NCT05985434

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
191

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 21, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2019

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
9 months until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

January 3, 2024

Status Verified

January 1, 2024

Enrollment Period

4.3 years

First QC Date

January 8, 2019

Last Update Submit

January 2, 2024

Conditions

Vertebral Metastasis

Outcome Measures

Primary Outcomes (21)

  • Pain evaluation

    Visual Analogue Scale (VAS) patient-administered questionnaire

    At baseline (day 0)

  • Pain evaluation

    Visual Analogue Scale (VAS) patient-administered questionnaire

    At 3 months follow up

  • Pain evaluation

    Visual Analogue Scale (VAS) patient-administered questionnaire

    At 6 months follow up

  • Pain evaluation

    Visual Analogue Scale (VAS) patient-administered questionnaire

    At 12 months follow up

  • Pain evaluation

    Visual Analogue Scale (VAS) patient-administered questionnaire

    At 18 months follow up

  • Pain evaluation

    Visual Analogue Scale (VAS) patient-administered questionnaire

    At 24 months follow up

  • Pain evaluation

    Visual Analogue Scale (VAS) patient-administered questionnaire

    At 36 months follow up

  • Quality of life evaluation

    EuroQoL- 5D (EQ-5D) patient-administered questionnaire

    At baseline (day 0)

  • Quality of life evaluation

    EuroQoL- 5D (EQ-5D) patient-administered questionnaire

    At 3 months follow up

  • Quality of life evaluation

    EuroQoL- 5D (EQ-5D) patient-administered questionnaire

    At 6 months follow up

  • Quality of life evaluation

    EuroQoL- 5D (EQ-5D) patient-administered questionnaire

    At 12 months follow up

  • Quality of life evaluation

    EuroQoL- 5D (EQ-5D) patient-administered questionnaire

    At 18 months follow up

  • Quality of life evaluation

    EuroQoL- 5D (EQ-5D) patient-administered questionnaire

    At 24 months follow up

  • Quality of life evaluation

    EuroQoL- 5D (EQ-5D) patient-administered questionnaire

    At 36 months follow up

  • Health survey

    Short Form Health Survey 36 (SF-36) patient-administered questionnaire

    At baseline (day 0)

  • Health survey

    Short Form Health Survey 36 (SF-36) patient-administered questionnaire

    At 3 months follow up

  • Health survey

    Short Form Health Survey 36 (SF-36) patient-administered questionnaire

    At 6 months follow up

  • Health survey

    Short Form Health Survey 36 (SF-36) patient-administered questionnaire

    At 12 months follow up

  • Health survey

    Short Form Health Survey 36 (SF-36) patient-administered questionnaire

    At 18 months follow up

  • Health survey

    Short Form Health Survey 36 (SF-36) patient-administered questionnaire

    At 24 months follow up

  • Health survey

    Short Form Health Survey 36 (SF-36) patient-administered questionnaire

    At 36 months follow up

Secondary Outcomes (10)

  • Prognostic factor- 1

    3 months follow up

  • Prognostic factor- 2

    3 months follow up

  • Prognostic factor- 1

    6 months follow up

  • Prognostic factor- 2

    6 months follow up

  • Prognostic factor- 1

    12 months follow up

  • +5 more secondary outcomes

Interventions

Surgical treatmentPROCEDURE

decompression with or without stabilization; stabilization only; debulking; en bloc resection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients affected by vertebral metastasis eligible for surgical treatment

You may qualify if:

  • \- Patients who are candidates for surgery at the level of the spine at the SC of Spine Surgery, for: or vertebral metastases or or vertebral localizations from hemolymphoproliferative diseases
  • Patients aged ≥ 18 years
  • Patients giving written informed consent to the study

You may not qualify if:

  • Patients with malignant or benign vertebral tumors
  • Patients suffering from vertebral metastases or vertebral localizations from hemolymphoproliferative diseases for which there are no indications for surgical treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

  • Silvia Terzi, MD

    Istituto Ortopedico Rizzoli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2019

First Posted

August 14, 2023

Study Start

August 21, 2018

Primary Completion

December 1, 2022

Study Completion

December 1, 2023

Last Updated

January 3, 2024

Record last verified: 2024-01

Locations

IT(1)