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/NCT05985434</url>
    </required_header>
    <id_info>
      <org_study_id>0009120</org_study_id>
      <nct_id>NCT05985434</nct_id>
    </id_info>
    <brief_title>Prospective Observational Study on Vertebral Metastasis</brief_title>
    <acronym>CVODMetsVert</acronym>
    <official_title>Prospective Observational Study on Patients Treated for Vertebral Metastasis and Vertebral Localizations of Lymphoproliferative Disease: Impact of the Treatment on the Quality of Life.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istituto Ortopedico Rizzoli</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istituto Ortopedico Rizzoli</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>
        Perspective observational cohort study in which the data relating to patients affected by one&#xD;
        or more vertebral metastases or by vertebral localization of hemolifoproliferative malact and&#xD;
        surgical treatment candidates will be collected, which will be recruited at the Complex&#xD;
        Structure of Spine Surgery for Oncological and Degenerative Rizzoli Orthopedic Institute&#xD;
        starting from the date of approval of the same study.&#xD;
  &#xD;
        Patients of both sexes and aged 18 years or older will be included. Patients with primary&#xD;
        (benign or malignant) tumors of the vertebrae and patients unable to consent to the study&#xD;
        will be excluded from the study.&#xD;
  &#xD;
        For each patient, in addition to the demographic data, preoperative information will be&#xD;
        collected: type of tumor, involved vertebral levels, presence of pathological fracture,&#xD;
        presence of visceral metastases, presence and number of other bone metastases, neurological&#xD;
        picture according to Frankel's scale, evaluated pain according to the Visual Analogue Scale&#xD;
        (VAS), functional status according to Karnofsky, EuroQoL-5D and SF-36 questionnaires on the&#xD;
        quality of life; information related to the intervention itself: access, type of surgical&#xD;
        treatment, possible preoperative embolization; intraoperative complications; information at&#xD;
        discharge: postoperative complications, pain, neurological picture, functional status;&#xD;
        follow-up data: pain, neurological picture, functional status, SF-36 questionnaire, late&#xD;
        complications, local recurrence; systemic progression of the disease.&#xD;
  &#xD;
        Follow-up checks will be performed at 3 months, 6 months, 12 months, 18 months, 24 and 36&#xD;
        months. The timing of the controls and the examinations requested by the patients will be&#xD;
        those of normal clinical practice.&#xD;
  &#xD;
        Primary endpoint is the change in quality of life (measured by scores EQ-5D and SF-36) and&#xD;
        pain (measured using the VAS score) following surgery compared to pre-operative values.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        STUDY DESIGN Analytical Prospective Longitudinal cohort Not checked&#xD;
  &#xD;
        RATIONALE OF THE STUDY The improvement of the systemic control of oncological diseases&#xD;
        achieved in recent years has led to a considerable increase in patient survival; it was&#xD;
        associated with a parallel increase in the onset of symptomatic vertebral metastases.&#xD;
  &#xD;
        Such metastases are often associated with pain, mechanical instability of the spine, and even&#xD;
        possible neurological deficits, which negatively affect the patient's quality of life and&#xD;
        indirectly also on his survival.&#xD;
  &#xD;
        The treatment of these metastases is defined by a multidisciplinary approach; surgery is&#xD;
        indicated in the presence of mechanical instability, signs of neurological compression,&#xD;
        intractable pain, progression of disease during systemic treatment.&#xD;
  &#xD;
        The indication and the type of intervention are defined following a reference algorithm (A.&#xD;
        Gasbarrini, M. Cappuccio, L. Mirabile, S. Bandiera, S. Terzi, G. Barbanti Bròdano, S.&#xD;
        Boriani.) Spinal Metastases: treatment evaluation algorithm Eur Eur Med Pharmacol Sci 2004;&#xD;
        8: 265-274), in collaboration with the team of specialists involved.&#xD;
  &#xD;
        Within the multidisciplinary team it is usually the Oncologist who provides an estimate of&#xD;
        the prognosis quoad vitam, based on the general status of the patient and the residual&#xD;
        therapeutic possibilities.&#xD;
  &#xD;
        The goal of surgery is the local control of the disease and the improvement of the patient's&#xD;
        quality of life.&#xD;
  &#xD;
        Although there are works in the literature that demonstrate the effectiveness of surgical&#xD;
        treatment in vertebral metastases, there are few prospective studies in which, in addition to&#xD;
        survival, the improvement in the quality of life after the intervention is evaluated, and the&#xD;
        improvement over time is maintained.&#xD;
  &#xD;
        DESCRIPTION OF THE STUDY The study is monocentric, of a prospective observational type, with&#xD;
        a single arm.&#xD;
  &#xD;
        The study will collect data relating to patients affected by one or more vertebral metastases&#xD;
        or by vertebral localization of hemolymphoproliferative disease candidates for surgical&#xD;
        treatment, which will be recruited at the Complex Structure of Spine Surgery for Oncological&#xD;
        and Degenerative Address of the Rizzoli Orthopedic Institute starting from date of approval&#xD;
        of the study itself.&#xD;
  &#xD;
        Patients of both sexes and aged 18 years or older will be included&#xD;
