<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/NCT03763448</url>
  </required_header>
  <id_info>
    <org_study_id>2017-GJGBK-001</org_study_id>
    <nct_id>NCT03763448</nct_id>
  </id_info>
  <brief_title>Infrapatellar Fat Pad Preservation Versus Resection on Clinical Outcomes After Total Knee Arthroplasty(IPAKA)</brief_title>
  <acronym>IPAKA</acronym>
  <official_title>Effects of Infrapatellar Fat Pad Preservation Versus Resection on Clinical Outcomes After Total Knee Arthroplasty in Patients With Knee Osteoarthritis - A Multicenter Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhujiang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xiangya Hospital of Central South University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Anhui Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital of Jinan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Anhui Provincial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tianjin Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Affiliated Hospital of Youjiang Medical University for Nationalities</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Zhujiang 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>
      This study aims to compare the postoperative clinical outcomes of Infrapatellar Fat Pad&#xD;
      (IPFP) preservation versus resection after total knee arthroplasty (TKA) in patients with&#xD;
      knee osteoarthritis. Participants will be identified as normal IPFP or abnormal IPFP based on&#xD;
      MRI findings before randomization. The primary outcome is the summed score of Knee Injury and&#xD;
      Osteoarthritis Outcome Score (KOOS) covering pain, symptoms, activities of daily life, sport&#xD;
      &amp; recreation, knee-related quality of life, and KOOS subscale assessing activities of daily&#xD;
      life, sport &amp; recreation. The secondary endpoints will be included: KOOS subscales (pain,&#xD;
      symptoms and quality of life), Knee Society Score (KSS), 100 mm Visual Analogue Scale (VAS)&#xD;
      Pain, timed up-and-go test, depression, patellar tendon shortening, 100 mm VAS self-reported&#xD;
      efficacy of reduced pain and increased quality of life. Adverse events will be recorded.&#xD;
      Primary and secondary outcomes will be evaluated or reported blindly at baseline and at&#xD;
      postoperative 3 months, 6 months, and 1 year. Intention-to-treat analyses will be used.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Knee Osteoarthritis (KOA) is a common chronic disease, which often leads to joint pain and&#xD;
      limited function in the elderly, and thus affects participants' quality of life. Total knee&#xD;
      arthroplasty (TKA) has been developed as a mature surgical procedure to relieve end-stage&#xD;
      osteoarthritic joint pain and improve limb function. Although more than 80% of the patients&#xD;
      reported in the literature are satisfied with the postoperative efficacy of TKA, there are&#xD;
      still a large number of patients whose daily life is affected by persistent knee pain and&#xD;
      limited function after the operation of the affected limb.&#xD;
&#xD;
      The IPFP is a fat mass located behind the patellar ligament, between the lower part of the&#xD;
      patella and the tibial tubercle. The function of IPFP is controversial at present. It is&#xD;
      reported that IPFP can provide blood supply for anterior cruciate ligament, patella and&#xD;
      patellar ligament through the arterial network of the knee joint. In addition, it can fill&#xD;
      the joint gap to lubricate the surface of the joint, reduce friction and absorb impulse so as&#xD;
      to play a physiological protective role. On the contrary, studies have pointed out that&#xD;
      abnormal IPFP could produce various pro-inflammatory cytokines such as interleukin (IL)-1β,&#xD;
      tumour necrosis factor (TNF)-α, IL-6 and IL-8, as well as adipokines such as leptin and&#xD;
      resistin, and thus might play a detrimental role in knee OA. Traditionally, the IPFP has been&#xD;
      removed in order to improve surgical exposure and to prevent interposition during baseplate&#xD;
      implantation. Despite the significant evolution of TKA technology which no longer requires&#xD;
      the resection of IPFP for better surgical access, IPFP is still partially or totally resected&#xD;
      in around 88% of TKAs.&#xD;
&#xD;
      The investigators' previous population-based cohort study revealed that IPFP maximal area and&#xD;
      volume were associated with reduced knee pain, decreased loss of cartilage volume and reduced&#xD;
      risks of cartilage defect progression, indicating a beneficial effect of IPFP size. On the&#xD;
      other hand, the investigators' further investigation demonstrated that IPFP signal intensity&#xD;
      alteration was negatively associated with maximum area of IPFP, and moreover, associated with&#xD;
      increased knee cartilage defects, subchondral bone marrow lesion (BML) and knee pain,&#xD;
      suggesting IPFP with abnormal quality may play a detrimental role in knee OA. Based on these&#xD;
      findings, the investigators proposed that IPFP with normal quality should be preserved or not&#xD;
      damaged during TKA, while IPFP with abnormal quality should be resected. This multicentre&#xD;
      randomised controlled trial is designed to test the investigators' hypotheses: in patients&#xD;
