- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07326969
MOVEMENT ANALYSIS IN PATIENTS UNDERGOING VERTEBRECTOMIES FOR SPINE ONCOLOGY: A PILOT STUDY
December 24, 2025 updated by: Istituto Ortopedico Rizzoli
MOVEMENT ANALYSIS IN PATIENTS UNDERGOING VERTEBRECTOMIES FOR THE TREATMENT OF SPINE ONCOLOGY: A PILOT STUDY
Analyze the geometric and kinematic parameters of the spine in patients undergoing vertebrectomy through gait analysis, both during the execution of motor tasks such as walking, standing, and basic trunk movements, with the aim of improving the assessment and, therefore, possibly, the treatment and the final clinical outcome.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bologna, Italy, 40136
- Istituto Ortopedico Rizzoli
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
patients with vertebral tumors undergoing vertebrectomy
Description
Inclusion Criteria:
- Age 18 years or older
- Presence of spinal cancer with surgical indication for vertebrectomy
- Approval and signature of informed consent for the study
- Ability to undergo movement analysis before the surgery and the 6-month follow-up
Exclusion Criteria:
- Under 18 years of age
- Presence of degenerative, traumatic, or infectious pathologies or spinal deformities
- Absence of a signed informed consent form
- Inability to undergo movement analysis before the surgery or the 6-month follow-up
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
vertebrectomy
patients with vertebral tumors undergoing vertebrectomy
|
en bloc resection of oncological vertebra
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gait Analysis
Time Frame: 6 months after vertebrectomy
|
Measure and correlate geometric and kinematic parameters of the trunk and spine through instrumental motion analysis, before and after vertebrectomy surgery in patients with oncological spinal diseases.
|
6 months after vertebrectomy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
questionnaire
Time Frame: 6 months after vertebrectomy
|
Evaluate patient-reported functional outcomes through self-administered questionnaires: Oswestry Disability Index and Fall Efficacy Scale-International
|
6 months after vertebrectomy
|
|
spino-pelvic parameters
Time Frame: 6 months after vertebrectomy
|
Measure the geometric spino-pelvic parameters (static) and compare them with the kinematic parameters (dynamic)
|
6 months after vertebrectomy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 3, 2023
Primary Completion (Actual)
December 20, 2024
Study Completion (Actual)
December 21, 2025
Study Registration Dates
First Submitted
December 24, 2025
First Submitted That Met QC Criteria
December 24, 2025
First Posted (Actual)
January 8, 2026
Study Record Updates
Last Update Posted (Actual)
January 8, 2026
Last Update Submitted That Met QC Criteria
December 24, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- GAV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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