
description: The mean score for the KOOS subscales Pain, Symptoms, Function in sports and recreational activities, and Quality of life. All visits (baseline, 3, 6 and 12 months) will be included in the analysis. Will also be assessed after 24 months.
measure: The five KOOS subscales
time frame: Primary endpoint: Change from baseline to 12 months.
description: To allow for clinical in-depth interpretation, the primary outcome will be complemented by subscale scores from each of the five individual KOOS subscales. All visits (baseline, 3, 6 and 12 months) will be included in the analysis. Will also be assessed after 24 months.
measure: Western Ontario Meniscal Evaluation Tool (WOMET)
time frame: Primary endpoint: Change from baseline to 12 months.
description: WOMET is a meniscus specific patient-reported outcome measure that will be used to complement the KOOS score. All visits (baseline, 3, 6 and 12 months) will be included in the analysis. Will also be assessed after 24 months.
measure: Isometric muscle strength
time frame: Primary endpoint: Change from baseline to 3 months.
description: Isometric muscle strength will be assessed using the FysioMeter. Assessed at baseline, 3 and 12 months.
measure: The maximum number of knee-bends in 30s
time frame: Primary endpoint: Change from baseline to 12 months.
description: The maximum number of knee-bends in 30s is one of three measures of functional performance. All visits (baseline, 3, 6 and 12 months) will be included in the analysis.
measure: The one-leg hop for distance
time frame: Primary endpoint: 12 months.
description: The one-leg hop for distance is one of three measures of functional performance. Assessed only at 12 months.
measure: The 6 m timed hop
time frame: Primary endpoint: 12 months.
description: The 6 m timed hop is one of three measures of functional performance. Assessed only at 12 months.
measure: Adverse events
time frame: Primary endpoint: 12 months.
description: Adverse events (AE) and serious adverse events (SAE) will be recorded at all follow-ups by asking the participants about potential AEs using open-probe questioning to ensure that all AEs are recorded. Furthermore, the medical records from the participating hospitals will be checked at the primary endpoint (12 months) for all AEs occurring from inclusion until the 12 months follow-up. AEs will be categorized into index knee or other sites and will be recorded and assessed for severity independent of whether or not there is a causal relationship with study treatments. Assessed at 3, 6 and 12 months. Will also be assessed after 24 months.
measure: Structural knee joint changes
time frame: Baseline to 24 months
description: Structural knee joint changes from baseline to 24 months will be assessed using the Anterior Cruciate Ligament OsteoArthritis Score (ACLOAS).
measure: EQ-5D
time frame: Primary endpoint: Change from baseline to 12 months.
description: General health will be assessed using the EQ-5D-5L questionnaire (5-level version), both the descriptive index and the EQ-VAS. This will also allow for a later cost-effectiveness analysis. Assessed at baseline, 3, 6 and 12 months. Will also be assessed after 24 months.
measure: Questions on function with Short Message Service (SMS)
time frame: Each week during the first 3 months and after that each month until the 12 months follow-up
description: The subscale Sport/Rec from the KOOS
measure: Questions on pain with Short Message Service (SMS)
time frame: Each week during the first 3 months and after that each month until the 12 months follow-up
description: Pain intensity going up/down stairs and pain intensity during sitting/lying on a 11-point Numeric Rating Scale (NRS)
measure: Physical activity level
time frame: Primary endpoint: 12 months. Assessed at baseline, 3, 6 and 12 months. Will also be assessed after 24 months.
measure: Participation in sports (Tegner activity scale)
time frame: Primary endpoint: 12 months. Assessed at baseline, 3, 6 and 12 months. Will also be assessed after 24 months.
measure: Global Perceived Effect (GPE)
time frame: Primary endpoint: 12 months.
description: Answered on 7-point Likert scale. Assessed at 3, 6 and 12 months. Will also be assessed after 24 months.
measure: Patient Acceptable Symptom State (PASS)
time frame: Primary endpoint: 12 months.
description: "When you think of your knee function, will you consider your current condition as satisfying? By knee function, you should take into account your activities of daily living, sport and recreational activities, your pain and other symptoms and your quality of life". Answered by "yes" or "no". Assessed at 3, 6 and 12 months. Will also be assessed after 24 months.
measure: Patient-reported treatment failure.
time frame: Primary endpoint: 12 months. Will also be assessed after 24 months.
description: Only answered by patients answering "no" to PASS. "Would you consider your current state as being so unsatisfactory that you consider the treatment to have failed?". Answered by "yes" or "no".
