Vertebral FractureNCT06525883
Analysis of Patients With Post-traumatic Vertebral Fracture and Accompanying Rib Fracture
An observational study of Vertebral Fracture and Rib Fractures, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertebral Fracture, Rib Fractures, Trauma
- What is being tested?
- No intervation
- How many people
- 151 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who had vertebral and rib fractures due to trauma
Who may be able to join
- Patients who had vertebral and rib fractures due to trauma
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Faculty of Medicine
Izmir, Bornova, 35100
About this study
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.
Read the 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.
- Conditions
- Vertebral Fracture, Rib Fractures, Trauma
- Being tested
- No intervation
- Keywords
- trauma, rib fracture, vertebral fracture, complication
- Medical subject headings
- Spinal Fractures, Rib Fractures, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervationOther
No intervention was made to the groups
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | upper cervical Receives: Other: No intervation | |
| Group 2 | lower cervical Receives: Other: No intervation | |
| Group 3 | thoracolumbar Receives: Other: No intervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
rib fracture
number of accompanying rib fractures
Measured: 12 months
complications
Number of patients developing complications
Measured: 12 months
surgical intervention
Number of patients requiring surgical intervention
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Jan 2023
- Primary completion1 Jan 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Vertebral FractureStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gizem Kececi Ozgur, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525883
- Sponsor's protocol ID
- 2023-0312
- Status last verified
- Jul 2024
- First submitted
- 25 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The dataset of the research presented in this article is under record. Corresponding author can be contacted to reach the required data network.
Publications
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.
PubMed 23206720Cameron 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.
PubMed 8712986Coary 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.
PubMed 31858117Looby S, Flanders A. Spine trauma. Radiol Clin North Am. 2011 Jan;49(1):129-63. doi: 10.1016/j.rcl.2010.07.019.
PubMed 21111133Ahern 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.
PubMed 31064710Yang 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.
PubMed 19889411Chiu 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.
PubMed 20032030Aghakhani 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.
PubMed 29571167Oken 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.
PubMed 21259336Machino 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.
PubMed 21079623Wang 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.
PubMed 22978439Watanabe 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.
PubMed 20721716Rosenthal 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.
PubMed 29578877
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Patients With Post-traumatic Vertebral Fracture and Accompanying Rib Fracture
- ClinicalTrials.gov ID
- NCT06525883
- Acronym / sponsor ID
- 2023-0312
- Conditions
- Vertebral Fracture, Rib Fractures, Trauma
- Keywords
- trauma, rib fracture, vertebral fracture, complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: No intervationupper cervical |
| Group 2 | – | Other: No intervationlower cervical |
| Group 3 | – | Other: No intervationthoracolumbar |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who had vertebral and rib fractures due to trauma
Key inclusion criteria (1 listed)
- Patients who had vertebral and rib fractures due to trauma
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervationNo intervention was made to the groups | Other | Group 1, Group 2, Group 3 |
Primary outcome
rib fracture
Time frame: 12 months
number of accompanying rib fractures
complications
Time frame: 12 months
Number of patients developing complications
surgical intervention
Time frame: 12 months
Number of patients requiring surgical intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Results publication: PubMed 23206720Broderick 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.
- Results publication: PubMed 8712986Cameron 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.
- Results publication: PubMed 31858117Coary 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.
- Results publication: PubMed 21111133Looby S, Flanders A. Spine trauma. Radiol Clin North Am. 2011 Jan;49(1):129-63. doi: 10.1016/j.rcl.2010.07.019.
- Results publication: PubMed 31064710Ahern 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.
- Results publication: PubMed 19889411Yang 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.
- Results publication: PubMed 20032030Chiu 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.
- Results publication: PubMed 29571167Aghakhani 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.
- Results publication: PubMed 21259336Oken 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.
- Results publication: PubMed 21079623Machino 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.
- Results publication: PubMed 22978439Wang 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.
- Results publication: PubMed 20721716Watanabe 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.
- Türkiye İstatistik Kurumu (TUİK). Ölüm ve Ölüm Nedeni İstatistikleri, 2019.Link provided by the sponsor.
- Individual participant dataSharing planned: No. The dataset of the research presented in this article is under record. Corresponding author can be contacted to reach the required data network.
Related trials for Vertebral Fracture
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingPhase 2
Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Lesions
Spinal Metastases
Active, not recruiting
StUdy oN Burst Fractures (SunBurst)
Thoracolumbar Burst Fracture
RecruitingObservational study
Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures
Vertebral Compression Fractures, Pathological Fracture
Active, not recruitingPhase 2
Cement Augmentation in Preventing Vertebral Body Compression Fracture Following Spine Stereotactic Radiosurgery in Patients With Solid Tumors and Spinal Metastases
Metastatic Malignant Neoplasm in the Spine, Metastatic Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vertebral Fracture and Rib Fractures, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rib fracture (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06525883, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.