<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/NCT02236689</url>
  </required_header>
  <id_info>
    <org_study_id>20140553-01H</org_study_id>
    <nct_id>NCT02236689</nct_id>
  </id_info>
  <brief_title>Comparing Arthroscopic Tennis Elbow Release With Arthroscopic Debridement</brief_title>
  <official_title>A Randomized, Double-blind Controlled Trial Comparing Arthroscopic Tennis Elbow Release With Arthroscopic Debridement for the Management of Chronic Lateral Epicondylitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ottawa Hospital Research Institute</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>
      We propose a randomized, double-blind controlled trial comparing arthroscopic release with&#xD;
      arthroscopic debridement for the management of chronic tennis elbow in an effort to&#xD;
      definitively determine whether arthroscopic tennis elbow release is an effective treatment of&#xD;
      tennis elbow, and to further provide better recommendations for the use of this procedure, in&#xD;
      an effort to improve patient care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lateral epicondylitis (tennis elbow) is a common occurrence in the general population with an&#xD;
      incidence of 4-7/1000/year. More recent literature describes a 1-3% rate over the course of a&#xD;
      lifetime, most typically affecting individuals between the ages of 35 and 50.&#xD;
&#xD;
      Tennis elbow is a common occurrence in the general population that causes lateral elbow pain&#xD;
      and diminished grip strength, which may be debilitating. Most affected individuals achieve&#xD;
      symptom resolution within 6 months to 1 year with measures such as physiotherapy,&#xD;
      anti-inflammatories and corticosteroid injections, but a small subset will go on to develop&#xD;
      chronic symptoms. Chronic tennis elbow can be treated surgically, by arthroscopic tennis&#xD;
      elbow release (ATER), which has gained popularity in recent years as it presents a less&#xD;
      invasive option, allows for direct visualization of the elbow joint for other pathology and&#xD;
      has a faster return-to-work time compared to other surgical procedures. Despite its promise&#xD;
      there have been no high quality studies evaluating the efficacy of arthroscopic tennis elbow&#xD;
      release, bringing the actual efficacy of this procedure into question. A randomized&#xD;
      controlled trial on arthroscopic tennis elbow release would provide much needed evidence in&#xD;
      order to define its role in the management of tennis elbow and to help refine treatment&#xD;
      protocols.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 2016</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">June 2025</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Mayo Elbow Performance Score</measure>
    <time_frame>From baseline to up until 24-Months Post-Operative</time_frame>
    <description>The Mayo Elbow Performance score is an outcome measure specific to the elbow to assess activities of daily living (ADLs). This outcome measure consists of 4 subscales: pain, range of motion, stability and daily function. Each section is combined for a total score out of 100 points. A higher score, indicates a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Disabilities of the Arm, Shoulder and Hand (DASH)</measure>
    <time_frame>From baseline to up until 24-Months Post-Operative</time_frame>
    <description>The Disabilities of the Arm, Shoulder and Hand (DASH), is a questionnaire that measures physical function and symptoms in those with an upper extremity disorder. The DASH is a 30 item questionnaire, each question is rated using a Likert scale. The question points are combined for a total of 100 points. A higher score indicates a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in American Shoulder and Elbow Surgeons Elbow (ASES)</measure>
    <time_frame>From baseline to up until 24-Months Post-Operative</time_frame>
    <description>The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Oxford Elbow Score (OES)</measure>
    <time_frame>From time of enrollment up until 2-years post-operative</time_frame>
    <description>The Oxford Elbow Score (OES) is an outcome measure specific to patients who have had elbow surgery. The OES consists of 12 questions, looking into 3 domains: elbow function, pain, and social-psychological, using a Likert scale. Questions are summed, for a total score of 100 points. A higher score indicates a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Grip Strength</measure>
    <time_frame>From time of enrollment up until 2-years post-operative</time_frame>
    <description>Grip strength will be measured using a hand-held dynamometer. Each participant will be asked to squeeze as much as they are comfortably able for approximately 3 seconds. 3 trials will be completed on each hand. Results will be averaged, and recorded in kilograms. Higher strength is a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>Ongoing from time of enrollment, up until 24-months post-operative</time_frame>
    <description>Rates of study adverse events or serious adverse events (e.g. number of reoperations) will be monitored and recorded and compared between study groups. A higher rate of adverse events indicates a worse outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">68</enrollment>
  <condition>Tennis Elbow</condition>
  <arm_group>
    <arm_group_label>Arthroscopic tennis elbow release</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will have arthroscopic tennis elbow release through a standard, two-portal technique,</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non Operative</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>control group will not undergo a second portal or muscle release.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Non operative</intervention_name>
    <description>no surgical intervention</description>
    <arm_group_label>Non Operative</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Arthroscopic tennis elbow release</intervention_name>
    <description>Patients randomized to Arthroscopic tennis elbow release (ATER) will receive arthroscopic release of the origin of the extensor carpi radialis brevis tendon through a standard, two-portal arthroscopic technique (medial and lateral).</description>
    <arm_group_label>Arthroscopic tennis elbow release</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients eligible for inclusion in the study will have had symptoms for at least 9&#xD;
             months and have failed conservative management.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant prior elbow trauma will be excluded alternative diagnoses that better&#xD;
             explain their symptoms&#xD;
&#xD;
          -  Patients who have had significant prior elbow trauma or surgery&#xD;
&#xD;
          -  WSIB patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>J W Pollock, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Ottawa Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>J W Pollock, MD</last_name>
    <phone>613-737-8899</phone>
    <phone_ext>73031</phone_ext>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Katie McIlquham</last_name>
    <phone>613-737-8899</phone>
    <phone_ext>79839</phone_ext>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Ottawa Hospital, General Campus</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>J Pollock, MD</last_name>
      <phone>613-737-8899</phone>
      <phone_ext>73031</phone_ext>
    </contact>
    <investigator>
      <last_name>J W Pollock, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>September 21, 2022</last_update_submitted>
  <last_update_submitted_qc>September 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2022</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>Tennis Elbow</mesh_term>
  </condition_browse>
  <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/NCT02236689
org study id: 20140553-01H
nct id: NCT02236689
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
We propose a randomized, double-blind controlled trial comparing arthroscopic release with
      arthroscopic debridement for the management of chronic tennis elbow in an effort to
      definitively determine whether arthroscopic tennis elbow release is an effective treatment of
      tennis elbow, and to further provide better recommendations for the use of this procedure, in
      an effort to improve patient care.
