Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05985434 |
| Other study ID # |
0009120 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 21, 2018 |
| Est. completion date |
December 1, 2023 |
Study information
| Verified date |
January 2024 |
| Source |
Istituto Ortopedico Rizzoli |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
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.
