<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/NCT03291015</url>
  </required_header>
  <id_info>
    <org_study_id>kienbock disease</org_study_id>
    <nct_id>NCT03291015</nct_id>
  </id_info>
  <brief_title>Kienbock Disease Radiographic Guided Treatment Versus Arthroscopic Guided Treatment</brief_title>
  <official_title>Kienbock Disease Radiographic Guided Treatment Versus Arthroscopic Guided Treatment</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>
      To Compare Between Radiological Guided Treatment And Arthroscopic Guided Treatment Of&#xD;
      KIENBOCK Disease&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Kienbock'sdisease is defined as avascular necrosis of the lunate bone, which may ultimately&#xD;
      progress to lunate sclerosis, collapse, and wrist instability. Incidence is highest in males&#xD;
      20-40 years of age, although it may occur in any age group. Kienbock's disease is uncommon in&#xD;
      skeletally immature patients. The cause of Kienbock's disease is likely multi factorial, but&#xD;
      potential risk factors have been identified including variant lunate arterial supply and&#xD;
      ulnar negative variance. In fewer than 20% of patients, the dorsal blood supply is absent and&#xD;
      the lunate is supplied by the palmar radiocarpal arch only; this may represent a risk factor&#xD;
      for Kienbock's disease .&#xD;
&#xD;
      Negative ulnar variance may also predispose to Kienbock's disease due to abnormal force&#xD;
      loading on the lunate.&#xD;
&#xD;
      Kienbock's disease may be staged according to radiologic appearance using Lichtman&#xD;
      classification Stage I is defined as normal radiographic appearance of the lunate with marrow&#xD;
      edema present on MRI.&#xD;
&#xD;
      In Stage II disease, there is sclerosis of the lunate, with or without a fracture line, but&#xD;
      without lunate collapse.&#xD;
&#xD;
      Stage III, defined as presence of lunate articular surface collapse, may be divided further&#xD;
      into three subcategories.&#xD;
&#xD;
      In Stage IIIA, there is no scaphoid rotation; in Stage IIIB, there is fixed scaphoid rotatory&#xD;
      subluxation, and in Stage IIIC, a coronal fracture of the lunate is present in addition to&#xD;
      scaphoid rotation. Stage III C in 2010 as an addition to the classification scheme.&#xD;
&#xD;
      Stage IV disease is present when secondary radiocarpal or midcarpal osteoarthritis is present&#xD;
      in addition to Stage III findings.&#xD;
&#xD;
      An alternate classification of Kienbock's disease, the Bain and Begg&#xD;
&#xD;
      The assessment and management of Kienböck Disease (KD) has always been conundrum. The&#xD;
      Lichtman classification has traditionally been used to guide treatment based on imaging.&#xD;
      Arthroscopy provides a direct visualization of the articular surface,allows probing of the&#xD;
      surfaces, and enables minimally invasive techniques to be performed. The Lichtman-Bain&#xD;
      classification is a new classification that takes into account the osseous, vascular, and&#xD;
      cartilage aspects of the lunate and the secondary effects on the wrist. It identifies the&#xD;
      important prognostic factors including age, the status of the lunate, and the status of the&#xD;
      wrist.&#xD;
&#xD;
      With arthroscopy, the articular surfaces of the lunate can be assessed to better understand&#xD;
      the status of the lunate. The lunate can be defined as intact, compromised,or not&#xD;
      reconstructable. If the lunate is intact then lunate decompression (forage) and arthroscopic&#xD;
      assisted bone grafting can be performed. If the lunate facet and capitate are functional,&#xD;
      then proximal carpectomy can be performed.&#xD;
&#xD;
      Assessment of the wrist includes assessment of the adjacent articular surfaces of the central&#xD;
      column articulations (radiocarpal and midcarpal articulations). Instability of the proximal&#xD;
      carpal row can also be assessed. The radioscaphoid articulation is often preserved except in&#xD;
      late KD, which allows the scaphocapitate fusion to be a good surgical option. This can now be&#xD;
      performed as an arthroscopic procedure. Once the radioscaphoid articulation is degenerate, a&#xD;
      salvage procedure is required Wrist arthroscopy is a commonly used procedure that has&#xD;
      undergone many modifications and improvements since it was first described. The advent of new&#xD;
      portals (both dorsal and volar) means that the wrist joint can be viewed from virtually any&#xD;
      perspective (&quot;box concept&quot;). Indications for wrist arthroscopy have continued to expand and&#xD;
      include diagnostic and reparative procedures and, more recently, reconstructive, soft-tissue,&#xD;
      and bony procedures. Arthroscopic grading of Kienböck's disease better describes articular&#xD;
      damage compared with plain radiographs and can help guide surgical treatment options This&#xD;
      grading system assists in classifying the severity of the disease and better directs the&#xD;
      surgeon toward the reconstructive surgical options grade 0 disorder could be treated with an&#xD;
      extra-articular procedure, such as a joint-leveling procedure or revascularization of the&#xD;
      lunate. Patients with grade 1or 2a can be treated with a radio-scapho-lunate fusion Patients&#xD;
      with grade 1 or 2b can be treated with aproximal-row carpectomy, whereas those with grade 3or&#xD;
      4 require salvage procedures (such as wrist arthrodesis or arthoplasty) Menth-Chiari et al.15&#xD;
      reported on the use of arthroscopic debridement for Kienböck's disease. They&#xD;
      reportedexcellent pain relief and improved range of motion in all grades of patients with up&#xD;
