Clinical Trials Logo

Clinical Trial Summary

Fractures of the second cervical vertebra (C2) are the most common spinal fracture among the elderly. Non-surgical treatment comprises of cervical collar treatment for 12 weeks, while surgical treatment for elderly could mean posterior fixation C1-C2 without collar treatment or anterior screw osteosynthesis C2 with 6 weeks of collar treatment. A meta-analysis of retrospective studies has recently found an improved survival with surgical treatment. This national registry study is designed to estimate the survival of non-surgical and surgical treatment in a population-based cohort.


Clinical Trial Description

The Swedish National Patient Registry (NPR) is hosted by the Swedish Agency of Health and Welfare and contains all patient contacts within Sweden with a coverage of >90% for orthopaedic diagnoses. Registered are main diagnosis and co-morbidity using the ICD-9 code until 1996 and from 1997 onward ICD-10 codes. Treatment is coded since 1996 using the Swedish classification of surgical procedures. Furthermore, information on hospitalisation time is available from the registry.

In the Swedish Cause of Death Registry (CDR) all deaths in Sweden are registered with date of death and cause of death. While date of death coverage is complete, the cause of death has only 46% agreement with the final hospital diagnosis.

All patients with the main diagnosis of C2 fracture (ICD-10: S12.1) treated between January 1st 1996 to December 31st 2014 are extracted from the NPR and merged with the CDR for incident deaths. Prior to data transmission, the Swedish Agency of Health and Welfare anonymised the individual personal identification numbers using a key which remained with the Agency.

Invalid age data will be excluded either due to missing entries or mismatch with date of death. Multiple admissions (cases with same identification number but more than 12 months between admissions) and duplicate entries (cases with same identification number) will be removed from the dataset, after valuable co-morbidity data from the duplicate entries were stored in the original record. Duplicate entries originate from separate recordings from each hospital if the patient is referred to a specialised hospital. Furthermore, primarily non-surgically treated cases with a change of treatment modality are registered as surgical patients. The registered hospitalisation time for these patients is the combined non-surgical and surgical in-hospital treatment period.

From each record the Charlson Comorbidity Index (CCI) is calculated. Using Swedish surgical procedure codes for spinal fusion ("NAG") and spinal osteosynthesis ("NAJ") patients receiving surgical treatment were marked, and the cohort divided into two groups receiving non-surgical or surgical treatment.

The age distribution differences of patients with C2-fractures treated surgically and non-surgically was visualised with a density distribution plot. A logit logistic regression analysis identified covariates of surgical treatment assignment and was presented with 95% confidence intervals (C.I.) and statistical probability p. Goodness-of-fit of the model was presented with pseudo-r2 according to McFadden.

Using the Kaplan-Meier method for non-surgical and surgical treatment mean survival, as well as survival rate at 3 months, 1 year, and 2 years was determined, and visualised using a Kaplan-Meier plot with 99% C.I. With the Cox proportional hazards regression method multiple covariates contributing to survival are entered and hazard ratio (HR) presented with 95% C.I. and probability p. As relevant covariates for survival besides surgical treatment age, gender, spinal cord injury, and CCI were identified. Since the assumption was that the medical advancement improved patient survival in general during the last decades, even year of admission was included as covariate in the model. In order to identify a cut-off age where a treatment modality is not associated anymore with greater survival the adjusted HR of a certain age and above was plotted over age with 95% C.I. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02839057
Study type Observational [Patient Registry]
Source Uppsala University
Contact
Status Completed
Phase N/A
Start date October 2015
Completion date December 2016

See also
  Status Clinical Trial Phase
Terminated NCT02931266 - PASS MIS® Post-market Clinical Follow-up
Completed NCT02566655 - Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis Phase 1
Unknown status NCT00290862 - A Safety and Efficacy Study for Treatment of Painful Vertebral Compression Fractures Caused by Osteoporosis N/A
Completed NCT04956588 - Evaluation of the Safety and Efficacy of Smart Orthopedic Minimally Invasive Surgical Systems for Spinal Surgery Phase 3
Completed NCT04201678 - Effectiveness of Erector Spinae Block in Kyphoplasty N/A
Completed NCT02950532 - Posterior Ligament Complex Assessment Without Magnetic Resonance Image in Thoracolumbar Fractures
Completed NCT02931279 - PASS OCT® Post-market Clinical Follow-up
Completed NCT02719340 - Short Segment Fixation in Thoracolumbar Osteoporotic Fracture N/A
Completed NCT02826889 - Assessing the Diagnostic Accuracy of Corrected Flow Time (FTc) and Pleth Variability Index (PVI) as Predictors of Fluid Responsiveness in Patients in the Prone Position Using the Jackson Table N/A
Recruiting NCT02768675 - Intra-operative Assessment of the Intellirod LOADPRO Spinal Rod Strain Sensor for Use During Kyphotic Corrective Surgery N/A
Completed NCT00211237 - CAFE Study - Cancer Patient Fracture Evaluation N/A
Recruiting NCT02784782 - Thoracolumbar Burstfractures, Orthesis or No Orthesis Phase 4
Withdrawn NCT04325165 - DBS of PPN to Improve Walking in Chronic SCI Patients N/A
Completed NCT01123512 - The Kiva® System as a Vertebral Augmentation Treatment Phase 3
Withdrawn NCT00594321 - Evaluation of Fracture Fixation With Energy and Cement in Tumors of the Spine N/A
Not yet recruiting NCT02603874 - The Development of a Vertebra Localizing Aid Medical Device N/A
Completed NCT01761084 - Build Better Bones With Exercise N/A
Completed NCT02840695 - Effect of Biological Disease Modifying Anti Rheumatic Drug (bDMARD) Treatment on Spinal Fracture Incidence in Patients With Ankylosing Spondylitis (AS) N/A
Completed NCT02657265 - SpineJack® Versus Conservative Treatment Study (SPICO Study) N/A
Active, not recruiting NCT02789774 - Uppsala Study on Odontoid Fracture Treatment in the Elderly N/A