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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04983576
Acronym
RachideMDS
Enrollment
393
Registered
2021-07-30
Start date
2021-08-30
Completion date
2021-12-20
Last updated
2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Fusion, Spine Disease, Surgery--Complications

Brief 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.

Interventions

PROCEDUREspinal fusion

patients undergoing spinal fusion

Sponsors

Istituto Ortopedico Rizzoli
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
incidence of mechanical failureup to 1 year from the surgerynumber of mechanical failure / total number of spinal fusion performed

Secondary

MeasureTime frameDescription
deambulation performed during hospitalizationup to the first day(up to 1 day) for ambulation from the surgerynumber of patients that are able to achieve ambulation after surgery

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026