      with normal IPFP quality, preservation of IPFP during TKA procedure will reduce postoperative&#xD;
      knee symptoms and improve joint function, comparing with IPFP resection during TKA&#xD;
      procedures; in patients with abnormal IPFP quality, resection of IPFP during TKA procedure&#xD;
      will reduce postoperative knee symptoms and improve joint function, comparing with IPFP&#xD;
      preservation during TKA procedures. The results would provide evidence-based recommendations&#xD;
      on clinical practice to improve OA patients' postoperative outcomes.&#xD;
&#xD;
      Three hundred and sixty eligible participants will be recruited and identified as having&#xD;
      normal IPFP quality (signal intensity alteration score ≤ 1) or abnormal IPFP quality (signal&#xD;
      intensity alteration score ≥ 2). Participants in each site will be randomly allocated to IPFP&#xD;
      resection group or preservation group using computer-generated block randomisation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 17, 2018</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>participants, outcome assessors, data analysts and chief investigators are masked during the study procedure.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The total score of Knee Injury and Osteoarthritis Outcome Score(KOOS)</measure>
    <time_frame>From pre-operation to 12 months after operation</time_frame>
    <description>The KOOS is a knee-specific patient-reported questionnaire with 42-items in five separately analysed subscales of pain, other symptoms, function in daily living, function in sport and recreation, and knee-related quality of life. Scores are transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no problems.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The functional subscale score of Knee Injury and Osteoarthritis Outcome Score(KOOS)</measure>
    <time_frame>From pre-operation to 12 months after operation</time_frame>
    <description>KOOS functional subscale score including function in daily living and function in sport and recreation. Scores range from 0 (worst) to 100 (best).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Other subscales of Knee Injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>From pre-operation to 12 months after operation</time_frame>
    <description>KOOS subscales including pain, symptoms and quality of life. Scores are transformed to a 0-100 scale, with 0 representing worst health and 100 representing best health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Society Score(KSS)</measure>
    <time_frame>From pre-operation to 12 months after operation</time_frame>
    <description>KSS is a rating system that consists of two scores: joint score and functional score. Both scores range from 0 (worst health or functioning) to 100 (best health or functioning).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported efficacy of reduced pain and increased quality of life</measure>
    <time_frame>From pre-operation to 12 months after operation</time_frame>
    <description>Using a 100mm VAS with terminal descriptors of &quot;very unsure&quot; and &quot;very sure&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insall - Salvati Ratio (ISR)</measure>
    <time_frame>From pre-operation to 12 months after operation</time_frame>
    <description>It is used to assess changes in the length of the patellar tendon at baseline and month 12. Lateral radiographs with the knee in about 30 degree of flexion will be taken by well experienced X-ray technicians using standardized radiographic techniques. The numerator of the ISR-the length of the patellar tendon-was determined by measuring the distance from inferior aspect of the patella to the superior aspect of the tibial tubercle. The longest dimension of the patella on the lateral radiograph will be obtained as denominator of the ISR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed Up and Go test</measure>
    <time_frame>From pre-operation to 12 months after operation</time_frame>
    <description>It is a simple test used to assess a person's mobility. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scale (VAS) Pain</measure>
    <time_frame>From pre-operation to 12 months after operation</time_frame>
    <description>Pain intensity measured on a 100 mm VAS with terminal descriptors of &quot;no pain&quot; and &quot;worst pain possible&quot; in the following situations: at rest, after 30-min of walking, and on most days of the last month.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">360</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <condition>Arthropathy of Knee</condition>
  <arm_group>
    <arm_group_label>Infrapatellar Fat Pad Preservation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The IPFP retention of more than 80% in actual operation shall be regarded as IPFP retention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Infrapatellar Fat Pad Resection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the clinical practice, more than 80% of IPFP volume is commonly resected by surgeons during total knee arthroplasty. The investigators hereby define resection of more than 80% IPFP volume as IPFP excision.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Infrapatellar Fat Pad preservation</intervention_name>
    <description>In the IPFP preservation group, IPFP (more than 80%) will be preserved by retracting out of the operative field.</description>
    <arm_group_label>Infrapatellar Fat Pad Preservation</arm_group_label>
