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/NCT05982808</url>
    </required_header>
    <id_info>
      <org_study_id>CLIF correction for ASD</org_study_id>
      <nct_id>NCT05982808</nct_id>
    </id_info>
    <brief_title>CLIF Correction VS. Conventional Correction Strategy for ASD</brief_title>
    <official_title>A Novel Surgical Technique of CLIF Correction VS. Conventional Corrective Strategy on the Treatment of Adult Complex Spinal Deformity With a Multicenter Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The present study intends to: 1）establish a multi-center large-sample randomized controlled&#xD;
        trial to explore the technical advantages and surgical indications of the novel surgical&#xD;
        technique of CLIF correction for ASD compared with the conventional correction strategy;&#xD;
        2）analyze the postoperative clinical and imaging results, and to explore the related&#xD;
        complications and preventive measures; 3） establish 2-year follow-up to further quantify the&#xD;
        clinical and radiographical outcomes of CLIF correction.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Adult spinal deformity (ASD) is the most common spinal deformity in the elder, which often&#xD;
        causes the low back pain and/or physical deformity. Severe cases need surgical treatment.&#xD;
        Because the conventional posterior approach had the disadvantages of big trauma and slow&#xD;
        recovery, and the elder were always complicated with complicated medical diseases, the&#xD;
        perioperative risk was high. At present, the novel surgical technique of CLIF correction was&#xD;
        a popular way for ASD treatment. Preliminary results showed that it had less trauma, shorter&#xD;
        operation time, faster recovery, fewer complications and remarkable clinical and&#xD;
        adiographical outcomes. Therefore, the present study intends to: 1) establish a multi-center&#xD;
        large-sample randomized controlled trial to explore the technical advantages and surgical&#xD;
        indications of the novel CLIF correction for ASD treatment compared with the conventional&#xD;
        correction strategy; 2) establish 2-year follow-up to further quantify the clinical and&#xD;
        radiographical outcomes, and to explore the related complications and preventive measures;.&#xD;
        Therefore, the present project aims to explore the best surgical plan for treating ASD by&#xD;
        studying the safety and effectiveness of the novel CLIF correction, and provide new surgical&#xD;
        strategies for minimally invasive and Individualized treatment for ASD.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 1, 2024</start_date>
    <completion_date type="Anticipated">June 1, 2028</completion_date>
    <primary_completion_date type="Anticipated">June 1, 2026</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>
      <intervention_model_description>with/without novel CLIF correction</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>ODI score</measure>
      <time_frame>2 year after surgery</time_frame>
      <description>ODI score is Oswestry Disability Index（0-100）, indicating the back pain; the higher score, the greater back pain</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>SF-36 score</measure>
      <time_frame>2 year after surgery</time_frame>
      <description>SF-36 score is the MOS item short from health survey (0-100), indicating the life quality; the higher score, the better life quality</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">420</enrollment>
    <condition>Spinal Deformity</condition>
    <arm_group>
      <arm_group_label>Novel CLIF correction</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>ASD patients with novel CLIF correction</description>
    </arm_group>
    <arm_group>
      <arm_group_label>conventional correction strategy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>ASD patients with conventional correction strategy</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>CLIF correction</intervention_name>
      <description>CLIF correction was a novel surgical techqiue of correction of spinal deformtiy with minimal invasive approach</description>
      <arm_group_label>Novel CLIF correction</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>conventional correction strategy</intervention_name>
      <description>conventional correction was the classic surgical techqiue of correction of spinal deformtiy with open posterior approach</description>
      <arm_group_label>conventional correction strategy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  adult spinal deformtiy;&#xD;
  &#xD;
            -  40yrs≤age≤80yrs;&#xD;
  &#xD;
            -  Lenke-Silva classification II-V grade;&#xD;
  &#xD;
            -  ineffective with conservative treatment;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  severe osteoprosis with T value &lt;-2.5;&#xD;
  &#xD;
            -  with preliminary spinal surgery;&#xD;
  &#xD;
            -  ASA score≥III grade;&#xD;
  &#xD;
            -  more than II degree spondylisthesis;&#xD;
  &#xD;
            -  with mental disease;&#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>Zhi-wei WANG, Ph.D and MD.</last_name>
      <role>Principal Investigator</role>
      <affiliation>2nd Hospital, Zhejiang University, School of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Zhi-wei WANG, Ph.D and MD.</last_name>
      <phone>0571-88981080</phone>
      <phone_ext>86</phone_ext>
      <email>2316002@zju.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Fang-cai LI, Ph.D and MD.</last_name>
      <phone>0571-88981080</phone>
      <email>2505004@zju.edu.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Second Affiliated Hospital, School of Medicine, Zejiang University</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <zip>310000</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <results_reference>
      <citation>Aebi M. The adult scoliosis. Eur Spine J. 2005 Dec;14(10):925-48. doi: 10.1007/s00586-005-1053-9. Epub 2005 Nov 18.</citation>
      <PMID>16328223</PMID>
    </results_reference>
    <results_reference>
      <citation>Ailon T, Smith JS, Shaffrey CI, Lenke LG, Brodke D, Harrop JS, Fehlings M, Ames CP. Degenerative Spinal Deformity. Neurosurgery. 2015 Oct;77 Suppl 4:S75-91. doi: 10.1227/NEU.0000000000000938.</citation>
      <PMID>26378361</PMID>
    </results_reference>
    <results_reference>
      <citation>Schwab F, Dubey A, Gamez L, El Fegoun AB, Hwang K, Pagala M, Farcy JP. Adult scoliosis: prevalence, SF-36, and nutritional parameters in an elderly volunteer population. Spine (Phila Pa 1976). 2005 May 1;30(9):1082-5. doi: 10.1097/01.brs.0000160842.43482.cd.</citation>
      <PMID>15864163</PMID>
    </results_reference>
    <results_reference>
      <citation>Smith JS, Shaffrey CI, Glassman SD, Berven SH, Schwab FJ, Hamill CL, Horton WC, Ondra SL, Sansur CA, Bridwell KH; Spinal Deformity Study Group. Risk-benefit assessment of surgery for adult scoliosis: an analysis based on patient age. Spine (Phila Pa 1976). 2011 May 1;36(10):817-24. doi: 10.1097/BRS.0b013e3181e21783.</citation>
      <PMID>20683385</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Second Affiliated Hospital, School of Medicine, Zhejiang University</investigator_affiliation>
      <investigator_full_name>Wang Zhiwei, MD</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>adult spinal deformity</keyword>
    <keyword>CLIF</keyword>
    <keyword>crenal lumbar interbody fusion</keyword>
    <keyword>minimal invasive</keyword>
    <keyword>correction</keyword>
    <keyword>surgical strategy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Congenital Abnormalities</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>When the first stage is done, the study plan would be open for others</ipd_description>
    </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/NCT05982808
  org study id: CLIF correction for ASD
  nct id: NCT05982808
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The present study intends to: 1）establish a multi-center large-sample randomized controlled
        trial to explore the technical advantages and surgical indications of the novel surgical
        technique of CLIF correction for ASD compared with the conventional correction strategy;
        2）analyze the postoperative clinical and imaging results, and to explore the related
        complications and preventive measures; 3） establish 2-year follow-up to further quantify the
        clinical and radiographical outcomes of CLIF correction.
  Adult spinal deformity (ASD) is the most common spinal deformity in the elder, which often
        causes the low back pain and/or physical deformity. Severe cases need surgical treatment.
