<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/NCT04458025</url>
  </required_header>
  <id_info>
    <org_study_id>RAPIDREHAB</org_study_id>
    <nct_id>NCT04458025</nct_id>
  </id_info>
  <brief_title>Prospective, Randomized Clinical Trial Comparing Early Versus Delayed Postoperative Mobilization After Arthroscopic Rotator Cuff Tear Reapair.</brief_title>
  <acronym>RAPIDREHAB</acronym>
  <official_title>Prospective, Randomized Clinical Trial Comparing Early Versus Delayed Postoperative Mobilization After Arthroscopic Rotator Cuff Tear Reapair.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Borja Alcobía-Díaz MD, PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital San Carlos, Madrid</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>
      Arthroscopic suture for complete and partial &gt;50% thickness Rotator Cuff Tears (RCT) is the&#xD;
      gold standard. However, there is no evidence of superiority of delayed postoperative&#xD;
      mobilization protocols versus early ones, in terms of ROM, pain, quality of life and&#xD;
      complications in last review published in 2019 by AAOS. Although, excessive immobilization&#xD;
      can lead into stiffness, neuropathic pain or adhesive capsulitis. All of these are&#xD;
      complications which can diminish patient quality of life or prolong their return to work or&#xD;
      sports activities.&#xD;
&#xD;
      This is an experimental, prospective, non-blind, comparative, randomized clinical trial,&#xD;
      between two options of treatment. On one treatment branch, we will continue applying our&#xD;
      standard postoperative 4 weeks immobilization rehabilitation program with a sling in&#xD;
      adduction and internal rotation. On the other treatment branch, we will start passive&#xD;
      mobilization during second week after surgery, including controlled external rotation&#xD;
      movements. All recruited patients will be followed-up during 12 months.&#xD;
&#xD;
      Our main objective is to compare differences in terms of functionality (using ASES scale).&#xD;
      Secondary objectives are to compare differences in terms of ROM, functionality (using CMS and&#xD;
      UCLA scales), pain (using VAS score), need of analgesic drugs, quality of life (using EQ-5D&#xD;
      scale), return to previous work and sports activities, patient adhesion to protocol,&#xD;
      complications and MRI rotator cuff retear ratio at 12 months follow-up.&#xD;
&#xD;
      After this study, we hope to develop a new postoperative mobilization protocol for patients.&#xD;
      This protocol will be focused on timing, and self-administrated exercises in order to involve&#xD;
      patients in their recovery, in the fastest and safest way for them.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 30, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Functionality</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Functionality assessment using ASES scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functionality-Constant-Murley scale</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Functionality assessment using Constant-Murley scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functionality-UCLA</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Functionality assessment using UCLA scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Pain estimation according to visual analogic scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of motion</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Range of motion measured in degrees of a circle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analgesic use</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Need of analgesic drugs during the follow up period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Quality of life according to EQ-5D scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Complications related to the surgery or rehabilitation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRI rotator cuff retear ratio</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>MRI rotator cuff retear ratio determinate by MRI</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">64</enrollment>
  <condition>Rotator Cuff Tear Repair</condition>
  <arm_group>
    <arm_group_label>Standard rehabilitation program</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard postoperative 4 weeks immobilization rehabilitation program with a sling in adduction and internal rotation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Early rehabilitation program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Early rehabilitation program will start passive mobilization during second week after surgery, including controlled external rotation movements</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard rehabilitation program</intervention_name>
    <description>Standard rehabilitation will start 4 weeks after surgery according to the standard of cre</description>
    <arm_group_label>Standard rehabilitation program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Early rehabilitation program</intervention_name>
    <description>Early rehabilitation program will start 2 weeks</description>
    <arm_group_label>Early rehabilitation program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: Less tan 70 years old.&#xD;
&#xD;
          -  Sex: Male or Female.&#xD;
&#xD;
          -  Treatment: Arthroscopic RCT suture.&#xD;
&#xD;
          -  RCT type: Degenerative, total or partial &gt;50% thickness, less than 3 cm length tear.&#xD;
&#xD;
          -  MRI Tear Classification: Patté's in coronal view I or II, Goutalier's &lt;2, Fukuda's &lt;2&#xD;
             and Seebauer´s 1A maximum.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not meet the inclusion criteria.&#xD;
&#xD;
          -  Previous surgical procedure in affected shoulder.&#xD;
&#xD;
          -  Have been treated with 2 or more glucocorticoid injections in last year.&#xD;
&#xD;
          -  High anesthetic risk.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Borja Alcobía Díaz, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Clinico San Carlos</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Borja Alcobía Díaz, MD PhD</last_name>
    <phone>913303638</phone>
    <email>balcobiadiaz@gmail.com</email>
  </overall_contact>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hospital San Carlos, Madrid</investigator_affiliation>
    <investigator_full_name>Borja Alcobía-Díaz MD, PhD</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rotator Cuff 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/NCT04458025
org study id: RAPIDREHAB
nct id: NCT04458025
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Arthroscopic suture for complete and partial >50% thickness Rotator Cuff Tears (RCT) is the
      gold standard. However, there is no evidence of superiority of delayed postoperative
      mobilization protocols versus early ones, in terms of ROM, pain, quality of life and
      complications in last review published in 2019 by AAOS. Although, excessive immobilization
      can lead into stiffness, neuropathic pain or adhesive capsulitis. All of these are
      complications which can diminish patient quality of life or prolong their return to work or
      sports activities.