  &#xD;
        DATA COLLECTION&#xD;
  &#xD;
        For each patient will be collected, in addition to demographic data:&#xD;
  &#xD;
          -  preoperative information: type of tumor, vertebral levels involved, presence of&#xD;
             pathological fracture, presence of visceral metastases, presence and number of other&#xD;
             bone metastases, functional status according to Karnofsky (Annex 1), neurological&#xD;
             picture according to Frankel's scale (Annex 2) , pain assessed according to the Visual&#xD;
             Analogue Scale (VAS), EuroQoL-5D and SF-36 questionnaires on the quality of life;&#xD;
  &#xD;
          -  information on the intervention: access, type of surgical treatment, possible&#xD;
             preoperative embolization; intraoperative complications;&#xD;
  &#xD;
          -  information at discharge: postoperative complications, pain, neurological picture,&#xD;
             functional status;&#xD;
  &#xD;
          -  follow-up data: pain (VAS scale), neurological picture (according to the Frankel scale),&#xD;
             functional status according to Karnofsky, EuroQoL-5D and SF-36 questionnaires on quality&#xD;
             of life, late complications, local recurrence; systemic progression of the disease.&#xD;
  &#xD;
        The clinical data necessary for the research will be extracted from the patient's medical&#xD;
        record and from its source documents.&#xD;
  &#xD;
        A specific data collection form will be used to collect the clinical information and the&#xD;
        results of the analysis foreseen by the study.&#xD;
  &#xD;
        For each patient included in the study, the data collection form (Case Report Form - CRF)&#xD;
        will be compiled.&#xD;
  &#xD;
        Follow-up checks will be performed, as per clinical practice, at 3 months, 6 months, 12&#xD;
        months, 18 months, 24 months and 36 months.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 21, 2018</start_date>
    <completion_date type="Anticipated">August 21, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 21, 2023</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>Pain evaluation</measure>
      <time_frame>At baseline (day 0)</time_frame>
      <description>Visual Analogue Scale (VAS) patient-administered questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain evaluation</measure>
      <time_frame>At 3 months follow up</time_frame>
      <description>Visual Analogue Scale (VAS) patient-administered questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain evaluation</measure>
      <time_frame>At 6 months follow up</time_frame>
      <description>Visual Analogue Scale (VAS) patient-administered questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain evaluation</measure>
      <time_frame>At 12 months follow up</time_frame>
      <description>Visual Analogue Scale (VAS) patient-administered questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain evaluation</measure>
      <time_frame>At 18 months follow up</time_frame>
      <description>Visual Analogue Scale (VAS) patient-administered questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain evaluation</measure>
      <time_frame>At 24 months follow up</time_frame>
      <description>Visual Analogue Scale (VAS) patient-administered questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain evaluation</measure>
      <time_frame>At 36 months follow up</time_frame>
      <description>Visual Analogue Scale (VAS) patient-administered questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quality of life evaluation</measure>
      <time_frame>At baseline (day 0)</time_frame>
      <description>EuroQoL- 5D (EQ-5D) patient-administered questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quality of life evaluation</measure>
      <time_frame>At 3 months follow up</time_frame>
      <description>EuroQoL- 5D (EQ-5D) patient-administered questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quality of life evaluation</measure>
      <time_frame>At 6 months follow up</time_frame>
      <description>EuroQoL- 5D (EQ-5D) patient-administered questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quality of life evaluation</measure>
      <time_frame>At 12 months follow up</time_frame>
      <description>EuroQoL- 5D (EQ-5D) patient-administered questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quality of life evaluation</measure>
      <time_frame>At 18 months follow up</time_frame>
      <description>EuroQoL- 5D (EQ-5D) patient-administered questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quality of life evaluation</measure>
      <time_frame>At 24 months follow up</time_frame>
      <description>EuroQoL- 5D (EQ-5D) patient-administered questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quality of life evaluation</measure>
      <time_frame>At 36 months follow up</time_frame>
      <description>EuroQoL- 5D (EQ-5D) patient-administered questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Health survey</measure>
      <time_frame>At baseline (day 0)</time_frame>
      <description>Short Form Health Survey 36 (SF-36) patient-administered questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Health survey</measure>
      <time_frame>At 3 months follow up</time_frame>
      <description>Short Form Health Survey 36 (SF-36) patient-administered questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Health survey</measure>
      <time_frame>At 6 months follow up</time_frame>
      <description>Short Form Health Survey 36 (SF-36) patient-administered questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Health survey</measure>
      <time_frame>At 12 months follow up</time_frame>
