<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/NCT04503512</url>
  </required_header>
  <id_info>
    <org_study_id>4263</org_study_id>
    <nct_id>NCT04503512</nct_id>
  </id_info>
  <brief_title>Surgical Excision of the Fat Pad</brief_title>
  <official_title>Effect of Excision of the Fat Pad in Total Knee Replacement Surgery. A Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Liverpool University Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Liverpool University Hospitals NHS Foundation Trust</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>
      Introduction:&#xD;
&#xD;
      The infrapatellar fat pad (Hoffa's fat pad) is a structure which is located&#xD;
      intra-articularly. Its function is not well known. During knee replacement surgery, some&#xD;
      surgeons would prefer removing the whole of the fat pad as this can improve exposure of the&#xD;
      knee joint, as it can affect exposure of the knee joint which will in turn make the procedure&#xD;
      slightly more efficient. Other surgeons would rather resect the minimum amount and preserve&#xD;
      the bulk of the structure as anecdotally this is thought to decrease the level of post&#xD;
      operative pain. This surgical step fat pad resection is a very small part of the whole total&#xD;
      knee replacement procedure.&#xD;
&#xD;
      A previous retrospective review of patients whose fat pad had been removed showed that they&#xD;
      were nearly twice as likely to experience postoperative pain (P = 0.0005), while another&#xD;
      study showed that they are at a slight risk of patellar tendon shortening.&#xD;
&#xD;
      A randomised controlled trial of 68 patients did not show any difference in patella tendon&#xD;
      length at six months and no difference in pain relief in both groups 3. However this study&#xD;
      did not evaluate the functional outcome in both groups.&#xD;
&#xD;
      To our knowledge, there are no RCT looking at the effect of the excision or preservation of&#xD;
      the fat pad in TKR and the functional outcomes post operatively.&#xD;
&#xD;
      Study Hypothesis:&#xD;
&#xD;
      Excision of Hoffa's fat pad during total knee replacement surgery does not affect functional&#xD;
      outcome, pain level after surgery or the patella tendon length at either one or two years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      RCT of excision or preservation of fat pad in TKR and the functional outcomes post&#xD;
      operatively&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 23, 2012</start_date>
  <completion_date type="Anticipated">December 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 1, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Koos Knee Score</measure>
    <time_frame>3 months post op,</time_frame>
    <description>The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">154</enrollment>
  <condition>Osteo Arthritis Knee</condition>
  <arm_group>
    <arm_group_label>Non removal of fat pad</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Non removal of fat pad</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Removal of fat pad</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Removal of fat pad</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>removal of fat pad</intervention_name>
    <description>Removal removal of fat pad</description>
    <arm_group_label>Removal of fat pad</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>non removal of fat pad</intervention_name>
    <description>non removal of fat pad</description>
    <arm_group_label>Non removal of fat pad</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1- Primary total knee replacement for knee osteoarthritis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Revision Surgery.&#xD;
&#xD;
          2. Primary Knee Replacement for pathologies other than Osteoarthritis.&#xD;
&#xD;
          3. Previous knee fractures around the knee.&#xD;
&#xD;
          4. Previous confirmed intra-articular infections.&#xD;
&#xD;
          5. Non English speaking/reading patients.&#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>
  <overall_official>
    <last_name>A Howard</last_name>
    <role>Study Director</role>
    <affiliation>Liverpool University Hospitals NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Antony Howard</last_name>
    <email>'anthonyjhoward@aol.com'</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jo Banks</last_name>
    <email>Joanne.Banks@LiverpoolFT@nhs.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Broadgreen Hospital</name>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anthony Howard, PhD</last_name>
      <phone>07769116998</phone>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 23, 2019</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</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>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</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/NCT04503512
org study id: 4263
nct id: NCT04503512
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Introduction:

      The infrapatellar fat pad (Hoffa's fat pad) is a structure which is located
      intra-articularly. Its function is not well known. During knee replacement surgery, some
      surgeons would prefer removing the whole of the fat pad as this can improve exposure of the
      knee joint, as it can affect exposure of the knee joint which will in turn make the procedure
      slightly more efficient. Other surgeons would rather resect the minimum amount and preserve
      the bulk of the structure as anecdotally this is thought to decrease the level of post
      operative pain. This surgical step fat pad resection is a very small part of the whole total
      knee replacement procedure.

      A previous retrospective review of patients whose fat pad had been removed showed that they
      were nearly twice as likely to experience postoperative pain (P = 0.0005), while another
      study showed that they are at a slight risk of patellar tendon shortening.

      A randomised controlled trial of 68 patients did not show any difference in patella tendon
      length at six months and no difference in pain relief in both groups 3. However this study
      did not evaluate the functional outcome in both groups.

      To our knowledge, there are no RCT looking at the effect of the excision or preservation of
      the fat pad in TKR and the functional outcomes post operatively.

      Study Hypothesis:

      Excision of Hoffa's fat pad during total knee replacement surgery does not affect functional
      outcome, pain level after surgery or the patella tendon length at either one or two years.
RCT of excision or preservation of fat pad in TKR and the functional outcomes post
      operatively
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Koos Knee Score
time frame: 3 months post op,
description: The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury.
arm group label: Non removal of fat pad
arm group type: Active Comparator
description: Non removal of fat pad
arm group label: Removal of fat pad
arm group type: Active Comparator
description: Removal of fat pad
intervention type: Procedure
intervention name: removal of fat pad
description: Removal removal of fat pad
arm group label: Removal of fat pad
intervention type: Procedure
intervention name: non removal of fat pad
description: non removal of fat pad
arm group label: Non removal of fat pad
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: A Howard
role: Study Director
affiliation: Liverpool University Hospitals NHS Foundation Trust
last name: Antony Howard
email: 'anthonyjhoward@aol.com'
last name: Jo Banks
email: Joanne.Banks@LiverpoolFT@nhs.uk
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No