<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/NCT04458480</url>
  </required_header>
  <id_info>
    <org_study_id>M2019113</org_study_id>
    <nct_id>NCT04458480</nct_id>
  </id_info>
  <brief_title>Effect of Fast Inpatient Rehabilitation After TKA</brief_title>
  <official_title>Effect of Fast Inpatient Rehabilitation After Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Third Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rehabilitation is an important part of the post-operative treatment after TKA by consensus.&#xD;
      This study intends to analysis whether fast inpatient rehabilitation after TKA can improve&#xD;
      knee joint or general function, and ultimately explore for effects and values of fast&#xD;
      inpatient rehabilitation after TKA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rehabilitation, which is an important part of the post-operative treatment after TKA, could&#xD;
      effectively alleviate symptoms of pain and swell, as well as improve knee joint and general&#xD;
      function. It has reached a consensus that post-TKA rehabilitation should contain muscle&#xD;
      strengthening, ROM, proprioceptive, balance training and physical factor therapy, etc. This&#xD;
      study intends to use observational cohort study methods with exposure factor of fast&#xD;
      inpatient rehabilitation after TKA, establish a TKA exposure group and a control group of TKA&#xD;
      without inpatient rehabilitation, analysis whether fast inpatient rehabilitation after TKA&#xD;
      can improve knee joint or general function, and ultimately explore for effects and values of&#xD;
      fast inpatient rehabilitation after TKA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 7, 2019</start_date>
  <completion_date type="Anticipated">March 6, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 6, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>bilateral knee Rang Of Motion (ROM)</measure>
    <time_frame>1 day after TKA</time_frame>
    <description>bilateral knee flexion and extension ROM are measured by articular protractor</description>
  </primary_outcome>
  <primary_outcome>
    <measure>bilateral quadriceps femurs</measure>
    <time_frame>1 day after TKA</time_frame>
    <description>measured by manual muscle test (MMT)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>hamstrings muscle strength</measure>
    <time_frame>1 day after TKA</time_frame>
    <description>measured by manual muscle test (MMT)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospital for Special Surgery-Knee Rating scale (HSSKR)</measure>
    <time_frame>1 day after TKA</time_frame>
    <description>to measure knee function, with the minimum 0 and maximum 100, higher score means a better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>modified Barthel Index (mBI)</measure>
    <time_frame>1 day after TKA</time_frame>
    <description>to measure ADL, with the minimum 0 and maximum 100, higher score means a better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Numerical Rating Scale (NRS) for pain</measure>
    <time_frame>1 day after TKA</time_frame>
    <description>the minimum is 0 and maximum 10, higher score means a worse outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NRS for pain</measure>
    <time_frame>6 weeks after TKA</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>NRS for pain</measure>
    <time_frame>3 months after TKA</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>NRS for pain</measure>
    <time_frame>6 months after TKA</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee Injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>1 day after TKA</time_frame>
    <description>to measure knee function and global function, with the minimum 0 and maximum 100, higher score means a better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>KOOS</measure>
    <time_frame>6 weeks after TKA</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>KOOS</measure>
    <time_frame>3 months after TKA</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>KOOS</measure>
    <time_frame>6 months after TKA</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Total Knee Arthroplasty</condition>
  <condition>Rehabilitation</condition>
  <arm_group>
    <arm_group_label>Exposed Group</arm_group_label>
    <description>Both exposed group and control group are undertaken TKA surgery and routine postoperative management for 2 days in orthopedics department. Exposed group patients are transferred from orthopedics department to rehabilitation department on 2nd day after TKA, and accept fast inpatient rehabilitation for 1 week before hospital discharge, while control group patients continue to accept routine peri-operative management and conventional oral instructions of exercises in orthopedics department until hospital discharge.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <description>Both exposed group and control group are undertaken TKA surgery and routine postoperative management for 2 days in orthopedics department. Exposed group patients are transferred from orthopedics department to rehabilitation department on 2nd day after TKA, and accept fast inpatient rehabilitation for 1 week before hospital discharge, while control group patients continue to accept routine peri-operative management and conventional oral instructions of exercises in orthopedics department until hospital discharge.</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Fast Inpatient Rehabilitation</intervention_name>
    <description>Routine inpatient rehabilitation protocol, administered by licensed Physical Therapist, duration period of 1.5h-2h each time, 2 times for weekdays and 1 time for weekends, totally lasting for 1 week, are applied to the exposed group. After the fast inpatient rehabilitation for 1 week, the patients can get discharged if reaching to the rehabilitation goals of symptoms of pain and swell reduced, knee flexion ≥ 90° and knee extension ≥ 0°, quadriceps femurs and hamstrings muscle strength enhanced, recovery to aided standing and walking, and acquiring of rehabilitation training methods.</description>
    <arm_group_label>Exposed Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        He/She is admitted to orthopedics department of Peking University Third Hospital and&#xD;
        undertaken initial unilateral TKA due to osteoarthritis, rheumatoid arthritis, etc.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Initial unilateral TKA patients due to osteoarthritis, rheumatoid arthritis, etc.&#xD;
&#xD;
          -  Satisfactory operative knee joint ROM: knee flexion ≥120° and extension ≥ 0°.&#xD;
&#xD;
          -  Prior informed consent by patients.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Complication of other medical conditions and disability to cooperate with&#xD;
             rehabilitation.&#xD;
&#xD;
          -  Complication of other conditions affecting bilateral lower limbs such as fracture,&#xD;
             tumor, neurologic disorder, etc.&#xD;
&#xD;
          -  Deep venous thrombosis of lower limbs with exception of inter-muscular venous&#xD;
             thrombosis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mouwang Zhou, MM</last_name>
    <role>Study Chair</role>
    <affiliation>Peking University Third Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yanyan Yang, MD</last_name>
    <phone>+86 15611963453</phone>
    <email>yyykaixin@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wenjing Qi, MD</last_name>
    <phone>+86 15611105099</phone>
    <email>qwj2000@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mouwang Zhou, MM</last_name>
      <phone>13910092892</phone>
      <email>zhoumouwang@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 2, 2020</last_update_submitted>
  <last_update_submitted_qc>July 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fast Rehabilitation</keyword>
  <keyword>Inpatient Rehabilitation</keyword>
  <keyword>Total Knee Arthroplasty</keyword>
  <patient_data>
    <sharing_ipd>Yes</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/NCT04458480
org study id: M2019113
nct id: NCT04458480
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Rehabilitation is an important part of the post-operative treatment after TKA by consensus.
