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NCT04983576 Clinical Trial

Risk Factors for Mechanical Failure After Spinal Fusion : an Observational Study

Surgery--Complications Clinical Trial

— RachideMDS  

Official title:
Risk Factors for Mechanical Failure After Spinal Fusion : an Observational Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04983576
Other study ID # CE-AVEC 354/2021/Oss/IOR
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 30, 2021
Est. completion date December 20, 2021

Study information
Verified date March 2022
Source Istituto Ortopedico Rizzoli
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this of study is to identify the incidence of mechanical failures after spinal fusion within one year of surgery and to assess the related risk factors.

Recruitment information / eligibility
Status Completed
Enrollment 393
Est. completion date December 20, 2021
Est. primary completion date December 13, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - All patients undergoing spine fusion and followed up for clinical checks in the year following the surgery . Exclusion Criteria: - patients undergoing spine surgery without the application of instrumentation

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• spinal fusion
patients undergoing spinal fusion

Locations
Country Name City State
Italy Vincenzo Peccerillo Bologna BO

Sponsors (1)
Lead Sponsor Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary incidence of mechanical failure number of mechanical failure / total number of spinal fusion performed up to 1 year from the surgery
Secondary deambulation performed during hospitalization number of patients that are able to achieve ambulation after surgery up to the first day(up to 1 day) for ambulation from the surgery
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