Spinal FracturesNCT02839057
Survival After Surgical Treatment of Axis Fractures in Elderly
An observational study of Spinal Fractures, run by Uppsala University.
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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Spinal Fractures
- What is being tested?
- Non-surgical treatment and Surgical treatment
- Type of treatment
- Surgery or procedure
- How many people
- 6,231 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Dec 2016
- How long will I take part?
- 20 Years
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: National patient registry extract with patients suffering from C2 fracture
Who may be able to join
- C2-fracture
- Age ≥70 years
Who cannot join
- no C2-fracture
- Age <70 years
About this study
Official title: Survival After Surgical Treatment of Axis Fractures in Elderly: A National Registry Based Cohort Study
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.
Read the detailed 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.
- Conditions
- Spinal Fractures
- Being tested
- Non-surgical treatment, Surgical treatment
- Keywords
- Axis fractures, Elderly, Mortality, Surgical treatment
- Medical subject headings
- Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical treatmentProcedure or surgery
Also called Conservative treatment
Cervical collar immobilisation for 12 weeks.
Surgical treatmentProcedure or surgery
Stabilisation of C2-fracture by posterior fusion C1-C2, posterior fusion C2-C3, anterior fusion C2-C3 (no postoperative collar) or anterior screw osteosynthesis C2 (postoperative collar for 6 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Surgical treatment | Patients ≥70 years with C2 fracture coded in patient registry (ICD-10: S12.1) treated with surgical fracture stabilisation Receives: Procedure: Surgical treatment | |
| Non-surgical treatment | Patients ≥70 years with C2 fracture coded in patient registry (ICD-10: S12.1) treated non-surgically Receives: Procedure: Non-surgical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Survival as registered in Swedish National Cause of Death Registry
Measured: Censored observational time (20 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startOct 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal FracturesStudies of the same condition, open and under way.
- More trials run by Uppsala 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,231 participants (actual)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839057
- Sponsor's protocol ID
- AxisFractureSweden
- Status last verified
- May 2017
- First submitted
- 18 Jul 2016
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Robinson Y, Robinson AL, Olerud C. Systematic review on surgical and nonsurgical treatment of type II odontoid fractures in the elderly. Biomed Res Int. 2014;2014:231948. doi: 10.1155/2014/231948. Epub 2014 Feb 10.
PubMed 24683543Robinson AL, Olerud C, Robinson Y. Surgical treatment improves survival of elderly with axis fracture-a national population-based multiregistry cohort study. Spine J. 2018 Oct;18(10):1853-1860. doi: 10.1016/j.spinee.2018.03.021. Epub 2018 Apr 9.
PubMed 29649609
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival After Surgical Treatment of Axis Fractures in Elderly: A National Registry Based Cohort Study
- ClinicalTrials.gov ID
- NCT02839057
- Acronym / sponsor ID
- AxisFractureSweden
- Conditions
- Spinal Fractures
- Keywords
- Axis fractures, Elderly, Mortality, Surgical treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,231 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Jul 2016 (estimated)
- 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.
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.
Detailed 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment | – | Procedure: Surgical treatmentPatients ≥70 years with C2 fracture coded in patient registry (ICD-10: S12.1) treated with surgical fracture stabilisation |
| Non-surgical treatment | – | Procedure: Non-surgical treatmentPatients ≥70 years with C2 fracture coded in patient registry (ICD-10: S12.1) treated non-surgically |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- National patient registry extract with patients suffering from C2 fracture
Key inclusion criteria (2 listed)
- C2-fracture
- Age ≥70 years
Key exclusion criteria (2 listed)
- no C2-fracture
- Age <70 years
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 |
|---|---|---|
| Non-surgical treatmentAlso: Conservative treatmentCervical collar immobilisation for 12 weeks. | Procedure or surgery | Non-surgical treatment |
| Surgical treatmentStabilisation of C2-fracture by posterior fusion C1-C2, posterior fusion C2-C3, anterior fusion C2-C3 (no postoperative collar) or anterior screw osteosynthesis C2 (postoperative collar for 6 weeks). | Procedure or surgery | Surgical treatment |
Primary outcome
Survival
Time frame: Censored observational time (20 years)
Survival as registered in Swedish National Cause of Death Registry
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 19 May 2017.
- Background: PubMed 24683543Robinson Y, Robinson AL, Olerud C. Systematic review on surgical and nonsurgical treatment of type II odontoid fractures in the elderly. Biomed Res Int. 2014;2014:231948. doi: 10.1155/2014/231948. Epub 2014 Feb 10.
- Derived from this study: PubMed 29649609Robinson AL, Olerud C, Robinson Y. Surgical treatment improves survival of elderly with axis fracture-a national population-based multiregistry cohort study. Spine J. 2018 Oct;18(10):1853-1860. doi: 10.1016/j.spinee.2018.03.021. Epub 2018 Apr 9.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Fractures, run by Uppsala University.
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 2 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 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Survival (time frame: Censored observational time (20 years)). 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 NCT02839057, which also lists 2 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 19 May 2017.