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

Completed

• Conditions: Spinal Fusion; Surgery--Complications; Spine Disease

• Registration Number: NCT04983576
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-03
• Study First Submitted QC: 2021-07-21
• Study First Posted: 2021-07-30
• Study Start: 2021-08-30
• Primary Completion: 2021-12-13
• Study Completion: 2021-12-20
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-29
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 393

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of mechanical failure	up to 1 year from the surgery	number of mechanical failure / total number of spinal fusion performed

Secondary Outcome Measures

Name	Time	Method
deambulation performed during hospitalization	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

Trial Locations

Locations (1)

Vincenzo Peccerillo; 🇮🇹 Bologna, BO, Italy