      to 2 years of follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2017</start_date>
  <completion_date type="Anticipated">February 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 1, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison Between Radiological Guided Treatment(15Patient) And Arthroscopic Guided Treatment(Other 15Patient) Of KIENBOCK Disease</measure>
    <time_frame>baseline</time_frame>
    <description>it is found tht 70% ofkienbock disease patient treated by radiographic guided treatment plan is not satisfied sothat we will analyse the persentage of satisfied patient treated by arthroscopic guided treatment plan versus radiographic guided treatment plan</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Kienbock Disease</condition>
  <arm_group>
    <arm_group_label>radiographic guided treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>radiographic guided treatment of kienbock disease using plain x ray for determine treatment plan</description>
  </arm_group>
  <arm_group>
    <arm_group_label>arthroscopic guided treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>arthroscopic guided treatment of kienbock disease using wrist arthroscopy for determine treatment plan (Wrist arthroscopy)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>radiographic</intervention_name>
    <description>using plain x ray to determind the treatment plan</description>
    <arm_group_label>radiographic guided treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>arthroscopy</intervention_name>
    <description>using wrist arthroscopy to determind the treatment plan</description>
    <arm_group_label>arthroscopic guided treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult persons with average age of 20-60 years.&#xD;
&#xD;
          -  Persons coming to outpatient clinic and trauma unit complaining Of Chronic Wrist pain&#xD;
&#xD;
          -  Plain x-ray films Antero-posterior View And lateral views of the Wrist&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Persons &lt; 20 years or &gt; 60 years.&#xD;
&#xD;
          -  Traumatic WristWithFracture&#xD;
&#xD;
          -  Previous Wrist surgery.&#xD;
&#xD;
          -  Patient With Condraindication To plain X-Ray&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>youssef zaki, resident</last_name>
    <phone>01222364028</phone>
    <email>youssefmalak33@yahoo.com</email>
  </overall_contact>
  <reference>
    <citation>Nealey EM, Petscavage-Thomas JM, Chew FS, Allan CH, Ha AS. Radiologic Guide to Surgical Treatment of Kienbock's Disease. Curr Probl Diagn Radiol. 2018 Mar-Apr;47(2):103-109. doi: 10.1067/j.cpradiol.2017.04.012. Epub 2017 Apr 25.</citation>
    <PMID>28619441</PMID>
  </reference>
  <reference>
    <citation>Lichtman DM, Lesley NE, Simmons SP. The classification and treatment of Kienbock's disease: the state of the art and a look at the future. J Hand Surg Eur Vol. 2010 Sep;35(7):549-54. doi: 10.1177/1753193410374690. Epub 2010 Jul 9.</citation>
    <PMID>20621943</PMID>
  </reference>
  <reference>
    <citation>Stahl S, Stahl AS, Meisner C, Hentschel PJH, Valina S, Luz O, Schaller HE, Lotter O. Critical analysis of causality between negative ulnar variance and Kienbock disease. Plast Reconstr Surg. 2013 Oct;132(4):899-909. doi: 10.1097/PRS.0b013e31829f4a2c.</citation>
    <PMID>24076682</PMID>
  </reference>
  <reference>
    <citation>Roth JH, Poehling GG, Whipple TL. Arthroscopic surgery of the wrist. Instr Course Lect. 1988;37:183-94.</citation>
    <PMID>3418121</PMID>
  </reference>
  <reference>
    <citation>Bain GI, Munt J, Turner PC. New advances in wrist arthroscopy. Arthroscopy. 2008 Mar;24(3):355-67. doi: 10.1016/j.arthro.2007.11.002. Epub 2008 Jan 29.</citation>
    <PMID>18308189</PMID>
  </reference>
  <reference>
    <citation>Bain GI, Begg M. Arthroscopic assessment and classification of Kienbock's disease. Tech Hand Up Extrem Surg. 2006 Mar;10(1):8-13. doi: 10.1097/00130911-200603000-00003.</citation>
    <PMID>16628114</PMID>
  </reference>
  <reference>
    <citation>Bain GI, MacLean SB, Tse WL, Ho PC, Lichtman DM. Kienbock Disease and Arthroscopy: Assessment, Classification, and Treatment. J Wrist Surg. 2016 Nov;5(4):255-260. doi: 10.1055/s-0036-1584546. Epub 2016 Jun 20.</citation>
    <PMID>27777814</PMID>
  </reference>
  <reference>
    <citation>Bain GI, Durrant A. An articular-based approach to Kienbock avascular necrosis of the lunate. Tech Hand Up Extrem Surg. 2011 Mar;15(1):41-7. doi: 10.1097/BTH.0b013e31820e82e8.</citation>
    <PMID>21358525</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>September 19, 2017</last_update_submitted>
  <last_update_submitted_qc>September 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Youssef Abdelmalak</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>arthroscopy</keyword>
  <keyword>radiographic(plain X ray)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteonecrosis</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/NCT03291015
org study id: kienbock disease
nct id: NCT03291015
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To Compare Between Radiological Guided Treatment And Arthroscopic Guided Treatment Of
      KIENBOCK Disease
Kienbock'sdisease is defined as avascular necrosis of the lunate bone, which may ultimately
      progress to lunate sclerosis, collapse, and wrist instability. Incidence is highest in males
      20-40 years of age, although it may occur in any age group. Kienbock's disease is uncommon in
      skeletally immature patients. The cause of Kienbock's disease is likely multi factorial, but
      potential risk factors have been identified including variant lunate arterial supply and
      ulnar negative variance. In fewer than 20% of patients, the dorsal blood supply is absent and
      the lunate is supplied by the palmar radiocarpal arch only; this may represent a risk factor
      for Kienbock's disease .

