- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07425470
SCI Epidemiology and Complications
Epidemiological Evaluation and Complications of Spinal Cord Injury Patients Admitted to Our Clinic: A Retrospective Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study was designed as a retrospective descriptive study. Patients who were admitted to the Physical Medicine and Rehabilitation outpatient clinic of Bandırma Training and Research Hospital with a diagnosis of paraplegia or tetraplegia between December 1, 2020, and December 1, 2025, were included in the study. These diagnoses were screened using the following ICD-10 codes: G82 (paraplegia and tetraplegia), G82.0 (flaccid paraplegia), G82.1 (spastic paraplegia), G82.2 (paraparesis and paraplegia, unspecified), G82.3 (flaccid tetraplegia), G82.4 (spastic tetraplegia), and G82.5 (tetraplegia, unspecified).
Data regarding patients' age, sex, etiology of spinal cord injury, level of injury, and the presence of complications were recorded. In cases where complications were present, the time from injury to the development of complications was recorded in months.
Since the most common causes of spinal cord injury differ across age groups, age categories were defined as ≤29 years, 30-44 years, 45-59 years, 60-74 years, and ≥75 years. Etiological classification was based on the most common causes reported in the literature, including traffic accidents, falls from height, sports-related injuries, post-disc herniation or surgery, non-traumatic/inflammatory causes, and other causes.
As the level of injury affects both clinical presentation and the development of complications, injury levels were categorized as cervical (C1-C8), thoracic (T1-T12), and lumbosacral (L1-S5). Evaluation parameters and grouping methods were determined based on similar studies reported in the literature.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Nurten NAS KIRDAR, Assistant Professor
- Phone Number: +905415511691
- Email: nkirdar@bandirma.edu.tr
Study Contact Backup
- Name: Naime Meriç KONAR EROL, Associate Professor
- Email: mkonar@bandirma.edu.tr
Study Locations
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Bandırma
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Balıkesir, Bandırma, Turkey (Türkiye), 10200
- Bandırma Onyedi Eylul University Faculty of Medicine
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Contact:
- Ayşe Güldem Kilciler, Prof.
- Phone Number: +9 0266 717 01 17
- Email: akilciler@bandirma.edu.tr
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Principal Investigator:
- Nurten Nas Kırdar, Assistant Professor
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- clinical diagnosis of paraplegia
- clinical diagnosis of tetraplegia
Exclusion Criteria:
- traumatic brain injury
- brain tumor
- cranial lesions
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients who presented to our clinic with SCI between December 1, 2020, and December 1, 2025
Patients who presented to our hospital's Physical Medicine and Rehabilitation outpatient clinic with diagnoses of paraplegia and tetraplegia between December 1, 2020, and December 1, 2025.
|
Patient data regarding age, gender, etiology of spinal cord injury, level of injury, and whether complications develop will be recorded.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average age and gender of patients followed up in our clinic due to spinal cord injury
Time Frame: 1 month
|
-Average age and gender of patients followed up in our clinic due to spinal cord injury
|
1 month
|
|
Etiology of injury in patients followed up in our clinic due to spinal cord injury
Time Frame: 1 month
|
Etiology of injury in patients followed up in our clinic due to spinal cord injury
|
1 month
|
|
Stage of injury in patients followed up in our clinic due to spinal cord injury
Time Frame: 1 month
|
-Stage of injury in patients followed up in our clinic due to spinal cord injury
|
1 month
|
|
Whether or not complications developed in patients followed up in our clinic due to spinal cord injury
Time Frame: 1 month
|
-Whether or not complications developed in patients followed up in our clinic due to spinal cord injury These complications include: Pressure ulcer, Urinary tract infection, Deep vein thrombosis, Joint contracture, Osteoporosis/fracture, Spasticity, Autonomic dysreflexia, Psychological problems, Sexual problems, Charcot joint, Urethral stricture, Post-traumatic syringomyelia, Heterotopic ossification, Other systemic problems (respiratory problems, cardiac problems, gastrointestinal problems, metabolic and endocrine problems). |
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the time when the complication developed
Time Frame: 1 month
|
- In patients followed up in our clinic due to spinal cord injury who developed complications, the time when the complication developed.
|
1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nurten Nas Kırdar, Assistant Professor, Bandırma Onyedi Eylül University
Publications and helpful links
General Publications
- Josefson C, Rekand T, Lundgren-Nilsson A, Sunnerhagen KS. Epidemiology of Spinal Cord Injury in Adults in Sweden, 2016-2020: A Retrospective Registry-Based Study. Neuroepidemiology. 2025;59(4):334-342. doi: 10.1159/000540818. Epub 2024 Aug 13.
- Bombardier CH, Lee DC, Tan DL, Barber JK, Hoffman JM. Comorbid Traumatic Brain Injury and Spinal Cord Injury: Screening Validity and Effect on Outcomes. Arch Phys Med Rehabil. 2016 Oct;97(10):1628-34. doi: 10.1016/j.apmr.2016.03.008. Epub 2016 Apr 12.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-67961857-050.04-2500085688
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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