measure: Patient-reported mechanical symptoms related to the knee
time frame: Assessed at baseline, 3, 6 and 12 months.
description: Patient-reported mechanical symptoms, i.e. catching and locking of the knee. Presence and frequency answered on 5-point scale.
measure: Knee instability
time frame: Assessed at baseline, 3, 6 and 12 months. Will also be assessed after 24 months.
description: Patient-reported knee instability. Presence and frequency of knee instability answered on a 6-point scale and how much it affects activity level answered on a 6-point scale.
measure: Compliance with exercise (only for patients in the exercise group)
time frame: Assessed at 3 months
description: The number of exercise sessions that the patient participate in out of the total 24 supervised sessions.
measure: Patient-reported participation in post-surgery exercise (only for patients in the surgery group)
time frame: Assessed at 3 months
description: Supervised or unsupervised and number of sessions.
measure: Surgery and other treatments during follow-up
time frame: Primary endpoint: 12 months.
description: Assessed at baseline, 3, 6 and 12 months by self-report and review of medical journals (surgery only). Other knee surgery will also be assessed at 24 months.
measure: Pain intensity on a 11-point Numeric Rating Scale (NRS)
time frame: Assessed at 3 months
description: Before and after each of the 24 supervised exercise sessions the patients will report their pain intensity. Only the patients in the group randomized to exercise and education.
measure: Expanded version of the International Society of Arthroscopy, Knee Surgery and Orthopedic Sports Medicine (ISAKOS) classification of meniscal tears questionnaire
time frame: Day 1 after surgery
description: Information about location of tear, type of tear and type of treatment (repair or resection) will be collected using an expanded version of the International Society of Arthroscopy, Knee Surgery and Orthopedic Sports Medicine (ISAKOS) classification of meniscal tears questionnaire by the operating surgeon. This will be supplemented with data from surgery reports.
arm group label: Arthroscopy
arm group type: Experimental
description: Arthroscopic meniscal repair or resection will be conducted at the discretion of the operating surgeon (this cannot be determined before the surgeon has visual confirmation about the exact knee pathology and extend of the meniscal tear by scope).
arm group label: Exercise and Education
arm group type: Active Comparator
description: Patients allocated to exercise therapy and education will participate in a 12-week (2 exercise sessions per week) supervised neuromuscular and strengthening exercise program tailored to 18-40 years old patients with a meniscal tear. Furthermore, they will participate in a patient education program developed through interviews with pilot study participants, from our experiences from the Good Life with osteoArthritis in Denmark (GLA:D) program for patients with knee and hip pain. Both the exercise and education will take place in a number of private physiotherapy clinics associated with the GLA:D program, specifically trained to supervise and lead the treatment in this study.
intervention type: Procedure
intervention name: Arthroscopic meniscal repair or resection
description: Arthroscopic meniscal repair or resection following standard procedures.
arm group label: Arthroscopy
intervention type: Behavioral
intervention name: Exercise and education
description: A 12-week (2 exercise sessions per week) supervised neuromuscular and strengthening exercise program tailored to 18-40 years old patients with a meniscal tear combined with patient education teaching the participants about their disease and how to manage it through exercise and in their daily life.
arm group label: Exercise and Education
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Søren T. Skou, PT, PhD
role: Principal Investigator
affiliation: University of Southern Denmark and Næstved-Slagelse-Ringsted Hospitals
last name: Jonas B Thorlund, MSc, PhD
role: Study Chair
affiliation: University of Southern Denmark
last name: Martin Lind, Prof, MD, PhD, DMSc
role: Study Chair
affiliation: Aarhus University Hospital
last name: Per Hölmich, Prof, MD, DMSc
role: Study Chair
affiliation: Copenhagen University Hospital, Amager-Hvidovre
last name: Hans P Jensen, MD
role: Study Chair
affiliation: Aalborg University Hospital
last name: Carsten Jensen, MSc, PhD
role: Study Chair
affiliation: Lillebælt Hospital in Kolding
last name: Muhammad Afzal, MD
role: Study Chair
affiliation: Naestved Hospital
last name: Uffe Jørgensen, Prof, MD, DMSc
role: Study Chair
affiliation: Odense University Hospital
last name: Mogens Strange Hansen, MD, PhD
role: Study Chair
affiliation: Elective Surgery Centre, Regionshospitalet Silkeborg
facility: 
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country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Southern Denmark
investigator full name: Søren Thorgaard Skou
investigator title: PT, PhD, Professor
sharing ipd: No