      Negative ulnar variance may also predispose to Kienbock's disease due to abnormal force
      loading on the lunate.

      Kienbock's disease may be staged according to radiologic appearance using Lichtman
      classification Stage I is defined as normal radiographic appearance of the lunate with marrow
      edema present on MRI.

      In Stage II disease, there is sclerosis of the lunate, with or without a fracture line, but
      without lunate collapse.

      Stage III, defined as presence of lunate articular surface collapse, may be divided further
      into three subcategories.

      In Stage IIIA, there is no scaphoid rotation; in Stage IIIB, there is fixed scaphoid rotatory
      subluxation, and in Stage IIIC, a coronal fracture of the lunate is present in addition to
      scaphoid rotation. Stage III C in 2010 as an addition to the classification scheme.

      Stage IV disease is present when secondary radiocarpal or midcarpal osteoarthritis is present
      in addition to Stage III findings.

      An alternate classification of Kienbock's disease, the Bain and Begg

      The assessment and management of Kienböck Disease (KD) has always been conundrum. The
      Lichtman classification has traditionally been used to guide treatment based on imaging.
      Arthroscopy provides a direct visualization of the articular surface,allows probing of the
      surfaces, and enables minimally invasive techniques to be performed. The Lichtman-Bain
      classification is a new classification that takes into account the osseous, vascular, and
      cartilage aspects of the lunate and the secondary effects on the wrist. It identifies the
      important prognostic factors including age, the status of the lunate, and the status of the
      wrist.

      With arthroscopy, the articular surfaces of the lunate can be assessed to better understand
      the status of the lunate. The lunate can be defined as intact, compromised,or not
      reconstructable. If the lunate is intact then lunate decompression (forage) and arthroscopic
      assisted bone grafting can be performed. If the lunate facet and capitate are functional,
      then proximal carpectomy can be performed.

