xml: <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/NCT05991557</url>
    </required_header>
    <id_info>
      <org_study_id>peroneus longus graft</org_study_id>
      <nct_id>NCT05991557</nct_id>
    </id_info>
    <brief_title>Peroneus Longus Graft :Effect in Foot and Ankle Function</brief_title>
    <official_title>Peroneus Longus Autograft Use in Knee, Shoulder, Elbow Ligaments Reconstruction Surgery : Effect On Ankle And Foot Function</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</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>
        The purpose of this study is to report the ankle and foot functions via American orthopedic&#xD;
        foot and ankle society score (AOFAS), peronei muscle testing ,handheld dynamometer and&#xD;
        radiological outcomes after harvesting autogenous peroneus longus tendons for ligaments&#xD;
        reconstruction.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Using a Peroneus longus tendon (PLT) as an autograft is a common procedure and has been used&#xD;
        previously for deltoid ligament reconstruction in flatfoot deformity correction . Recently,&#xD;
        (PLT) is gaining popularity as a graft option in primary anterior cruciate ligament (ACL)&#xD;
        reconstruction surgeries with biomechanical studies showing tensile strength and clinical&#xD;
        outcomes comparable to quadrupled hamstring grafts.&#xD;
  &#xD;
        In addition to using PLT for isolated (ACL), it is also used in posterior cruciate ligament&#xD;
        (PCL) reconstruction, medial collateral ligament reconstruction, posterolateral corner&#xD;
        reconstruction of the knee, or knee multiple ligament injuries . The partial-thickness of the&#xD;
        tendon has been used variably in knee ligament surgery..&#xD;
  &#xD;
        Being a powerful muscle in plantar flexion and eversion of the foot, there might be&#xD;
        associated ankle functional impairment. To the authors knowledge, there is a gap in science&#xD;
        evaluating donor site morbidity. The aim of this study is to report the clinical and&#xD;
        functional outcome of the donor site for better explanation of the cons and pros of using PLT&#xD;
        as a graft in joint ligamentous injury .&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>peronei muscle strength testing using handheld dynamometer</measure>
      <time_frame>preoperative, three months postoperative and six months postoperative</time_frame>
      <description>power of plantar flexion and eversion of foot and ankle</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">54</enrollment>
    <condition>Ligament Injury</condition>
    <arm_group>
      <arm_group_label>treatment arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>peroneus longus autograft</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>peroneus longus autograft</intervention_name>
      <description>Peroneus longus tendon graft will be harvested with a longitudinal skin incision at 2 to 3 cm (2 finger-breadths) above and 1 cm (1 finger-breadth) behind the lateral malleolus, followed by superficial fascia incision in line with skin incision followed by incision of the tendon sheath proximal to the retinaculum. The peroneus longus and peroneus brevis tendons will be then identified. The tendon division location marked at 2 to 3 cm above the level of the lateral malleolus.The peroneus longus tendon will be exposed on its posterolateral surface through the incision after carefully incising the fascia</description>
      <arm_group_label>treatment arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. clinical and radiological diaginsis of joint ligament injury and needs to ligament&#xD;
               reconstruction .&#xD;
  &#xD;
            2. people with asymptomatic ankle and foot pre and post injury&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Associated ankle and/or foot fractures.&#xD;
  &#xD;
            2. Associated hip or pelvic fractures&#xD;
  &#xD;
            3. Abnormal ankle function pre-injury.&#xD;
  &#xD;
            4. Contralateral limb fractures&#xD;
  &#xD;
            5. Traumatic brain injury (TBI) that limits their ability to participate in their&#xD;
               post-operative care;&#xD;
  &#xD;
            6. Presence of neurological condition that result in spasticity or any abnormal lower&#xD;
               limb muscles tone.&#xD;
  &#xD;
            7. Any condition that would preclude the ability to comply with post-operative&#xD;
               guidelines.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>mahmoud sabra ahmed, resident doctor</last_name>
      <phone>+0201006721501</phone>
      <email>ahmedsabra310@gmail.com</email>
    </overall_contact>
    <link>
      <url>http://doi.org/10.1016/j.ijso.2017.10.002</url>
      <description>2- Rudy ME, Phatama KY (2017) Tensile strength comparison between peroneus longus and hamstring tendons: a biomechanical study. Int J Surg Open 9:41-44</description>
    </link>
    <link>
      <url>http://doi.org/10.1007/s00167-019-05455-w</url>
      <description>3- Rhatomy S, Asikin AIZ, Wardani AE et al (2019) Peroneus longus autograft can be recommended as a superior graft to hamstring tendon in single-bundle ACL reconstruction. Knee Surg, Sport Traumatol Arthrosc.</description>
    </link>
    <link>
      <url>http://doi.org/10.1055/s-0038-1669951</url>
      <description>Shi F-D, Hess DE, Zuo J-Z et al (2019) Peroneus longus tendon autograft is a safe and effective alternative for anterior cruciate ligament reconstruction. J Knee Surg 32:804-811</description>
    </link>
    <link>
      <url>http://doi.org/10.1016/j.amsu.2019.05.009</url>
      <description>-Setyawan R, Soekarno NR, Asikin AIZ, Rhatomy S (2019) Posterior cruciate ligament reconstruction with peroneus longus tendon graft: 2-years follow-up. Ann Med Surg 43:38-43</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 12, 2023</last_update_submitted>
    <last_update_submitted_qc>August 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Mahmoud Sabra Ahmed</investigator_full_name>
      <investigator_title>resident doctor</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05991557
  org study id: peroneus longus graft
  nct id: NCT05991557
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to report the ankle and foot functions via American orthopedic
        foot and ankle society score (AOFAS), peronei muscle testing ,handheld dynamometer and
        radiological outcomes after harvesting autogenous peroneus longus tendons for ligaments
        reconstruction.