      <description>Short Form Health Survey 36 (SF-36) patient-administered questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Health survey</measure>
      <time_frame>At 18 months follow up</time_frame>
      <description>Short Form Health Survey 36 (SF-36) patient-administered questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Health survey</measure>
      <time_frame>At 24 months follow up</time_frame>
      <description>Short Form Health Survey 36 (SF-36) patient-administered questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Health survey</measure>
      <time_frame>At 36 months follow up</time_frame>
      <description>Short Form Health Survey 36 (SF-36) patient-administered questionnaire</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Prognostic factor- 1</measure>
      <time_frame>3 months follow up</time_frame>
      <description>Surgery-related adverse events collected by SAVES-v.2 system</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prognostic factor- 2</measure>
      <time_frame>3 months follow up</time_frame>
      <description>Survival rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prognostic factor- 1</measure>
      <time_frame>6 months follow up</time_frame>
      <description>Surgery-related adverse events collected by SAVES-v.2 system</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prognostic factor- 2</measure>
      <time_frame>6 months follow up</time_frame>
      <description>Survival rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prognostic factor- 1</measure>
      <time_frame>12 months follow up</time_frame>
      <description>Surgery-related adverse events collected by SAVES-v.2 system</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prognostic factor- 2</measure>
      <time_frame>12 months follow up</time_frame>
      <description>Survival rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prognostic factor- 1</measure>
      <time_frame>24 months follow up</time_frame>
      <description>Surgery-related adverse events collected by SAVES-v.2 system</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prognostic factor- 2</measure>
      <time_frame>24 months follow up</time_frame>
      <description>Survival rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prognostic factor- 1</measure>
      <time_frame>36 months follow up</time_frame>
      <description>Surgery-related adverse events collected by SAVES-v.2 system</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prognostic factor- 2</measure>
      <time_frame>36 months follow up</time_frame>
      <description>Survival rate</description>
    </secondary_outcome>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Vertebral Metastasis</condition>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Surgical treatment</intervention_name>
      <description>decompression with or without stabilization; stabilization only; debulking; en bloc resection</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients affected by vertebral metastasis eligible for surgical treatment&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - Patients who are candidates for surgery at the level of the spine at the SC of Spine&#xD;
          Surgery, for: or vertebral metastases or or vertebral localizations from&#xD;
          hemolymphoproliferative diseases&#xD;
  &#xD;
            -  Patients aged ≥ 18 years&#xD;
  &#xD;
            -  Patients giving written informed consent to the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with malignant or benign vertebral tumors&#xD;
  &#xD;
            -  Patients suffering from vertebral metastases or vertebral localizations from&#xD;
               hemolymphoproliferative diseases for which there are no indications for surgical&#xD;
               treatment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Silvia Terzi, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Istituto Ortopedico Rizzoli</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Andrea Rizzi, Dr</last_name>
      <phone>+390516366923</phone>
      <email>andrea.rizzi@ior.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>Istituto Ortopedico Rizzoli</name>
        <address>
          <city>Bologna</city>
          <zip>40136</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Cristiana Griffoni, PhD</last_name>
        <phone>+39-0516366971</phone>
        <email>cgriffoni@hotmail.com</email>
      </contact>
      <investigator>
        <last_name>Giovanni Barbanti Brodano, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Alessandro Gasbarrini, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Stefano Bandiera, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Silvia Terzi, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Riccardo Ghermandi, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Giuseppe Tedesco, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Gisberto Evangelisti, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>January 8, 2019</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 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>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasm Metastasis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </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/NCT05985434
  org study id: 0009120
  nct id: NCT05985434
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Perspective observational cohort study in which the data relating to patients affected by one
        or more vertebral metastases or by vertebral localization of hemolifoproliferative malact and
        surgical treatment candidates will be collected, which will be recruited at the Complex
        Structure of Spine Surgery for Oncological and Degenerative Rizzoli Orthopedic Institute
        starting from the date of approval of the same study.
  