    <other_name>Infrapatellar fat pad retention</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Infrapatellar Fat Pad resection</intervention_name>
    <description>In the IPFP resection group, more than 80% IPFP will be resected during the total knee arthroplasty.</description>
    <arm_group_label>Infrapatellar Fat Pad Resection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants diagnosed with knee osteoarthritis by X-ray plain film (Kellgren-Lawrence&#xD;
             score of ≥ 2)&#xD;
&#xD;
          -  The need for TKA was confirmed after evaluation by the orthopedic surgeon&#xD;
&#xD;
          -  One week before surgery, knee pain 100mm pain visual analogue scale score was greater&#xD;
             than 20mm&#xD;
&#xD;
          -  Understanding of the study requirements and willing to participate in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Rheumatoid arthritis,psoriatic arthritis,lupus,malignant tumor&#xD;
&#xD;
          -  Requiring contralateral TKA within one year&#xD;
&#xD;
          -  The visual analogue score of 100mm of knee pain before operation was less than 20mm&#xD;
&#xD;
          -  Having a possible or planned pregnancy&#xD;
&#xD;
          -  With poor compliance&#xD;
&#xD;
          -  Suffering from somatic disease, psychiatric or cognitive disorders, neurological&#xD;
             disorders that will compromise the safety, compliance, consent, participation,&#xD;
             follow-up and the interpretation of the results&#xD;
&#xD;
          -  Severe knee valgus&#xD;
&#xD;
          -  Contraindications with TKA or MRI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Changhai Ding, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Research Center of Zhujiang Hospital,Southern Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jianhao Lin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University People's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xisheng Weng, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Guanghua Lei, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xiangya Hospital of Central South University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zongsheng Yin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital of Anhui Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zhengang Zha, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital of Jinan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jing Tian, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhujiang Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xifu Shang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Anhui Provincial Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yujin Tang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Affiliated Hospital of Youjiang Medical University for Nationalities</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jun Liu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tianjin Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Weiyu Han, MD</last_name>
    <phone>+86-13922222718</phone>
    <email>hanweiyu@live.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Youling Xu, RN</last_name>
    <phone>+86-18210623686</phone>
    <email>xuyoulinghao@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Zhujiang Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510285</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Weiyu Han, MD</last_name>
      <phone>13922222718</phone>
      <email>hanweiyu@live.com</email>
    </contact>
    <contact_backup>
      <last_name>Youling Xu, RN</last_name>
      <phone>18210623686</phone>
      <email>805048508@qq.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>October 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>November 4, 2022</last_update_submitted>
  <last_update_submitted_qc>November 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zhujiang Hospital</investigator_affiliation>
    <investigator_full_name>Ding Changhai</investigator_full_name>
    <investigator_title>Director,Clinical Research Center</investigator_title>
  </responsible_party>
  <keyword>Infrapatellar Fat Pad</keyword>
  <keyword>Knee Osteoarthritis</keyword>
  <keyword>Total Knee Arthroplasty</keyword>
  <keyword>Randomized Clinical Trial</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>
  <!-- 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/NCT03763448
org study id: 2017-GJGBK-001
nct id: NCT03763448
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study aims to compare the postoperative clinical outcomes of Infrapatellar Fat Pad
      (IPFP) preservation versus resection after total knee arthroplasty (TKA) in patients with
      knee osteoarthritis. Participants will be identified as normal IPFP or abnormal IPFP based on
      MRI findings before randomization. The primary outcome is the summed score of Knee Injury and
      Osteoarthritis Outcome Score (KOOS) covering pain, symptoms, activities of daily life, sport
      & recreation, knee-related quality of life, and KOOS subscale assessing activities of daily
      life, sport & recreation. The secondary endpoints will be included: KOOS subscales (pain,
      symptoms and quality of life), Knee Society Score (KSS), 100 mm Visual Analogue Scale (VAS)
      Pain, timed up-and-go test, depression, patellar tendon shortening, 100 mm VAS self-reported
      efficacy of reduced pain and increased quality of life. Adverse events will be recorded.