      This is an experimental, prospective, non-blind, comparative, randomized clinical trial,
      between two options of treatment. On one treatment branch, we will continue applying our
      standard postoperative 4 weeks immobilization rehabilitation program with a sling in
      adduction and internal rotation. On the other treatment branch, we will start passive
      mobilization during second week after surgery, including controlled external rotation
      movements. All recruited patients will be followed-up during 12 months.

      Our main objective is to compare differences in terms of functionality (using ASES scale).
      Secondary objectives are to compare differences in terms of ROM, functionality (using CMS and
      UCLA scales), pain (using VAS score), need of analgesic drugs, quality of life (using EQ-5D
      scale), return to previous work and sports activities, patient adhesion to protocol,
      complications and MRI rotator cuff retear ratio at 12 months follow-up.

      After this study, we hope to develop a new postoperative mobilization protocol for patients.
      This protocol will be focused on timing, and self-administrated exercises in order to involve
      patients in their recovery, in the fastest and safest way for them.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Functionality
time frame: 12 months after surgery
description: Functionality assessment using ASES scale
measure: Functionality-Constant-Murley scale
time frame: 12 months after surgery
description: Functionality assessment using Constant-Murley scale
measure: Functionality-UCLA
time frame: 12 months after surgery
description: Functionality assessment using UCLA scale
measure: Pain
time frame: 12 months after surgery
description: Pain estimation according to visual analogic scale
measure: Range of motion
time frame: 12 months after surgery
description: Range of motion measured in degrees of a circle
measure: Analgesic use
time frame: 12 months after surgery
description: Need of analgesic drugs during the follow up period
measure: Quality of life
time frame: 12 months after surgery
description: Quality of life according to EQ-5D scale
measure: Complications
time frame: 12 months after surgery
description: Complications related to the surgery or rehabilitation
measure: MRI rotator cuff retear ratio
time frame: 12 months after surgery
description: MRI rotator cuff retear ratio determinate by MRI
arm group label: Standard rehabilitation program
arm group type: Active Comparator
description: Standard postoperative 4 weeks immobilization rehabilitation program with a sling in adduction and internal rotation
arm group label: Early rehabilitation program
arm group type: Experimental
description: Early rehabilitation program will start passive mobilization during second week after surgery, including controlled external rotation movements
intervention type: Other
intervention name: Standard rehabilitation program
description: Standard rehabilitation will start 4 weeks after surgery according to the standard of cre
arm group label: Standard rehabilitation program
intervention type: Other
intervention name: Early rehabilitation program
description: Early rehabilitation program will start 2 weeks
arm group label: Early rehabilitation program
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Borja Alcobía Díaz, MD PhD
role: Principal Investigator
affiliation: Hospital Clinico San Carlos
last name: Borja Alcobía Díaz, MD PhD
phone: 913303638
email: balcobiadiaz@gmail.com
responsible party type: Sponsor-Investigator
investigator affiliation: Hospital San Carlos, Madrid
investigator full name: Borja Alcobía-Díaz MD, PhD
investigator title: MD, PhD
mesh term: Rotator Cuff Injuries
sharing ipd: Undecided