xml: <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/NCT05980312</url>
    </required_header>
    <id_info>
      <org_study_id>19-196</org_study_id>
      <nct_id>NCT05980312</nct_id>
    </id_info>
    <brief_title>Does Early Elbow Motion Improve Patient Outcomes After Surgically Treated Elbow Fractures?</brief_title>
    <official_title>Early Range of Motion Versus Plaster Immobilization After Open Reduction Internal Fixation of Elbow Fractures: A Prospective, Randomized Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Cooper Health System</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Cooper Health System</source>
    <oversight_info>
      <has_dmc>No</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>
        The purpose of this study is to compare the safety and efficacy, defined as improved range of&#xD;
        motion and functional outcome scores, of early elbow motion in the early (immediately&#xD;
        post-op) and late postoperative periods (2 week post-op).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A prospective randomized clinical trial will be performed. Patients over the age of 18&#xD;
        undergoing operative fixation of an elbow fracture by a Cooper orthopaedic surgeon will be&#xD;
        considered for study inclusion. Patients who are under the age of 18, pregnant, admitted to&#xD;
        the ICU, have a history of trauma/injury to the joint, or extensive soft tissue injury as&#xD;
        determined by the treating orthopaedic surgeon will be excluded from study participation. All&#xD;
        surgeons listed as co-investigators on this study have agreed to participate. Surgeons who&#xD;
        may want to handle postop care differently despite randomization were not listed as&#xD;
        co-investigators on this study. All patients will undergo operative fracture fixation of the&#xD;
        elbow, which is standard of care. The decision for operative treatment will be made prior to&#xD;
        study participation based on fracture classification and the discretion of the orthopaedic&#xD;
        trauma team. There are discrete indications for operative treatment of elbow fractures in the&#xD;
        orthopaedic literature. These guidelines are based upon the AO/OTA fracture classifications.&#xD;
        Operative indications for elbow fractures include: type 13 humerus fractures including all&#xD;
        subtypes, type 2r1 radius fractures including all subtypes, and type 2u1 ulna fractures&#xD;
        including all subtypes. After this decision is made, the patient will be considered for study&#xD;
        inclusion. There will be two treatment groups. The control group will be immobilized in a&#xD;
        splint for 2 weeks and will be allowed to resume unrestricted motion at 2 weeks postop. The&#xD;
        experimental group will be allowed to use unrestricted motion immediately after surgery. Both&#xD;
        groups will be followed up postoperatively to monitor for pain, range of motion, and elbow&#xD;
        function as well as the presence of complications. Once there is adequate pain control and if&#xD;
        there are no complications, the patient will be discharged. All patients will be instructed&#xD;
        to follow up with their surgeon within 2 weeks. If patients do not follow-up with the surgeon&#xD;
        in 2 weeks time, the research team will call the patient to monitor clinical progress. At the&#xD;
        time of follow-up, all patients will be recommended to go to physical therapy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 27, 2019</start_date>
    <completion_date type="Actual">April 20, 2023</completion_date>
    <primary_completion_date type="Actual">January 1, 2023</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>
      <intervention_model_description>Prospective, randomized clinical trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>ASES-E Scores</measure>
      <time_frame>Preoperative and postoperatively as 2 weeks, 6 weeks, 3 months, 6 months, and 1 year</time_frame>
      <description>A standardized elbow evaluation was developed by the Research Committee of the American Shoulder and Elbow Surgeons 1 (ASES). This score allows the evaluation of elbow function independently from the underlying diagnosis.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>HSS Elbow Score</measure>
      <time_frame>Preoperative and postoperatively as 2 weeks, 6 weeks, 3 months, 6 months, and 1 year</time_frame>
      <description>The Hospital for Special Surgery (HSS) scoring system 31 consists of eight domains described as pain, function, sagittal range, muscle strength, flexion contracture, extension contracture, pronation, and supination.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Range of Motion</measure>
      <time_frame>Preoperative and postoperatively as 2 weeks, 6 weeks, 3 months, 6 months, and 1 year</time_frame>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">80</enrollment>
    <condition>Elbow Fracture</condition>
    <condition>Range of Motion</condition>
    <condition>Immobilization</condition>
    <arm_group>
      <arm_group_label>Immobilized</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients in the control group will be immobilized for 2 weeks and resume unrestricted motion once the splint is taken off.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Early Range of Motion</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients in the experimental group will start early motion immediately after surgery.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Splint Immobilization</intervention_name>
      <description>Patients will be randomized to receive a splint following their surgical procedure.</description>
      <arm_group_label>Immobilized</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Early Motion</intervention_name>
      <description>Patients will be randomized to receive no splint following their surgical procedure.</description>
      <arm_group_label>Early Range of Motion</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subjects must have undergone operative treatment for an elbow fracture&#xD;
  &#xD;
            -  Operative indications for elbow fractures include: Type 13 humerus fractures including&#xD;
               all subtypes, Type 2r1 radius fractures including all subtypes, Type 2u1 ulna&#xD;
