NCT06525883

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
151

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

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

Study Start

First participant enrolled

January 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2024

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

July 25, 2024

Last Update Submit

July 29, 2024

Conditions

Keywords

traumarib fracturevertebral fracturecomplication

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (3)

Group 1

upper cervical

Other: No intervation

Group 2

lower cervical

Other: No intervation

Group 3

thoracolumbar

Other: No intervation

Interventions

No intervention was made to the groups

Group 1Group 2Group 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who had vertebral and rib fractures due to trauma

You may qualify if:

  • Patients who had vertebral and rib fractures due to trauma

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University Faculty of Medicine

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

Related Publications (13)

  • 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.

  • 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.

  • Coary R, Skerritt C, Carey A, Rudd S, Shipway D. New horizons in rib fracture management in the older adult. Age Ageing. 2020 Feb 27;49(2):161-167. doi: 10.1093/ageing/afz157.

  • Looby S, Flanders A. Spine trauma. Radiol Clin North Am. 2011 Jan;49(1):129-63. doi: 10.1016/j.rcl.2010.07.019.

  • Ahern DP, McDonnell J, O Doinn T, Butler JS. Timing of surgical fixation in traumatic spinal fractures: A systematic review. Surgeon. 2020 Feb;18(1):37-43. doi: 10.1016/j.surge.2019.04.002. Epub 2019 May 4.

  • Yang Z, Lowe AJ, de la Harpe DE, Richardson MD. Factors that predict poor outcomes in patients with traumatic vertebral body fractures. Injury. 2010 Feb;41(2):226-30. doi: 10.1016/j.injury.2009.10.019. Epub 2009 Nov 3.

  • Chiu WT, Lin HC, Lam C, Chu SF, Chiang YH, Tsai SH. Review paper: epidemiology of traumatic spinal cord injury: comparisons between developed and developing countries. Asia Pac J Public Health. 2010 Jan;22(1):9-18. doi: 10.1177/1010539509355470.

  • Aghakhani K, Kordrostami R, Memarian A, Asl ND, Zavareh FN. The association between type of spine fracture and the mechanism of trauma: A useful tool for identifying mechanism of trauma on legal medicine field. J Forensic Leg Med. 2018 May;56:80-82. doi: 10.1016/j.jflm.2018.01.004. Epub 2018 Feb 7.

  • Oken F, Yildirim O, Oken O, Gulcek M, Yavuzer G, Ucaner A. Short or long fusion after thoracolumbar burst fractures does not alter selected gait parameters: a preliminary study. J Orthop Res. 2011 Jun;29(6):915-8. doi: 10.1002/jor.21329. Epub 2011 Jan 21.

  • Machino M, Yukawa Y, Ito K, Nakashima H, Kato F. Posterior/anterior combined surgery for thoracolumbar burst fractures--posterior instrumentation with pedicle screws and laminar hooks, anterior decompression and strut grafting. Spinal Cord. 2011 Apr;49(4):573-9. doi: 10.1038/sc.2010.159. Epub 2010 Nov 16.

  • Wang H, Zhang Y, Xiang Q, Wang X, Li C, Xiong H, Zhou Y. Epidemiology of traumatic spinal fractures: experience from medical university-affiliated hospitals in Chongqing, China, 2001-2010. J Neurosurg Spine. 2012 Nov;17(5):459-68. doi: 10.3171/2012.8.SPINE111003. Epub 2012 Sep 14.

  • Watanabe M, Sakai D, Yamamoto Y, Sato M, Mochida J. Upper cervical spine injuries: age-specific clinical features. J Orthop Sci. 2010 Jul;15(4):485-92. doi: 10.1007/s00776-010-1493-x. Epub 2010 Aug 19.

  • Rosenthal BD, Boody BS, Jenkins TJ, Hsu WK, Patel AA, Savage JW. Thoracolumbar Burst Fractures. Clin Spine Surg. 2018 May;31(4):143-151. doi: 10.1097/BSD.0000000000000634.

Related Links

MeSH Terms

Conditions

Spinal FracturesRib FracturesWounds and Injuries

Condition Hierarchy (Ancestors)

Spinal InjuriesBack InjuriesFractures, BoneThoracic Injuries

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 25, 2024

First Posted

July 29, 2024

Study Start

January 1, 2023

Primary Completion

January 1, 2024

Study Completion

February 1, 2024

Last Updated

July 31, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

The dataset of the research presented in this article is under record. Corresponding author can be contacted to reach the required data network.

Locations