<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/NCT04418687</url>
  </required_header>
  <id_info>
    <org_study_id>IRAS 235931</org_study_id>
    <nct_id>NCT04418687</nct_id>
  </id_info>
  <brief_title>Use of the Orthoglide for Improved Patient Outcome Following Total Knee Replacement</brief_title>
  <official_title>Does the Use of an Orthoglide Device Improve Patient Outcome, Following Total Knee Replacement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ambreen Chohan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Blackpool Victoria Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Central Lancashire</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>
      Total knee replacements are a common orthopaedic procedure undertaken at Blackpool Victoria&#xD;
      Hospital. Following surgery patients are routinely seen by Physiotherapists who prescribe&#xD;
      exercises to improve the range of movement and strength of the knee joint, thus aiding&#xD;
      recovery. One of the key exercises prescribed involves the bending and straightening of the&#xD;
      knee to improve range of movement. At this early stage of rehabilitation , due to weakness in&#xD;
      the knee joint, reducing any resistance to this motion is beneficial. The Orthoglide device&#xD;
      is designed to aid the patient in performing this movement by reducing the&#xD;
      friction/resistance caused by the heel sliding against the bed. Currently this is achieved&#xD;
      using a 'slider board' and placing a rolled up piece of fabric under the patients heel. The&#xD;
      aim of this study is to investigate whether or not issuing an Orthoglide device to patients&#xD;
      following total knee replacements improves functional outcomes reported by the patient at 6&#xD;
      weeks and 12 weeks post-surgery. Participants will be assigned to either receive an&#xD;
      Orthoglide device and standard Physiotherapy or standard Physiotherapy alone. A series of&#xD;
      patient reported outcome measures will be taken pre-surgery, 6 weeks post surgery and 12&#xD;
      weeks post surgery and the results compared.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is hypothesised that issuing an Orthoglide device following total knee replacement will&#xD;
      improve patient reported outcomes. The null-hypothesis is that there is no correlation&#xD;
      between the issuing of an Orthoglide device and improved patient reported outcome measures&#xD;
      post total knee replacement.&#xD;
&#xD;
      The following outlines the various stages which the research participants will pass through&#xD;
      during the study:&#xD;
&#xD;
        1. Initial contact - having been identified as requiring a total knee replacement the&#xD;
           patient will attend Blackpool Victoria Hospital for a routine pre-operative assessment.&#xD;
           During this contact the patient will be given an information pack relating to the&#xD;
           project, this patient information sheet will include an invitation to participate,&#xD;
           information regarding confidentiality, contact information as well as a consent form to&#xD;
           be taken away and considered at home.&#xD;
&#xD;
        2. Homeward visit - The Homeward team routinely complete home visits with all patients who&#xD;
           are awaiting a total knee replacement. During this visit the clinician will further&#xD;
           discuss the study and, if the patient wishes to take part, the consent forms may be&#xD;
           collected. The visiting clinician will store these sealed envelopes in-line with trust&#xD;
           policy on data protection - in a lockable drawer/cabinet upon return to the hospital,&#xD;
           this will only be accessible by the Homeward Team and research team.&#xD;
&#xD;
        3. Establishing baseline measurements - Consent forms will be reviewed by Robyn Jones and a&#xD;
           copy placed in the patients records. Contact details will be recorded on secure access&#xD;
           computer folder and participants contacted on preferred telephone number to establish&#xD;
           baseline scores of outcome measures, gaining verbal consent prior to commencing. Consent&#xD;
           forms will be stored in patients notes via coding with a further copy remaining in a&#xD;
           secured storage location only accessible by the research team, for our records. Outcome&#xD;
           measure scores will be inputted onto an anonymised and encrypted spreadsheet which will&#xD;
           be stored on a password protected computer folder.&#xD;
&#xD;
        4. Randomisation - Due to the time period the trial will take place over the investigators&#xD;
           will employ block randomisation to allow the participants to be grouped in a timely&#xD;
           manner prior to their surgery. Once the participants identity has been anonymised and&#xD;
           encrypted participants will be randomised in groups of 10, i.e. every 10 patients&#xD;
           recruited will be randomised as one block. This process will repeat for every group of&#xD;
           10 recruited until capacity is reached for the intervention group and the control group.&#xD;
           As a feasibility study it is estimated that 30 participants in each arm will be&#xD;
           sufficient to give adequate power.&#xD;
&#xD;
        5. Identification of participants on weekly operation list - The Orthopaedic Physiotherapy&#xD;
           team routinely access operation lists to identify the appropriate patients for&#xD;
           Physiotherapy input. These operation lists will be cross referenced with our participant&#xD;
           list to identify those taking part in the study and which group participants have been&#xD;
           randomised into.&#xD;
&#xD;
        6. Patients will attend Blackpool Victoria Hospital for surgery. Routine post-operative&#xD;
           Physiotherapy rehabilitation protocols will be followed with the only variation being&#xD;
           the issue of an Orthoglide device to those in the study group and not to those in the&#xD;
           control group - as identified in stage 5. Patients generally remain an in-patient for&#xD;
           approximately 3 days post surgery.&#xD;
&#xD;
        7. 6 week follow up call - 6 weeks after the date of surgery (recorded in the secured&#xD;
           spreadsheet from the weekly operation list)the research team will contact the patient to&#xD;
           complete the outcome measures as used in stage 3, this data will be inputted onto the&#xD;
           anonymised and encrypted spreadsheet stored on a password protected computer.&#xD;
&#xD;
        8. 12 week follow up call - 12 weeks after the date of surgery the research team will&#xD;
           contact the patient to complete the outcome measures as used in stage 3 and 7, this data&#xD;
           will be inputted onto the anonymised and encrypted spreadsheet stored on a password&#xD;
           protected computer.&#xD;
&#xD;
        9. Data analysis and write up - Once all data is collected it will be analysed using the&#xD;
           appropriate statistical analysis method and software. This study is designed to cause as&#xD;
           little disruption to the routine patient journey as possible. Outside of routine&#xD;
           contacts made by the direct care team, the only additional commitments participants must&#xD;
           make is to be contacted by telephone by the research team 3 times (pre-operative&#xD;