  Using a Peroneus longus tendon (PLT) as an autograft is a common procedure and has been used
        previously for deltoid ligament reconstruction in flatfoot deformity correction . Recently,
        (PLT) is gaining popularity as a graft option in primary anterior cruciate ligament (ACL)
        reconstruction surgeries with biomechanical studies showing tensile strength and clinical
        outcomes comparable to quadrupled hamstring grafts.
  
        In addition to using PLT for isolated (ACL), it is also used in posterior cruciate ligament
        (PCL) reconstruction, medial collateral ligament reconstruction, posterolateral corner
        reconstruction of the knee, or knee multiple ligament injuries . The partial-thickness of the
        tendon has been used variably in knee ligament surgery..
  
        Being a powerful muscle in plantar flexion and eversion of the foot, there might be
        associated ankle functional impairment. To the authors knowledge, there is a gap in science
        evaluating donor site morbidity. The aim of this study is to report the clinical and
        functional outcome of the donor site for better explanation of the cons and pros of using PLT
        as a graft in joint ligamentous injury .
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: peronei muscle strength testing using handheld dynamometer
  time frame: preoperative, three months postoperative and six months postoperative
  description: power of plantar flexion and eversion of foot and ankle
  arm group label: treatment arm
  arm group type: Experimental
  description: peroneus longus autograft
  intervention type: Procedure
  intervention name: peroneus longus autograft
  description: Peroneus longus tendon graft will be harvested with a longitudinal skin incision at 2 to 3 cm (2 finger-breadths) above and 1 cm (1 finger-breadth) behind the lateral malleolus, followed by superficial fascia incision in line with skin incision followed by incision of the tendon sheath proximal to the retinaculum. The peroneus longus and peroneus brevis tendons will be then identified. The tendon division location marked at 2 to 3 cm above the level of the lateral malleolus.The peroneus longus tendon will be exposed on its posterolateral surface through the incision after carefully incising the fascia
  arm group label: treatment arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: No
  last name: mahmoud sabra ahmed, resident doctor
  phone: +0201006721501
  email: ahmedsabra310@gmail.com
  url: http://doi.org/10.1016/j.ijso.2017.10.002
  description: 2- Rudy ME, Phatama KY (2017) Tensile strength comparison between peroneus longus and hamstring tendons: a biomechanical study. Int J Surg Open 9:41-44
  url: http://doi.org/10.1007/s00167-019-05455-w
  description: 3- Rhatomy S, Asikin AIZ, Wardani AE et al (2019) Peroneus longus autograft can be recommended as a superior graft to hamstring tendon in single-bundle ACL reconstruction. Knee Surg, Sport Traumatol Arthrosc.
  url: http://doi.org/10.1055/s-0038-1669951
  description: Shi F-D, Hess DE, Zuo J-Z et al (2019) Peroneus longus tendon autograft is a safe and effective alternative for anterior cruciate ligament reconstruction. J Knee Surg 32:804-811
  url: http://doi.org/10.1016/j.amsu.2019.05.009
  description: -Setyawan R, Soekarno NR, Asikin AIZ, Rhatomy S (2019) Posterior cruciate ligament reconstruction with peroneus longus tendon graft: 2-years follow-up. Ann Med Surg 43:38-43
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Mahmoud Sabra Ahmed
  investigator title: resident doctor
  sharing ipd: No