NCT02839057

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
6,231

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

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

October 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 19, 2017

Status Verified

May 1, 2017

Enrollment Period

1.2 years

First QC Date

July 18, 2016

Last Update Submit

May 18, 2017

Conditions

Keywords

Axis fracturesElderlyMortalitySurgical treatment

Outcome Measures

Primary Outcomes (1)

  • Survival

    Survival as registered in Swedish National Cause of Death Registry

    Censored observational time (20 years)

Study Arms (2)

Surgical treatment

Patients ≥70 years with C2 fracture coded in patient registry (ICD-10: S12.1) treated with surgical fracture stabilisation

Procedure: Surgical treatment

Non-surgical treatment

Patients ≥70 years with C2 fracture coded in patient registry (ICD-10: S12.1) treated non-surgically

Procedure: Non-surgical treatment

Interventions

Cervical collar immobilisation for 12 weeks.

Also known as: Conservative treatment
Non-surgical treatment

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).

Surgical treatment

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

National patient registry extract with patients suffering from C2 fracture

You may qualify if:

  • C2-fracture
  • Age ≥70 years

You may not qualify if:

  • no C2-fracture
  • Age \<70 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 24683543BACKGROUND

MeSH Terms

Conditions

Spinal Fractures

Interventions

Conservative TreatmentSurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Spinal InjuriesBack InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
20 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2016

First Posted

July 20, 2016

Study Start

October 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

May 19, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share