<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/NCT04419142</url>
  </required_header>
  <id_info>
    <org_study_id>1464/2017</org_study_id>
    <nct_id>NCT04419142</nct_id>
  </id_info>
  <brief_title>Total Fat Pad Excision Leads to Worse Isokinetic Performance in Total Knee Arthroplasty</brief_title>
  <official_title>Total Infrapatellar Fat Pad Excision Leads to Worse Isokinetic Performance in Total Knee Arthroplasty: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aksaray University Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aksaray University Training and Research 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>
      There are concerns that total infrapatellar fat pad (IPFP) excision in total knee&#xD;
      arthroplasty (TKA) results in patellar tendon shortening due to ischemic contracture. But,&#xD;
      individual preference of the surgeon is still the main determinant between total or partial&#xD;
      excision. The aim of this randomized controlled trial is to compare knee society score (KSS),&#xD;
      knee extension and flexion peak torque in patients undergoing TKA with total IPFP excision or&#xD;
      partial IPFP excision. The hypothesis of the study is that during TKA, total IPFP excision&#xD;
      would lead to worse isokinetic performance and clinical outcome.&#xD;
&#xD;
      A total of 72 patients scheduled to undergo TKA for primary osteoarthritis of the knee by a&#xD;
      single surgeon were randomly assigned to either the total or partial excision group. Patients&#xD;
      were evaluated preoperatively and at postoperative 1 year, with Knee Society Score (KSS) and&#xD;
      isokinetic measurements. Physiatrist doing isokinetic tests and patients were blinded to the&#xD;
      study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 5, 2017</start_date>
  <completion_date type="Actual">October 24, 2018</completion_date>
  <primary_completion_date type="Actual">October 24, 2018</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>Patients were randomized in a 1:1 ratio via computer-generated randomization using Microsoft Excel 2016 (Microsoft Corporation, Seattle, WA, USA) to be allocated in the total or partial infrapatellar fat pad excision group before the TKA operation (Figure 1). Unblinded senior resident implemented the randomization. Patients and physiatrists performing isokinetic measurements were blinded to group allocation.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Patients and physiatrists performing isokinetic measurements were blinded to group allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Peak knee extensor torque change from baseline to postoperative 12 months</measure>
    <time_frame>Preoperative - Postoperative 12 months</time_frame>
    <description>Change in peak knee extensor torque from baseline (preoperatively) to 12 months post implantation was evaluated for the operated knee under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak knee flexor torque change from baseline to postoperative 12 months</measure>
    <time_frame>Preoperative - Postoperative 12 months</time_frame>
    <description>Change in peak knee flexor torque from baseline (preoperatively) to 12 months post implantation was evaluated for the operated knee under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knee Society Score (KSS) change from baseline to postoperative 12 months</measure>
    <time_frame>Preoperative - Postoperative 12 months</time_frame>
    <description>Change in the Knee Society Score from baseline (preoperatively) to 12 months post implantation was evaluated.&#xD;
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and &lt; 60 = poor.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <condition>Knee Arthritis</condition>
  <arm_group>
    <arm_group_label>Total infrapatellar fat pad excision group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infrapatellar fat pad was totally excised during total knee arthroplasty in patients randomized to this group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Partial infrapatellar fat pad excision group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infrapatellar fat pad was partially excised during total knee arthroplasty in patients randomized to this group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Total infrapatellar fat pad excision</intervention_name>
    <description>Exposure for total knee arthroplasty (TKA) commonly includes total excision of the infrapatellar fat pad (IPFP). The rationale behind this is to obtain improved access to the lateral tibial plateau allowing a more accurate bone cut, baseplate placement and easier management of soft tissue interposition in the bone and cement interface. However, there is growing concern that as the IPFP is a highly vascularized and innervated fibrous adipose tissue filling the anterior compartment of the knee, its complete excision may have a detrimental effect on knee biomechanics and ultimately, TKA outcome. The reason for this effect has been suggested to be patellar tendon (PT) scarring and shortening via ischemic contracture following impaired vascularization, maintenance and biological repair of the tendon.</description>
    <arm_group_label>Total infrapatellar fat pad excision group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Partial infrapatellar fat pad excision</intervention_name>
    <description>It has been suggested in the literature that partial infrapatellar fat pad excision instead of total excision would diminish the potential negative effect on patellar tendon and knee biomechanics. However, there is only limited data in the literature and choice of total/partial infrapatellar fat pad excision in TKA remains debatable.</description>
    <arm_group_label>Partial infrapatellar fat pad excision group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 55 and 80 years&#xD;
&#xD;
          -  Scheduled to undergo unilateral TKA on for primary knee osteoarthritis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inflammatory arthritis&#xD;
&#xD;
          -  Post-traumatic osteoarthritis&#xD;
&#xD;
          -  Previous knee surgery&#xD;
&#xD;
          -  Neuromuscular diseases&#xD;
&#xD;
          -  Bilateral TKA&#xD;
&#xD;
          -  Insufficiency of collateral ligaments&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Deniz Çankaya, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aksaray University Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aksaray University Training and Research Hospital</name>
      <address>
        <city>Aksaray</city>
        <zip>68200</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>June 3, 2020</last_update_submitted>
  <last_update_submitted_qc>June 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aksaray University Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Erdem A Sezgin</investigator_full_name>
    <investigator_title>Co-Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Infrapatellar fat pad</keyword>
  <keyword>Total knee arthroplasty</keyword>
  <keyword>Isokinetic test</keyword>
  <keyword>Strength</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <!-- 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/NCT04419142
org study id: 1464/2017
nct id: NCT04419142
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
There are concerns that total infrapatellar fat pad (IPFP) excision in total knee
      arthroplasty (TKA) results in patellar tendon shortening due to ischemic contracture. But,
      individual preference of the surgeon is still the main determinant between total or partial
      excision. The aim of this randomized controlled trial is to compare knee society score (KSS),
      knee extension and flexion peak torque in patients undergoing TKA with total IPFP excision or
      partial IPFP excision. The hypothesis of the study is that during TKA, total IPFP excision
      would lead to worse isokinetic performance and clinical outcome.