           baseline, 6 week follow-up and 12 week follow-up), each lasting approximately 20-15&#xD;
           minutes. It is estimated that from recruitment a participant will be involved with the&#xD;
           study for a maximum of 24 weeks - preoperative clinics must be no more than 12 weeks&#xD;
           prior to the surgery and the second follow-up phone call will be 12 weeks post&#xD;
           operation. The overall timeframe for the project will be 24 months from April 2018 to&#xD;
           April 2020, this includes ethics applications, data collection (to begin from November&#xD;
           2018), analysis and write up. Both arms of the trial will receive the same amount of&#xD;
           Physiotherapy input (2 x daily visits) during their in-patient stay.&#xD;
&#xD;
      The only variable will be the issue of an Orthoglide device for the trial group to assist&#xD;
      with completion of their knee exercises instead of a 'slider-board'. As a feasibility study&#xD;
      no interim reports are planned however as soon as data has been analysed and reported upon it&#xD;
      will be made available to the participants. participants will be randomised using block&#xD;
      randomisation and data sets anonymised for analysis thus minimising researcher bias by all&#xD;
      reasonable means for a study of this nature.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 28, 2018</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">February 15, 2020</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>Group 1: Physiotherapy with Orthoglide&#xD;
Group 2: Physiotherapy only</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Due to the nature of the study it was not possible to blind the participant to the treatment being received.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Knee Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>Change from Baseline to 6 and 12 weeks</time_frame>
    <description>Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. A better score would be indicated by a higher number closer to 100.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Numerical Pain Rating Score (NPRS)</measure>
    <time_frame>Change from Baseline to 6 and 12 weeks</time_frame>
    <description>Scored from 0 to 10. Higher scores (closer to 10) indicate a higher level of pain and lower numbers indicate less pain. A minimal clinically important change in NPRS is a 2 point improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Exercise Adherence Rating Scale</measure>
    <time_frame>Change from Baseline to 6 and 12 weeks</time_frame>
    <description>EARS consists of 6 questions scored on a 5-point Likert scale, with positively worded questions reverse scored, giving a final rating from 0 (lowest adherence) to 24 (highest adherence). Better adherence is sought with any intervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <condition>Physiotherapy</condition>
  <condition>Intervention</condition>
  <condition>Rehabilitation</condition>
  <condition>Exercise</condition>
  <arm_group>
    <arm_group_label>Physiotherapy only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard treatment post Total Knee Arthroplasty</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physiotherapy + Orthoglide intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard treatment post TKA, with additional Orthoglide device provided.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Orthoglide</intervention_name>
    <description>Knee rehabilitation device.</description>
    <arm_group_label>Physiotherapy + Orthoglide intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physiotherapy only</intervention_name>
    <description>Physiotherapy only.</description>
    <arm_group_label>Physiotherapy only</arm_group_label>
    <other_name>Physiotherapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients planned to undergo a unilateral total knee replacement at Blackpool Victoria&#xD;
             Hospital aged between 45 to 75 years,&#xD;
&#xD;
          -  Independently mobile with or without a walking aid.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other lower limb orthopaedic surgery within the last six-months,&#xD;
&#xD;
          -  No anticipated further lower limb orthopaedic surgery within the next 12-months,&#xD;
&#xD;
          -  No rheumatoid arthritis, neurological conditions affecting lower limb function.&#xD;
&#xD;
          -  No Cognitive impairment,&#xD;
&#xD;
          -  No co-morbidity which would act as a contraindication to engaging with prescribed&#xD;
             exercise&#xD;
&#xD;
          -  No existing participation in other clinical trials which may impact rehabilitation&#xD;
             outcomes.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James Richards, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Central Lancashire</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Blackpool Victoria Hospital</name>
      <address>
        <city>Blackpool</city>
        <state>Lancashire</state>
        <zip>FY3 8NR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>March 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Central Lancashire</investigator_affiliation>
    <investigator_full_name>Ambreen Chohan</investigator_full_name>
    <investigator_title>Research Fellow, Sponsor-Investigator</investigator_title>
  </responsible_party>
  <keyword>Knee Osteoarthritis</keyword>
  <keyword>Orthoglide</keyword>
  <keyword>Knee exercises</keyword>
  <keyword>KOOS</keyword>
  <keyword>rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 7, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT04418687/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04418687
org study id: IRAS 235931
nct id: NCT04418687
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Total knee replacements are a common orthopaedic procedure undertaken at Blackpool Victoria
      Hospital. Following surgery patients are routinely seen by Physiotherapists who prescribe
      exercises to improve the range of movement and strength of the knee joint, thus aiding
      recovery. One of the key exercises prescribed involves the bending and straightening of the
      knee to improve range of movement. At this early stage of rehabilitation , due to weakness in
      the knee joint, reducing any resistance to this motion is beneficial. The Orthoglide device
      is designed to aid the patient in performing this movement by reducing the
      friction/resistance caused by the heel sliding against the bed. Currently this is achieved
      using a 'slider board' and placing a rolled up piece of fabric under the patients heel. The
      aim of this study is to investigate whether or not issuing an Orthoglide device to patients
      following total knee replacements improves functional outcomes reported by the patient at 6
      weeks and 12 weeks post-surgery. Participants will be assigned to either receive an
      Orthoglide device and standard Physiotherapy or standard Physiotherapy alone. A series of
      patient reported outcome measures will be taken pre-surgery, 6 weeks post surgery and 12
      weeks post surgery and the results compared.
It is hypothesised that issuing an Orthoglide device following total knee replacement will
      improve patient reported outcomes. The null-hypothesis is that there is no correlation
      between the issuing of an Orthoglide device and improved patient reported outcome measures
      post total knee replacement.