      Assessment of the wrist includes assessment of the adjacent articular surfaces of the central
      column articulations (radiocarpal and midcarpal articulations). Instability of the proximal
      carpal row can also be assessed. The radioscaphoid articulation is often preserved except in
      late KD, which allows the scaphocapitate fusion to be a good surgical option. This can now be
      performed as an arthroscopic procedure. Once the radioscaphoid articulation is degenerate, a
      salvage procedure is required Wrist arthroscopy is a commonly used procedure that has
      undergone many modifications and improvements since it was first described. The advent of new
      portals (both dorsal and volar) means that the wrist joint can be viewed from virtually any
      perspective ("box concept"). Indications for wrist arthroscopy have continued to expand and
      include diagnostic and reparative procedures and, more recently, reconstructive, soft-tissue,
      and bony procedures. Arthroscopic grading of Kienböck's disease better describes articular
      damage compared with plain radiographs and can help guide surgical treatment options This
      grading system assists in classifying the severity of the disease and better directs the
      surgeon toward the reconstructive surgical options grade 0 disorder could be treated with an
      extra-articular procedure, such as a joint-leveling procedure or revascularization of the
      lunate. Patients with grade 1or 2a can be treated with a radio-scapho-lunate fusion Patients
      with grade 1 or 2b can be treated with aproximal-row carpectomy, whereas those with grade 3or
      4 require salvage procedures (such as wrist arthrodesis or arthoplasty) Menth-Chiari et al.15
      reported on the use of arthroscopic debridement for Kienböck's disease. They
      reportedexcellent pain relief and improved range of motion in all grades of patients with up
      to 2 years of follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Comparison Between Radiological Guided Treatment(15Patient) And Arthroscopic Guided Treatment(Other 15Patient) Of KIENBOCK Disease
time frame: baseline
description: it is found tht 70% ofkienbock disease patient treated by radiographic guided treatment plan is not satisfied sothat we will analyse the persentage of satisfied patient treated by arthroscopic guided treatment plan versus radiographic guided treatment plan
arm group label: radiographic guided treatment
arm group type: Other
description: radiographic guided treatment of kienbock disease using plain x ray for determine treatment plan
arm group label: arthroscopic guided treatment
arm group type: Other
description: arthroscopic guided treatment of kienbock disease using wrist arthroscopy for determine treatment plan (Wrist arthroscopy)
intervention type: Device
intervention name: radiographic
description: using plain x ray to determind the treatment plan
arm group label: radiographic guided treatment
intervention type: Device
intervention name: arthroscopy
description: using wrist arthroscopy to determind the treatment plan
arm group label: arthroscopic guided treatment
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: youssef zaki, resident
phone: 01222364028
email: youssefmalak33@yahoo.com
citation: Nealey EM, Petscavage-Thomas JM, Chew FS, Allan CH, Ha AS. Radiologic Guide to Surgical Treatment of Kienbock's Disease. Curr Probl Diagn Radiol. 2018 Mar-Apr;47(2):103-109. doi: 10.1067/j.cpradiol.2017.04.012. Epub 2017 Apr 25.
PMID: 28619441
citation: Lichtman DM, Lesley NE, Simmons SP. The classification and treatment of Kienbock's disease: the state of the art and a look at the future. J Hand Surg Eur Vol. 2010 Sep;35(7):549-54. doi: 10.1177/1753193410374690. Epub 2010 Jul 9.
PMID: 20621943
citation: Stahl S, Stahl AS, Meisner C, Hentschel PJH, Valina S, Luz O, Schaller HE, Lotter O. Critical analysis of causality between negative ulnar variance and Kienbock disease. Plast Reconstr Surg. 2013 Oct;132(4):899-909. doi: 10.1097/PRS.0b013e31829f4a2c.
PMID: 24076682
citation: Roth JH, Poehling GG, Whipple TL. Arthroscopic surgery of the wrist. Instr Course Lect. 1988;37:183-94.
PMID: 3418121
citation: Bain GI, Munt J, Turner PC. New advances in wrist arthroscopy. Arthroscopy. 2008 Mar;24(3):355-67. doi: 10.1016/j.arthro.2007.11.002. Epub 2008 Jan 29.
PMID: 18308189
citation: Bain GI, Begg M. Arthroscopic assessment and classification of Kienbock's disease. Tech Hand Up Extrem Surg. 2006 Mar;10(1):8-13. doi: 10.1097/00130911-200603000-00003.
PMID: 16628114
citation: Bain GI, MacLean SB, Tse WL, Ho PC, Lichtman DM. Kienbock Disease and Arthroscopy: Assessment, Classification, and Treatment. J Wrist Surg. 2016 Nov;5(4):255-260. doi: 10.1055/s-0036-1584546. Epub 2016 Jun 20.
PMID: 27777814
citation: Bain GI, Durrant A. An articular-based approach to Kienbock avascular necrosis of the lunate. Tech Hand Up Extrem Surg. 2011 Mar;15(1):41-7. doi: 10.1097/BTH.0b013e31820e82e8.
PMID: 21358525
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Youssef Abdelmalak
investigator title: Principal Investigator
mesh term: Osteonecrosis