Analysis of Patients With Post-traumatic Vertebral Fractu... | NCT06525883

Studies
Analysis of Patients With Post-traumatic Vertebral Fracture and Accompanying Rib Fracture

NCT06525883

Sponsor

Ege University

Status

Completed

Last Update Posted

Jul 31, 2024Actual

Enrollment

151Actual

Phase

Not provided

Conditions

Vertebral Fracture
Rib Fractures
Trauma

Interventions

No intervation

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Jan 1, 2024Actual

Completion Date

Feb 1, 2024Actual

First Submitted Date

Jul 25, 2024

First Submission Date that Met QC Criteria

Jul 25, 2024

First Posted Date

Jul 29, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2024

Last Update Posted Date

Jul 31, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The present study investigates the trauma mechanisms, the type and level of vertebral fractures, the number of accompanying rib fractures and thoracic pathologies, the surgical procedures employed and the development of complications in a sample of patients who presented with vertebral fractures and concurrent rib fractures after sustaining trauma.

Detailed Description

The study aimed to analyze the mechanisms of trauma, type and level of vertebral fractures, number of accompanying rib fractures and thoracic pathologies, necessity of surgery and development of complications in patients who developed vertebral fractures and rib fractures after trauma. Patients were divided into 3 groups: upper cervical , lower cervical and thoracolumbar. They were compared with each other in terms of trauma mechanisms, rib fracture numbers, accompanying thoracic pathologies, complication developments and need for surgery.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

151Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Group 1	upper cervical	Other: No intervation
Group 2	lower cervical	Other: No intervation
Group 3	thoracolumbar	Other: No intervation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervation	Other	No intervention was made to the groups	Group 1 Group 2 Group 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
rib fracture	number of accompanying rib fractures	12 months
complications	Number of patients developing complications	12 months
surgical intervention	Number of patients requiring surgical intervention	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who had vertebral and rib fractures due to trauma

Exclusion Criteria:

Patients whose electronic patient records and radiological imaging findings cannot be accessed
Patients whose development of complications could not be evaluated due to not coming to post-discharge check-ups

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients who had vertebral and rib fractures due to trauma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ege University Faculty of Medicine		Izmir	Bornova	35100	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23206720	Result	Broderick SR. Hemothorax: Etiology, diagnosis, and management. Thorac Surg Clin. 2013 Feb;23(1):89-96, vi-vii. doi: 10.1016/j.thorsurg.2012.10.003. Epub 2012 Nov 3.
8712986	Result	Cameron P, Dziukas L, Hadj A, Clark P, Hooper S. Rib fractures in major trauma. Aust N Z J Surg. 1996 Aug;66(8):530-4. doi: 10.1111/j.1445-2197.1996.tb00803.x.

ID	Term
D016103	Spinal Fractures
D012253	Rib Fractures
D014947	Wounds and Injuries

ID	Term
D013124	Spinal Injuries
D019567	Back Injuries
D050723	Fractures, Bone
D013898	Thoracic Injuries