        Patients of both sexes and aged 18 years or older will be included. Patients with primary
        (benign or malignant) tumors of the vertebrae and patients unable to consent to the study
        will be excluded from the study.
  
        For each patient, in addition to the demographic data, preoperative information will be
        collected: type of tumor, involved vertebral levels, presence of pathological fracture,
        presence of visceral metastases, presence and number of other bone metastases, neurological
        picture according to Frankel's scale, evaluated pain according to the Visual Analogue Scale
        (VAS), functional status according to Karnofsky, EuroQoL-5D and SF-36 questionnaires on the
        quality of life; information related to the intervention itself: access, type of surgical
        treatment, possible preoperative embolization; intraoperative complications; information at
        discharge: postoperative complications, pain, neurological picture, functional status;
        follow-up data: pain, neurological picture, functional status, SF-36 questionnaire, late
        complications, local recurrence; systemic progression of the disease.
  
        Follow-up checks will be performed at 3 months, 6 months, 12 months, 18 months, 24 and 36
        months. The timing of the controls and the examinations requested by the patients will be
        those of normal clinical practice.
  
        Primary endpoint is the change in quality of life (measured by scores EQ-5D and SF-36) and
        pain (measured using the VAS score) following surgery compared to pre-operative values.
  STUDY DESIGN Analytical Prospective Longitudinal cohort Not checked
  
        RATIONALE OF THE STUDY The improvement of the systemic control of oncological diseases
        achieved in recent years has led to a considerable increase in patient survival; it was
        associated with a parallel increase in the onset of symptomatic vertebral metastases.
  
        Such metastases are often associated with pain, mechanical instability of the spine, and even
        possible neurological deficits, which negatively affect the patient's quality of life and
        indirectly also on his survival.
  
        The treatment of these metastases is defined by a multidisciplinary approach; surgery is
        indicated in the presence of mechanical instability, signs of neurological compression,
        intractable pain, progression of disease during systemic treatment.
  
        The indication and the type of intervention are defined following a reference algorithm (A.
        Gasbarrini, M. Cappuccio, L. Mirabile, S. Bandiera, S. Terzi, G. Barbanti Bròdano, S.
        Boriani.) Spinal Metastases: treatment evaluation algorithm Eur Eur Med Pharmacol Sci 2004;
        8: 265-274), in collaboration with the team of specialists involved.
  
        Within the multidisciplinary team it is usually the Oncologist who provides an estimate of
        the prognosis quoad vitam, based on the general status of the patient and the residual
        therapeutic possibilities.
  
        The goal of surgery is the local control of the disease and the improvement of the patient's
        quality of life.
  
        Although there are works in the literature that demonstrate the effectiveness of surgical
        treatment in vertebral metastases, there are few prospective studies in which, in addition to
        survival, the improvement in the quality of life after the intervention is evaluated, and the
        improvement over time is maintained.
  
        DESCRIPTION OF THE STUDY The study is monocentric, of a prospective observational type, with
        a single arm.
  
        The study will collect data relating to patients affected by one or more vertebral metastases
        or by vertebral localization of hemolymphoproliferative disease candidates for surgical
        treatment, which will be recruited at the Complex Structure of Spine Surgery for Oncological
        and Degenerative Address of the Rizzoli Orthopedic Institute starting from date of approval
        of the study itself.
  
        Patients of both sexes and aged 18 years or older will be included
  
        DATA COLLECTION
  
        For each patient will be collected, in addition to demographic data:
  
          -  preoperative information: type of tumor, vertebral levels involved, presence of
             pathological fracture, presence of visceral metastases, presence and number of other
             bone metastases, functional status according to Karnofsky (Annex 1), neurological
             picture according to Frankel's scale (Annex 2) , pain assessed according to the Visual
             Analogue Scale (VAS), EuroQoL-5D and SF-36 questionnaires on the quality of life;
  
          -  information on the intervention: access, type of surgical treatment, possible
             preoperative embolization; intraoperative complications;
  
          -  information at discharge: postoperative complications, pain, neurological picture,
             functional status;
  
          -  follow-up data: pain (VAS scale), neurological picture (according to the Frankel scale),
             functional status according to Karnofsky, EuroQoL-5D and SF-36 questionnaires on quality
             of life, late complications, local recurrence; systemic progression of the disease.
  
        The clinical data necessary for the research will be extracted from the patient's medical
        record and from its source documents.
  
        A specific data collection form will be used to collect the clinical information and the
        results of the analysis foreseen by the study.
  
        For each patient included in the study, the data collection form (Case Report Form - CRF)
        will be compiled.
  