      The following outlines the various stages which the research participants will pass through
      during the study:

        1. Initial contact - having been identified as requiring a total knee replacement the
           patient will attend Blackpool Victoria Hospital for a routine pre-operative assessment.
           During this contact the patient will be given an information pack relating to the
           project, this patient information sheet will include an invitation to participate,
           information regarding confidentiality, contact information as well as a consent form to
           be taken away and considered at home.

        2. Homeward visit - The Homeward team routinely complete home visits with all patients who
           are awaiting a total knee replacement. During this visit the clinician will further
           discuss the study and, if the patient wishes to take part, the consent forms may be
           collected. The visiting clinician will store these sealed envelopes in-line with trust
           policy on data protection - in a lockable drawer/cabinet upon return to the hospital,
           this will only be accessible by the Homeward Team and research team.

        3. Establishing baseline measurements - Consent forms will be reviewed by Robyn Jones and a
           copy placed in the patients records. Contact details will be recorded on secure access
           computer folder and participants contacted on preferred telephone number to establish
           baseline scores of outcome measures, gaining verbal consent prior to commencing. Consent
           forms will be stored in patients notes via coding with a further copy remaining in a
           secured storage location only accessible by the research team, for our records. Outcome
           measure scores will be inputted onto an anonymised and encrypted spreadsheet which will
           be stored on a password protected computer folder.

        4. Randomisation - Due to the time period the trial will take place over the investigators
           will employ block randomisation to allow the participants to be grouped in a timely
           manner prior to their surgery. Once the participants identity has been anonymised and
           encrypted participants will be randomised in groups of 10, i.e. every 10 patients
           recruited will be randomised as one block. This process will repeat for every group of
           10 recruited until capacity is reached for the intervention group and the control group.
           As a feasibility study it is estimated that 30 participants in each arm will be
           sufficient to give adequate power.