      A total of 72 patients scheduled to undergo TKA for primary osteoarthritis of the knee by a
      single surgeon were randomly assigned to either the total or partial excision group. Patients
      were evaluated preoperatively and at postoperative 1 year, with Knee Society Score (KSS) and
      isokinetic measurements. Physiatrist doing isokinetic tests and patients were blinded to the
      study.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients were randomized in a 1:1 ratio via computer-generated randomization using Microsoft Excel 2016 (Microsoft Corporation, Seattle, WA, USA) to be allocated in the total or partial infrapatellar fat pad excision group before the TKA operation (Figure 1). Unblinded senior resident implemented the randomization. Patients and physiatrists performing isokinetic measurements were blinded to group allocation.
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Patients and physiatrists performing isokinetic measurements were blinded to group allocation.
measure: Peak knee extensor torque change from baseline to postoperative 12 months
time frame: Preoperative - Postoperative 12 months
description: Change in peak knee extensor torque from baseline (preoperatively) to 12 months post implantation was evaluated for the operated knee under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).
measure: Peak knee flexor torque change from baseline to postoperative 12 months
time frame: Preoperative - Postoperative 12 months
description: Change in peak knee flexor torque from baseline (preoperatively) to 12 months post implantation was evaluated for the operated knee under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).
measure: Knee Society Score (KSS) change from baseline to postoperative 12 months
time frame: Preoperative - Postoperative 12 months
description: Change in the Knee Society Score from baseline (preoperatively) to 12 months post implantation was evaluated.
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and < 60 = poor.
arm group label: Total infrapatellar fat pad excision group
arm group type: Experimental
description: Infrapatellar fat pad was totally excised during total knee arthroplasty in patients randomized to this group.
arm group label: Partial infrapatellar fat pad excision group
arm group type: Experimental
description: Infrapatellar fat pad was partially excised during total knee arthroplasty in patients randomized to this group.
intervention type: Procedure
intervention name: Total infrapatellar fat pad excision
description: Exposure for total knee arthroplasty (TKA) commonly includes total excision of the infrapatellar fat pad (IPFP). The rationale behind this is to obtain improved access to the lateral tibial plateau allowing a more accurate bone cut, baseplate placement and easier management of soft tissue interposition in the bone and cement interface. However, there is growing concern that as the IPFP is a highly vascularized and innervated fibrous adipose tissue filling the anterior compartment of the knee, its complete excision may have a detrimental effect on knee biomechanics and ultimately, TKA outcome. The reason for this effect has been suggested to be patellar tendon (PT) scarring and shortening via ischemic contracture following impaired vascularization, maintenance and biological repair of the tendon.
arm group label: Total infrapatellar fat pad excision group
intervention type: Procedure
intervention name: Partial infrapatellar fat pad excision
description: It has been suggested in the literature that partial infrapatellar fat pad excision instead of total excision would diminish the potential negative effect on patellar tendon and knee biomechanics. However, there is only limited data in the literature and choice of total/partial infrapatellar fat pad excision in TKA remains debatable.
arm group label: Partial infrapatellar fat pad excision group
criteria: 
gender: All
minimum age: 55 Years
maximum age: 80 Years
healthy volunteers: No
last name: Deniz Çankaya, MD
role: Principal Investigator
affiliation: Aksaray University Training and Research Hospital
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Aksaray University Training and Research Hospital
investigator full name: Erdem A Sezgin
investigator title: Co-Principal Investigator
mesh term: Osteoarthritis, Knee