      Primary and secondary outcomes will be evaluated or reported blindly at baseline and at
      postoperative 3 months, 6 months, and 1 year. Intention-to-treat analyses will be used.
Knee Osteoarthritis (KOA) is a common chronic disease, which often leads to joint pain and
      limited function in the elderly, and thus affects participants' quality of life. Total knee
      arthroplasty (TKA) has been developed as a mature surgical procedure to relieve end-stage
      osteoarthritic joint pain and improve limb function. Although more than 80% of the patients
      reported in the literature are satisfied with the postoperative efficacy of TKA, there are
      still a large number of patients whose daily life is affected by persistent knee pain and
      limited function after the operation of the affected limb.

      The IPFP is a fat mass located behind the patellar ligament, between the lower part of the
      patella and the tibial tubercle. The function of IPFP is controversial at present. It is
      reported that IPFP can provide blood supply for anterior cruciate ligament, patella and
      patellar ligament through the arterial network of the knee joint. In addition, it can fill
      the joint gap to lubricate the surface of the joint, reduce friction and absorb impulse so as
      to play a physiological protective role. On the contrary, studies have pointed out that
      abnormal IPFP could produce various pro-inflammatory cytokines such as interleukin (IL)-1β,
      tumour necrosis factor (TNF)-α, IL-6 and IL-8, as well as adipokines such as leptin and
      resistin, and thus might play a detrimental role in knee OA. Traditionally, the IPFP has been
      removed in order to improve surgical exposure and to prevent interposition during baseplate
      implantation. Despite the significant evolution of TKA technology which no longer requires
      the resection of IPFP for better surgical access, IPFP is still partially or totally resected
      in around 88% of TKAs.

      The investigators' previous population-based cohort study revealed that IPFP maximal area and
      volume were associated with reduced knee pain, decreased loss of cartilage volume and reduced
      risks of cartilage defect progression, indicating a beneficial effect of IPFP size. On the
      other hand, the investigators' further investigation demonstrated that IPFP signal intensity
      alteration was negatively associated with maximum area of IPFP, and moreover, associated with
      increased knee cartilage defects, subchondral bone marrow lesion (BML) and knee pain,
      suggesting IPFP with abnormal quality may play a detrimental role in knee OA. Based on these
      findings, the investigators proposed that IPFP with normal quality should be preserved or not
      damaged during TKA, while IPFP with abnormal quality should be resected. This multicentre
      randomised controlled trial is designed to test the investigators' hypotheses: in patients
      with normal IPFP quality, preservation of IPFP during TKA procedure will reduce postoperative
      knee symptoms and improve joint function, comparing with IPFP resection during TKA
      procedures; in patients with abnormal IPFP quality, resection of IPFP during TKA procedure
      will reduce postoperative knee symptoms and improve joint function, comparing with IPFP
      preservation during TKA procedures. The results would provide evidence-based recommendations
      on clinical practice to improve OA patients' postoperative outcomes.

      Three hundred and sixty eligible participants will be recruited and identified as having
      normal IPFP quality (signal intensity alteration score ≤ 1) or abnormal IPFP quality (signal
      intensity alteration score ≥ 2). Participants in each site will be randomly allocated to IPFP
      resection group or preservation group using computer-generated block randomisation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: participants, outcome assessors, data analysts and chief investigators are masked during the study procedure.
measure: The total score of Knee Injury and Osteoarthritis Outcome Score(KOOS)
time frame: From pre-operation to 12 months after operation
description: The KOOS is a knee-specific patient-reported questionnaire with 42-items in five separately analysed subscales of pain, other symptoms, function in daily living, function in sport and recreation, and knee-related quality of life. Scores are transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no problems.
measure: The functional subscale score of Knee Injury and Osteoarthritis Outcome Score(KOOS)
time frame: From pre-operation to 12 months after operation
description: KOOS functional subscale score including function in daily living and function in sport and recreation. Scores range from 0 (worst) to 100 (best).
