<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/NCT03229590</url>
  </required_header>
  <id_info>
    <org_study_id>SCFE</org_study_id>
    <nct_id>NCT03229590</nct_id>
  </id_info>
  <brief_title>Slipped Capital Femoral Epiphysis Treatment</brief_title>
  <official_title>Safe Surgical Dislocation in Slipped Capital Femoral Epiphysis</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>
      Slipped capital femoral epiphysis represents approximately 10.8 cases per 100,000 children.&#xD;
      The primary source for the blood supply of the head of the femur is the deep branch of the&#xD;
      medial femoral circumflex artery. Loder described a classification for Slipped capital&#xD;
      femoral epiphysis based on ability of the child to walk or not(walking=stable,&#xD;
      non-walking=unstable).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In slipped capital femoral epiphyses (SCFE), the severity of slippage correlates with poor&#xD;
      long-term clinical outcome scores and radiographic evidence of osteoarthritis . In situ&#xD;
      fixation of higher-grade SCFE has a low surgical risk and has been advocated by authors who&#xD;
      believe the deformed hip has the potential to remodel with some restoration of the disturbed&#xD;
      anatomic axes ; however, the remodeling potential remains controversial . Despite remodeling,&#xD;
      the head-neck offset will remain abnormal . This is the cause of potential impingement of the&#xD;
      femoral neck with the acetabular cartilage . Impingement in SCFE has been associated with&#xD;
      damage of the acetabular cartilage, which may explain the early onset of osteoarthritis after&#xD;
      SCFE .&#xD;
&#xD;
      Ganz et al. described a technique of surgical dislocation of hip involving trochanteric flip&#xD;
      osteotomy and anterior capsulotomy preserving the blood supply to femoral head. The technique&#xD;
      is based on extensive study of blood supply to the proximal femur. This technique allows us&#xD;
      to completely dislocate the joint which allows complete access to intra articular pathology&#xD;
      and allow reduction of the slipped capital femoral epiphysis .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2017</start_date>
  <completion_date type="Anticipated">August 2020</completion_date>
  <primary_completion_date type="Anticipated">August 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Harris Hip Score</measure>
    <time_frame>6 months</time_frame>
    <description>this is a score for post operative evaluation of the hip (it is evaluate pain, support, Distance walked, Limp, Activities - shoes, socks, Stairs, Public transportation, Sitting, Range of motion) every item take a number then the summation of all numbers which ranged from 0 to 100 : &lt;70 Poor 70 - 79 Fair 80-89 Good 90 -100 Excellent</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>SCFE</condition>
  <arm_group>
    <arm_group_label>Surgical dislocation</arm_group_label>
    <description>Reduction of slipped epiphysis via surgical dislocation technique</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgical dislocation</intervention_name>
    <description>Reduction of slipped epiphysis by surgical dislocation</description>
    <arm_group_label>Surgical dislocation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The purpose of this study is to evaluate management Of moderate and severe degrees Slipped&#xD;
        capital femoral epiphysis cases by using surgical dislocation technique .&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1- Patients with moderate Slipped capital femoral epiphysis 2- Patients with severe&#xD;
             Slipped capital femoral epiphysis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with mild Slipped capital femoral epiphysis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
  </eligibility>
  <reference>
    <citation>Song MH, Jang WY, Park MS, Yoo WJ, Choi IH, Cho TJ. Slipped capital femoral epiphysis in children younger than 10 years old: clinical characteristics and efficacy of physeal-sparing procedures. J Pediatr Orthop B. 2018 Sep;27(5):379-386. doi: 10.1097/BPB.0000000000000485.</citation>
    <PMID>28704299</PMID>
  </reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 19, 2017</study_first_submitted>
  <study_first_submitted_qc>July 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>July 22, 2017</last_update_submitted>
  <last_update_submitted_qc>July 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohamed Ibrahim</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Slipped Capital Femoral Epiphyses</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/NCT03229590
org study id: SCFE
nct id: NCT03229590
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Slipped capital femoral epiphysis represents approximately 10.8 cases per 100,000 children.
      The primary source for the blood supply of the head of the femur is the deep branch of the
      medial femoral circumflex artery. Loder described a classification for Slipped capital
      femoral epiphysis based on ability of the child to walk or not(walking=stable,
      non-walking=unstable).
In slipped capital femoral epiphyses (SCFE), the severity of slippage correlates with poor
      long-term clinical outcome scores and radiographic evidence of osteoarthritis . In situ
      fixation of higher-grade SCFE has a low surgical risk and has been advocated by authors who
      believe the deformed hip has the potential to remodel with some restoration of the disturbed
      anatomic axes ; however, the remodeling potential remains controversial . Despite remodeling,
      the head-neck offset will remain abnormal . This is the cause of potential impingement of the
      femoral neck with the acetabular cartilage . Impingement in SCFE has been associated with
      damage of the acetabular cartilage, which may explain the early onset of osteoarthritis after
      SCFE .

      Ganz et al. described a technique of surgical dislocation of hip involving trochanteric flip
      osteotomy and anterior capsulotomy preserving the blood supply to femoral head. The technique
      is based on extensive study of blood supply to the proximal femur. This technique allows us
      to completely dislocate the joint which allows complete access to intra articular pathology
      and allow reduction of the slipped capital femoral epiphysis .
observational model: Cohort
time perspective: Prospective
measure: Harris Hip Score
time frame: 6 months
description: this is a score for post operative evaluation of the hip (it is evaluate pain, support, Distance walked, Limp, Activities - shoes, socks, Stairs, Public transportation, Sitting, Range of motion) every item take a number then the summation of all numbers which ranged from 0 to 100 : <70 Poor 70 - 79 Fair 80-89 Good 90 -100 Excellent
arm group label: Surgical dislocation
description: Reduction of slipped epiphysis via surgical dislocation technique
intervention type: Procedure
intervention name: Surgical dislocation
description: Reduction of slipped epiphysis by surgical dislocation
arm group label: Surgical dislocation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 10 Years
maximum age: 18 Years
citation: Song MH, Jang WY, Park MS, Yoo WJ, Choi IH, Cho TJ. Slipped capital femoral epiphysis in children younger than 10 years old: clinical characteristics and efficacy of physeal-sparing procedures. J Pediatr Orthop B. 2018 Sep;27(5):379-386. doi: 10.1097/BPB.0000000000000485.
PMID: 28704299
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mohamed Ibrahim
investigator title: Principal Investigator
mesh term: Slipped Capital Femoral Epiphyses