Spinal Fractures
Conditions
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.
Interventions
PROCEDUREPosterior fusion C1-C2
Posterior access and screws in C1 (atlas) and C2 (axis) and fusion with addition of iliac crest bone graft. No postoperative collar.
PROCEDURERigid cervical collar
External immobilization of cervical spine in a rigid collar for 12 weeks.
Sponsors
Uppsala University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neck Disability Index (NDI questionnaire) | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| EQ5D questionnaire | 1 year |
| Number of participants that deceased after inclusion | 1 year |
Countries
Sweden
Outcome results
None listed