Lateral epicondylitis (tennis elbow) is a common occurrence in the general population with an
      incidence of 4-7/1000/year. More recent literature describes a 1-3% rate over the course of a
      lifetime, most typically affecting individuals between the ages of 35 and 50.

      Tennis elbow is a common occurrence in the general population that causes lateral elbow pain
      and diminished grip strength, which may be debilitating. Most affected individuals achieve
      symptom resolution within 6 months to 1 year with measures such as physiotherapy,
      anti-inflammatories and corticosteroid injections, but a small subset will go on to develop
      chronic symptoms. Chronic tennis elbow can be treated surgically, by arthroscopic tennis
      elbow release (ATER), which has gained popularity in recent years as it presents a less
      invasive option, allows for direct visualization of the elbow joint for other pathology and
      has a faster return-to-work time compared to other surgical procedures. Despite its promise
      there have been no high quality studies evaluating the efficacy of arthroscopic tennis elbow
      release, bringing the actual efficacy of this procedure into question. A randomized
      controlled trial on arthroscopic tennis elbow release would provide much needed evidence in
      order to define its role in the management of tennis elbow and to help refine treatment
      protocols.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change in Mayo Elbow Performance Score
time frame: From baseline to up until 24-Months Post-Operative
description: The Mayo Elbow Performance score is an outcome measure specific to the elbow to assess activities of daily living (ADLs). This outcome measure consists of 4 subscales: pain, range of motion, stability and daily function. Each section is combined for a total score out of 100 points. A higher score, indicates a better outcome.
measure: Change in Disabilities of the Arm, Shoulder and Hand (DASH)
time frame: From baseline to up until 24-Months Post-Operative
description: The Disabilities of the Arm, Shoulder and Hand (DASH), is a questionnaire that measures physical function and symptoms in those with an upper extremity disorder. The DASH is a 30 item questionnaire, each question is rated using a Likert scale. The question points are combined for a total of 100 points. A higher score indicates a worse outcome.
measure: Change in American Shoulder and Elbow Surgeons Elbow (ASES)
time frame: From baseline to up until 24-Months Post-Operative
description: The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome.
measure: Change in Oxford Elbow Score (OES)
time frame: From time of enrollment up until 2-years post-operative
description: The Oxford Elbow Score (OES) is an outcome measure specific to patients who have had elbow surgery. The OES consists of 12 questions, looking into 3 domains: elbow function, pain, and social-psychological, using a Likert scale. Questions are summed, for a total score of 100 points. A higher score indicates a better outcome.
measure: Change in Grip Strength
time frame: From time of enrollment up until 2-years post-operative
description: Grip strength will be measured using a hand-held dynamometer. Each participant will be asked to squeeze as much as they are comfortably able for approximately 3 seconds. 3 trials will be completed on each hand. Results will be averaged, and recorded in kilograms. Higher strength is a better outcome.
measure: Adverse Events
time frame: Ongoing from time of enrollment, up until 24-months post-operative
description: Rates of study adverse events or serious adverse events (e.g. number of reoperations) will be monitored and recorded and compared between study groups. A higher rate of adverse events indicates a worse outcome.
arm group label: Arthroscopic tennis elbow release
arm group type: Active Comparator
description: This group will have arthroscopic tennis elbow release through a standard, two-portal technique,
arm group label: Non Operative
arm group type: Placebo Comparator
description: control group will not undergo a second portal or muscle release.
intervention type: Procedure
intervention name: Non operative
description: no surgical intervention
arm group label: Non Operative
intervention type: Procedure
intervention name: Arthroscopic tennis elbow release
description: Patients randomized to Arthroscopic tennis elbow release (ATER) will receive arthroscopic release of the origin of the extensor carpi radialis brevis tendon through a standard, two-portal arthroscopic technique (medial and lateral).
arm group label: Arthroscopic tennis elbow release
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: J W Pollock, MD
role: Principal Investigator
affiliation: The Ottawa Hospital
last name: J W Pollock, MD
phone: 613-737-8899
phone ext: 73031
last name: Katie McIlquham
phone: 613-737-8899
phone ext: 79839
facility: 
status: Recruiting
contact: 
investigator: 
country: Canada
responsible party type: Sponsor
mesh term: Tennis Elbow
sharing ipd: No