        Follow-up checks will be performed, as per clinical practice, at 3 months, 6 months, 12
        months, 18 months, 24 months and 36 months.
  observational model: Cohort
  time perspective: Prospective
  measure: Pain evaluation
  time frame: At baseline (day 0)
  description: Visual Analogue Scale (VAS) patient-administered questionnaire
  measure: Pain evaluation
  time frame: At 3 months follow up
  description: Visual Analogue Scale (VAS) patient-administered questionnaire
  measure: Pain evaluation
  time frame: At 6 months follow up
  description: Visual Analogue Scale (VAS) patient-administered questionnaire
  measure: Pain evaluation
  time frame: At 12 months follow up
  description: Visual Analogue Scale (VAS) patient-administered questionnaire
  measure: Pain evaluation
  time frame: At 18 months follow up
  description: Visual Analogue Scale (VAS) patient-administered questionnaire
  measure: Pain evaluation
  time frame: At 24 months follow up
  description: Visual Analogue Scale (VAS) patient-administered questionnaire
  measure: Pain evaluation
  time frame: At 36 months follow up
  description: Visual Analogue Scale (VAS) patient-administered questionnaire
  measure: Quality of life evaluation
  time frame: At baseline (day 0)
  description: EuroQoL- 5D (EQ-5D) patient-administered questionnaire
  measure: Quality of life evaluation
  time frame: At 3 months follow up
  description: EuroQoL- 5D (EQ-5D) patient-administered questionnaire
  measure: Quality of life evaluation
  time frame: At 6 months follow up
  description: EuroQoL- 5D (EQ-5D) patient-administered questionnaire
  measure: Quality of life evaluation
  time frame: At 12 months follow up
  description: EuroQoL- 5D (EQ-5D) patient-administered questionnaire
  measure: Quality of life evaluation
  time frame: At 18 months follow up
  description: EuroQoL- 5D (EQ-5D) patient-administered questionnaire
  measure: Quality of life evaluation
  time frame: At 24 months follow up
  description: EuroQoL- 5D (EQ-5D) patient-administered questionnaire
  measure: Quality of life evaluation
  time frame: At 36 months follow up
  description: EuroQoL- 5D (EQ-5D) patient-administered questionnaire
  measure: Health survey
  time frame: At baseline (day 0)
  description: Short Form Health Survey 36 (SF-36) patient-administered questionnaire
  measure: Health survey
  time frame: At 3 months follow up
  description: Short Form Health Survey 36 (SF-36) patient-administered questionnaire
  measure: Health survey
  time frame: At 6 months follow up
  description: Short Form Health Survey 36 (SF-36) patient-administered questionnaire
  measure: Health survey
  time frame: At 12 months follow up
  description: Short Form Health Survey 36 (SF-36) patient-administered questionnaire
  measure: Health survey
  time frame: At 18 months follow up
  description: Short Form Health Survey 36 (SF-36) patient-administered questionnaire
  measure: Health survey
  time frame: At 24 months follow up
  description: Short Form Health Survey 36 (SF-36) patient-administered questionnaire
  measure: Health survey
  time frame: At 36 months follow up
  description: Short Form Health Survey 36 (SF-36) patient-administered questionnaire
  measure: Prognostic factor- 1
  time frame: 3 months follow up
  description: Surgery-related adverse events collected by SAVES-v.2 system
  measure: Prognostic factor- 2
  time frame: 3 months follow up
  description: Survival rate
  measure: Prognostic factor- 1
  time frame: 6 months follow up
  description: Surgery-related adverse events collected by SAVES-v.2 system
  measure: Prognostic factor- 2
  time frame: 6 months follow up
  description: Survival rate
  measure: Prognostic factor- 1
  time frame: 12 months follow up
  description: Surgery-related adverse events collected by SAVES-v.2 system
  measure: Prognostic factor- 2
  time frame: 12 months follow up
  description: Survival rate
  measure: Prognostic factor- 1
  time frame: 24 months follow up
  description: Surgery-related adverse events collected by SAVES-v.2 system
  measure: Prognostic factor- 2
  time frame: 24 months follow up
  description: Survival rate
  measure: Prognostic factor- 1
  time frame: 36 months follow up
  description: Surgery-related adverse events collected by SAVES-v.2 system
  measure: Prognostic factor- 2
  time frame: 36 months follow up
  description: Survival rate
  intervention type: Procedure
  intervention name: Surgical treatment
  description: decompression with or without stabilization; stabilization only; debulking; en bloc resection
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Silvia Terzi, MD
  role: Principal Investigator
  affiliation: Istituto Ortopedico Rizzoli
  last name: Andrea Rizzi, Dr
  phone: +390516366923
  email: andrea.rizzi@ior.it
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Neoplasm Metastasis
  sharing ipd: Undecided