measure: Other subscales of Knee Injury and Osteoarthritis Outcome Score (KOOS)
time frame: From pre-operation to 12 months after operation
description: KOOS subscales including pain, symptoms and quality of life. Scores are transformed to a 0-100 scale, with 0 representing worst health and 100 representing best health.
measure: Knee Society Score(KSS)
time frame: From pre-operation to 12 months after operation
description: KSS is a rating system that consists of two scores: joint score and functional score. Both scores range from 0 (worst health or functioning) to 100 (best health or functioning).
measure: Self-reported efficacy of reduced pain and increased quality of life
time frame: From pre-operation to 12 months after operation
description: Using a 100mm VAS with terminal descriptors of "very unsure" and "very sure"
measure: Insall - Salvati Ratio (ISR)
time frame: From pre-operation to 12 months after operation
description: It is used to assess changes in the length of the patellar tendon at baseline and month 12. Lateral radiographs with the knee in about 30 degree of flexion will be taken by well experienced X-ray technicians using standardized radiographic techniques. The numerator of the ISR-the length of the patellar tendon-was determined by measuring the distance from inferior aspect of the patella to the superior aspect of the tibial tubercle. The longest dimension of the patella on the lateral radiograph will be obtained as denominator of the ISR.
measure: Timed Up and Go test
time frame: From pre-operation to 12 months after operation
description: It is a simple test used to assess a person's mobility. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
measure: Visual Analogue Scale (VAS) Pain
time frame: From pre-operation to 12 months after operation
description: Pain intensity measured on a 100 mm VAS with terminal descriptors of "no pain" and "worst pain possible" in the following situations: at rest, after 30-min of walking, and on most days of the last month.
arm group label: Infrapatellar Fat Pad Preservation
arm group type: Experimental
description: The IPFP retention of more than 80% in actual operation shall be regarded as IPFP retention.
arm group label: Infrapatellar Fat Pad Resection
arm group type: Active Comparator
description: In the clinical practice, more than 80% of IPFP volume is commonly resected by surgeons during total knee arthroplasty. The investigators hereby define resection of more than 80% IPFP volume as IPFP excision.
intervention type: Procedure
intervention name: Infrapatellar Fat Pad preservation
description: In the IPFP preservation group, IPFP (more than 80%) will be preserved by retracting out of the operative field.
arm group label: Infrapatellar Fat Pad Preservation
other name: Infrapatellar fat pad retention
intervention type: Procedure
intervention name: Infrapatellar Fat Pad resection
description: In the IPFP resection group, more than 80% IPFP will be resected during the total knee arthroplasty.
arm group label: Infrapatellar Fat Pad Resection
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Changhai Ding, MD
role: Principal Investigator
affiliation: Clinical Research Center of Zhujiang Hospital,Southern Medical University
last name: Jianhao Lin, MD
role: Principal Investigator
affiliation: Peking University People's Hospital
last name: Xisheng Weng, MD
role: Principal Investigator
affiliation: Peking Union Medical College Hospital
last name: Guanghua Lei, MD
role: Principal Investigator
affiliation: Xiangya Hospital of Central South University
last name: Zongsheng Yin, MD
role: Principal Investigator
affiliation: The First Affiliated Hospital of Anhui Medical University
last name: Zhengang Zha, MD
role: Principal Investigator
affiliation: First Affiliated Hospital of Jinan University
last name: Jing Tian, MD
role: Principal Investigator
affiliation: Zhujiang Hospital
last name: Xifu Shang, MD
role: Principal Investigator
affiliation: Anhui Provincial Hospital
last name: Yujin Tang, MD
role: Principal Investigator
affiliation: Affiliated Hospital of Youjiang Medical University for Nationalities
last name: Jun Liu, MD
role: Principal Investigator
affiliation: Tianjin Hospital
last name: Weiyu Han, MD
phone: +86-13922222718
email: hanweiyu@live.com
last name: Youling Xu, RN
phone: +86-18210623686
email: xuyoulinghao@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Zhujiang Hospital
investigator full name: Ding Changhai
investigator title: Director,Clinical Research Center
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee