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/NCT05986006</url>
    </required_header>
    <id_info>
      <org_study_id>AHIL22D.618</org_study_id>
      <nct_id>NCT05986006</nct_id>
    </id_info>
    <brief_title>Fusion Status After ACDF</brief_title>
    <official_title>Fusion Status of Machined Allograft Versus Iliac Crest Allograft in Anterior Cervical Discectomy and Fusion: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Rothman Institute Orthopaedics</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Rothman Institute Orthopaedics</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>
        Pseudarthrosis, a failure of bony fusion, is one of the most common causes of revision&#xD;
        surgery following anterior cervical discectomy and fusion (ACDF). The interbody spacer is an&#xD;
        important component of bony fusion in ACDF, and we aim to compare machined allograft spacers&#xD;
        versus iliac crest allograft in a randomized controlled trial.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Pseudarthrosis, a failure of bony fusion, is one of the most common causes of revision&#xD;
        surgery following anterior cervical discectomy and fusion (ACDF). The interbody spacer is an&#xD;
        important component of bony fusion in ACDF, and we aim to compare machined allograft spacers&#xD;
        versus iliac crest allograft in a randomized controlled trial. We hypothesize that iliac&#xD;
        crest allograft will improve anterior cervical discectomy and fusion arthrodesis rates and&#xD;
        diminish the amount of intervertebral graft resorption when compared to off-the-shelf&#xD;
        machined allografts&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Anticipated">August 7, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2024</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>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Improved participant reported outcome measures (PROMs)-1</measure>
      <time_frame>2 years</time_frame>
      <description>Investigators will ask participants to complete the Short Form-12 survey (SF-12) at 3 months, 6 months, 12 months, and 24 months following surgery</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Improved participant reported outcome measures (PROMs)-2</measure>
      <time_frame>2 years</time_frame>
      <description>Investigators will ask participants to complete the Visual Analog Score (VAS) for Neck and Arm, Neck Disability Index (NDI), at 3 months, 6 months, 12 months, and 24 months following surgery</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Improved participant reported outcome measures (PROMs)-3</measure>
      <time_frame>2 years</time_frame>
      <description>Investigators will ask participants to complete the modified Japanese Orthopaedic Association (mJOA) score) at 3 months, 6 months, 12 months, and 24 months following surgery</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fusion status after surgery</measure>
      <time_frame>2 years</time_frame>
      <description>Fusion status will be assessed using Postoperative x-rays (AP, lateral, flexion, extension) which will be taken at 3 months, 6 months, 12 months, and 24 months following surgery</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">124</enrollment>
    <condition>Spine Fusion</condition>
    <condition>Spine Surgery</condition>
    <arm_group>
      <arm_group_label>Anterior Cervical Discectomy and Fusion (ACDF) w/Machined Allograft</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participant will undergo primary, elective one-level to four-level ACDF and will be randomized to machined bone allograft</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Anterior Cervical Discectomy and Fusion (ACDF) w/Iliac Crest Allograft</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participant will undergo primary, elective one-level to four-level ACDF and will be randomized to iliac crest bone allograft</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Anterior Cervical Disc Fusion (ACDF) Surgery w/ machined bone allograft</intervention_name>
      <description>Participant will undergo primary, elective one-level to four-level ACDF using machined bone allograft</description>
      <arm_group_label>Anterior Cervical Discectomy and Fusion (ACDF) w/Machined Allograft</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Anterior Cervical Disc Fusion (ACDF) Surgery w/ Iliac Crest Bone Graft</intervention_name>
      <description>Participant will undergo primary, elective one-level to four-level ACDF using iliac crest bone allograft</description>
      <arm_group_label>Anterior Cervical Discectomy and Fusion (ACDF) w/Iliac Crest Allograft</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients 18 years of age or older&#xD;
  &#xD;
            -  preoperative diagnosis of cervical radiculopathy and/or cervical myelopathy.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients undergoing a revision cervical procedure&#xD;
  &#xD;
            -  current smokers&#xD;
  &#xD;
            -  patient with surgical indications of tumor, infection, or trauma&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Rothman Orthopaedic Institute</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19107</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- 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/NCT05986006
  org study id: AHIL22D.618
  nct id: NCT05986006
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Pseudarthrosis, a failure of bony fusion, is one of the most common causes of revision
        surgery following anterior cervical discectomy and fusion (ACDF). The interbody spacer is an
        important component of bony fusion in ACDF, and we aim to compare machined allograft spacers
        versus iliac crest allograft in a randomized controlled trial.
  Pseudarthrosis, a failure of bony fusion, is one of the most common causes of revision
        surgery following anterior cervical discectomy and fusion (ACDF). The interbody spacer is an
        important component of bony fusion in ACDF, and we aim to compare machined allograft spacers
        versus iliac crest allograft in a randomized controlled trial. We hypothesize that iliac
        crest allograft will improve anterior cervical discectomy and fusion arthrodesis rates and
        diminish the amount of intervertebral graft resorption when compared to off-the-shelf
        machined allografts
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Improved participant reported outcome measures (PROMs)-1
  time frame: 2 years
  description: Investigators will ask participants to complete the Short Form-12 survey (SF-12) at 3 months, 6 months, 12 months, and 24 months following surgery
  measure: Improved participant reported outcome measures (PROMs)-2
  time frame: 2 years
  description: Investigators will ask participants to complete the Visual Analog Score (VAS) for Neck and Arm, Neck Disability Index (NDI), at 3 months, 6 months, 12 months, and 24 months following surgery
  measure: Improved participant reported outcome measures (PROMs)-3
  time frame: 2 years
  description: Investigators will ask participants to complete the modified Japanese Orthopaedic Association (mJOA) score) at 3 months, 6 months, 12 months, and 24 months following surgery
  measure: Fusion status after surgery
  time frame: 2 years
  description: Fusion status will be assessed using Postoperative x-rays (AP, lateral, flexion, extension) which will be taken at 3 months, 6 months, 12 months, and 24 months following surgery
  arm group label: Anterior Cervical Discectomy and Fusion (ACDF) w/Machined Allograft
  arm group type: Active Comparator
  description: Participant will undergo primary, elective one-level to four-level ACDF and will be randomized to machined bone allograft
  arm group label: Anterior Cervical Discectomy and Fusion (ACDF) w/Iliac Crest Allograft
  arm group type: Active Comparator
  description: Participant will undergo primary, elective one-level to four-level ACDF and will be randomized to iliac crest bone allograft
  intervention type: Procedure
  intervention name: Anterior Cervical Disc Fusion (ACDF) Surgery w/ machined bone allograft
  description: Participant will undergo primary, elective one-level to four-level ACDF using machined bone allograft
  arm group label: Anterior Cervical Discectomy and Fusion (ACDF) w/Machined Allograft
  intervention type: Procedure
  intervention name: Anterior Cervical Disc Fusion (ACDF) Surgery w/ Iliac Crest Bone Graft
  description: Participant will undergo primary, elective one-level to four-level ACDF using iliac crest bone allograft
  arm group label: Anterior Cervical Discectomy and Fusion (ACDF) w/Iliac Crest Allograft
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United States
  responsible party type: Sponsor