      This study intends to analysis whether fast inpatient rehabilitation after TKA can improve
      knee joint or general function, and ultimately explore for effects and values of fast
      inpatient rehabilitation after TKA.
Rehabilitation, which is an important part of the post-operative treatment after TKA, could
      effectively alleviate symptoms of pain and swell, as well as improve knee joint and general
      function. It has reached a consensus that post-TKA rehabilitation should contain muscle
      strengthening, ROM, proprioceptive, balance training and physical factor therapy, etc. This
      study intends to use observational cohort study methods with exposure factor of fast
      inpatient rehabilitation after TKA, establish a TKA exposure group and a control group of TKA
      without inpatient rehabilitation, analysis whether fast inpatient rehabilitation after TKA
      can improve knee joint or general function, and ultimately explore for effects and values of
      fast inpatient rehabilitation after TKA.
observational model: Cohort
time perspective: Prospective
measure: bilateral knee Rang Of Motion (ROM)
time frame: 1 day after TKA
description: bilateral knee flexion and extension ROM are measured by articular protractor
measure: bilateral quadriceps femurs
time frame: 1 day after TKA
description: measured by manual muscle test (MMT)
measure: hamstrings muscle strength
time frame: 1 day after TKA
description: measured by manual muscle test (MMT)
measure: Hospital for Special Surgery-Knee Rating scale (HSSKR)
time frame: 1 day after TKA
description: to measure knee function, with the minimum 0 and maximum 100, higher score means a better outcome
measure: modified Barthel Index (mBI)
time frame: 1 day after TKA
description: to measure ADL, with the minimum 0 and maximum 100, higher score means a better outcome
measure: Numerical Rating Scale (NRS) for pain
time frame: 1 day after TKA
description: the minimum is 0 and maximum 10, higher score means a worse outcome
measure: NRS for pain
time frame: 6 weeks after TKA
measure: NRS for pain
time frame: 3 months after TKA
measure: NRS for pain
time frame: 6 months after TKA
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
time frame: 1 day after TKA
description: to measure knee function and global function, with the minimum 0 and maximum 100, higher score means a better outcome
measure: KOOS
time frame: 6 weeks after TKA
measure: KOOS
time frame: 3 months after TKA
measure: KOOS
time frame: 6 months after TKA
arm group label: Exposed Group
description: Both exposed group and control group are undertaken TKA surgery and routine postoperative management for 2 days in orthopedics department. Exposed group patients are transferred from orthopedics department to rehabilitation department on 2nd day after TKA, and accept fast inpatient rehabilitation for 1 week before hospital discharge, while control group patients continue to accept routine peri-operative management and conventional oral instructions of exercises in orthopedics department until hospital discharge.
arm group label: Control Group
description: Both exposed group and control group are undertaken TKA surgery and routine postoperative management for 2 days in orthopedics department. Exposed group patients are transferred from orthopedics department to rehabilitation department on 2nd day after TKA, and accept fast inpatient rehabilitation for 1 week before hospital discharge, while control group patients continue to accept routine peri-operative management and conventional oral instructions of exercises in orthopedics department until hospital discharge.
intervention type: Combination Product
intervention name: Fast Inpatient Rehabilitation
description: Routine inpatient rehabilitation protocol, administered by licensed Physical Therapist, duration period of 1.5h-2h each time, 2 times for weekdays and 1 time for weekends, totally lasting for 1 week, are applied to the exposed group. After the fast inpatient rehabilitation for 1 week, the patients can get discharged if reaching to the rehabilitation goals of symptoms of pain and swell reduced, knee flexion ≥ 90° and knee extension ≥ 0°, quadriceps femurs and hamstrings muscle strength enhanced, recovery to aided standing and walking, and acquiring of rehabilitation training methods.
arm group label: Exposed Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: No
last name: Mouwang Zhou, MM
role: Study Chair
affiliation: Peking University Third Hospital
last name: Yanyan Yang, MD
phone: +86 15611963453
email: yyykaixin@163.com
last name: Wenjing Qi, MD
phone: +86 15611105099
email: qwj2000@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
sharing ipd: Yes