NCT02789774

Brief Summary

A multicenter randomized controlled trial is performed in Sweden (Uppsala, Malmo and Stockholm) comparing surgery with posterior C1-C2 fusion and conservative treatment with a rigid collar. Follow up will be performed up to one year after start of treatment registering EQ5D, NDI and cervical CT scans. Mortality will be documented during follow-up. All direct and indirect costs of treatment will be registered and used for cost-effectiveness analysis.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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

February 1, 2012

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2015

Completed
9 months until next milestone

First Posted

Study publicly available on registry

June 3, 2016

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

12.1 years

First QC Date

August 25, 2015

Last Update Submit

March 8, 2024

Conditions

Spinal Fractures

Outcome Measures

Primary Outcomes (1)

  • Neck Disability Index (NDI questionnaire)

    1 year

Secondary Outcomes (2)

  • EQ5D questionnaire

    1 year

  • Number of participants that deceased after inclusion

    1 year

Study Arms (2)

Surgical treatment

EXPERIMENTAL

Stabilization of odontoid fracture with posterior fusion C1-C2

Procedure: Posterior fusion C1-C2

Conservative treatment

ACTIVE COMPARATOR

External stabilization of odontoid fracture with a rigid cervical collar for 3 months.

Procedure: Rigid cervical collar

Interventions

Posterior fusion C1-C2PROCEDURE

Posterior access and screws in C1 (atlas) and C2 (axis) and fusion with addition of iliac crest bone graft. No postoperative collar.

Also known as: Posterior atlantoaxial fusion
Surgical treatment
Rigid cervical collarPROCEDURE

External immobilization of cervical spine in a rigid collar for 12 weeks.

Also known as: cervical orthosis
Conservative treatment

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Acute displaced odontoid fracture type II according to Anderson and D'Alonzo, age 75 years or older. Displacement defined as 4 mm anterior translator displacement, any posterior translator displacement, or 10 degrees of angulation.

You may not qualify if:

  • Any contraindication to surgery, anesthesia class ASA 4 or higher (Saklad 1941), severe senile dementia (defined as being admitted to a nursing home or hospital because of the dementia), anatomical or other prerequisites that makes an operation unsuitable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Uppsala University Hospital

Uppsala, Uppsala County, 75195, Sweden

Location

Malmö University Hospital

Malmo, 21428, Sweden

Location

Related Publications (3)

  • Kose et al. 2007

    BACKGROUND

  • Olerud et al. 1999

    BACKGROUND

  • Robinson AL, Schmeiser G, Robinson Y, Olerud C. Surgical vs. non-surgical management of displaced type-2 odontoid fractures in patients aged 75 years and older: study protocol for a randomised controlled trial. Trials. 2018 Aug 22;19(1):452. doi: 10.1186/s13063-018-2690-8.

    PMID: 30134944DERIVED

MeSH Terms

Conditions

Spinal Fractures

Condition Hierarchy (Ancestors)

Spinal InjuriesBack InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Anna-Lena Robinson, MD

    Uppsala University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2015

First Posted

June 3, 2016

Study Start

February 1, 2012

Primary Completion

March 1, 2024

Study Completion

June 1, 2024

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(2)