NCT05985434: CVODMetsVert

Prospective Observational Study on Vertebral Metastasis

Completed Last updated 3 January 2024

What this trial tests

trial testing Surgical treatment in Vertebral Metastasis in 191 participants. Completed in 1 December 2023.

Timeline

21 August 2018

Primary endpoint
1 December 2022

1 December 2023

Quick facts

Lead sponsor	Istituto Ortopedico Rizzoli
Status	Completed
Study type	OBSERVATIONAL
Enrollment	191
Start date	21 August 2018
Primary completion	1 December 2022
Estimated completion	1 December 2023
Sites	1 location across Italy

Drugs / interventions tested

• Surgical treatment

Conditions studied

• Vertebral Metastasis — all drugs for Vertebral Metastasis →

Sponsor

Istituto Ortopedico Rizzoli — full company profile →

Who can join

18 and older, any sex, with Vertebral Metastasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.