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

March 29, 2022 updated by: Vincenzo Peccerillo, Istituto Ortopedico Rizzoli
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

393

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

  • Italy
    • BO
      • Bologna, BO, Italy, 40141
        • Vincenzo Peccerillo

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoind spine surgery with arthrodesis

Description

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of mechanical failure
Time Frame: up to 1 year from the surgery
number of mechanical failure / total number of spinal fusion performed
up to 1 year from the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
deambulation performed during hospitalization
Time Frame: up to the first day(up to 1 day) for ambulation from the surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

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)

August 30, 2021

Primary Completion (Actual)

December 13, 2021

Study Completion (Actual)

December 20, 2021

Study Registration Dates

First Submitted

July 3, 2021

First Submitted That Met QC Criteria

July 21, 2021

First Posted (Actual)

July 30, 2021

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE-AVEC 354/2021/Oss/IOR

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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