NCT04983576

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
393

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 30, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

August 30, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2021

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

4 months

First QC Date

July 3, 2021

Last Update Submit

March 29, 2022

Conditions

Spinal FusionSurgery--ComplicationsSpine Disease

Outcome Measures

Primary Outcomes (1)

  • incidence of mechanical failure

    number of mechanical failure / total number of spinal fusion performed

    up to 1 year from the surgery

Secondary Outcomes (1)

  • deambulation performed during hospitalization

    up to the first day(up to 1 day) for ambulation from the surgery

Interventions

spinal fusionPROCEDURE

patients undergoing spinal fusion

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoind spine surgery with arthrodesis

You may qualify if:

  • All patients undergoing spine fusion and followed up for clinical checks in the year following the surgery .

You may not qualify if:

  • patients undergoing spine surgery without the application of instrumentation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vincenzo Peccerillo

Bologna, BO, 40141, Italy

Location

MeSH Terms

Conditions

Spinal Diseases

Interventions

Spinal Fusion

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

ArthrodesisOrthopedic ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist Vincenzo Peccerilo

Study Record Dates

First Submitted

July 3, 2021

First Posted

July 30, 2021

Study Start

August 30, 2021

Primary Completion

December 13, 2021

Study Completion

December 20, 2021

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations

IT(1)