<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/NCT04467970</url>
  </required_header>
  <id_info>
    <org_study_id>UKAVSHTOARCT</org_study_id>
    <nct_id>NCT04467970</nct_id>
  </id_info>
  <brief_title>Unicompartmental Knee Arthroplasty vs High Tibial Osteotomy.</brief_title>
  <official_title>Unicompartmental Knee Arthroplasty vs High Tibial Osteotomy: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Valgus high tibial osteotomy (HTO) and unicompartmental knee arthroplasty (UKA) are&#xD;
      established treatment options for patients with medial compartmental osteoarthritis (OA) of&#xD;
      the knee.However, the clinical outcomes of these treatment modalities for unicompartmental OA&#xD;
      have become subjects of debate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although HTO for the correction of malalignment in the medial osteoarthritic knee has been&#xD;
      shown to provide successful outcomes in some studies, it is technically difficult to achieve&#xD;
      the ideal valgus position postoperatively, and the likelihood of postoperative complications&#xD;
      after HTO is greater than that after UKA . As compared with HTO, UKA has been reported to&#xD;
      provide better long-term results, to have a shorter time to full weight bearing, to allow&#xD;
      easier rehabilitation, and to have fewer perioperative complications. Furthermore,&#xD;
      indications for UKA are broadening, including younger and more active patients, since&#xD;
      encouraging midterm and long-term results were published.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Anticipated">October 2023</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>Pain and Function using Oxford Knee Score</measure>
    <time_frame>at least two year follow up.</time_frame>
    <description>this will be measured by using the Oxford Knee Score, a patient reported outcome questionnairewhich is A patient reported outcome measure highest score that could a patient get is 48 and means that good outcome and the lowest score to be obtained is 0 whick means poor outcome ( the higher the score,the better the outcome)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Range of Motion and Function using the American Knee Society Score.</measure>
    <time_frame>at least two year follow up</time_frame>
    <description>this will be measured using the American Knee Society Score (AKSS). A clinician assessed score examining pain, stability, range of movement and function in which the maximum score to get is 100 and least score to get is 0 and the higher the score the better the outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <condition>Knee Arthroplasty</condition>
  <arm_group>
    <arm_group_label>Unicompartmental Knee Replacement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>High Tibial Osteotomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Unicompartmental Knee Replacement</intervention_name>
    <description>Unicompartmental Knee Replacement involves replacement of the medial compartment of the knee in patients with anteromedial osteoarthritis.</description>
    <arm_group_label>Unicompartmental Knee Replacement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>High Tibial Osteotomy</intervention_name>
    <description>High Tibial Osteotomy involves medial wedge opening high tibial osteotomy in cases of anteromedial osteoarthritis.</description>
    <arm_group_label>High Tibial Osteotomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. - Medial compartment osteoarthritis with exposed bone on both femur and tibia.&#xD;
&#xD;
          2. -Functionally intact Anterior Cruciate Ligament (superficial damage or splitting is&#xD;
             acceptable)&#xD;
&#xD;
          3. -Full thickness and good quality lateral cartilage present&#xD;
&#xD;
          4. -Correctable intra-articular varus deformity (suggestive of functionally intact&#xD;
             medical cruciate ligament) 5-Medically fit showing an American Society of&#xD;
             Anesthesiologists (ASA) of 1 or 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Require revision knee replacement surgery.&#xD;
&#xD;
          2. Have rheumatoid arthritis or other inflammatory disorders.&#xD;
&#xD;
          3. Are unlikely to be able to perform required clinical assessment tasks.&#xD;
&#xD;
          4. Have symptomatic foot, hip or spinal pathology.&#xD;
&#xD;
          5. Previous knee surgery other than diagnostic arthroscopy and medial menisectomy.&#xD;
&#xD;
          6. Previously had septic arthritis.&#xD;
&#xD;
          7. Have significant damage to the patella-Femoral Joint especially on the lateral facet.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Assiut University</name>
      <address>
        <city>Assiut</city>
        <zip>71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>July 19, 2022</last_update_submitted>
  <last_update_submitted_qc>July 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohammed Anter Ali Abdelhameed</investigator_full_name>
    <investigator_title>Assistant lecturer</investigator_title>
  </responsible_party>
  <keyword>Unicompartmental knee Replacement</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04467970
org study id: UKAVSHTOARCT
nct id: NCT04467970
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Valgus high tibial osteotomy (HTO) and unicompartmental knee arthroplasty (UKA) are
      established treatment options for patients with medial compartmental osteoarthritis (OA) of
      the knee.However, the clinical outcomes of these treatment modalities for unicompartmental OA
      have become subjects of debate.
Although HTO for the correction of malalignment in the medial osteoarthritic knee has been
      shown to provide successful outcomes in some studies, it is technically difficult to achieve
      the ideal valgus position postoperatively, and the likelihood of postoperative complications
      after HTO is greater than that after UKA . As compared with HTO, UKA has been reported to
      provide better long-term results, to have a shorter time to full weight bearing, to allow
      easier rehabilitation, and to have fewer perioperative complications. Furthermore,
      indications for UKA are broadening, including younger and more active patients, since
      encouraging midterm and long-term results were published.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pain and Function using Oxford Knee Score
time frame: at least two year follow up.
description: this will be measured by using the Oxford Knee Score, a patient reported outcome questionnairewhich is A patient reported outcome measure highest score that could a patient get is 48 and means that good outcome and the lowest score to be obtained is 0 whick means poor outcome ( the higher the score,the better the outcome)
measure: Range of Motion and Function using the American Knee Society Score.
time frame: at least two year follow up
description: this will be measured using the American Knee Society Score (AKSS). A clinician assessed score examining pain, stability, range of movement and function in which the maximum score to get is 100 and least score to get is 0 and the higher the score the better the outcome.
arm group label: Unicompartmental Knee Replacement
arm group type: Experimental
arm group label: High Tibial Osteotomy
arm group type: Experimental
intervention type: Procedure
intervention name: Unicompartmental Knee Replacement
description: Unicompartmental Knee Replacement involves replacement of the medial compartment of the knee in patients with anteromedial osteoarthritis.
arm group label: Unicompartmental Knee Replacement
intervention type: Procedure
intervention name: High Tibial Osteotomy
description: High Tibial Osteotomy involves medial wedge opening high tibial osteotomy in cases of anteromedial osteoarthritis.
arm group label: High Tibial Osteotomy
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mohammed Anter Ali Abdelhameed
investigator title: Assistant lecturer
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No