               fractures including all subtypes.&#xD;
  &#xD;
            -  Individuals over the age of 18 years old.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any patient who had not undergone operative treatment of an elbow fracture will be&#xD;
               excluded.&#xD;
  &#xD;
            -  Patients who were not treated surgically by an orthopaedic surgeon or were treated&#xD;
               outside of the study frame will be excluded.&#xD;
  &#xD;
            -  Individuals under the age of 18.&#xD;
  &#xD;
            -  Pregnant women.&#xD;
  &#xD;
            -  Patients admitted to the intensive care unit (ICU).&#xD;
  &#xD;
            -  Patients with a history of trauma or injury to the affected elbow will be excluded.&#xD;
  &#xD;
            -  Patients with extensive soft tissue injury of the elbow, which is defined as any&#xD;
               injury that requires graft coverage, will be excluded.&#xD;
  &#xD;
            -  Non-English speaking patients will be excluded.&#xD;
  &#xD;
            -  Decisional-impaired patients will be excluded (as no substitute consent is requested).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Cooper University Health Care</name>
        <address>
          <city>Camden</city>
          <state>New Jersey</state>
          <zip>08103</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The Cooper Health System</investigator_affiliation>
      <investigator_full_name>David Fuller</investigator_full_name>
      <investigator_title>Orthopaedic Surgeon</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fractures, Bone</mesh_term>
      <mesh_term>Elbow Fractures</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05980312
  org study id: 19-196
  nct id: NCT05980312
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to compare the safety and efficacy, defined as improved range of
        motion and functional outcome scores, of early elbow motion in the early (immediately
        post-op) and late postoperative periods (2 week post-op).
  A prospective randomized clinical trial will be performed. Patients over the age of 18
        undergoing operative fixation of an elbow fracture by a Cooper orthopaedic surgeon will be
        considered for study inclusion. Patients who are under the age of 18, pregnant, admitted to
        the ICU, have a history of trauma/injury to the joint, or extensive soft tissue injury as
        determined by the treating orthopaedic surgeon will be excluded from study participation. All
        surgeons listed as co-investigators on this study have agreed to participate. Surgeons who
        may want to handle postop care differently despite randomization were not listed as
        co-investigators on this study. All patients will undergo operative fracture fixation of the
        elbow, which is standard of care. The decision for operative treatment will be made prior to
        study participation based on fracture classification and the discretion of the orthopaedic
        trauma team. There are discrete indications for operative treatment of elbow fractures in the
        orthopaedic literature. These guidelines are based upon the AO/OTA fracture classifications.
        Operative indications for elbow fractures include: type 13 humerus fractures including all
        subtypes, type 2r1 radius fractures including all subtypes, and type 2u1 ulna fractures
        including all subtypes. After this decision is made, the patient will be considered for study
        inclusion. There will be two treatment groups. The control group will be immobilized in a
        splint for 2 weeks and will be allowed to resume unrestricted motion at 2 weeks postop. The
        experimental group will be allowed to use unrestricted motion immediately after surgery. Both
        groups will be followed up postoperatively to monitor for pain, range of motion, and elbow
        function as well as the presence of complications. Once there is adequate pain control and if
        there are no complications, the patient will be discharged. All patients will be instructed
        to follow up with their surgeon within 2 weeks. If patients do not follow-up with the surgeon
        in 2 weeks time, the research team will call the patient to monitor clinical progress. At the
        time of follow-up, all patients will be recommended to go to physical therapy.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Prospective, randomized clinical trial
  primary purpose: Treatment
  masking: None (Open Label)
  measure: ASES-E Scores
  time frame: Preoperative and postoperatively as 2 weeks, 6 weeks, 3 months, 6 months, and 1 year
  description: A standardized elbow evaluation was developed by the Research Committee of the American Shoulder and Elbow Surgeons 1 (ASES). This score allows the evaluation of elbow function independently from the underlying diagnosis.
  measure: HSS Elbow Score
  time frame: Preoperative and postoperatively as 2 weeks, 6 weeks, 3 months, 6 months, and 1 year
  description: The Hospital for Special Surgery (HSS) scoring system 31 consists of eight domains described as pain, function, sagittal range, muscle strength, flexion contracture, extension contracture, pronation, and supination.
  measure: Range of Motion
  time frame: Preoperative and postoperatively as 2 weeks, 6 weeks, 3 months, 6 months, and 1 year
  arm group label: Immobilized
  arm group type: Active Comparator
  description: Patients in the control group will be immobilized for 2 weeks and resume unrestricted motion once the splint is taken off.
  arm group label: Early Range of Motion
  arm group type: Experimental
  description: Patients in the experimental group will start early motion immediately after surgery.
  intervention type: Other
  intervention name: Splint Immobilization
  description: Patients will be randomized to receive a splint following their surgical procedure.
  arm group label: Immobilized
  intervention type: Other
  intervention name: Early Motion
  description: Patients will be randomized to receive no splint following their surgical procedure.
  arm group label: Early Range of Motion
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: The Cooper Health System
  investigator full name: David Fuller
  investigator title: Orthopaedic Surgeon
  mesh term: Fractures, Bone
  mesh term: Elbow Fractures
  sharing ipd: No