Back to resultsUppsala Study on Odontoid Fracture Treatment in the Elderly (USOFT)
Primary Purpose
Spinal Fractures
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Posterior fusion C1-C2
Rigid cervical collar
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Fractures
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Uppsala University HospitalRecruiting
- Malmö University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Surgical treatment
Conservative treatment
Arm Description
Stabilization of odontoid fracture with posterior fusion C1-C2
External stabilization of odontoid fracture with a rigid cervical collar for 3 months.
Outcomes
Primary Outcome Measures
Neck Disability Index (NDI questionnaire)
Secondary Outcome Measures
EQ5D questionnaire
Number of participants that deceased after inclusion
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02789774
Brief Title
Uppsala Study on Odontoid Fracture Treatment in the Elderly
Acronym
USOFT
Official Title
Randomised Controlled Trial on Surgical vs Non-surgical Treatment of Type II Odontoid Fracture Treatment in the Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2012 (undefined)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
50 patients, based on the following calculation of study size: The standard deviation for Neck Disability index, NDI, is just under 7, while "minimally clinical important difference" (MCID) is 7 points . That gives that 16 patients are needed in each group to get 80% power with a significance level of 5%. However, in the studied population the one year mortality rate is substantial, especially after a neck injury . In order to be able to draw conclusions from the study the investigators have elected to expand the study to 25 subjects in each group.
Follow up: 1w, 6w, 3m, 1y with CT, Questionaires: NDI, EQ5D. Bone density measurement at injury. Extension flexion x-ray after 1 year.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surgical treatment
Arm Type
Experimental
Arm Description
Stabilization of odontoid fracture with posterior fusion C1-C2
Arm Title
Conservative treatment
Arm Type
Active Comparator
Arm Description
External stabilization of odontoid fracture with a rigid cervical collar for 3 months.
Intervention Type
Procedure
Intervention Name(s)
Posterior fusion C1-C2
Other Intervention Name(s)
Posterior atlantoaxial fusion
Intervention Description
Posterior access and screws in C1 (atlas) and C2 (axis) and fusion with addition of iliac crest bone graft. No postoperative collar.
Intervention Type
Procedure
Intervention Name(s)
Rigid cervical collar
Other Intervention Name(s)
cervical orthosis
Intervention Description
External immobilization of cervical spine in a rigid collar for 12 weeks.
Primary Outcome Measure Information:
Title
Neck Disability Index (NDI questionnaire)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
EQ5D questionnaire
Time Frame
1 year
Title
Number of participants that deceased after inclusion
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna-Lena Robinson, MD
Phone
+46705696661
Email
robinsonannalena@icloud.com
First Name & Middle Initial & Last Name or Official Title & Degree
Catharina Strömstedt
Phone
+46708814114
Email
catharina.stromstedt@akademiska.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna-Lena Robinson, MD
Organizational Affiliation
Uppsala University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala University Hospital
City
Uppsala
State/Province
Uppsala County
ZIP/Postal Code
75195
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna-Lena Robinson
Phone
+46705696661
Email
robinsonannalena@icloud.com
First Name & Middle Initial & Last Name & Degree
Claes Olerud
Phone
+46186110000
Email
Claes.olerud@surgsci.uu.se
Facility Name
Malmö University Hospital
City
Malmö
ZIP/Postal Code
21428
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anders K Möller, MD, PhD
Email
anders.k.moller@skane.se
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Kose et al. 2007
Results Reference
background
Citation
Olerud et al. 1999
Results Reference
background
PubMed Identifier
30134944
Citation
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.
Results Reference
derived
Learn more about this trial
Uppsala Study on Odontoid Fracture Treatment in the Elderly
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