        Because the conventional posterior approach had the disadvantages of big trauma and slow
        recovery, and the elder were always complicated with complicated medical diseases, the
        perioperative risk was high. At present, the novel surgical technique of CLIF correction was
        a popular way for ASD treatment. Preliminary results showed that it had less trauma, shorter
        operation time, faster recovery, fewer complications and remarkable clinical and
        adiographical outcomes. Therefore, the present study intends to: 1) establish a multi-center
        large-sample randomized controlled trial to explore the technical advantages and surgical
        indications of the novel CLIF correction for ASD treatment compared with the conventional
        correction strategy; 2) establish 2-year follow-up to further quantify the clinical and
        radiographical outcomes, and to explore the related complications and preventive measures;.
        Therefore, the present project aims to explore the best surgical plan for treating ASD by
        studying the safety and effectiveness of the novel CLIF correction, and provide new surgical
        strategies for minimally invasive and Individualized treatment for ASD.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: with/without novel CLIF correction
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: ODI score
  time frame: 2 year after surgery
  description: ODI score is Oswestry Disability Index（0-100）, indicating the back pain; the higher score, the greater back pain
  measure: SF-36 score
  time frame: 2 year after surgery
  description: SF-36 score is the MOS item short from health survey (0-100), indicating the life quality; the higher score, the better life quality
  arm group label: Novel CLIF correction
  arm group type: Experimental
  description: ASD patients with novel CLIF correction
  arm group label: conventional correction strategy
  arm group type: Active Comparator
  description: ASD patients with conventional correction strategy
  intervention type: Procedure
  intervention name: CLIF correction
  description: CLIF correction was a novel surgical techqiue of correction of spinal deformtiy with minimal invasive approach
  arm group label: Novel CLIF correction
  intervention type: Procedure
  intervention name: conventional correction strategy
  description: conventional correction was the classic surgical techqiue of correction of spinal deformtiy with open posterior approach
  arm group label: conventional correction strategy
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Zhi-wei WANG, Ph.D and MD.
  role: Principal Investigator
  affiliation: 2nd Hospital, Zhejiang University, School of Medicine
  last name: Zhi-wei WANG, Ph.D and MD.
  phone: 0571-88981080
  phone ext: 86
  email: 2316002@zju.edu.cn
  last name: Fang-cai LI, Ph.D and MD.
  phone: 0571-88981080
  email: 2505004@zju.edu.cn
  facility: 
  country: China
  citation: Aebi M. The adult scoliosis. Eur Spine J. 2005 Dec;14(10):925-48. doi: 10.1007/s00586-005-1053-9. Epub 2005 Nov 18.
  PMID: 16328223
  citation: Ailon T, Smith JS, Shaffrey CI, Lenke LG, Brodke D, Harrop JS, Fehlings M, Ames CP. Degenerative Spinal Deformity. Neurosurgery. 2015 Oct;77 Suppl 4:S75-91. doi: 10.1227/NEU.0000000000000938.
  PMID: 26378361
  citation: Schwab F, Dubey A, Gamez L, El Fegoun AB, Hwang K, Pagala M, Farcy JP. Adult scoliosis: prevalence, SF-36, and nutritional parameters in an elderly volunteer population. Spine (Phila Pa 1976). 2005 May 1;30(9):1082-5. doi: 10.1097/01.brs.0000160842.43482.cd.
  PMID: 15864163
  citation: Smith JS, Shaffrey CI, Glassman SD, Berven SH, Schwab FJ, Hamill CL, Horton WC, Ondra SL, Sansur CA, Bridwell KH; Spinal Deformity Study Group. Risk-benefit assessment of surgery for adult scoliosis: an analysis based on patient age. Spine (Phila Pa 1976). 2011 May 1;36(10):817-24. doi: 10.1097/BRS.0b013e3181e21783.
  PMID: 20683385
  responsible party type: Principal Investigator
  investigator affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
  investigator full name: Wang Zhiwei, MD
  investigator title: Principal Investigator
  mesh term: Congenital Abnormalities
  sharing ipd: No
  ipd description: When the first stage is done, the study plan would be open for others