        5. Identification of participants on weekly operation list - The Orthopaedic Physiotherapy
           team routinely access operation lists to identify the appropriate patients for
           Physiotherapy input. These operation lists will be cross referenced with our participant
           list to identify those taking part in the study and which group participants have been
           randomised into.

        6. Patients will attend Blackpool Victoria Hospital for surgery. Routine post-operative
           Physiotherapy rehabilitation protocols will be followed with the only variation being
           the issue of an Orthoglide device to those in the study group and not to those in the
           control group - as identified in stage 5. Patients generally remain an in-patient for
           approximately 3 days post surgery.

        7. 6 week follow up call - 6 weeks after the date of surgery (recorded in the secured
           spreadsheet from the weekly operation list)the research team will contact the patient to
           complete the outcome measures as used in stage 3, this data will be inputted onto the
           anonymised and encrypted spreadsheet stored on a password protected computer.

        8. 12 week follow up call - 12 weeks after the date of surgery the research team will
           contact the patient to complete the outcome measures as used in stage 3 and 7, this data
           will be inputted onto the anonymised and encrypted spreadsheet stored on a password
           protected computer.

        9. Data analysis and write up - Once all data is collected it will be analysed using the
           appropriate statistical analysis method and software. This study is designed to cause as
           little disruption to the routine patient journey as possible. Outside of routine
           contacts made by the direct care team, the only additional commitments participants must
           make is to be contacted by telephone by the research team 3 times (pre-operative
           baseline, 6 week follow-up and 12 week follow-up), each lasting approximately 20-15
           minutes. It is estimated that from recruitment a participant will be involved with the
           study for a maximum of 24 weeks - preoperative clinics must be no more than 12 weeks
           prior to the surgery and the second follow-up phone call will be 12 weeks post
           operation. The overall timeframe for the project will be 24 months from April 2018 to
           April 2020, this includes ethics applications, data collection (to begin from November
           2018), analysis and write up. Both arms of the trial will receive the same amount of
           Physiotherapy input (2 x daily visits) during their in-patient stay.

      The only variable will be the issue of an Orthoglide device for the trial group to assist
      with completion of their knee exercises instead of a 'slider-board'. As a feasibility study
      no interim reports are planned however as soon as data has been analysed and reported upon it
      will be made available to the participants. participants will be randomised using block
      randomisation and data sets anonymised for analysis thus minimising researcher bias by all
      reasonable means for a study of this nature.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Group 1: Physiotherapy with Orthoglide
Group 2: Physiotherapy only
primary purpose: Supportive Care
masking: None (Open Label)
masking description: Due to the nature of the study it was not possible to blind the participant to the treatment being received.
measure: Change in Knee Osteoarthritis Outcome Score (KOOS)
time frame: Change from Baseline to 6 and 12 weeks
description: Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. A better score would be indicated by a higher number closer to 100.
measure: Change in Numerical Pain Rating Score (NPRS)
time frame: Change from Baseline to 6 and 12 weeks
description: Scored from 0 to 10. Higher scores (closer to 10) indicate a higher level of pain and lower numbers indicate less pain. A minimal clinically important change in NPRS is a 2 point improvement.
measure: Change in Exercise Adherence Rating Scale
time frame: Change from Baseline to 6 and 12 weeks
description: EARS consists of 6 questions scored on a 5-point Likert scale, with positively worded questions reverse scored, giving a final rating from 0 (lowest adherence) to 24 (highest adherence). Better adherence is sought with any intervention
arm group label: Physiotherapy only
arm group type: Active Comparator
description: Standard treatment post Total Knee Arthroplasty
arm group label: Physiotherapy + Orthoglide intervention
arm group type: Experimental
description: Standard treatment post TKA, with additional Orthoglide device provided.
intervention type: Device
intervention name: Orthoglide
description: Knee rehabilitation device.
arm group label: Physiotherapy + Orthoglide intervention
intervention type: Other
intervention name: Physiotherapy only
description: Physiotherapy only.
arm group label: Physiotherapy only
other name: Physiotherapy
criteria: 
gender: All
minimum age: 45 Years
maximum age: 75 Years
healthy volunteers: No
last name: James Richards, PhD
role: Principal Investigator
affiliation: University of Central Lancashire
facility: 
country: United Kingdom
responsible party type: Sponsor-Investigator
investigator affiliation: University of Central Lancashire
investigator full name: Ambreen Chohan
investigator title: Research Fellow, Sponsor-Investigator
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No
provided document: 